38 results on '"Harbeck, N."'
Search Results
2. The tale of TILs in breast cancer: A report from The International Immuno-Oncology Biomarker Working Group
- Author
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El Bairi, K., Haynes, H. R., Blackley, E., Fineberg, S., Shear, J., Turner, S., de Freitas, J. R., Sur, D., Amendola, L. C., Gharib, M., Kallala, A., Arun, I., Azmoudeh-Ardalan, F., Fujimoto, L., Sua, L. F., Liu, S. -W., Lien, H. -C., Kirtani, P., Balancin, M., El Attar, H., Guleria, P., Yang, W., Shash, E., Chen, I. -C., Bautista, V., Do Prado Moura, J. F., Rapoport, B. L., Castaneda, C., Spengler, E., Acosta-Haab, G., Frahm, I., Sanchez, J., Castillo, M., Bouchmaa, N., Md Zin, R. R., Shui, R., Onyuma, T., Husain, Z., Willard-Gallo, K., Coosemans, A., Perez, E. A., Provenzano, E., Ericsson, P. G., Richardet, E., Mehrotra, R., Sarancone, S., Ehinger, A., Rimm, D. L., Bartlett, J. M. S., Viale, G., Denkert, C., Hida, A. I., Sotiriou, C., Loibl, S., Hewitt, S. M., Badve, S., Symmans, W. F., Kim, R. S., Pruneri, G., Goel, S., Francis, P. A., Inurrigarro, G., Yamaguchi, R., Garcia-Rivello, H., Horlings, H., Afqir, S., Salgado, R., Adams, S., Kok, M., Dieci, M. V., Michiels, S., Demaria, S., Loi, S., Schelfhout, V., Arbzadeh, E., Bondanar, A., Reyes, S. A. G., Ruz, J. R., Kang, J., Xiang, L., Zimovjanova, M., Togores, P., Ozturk, T., Patil, A., Corpa, M., Whitehouse, A., Tan, B., de Paula, A., Rossetti, C., Lang-Schwarz, C., Mahon, S., Giacometti, C., Linderholm, B., Deman, F., Montagna, G., Gong, G., Pavcovich, M., Chaer, Y., Cabrero, I. A., de Brito, M. L., Ilieva, N., Fulop, A., Souza, M., Bilancia, D., Idowu, M., Johri, R., Szpor, J., Bachani, L., Schmitt, F., Giannotti, M., Kurebayashi, Y., Ramirez, B. E. A., Salido, E., Bortesi, L., Bonetto, S., Elomina, K., Lopez, P., Sharma, V., Edirisinghe, A., Mathur, D., Sahay, A., Mouloud, M. A., Giang, C. H., Mukolwe, E., Kiruka, E., Samberg, N., Abe, N., Brown, M., Millar, E., X. B., Li, Yuan, Z., Pasupathy, A., Miele, R., Luff, R., e Porfirio, M. M. A., Ajemba, O., Soni, R., Orvieto, E., Dimaio, M., Thomas, J., Merard, R., Subramaniam, M. M., Apolinario, T., Preda, O., Preda, R., Makanga, A., Maior, M. S., Li, L., Saghatchian, M., Saurine, T., Janssen, E., Cochran, J., Vlada, N., Cappellesso, R., Elfer, K., Hollick, M., Desai, S., Oner, G., Schreurs, A., Liu, S., Perera, R., Mercurio, P., Garcia, F., Hosny, K., Matsumoto, H., van Deurzen, C., Bianchini, G., Coban, I., Jahangir, A., Rahman, A., Stover, D., Luz, P., Martel, A., Waumans, Y., Stenzinger, A., Cortes, J., Dimitrova, P., Nauwelaers, I., Velasco, M., Fan, F., Akturk, G., Firer, M., Roxanis, I., Schneck, M., Wen, H., Cockenpot, V., Konstantinov, A., Calatrava, A., Vidya, M. N., Choi, H. J., Jank, P., Ciinen, A. H., Sabanathan, D., Floris, G., Hoeflmayer, D., Hamada, T., Laudus, N., Grigoriadis, A., Porcellato, I., Acs, B., Miglietta, F., Parrodi, J., Clunie, D., Calhoun, B., F. -I., Lu, Lefevre, A., Tabbarah, S., Tran, W., Garcia-murillas, I., Jelinic, P., Boeckx, C., Souza, S., Cebollero, M. C., Felip, E., Rendon, J. L. S., El Gabry, E., Saltz, J., Bria, E., Garufi, G., Hartman, J., Sebastian, M., Olofsson, H., Kooreman, L., Cucherousset, J., Mathieu, M. -C., Ballesteros-Merino, C., Siziopikou, P., Fong, J., Klein, M., Qulis, I. R. I., Wesseling, J., Bellolio, E., Araya, J. C., Naber, S., Cheang, M., Castellano, I., Ales, A., Laenkholm, A. -V., Kulka, J., Quinn, C., Sapino, A., Amendoeira, I., Marchio, C., Braybrooke, J., Vincent-Salomon, A., Korski, K. P., Sofopoulos, M., Stovgaard, E. I. S., Bianchi, S., Bago-Horvath, Z., Yu, C., Regitnig, P., Hall, S., Kos, Z., Sant, S., Tille, J. -C., Gallas, B., Bethmann, D., Savas, P., Mendes, L., Soler, T., van Seijen, M., Gruosso, T., Quintana, A., Giltnane, J., Van den Eynden, G., Duregon, E., de Cabo, R., Recamo, P. C., Gaboury, L., Zimmerman, J., Pop, C. S., Wernicke, A., Williams, D., Gill, A., Solomon, B., Thapa, B., Farshid, G., Gilham, L., Christie, M., O'Toole, S., Hendry, S., Fox, S. B., Luen, S. J., Lakhani, S. R., Fuchs, T., John, T., Brcic, I., Hainfellner, J., Sigurd, L., Preusser, M., Poortmans, P., Decaluwe, A., Carey, C., Colpaert, C., Larsimont, D., Peeters, D., Broeckx, G., van de Vijver, K., Buisseret, L., Dirix, L., Hertoghs, M., Piccart, M., Ignatiadis, M., Van Bockstal, M., Sirtaine, N., Vermeulen, P., de Wind, R., Declercq, S., Gevaert, T., Haibe-Kans, B., Nelson, B. H., Watson, P. H., Leung, S., Nielsen, T., Shi, L., Balslev, E., Thagaard, J., Almangush, A., Makitie, A., Joensuu, H., Lundin, J., Drubay, D., Roblin, E., Andre, F., Penault-Llorca, F., Lemonnier, J., Adam, J., Lacroix-Triki, M., Ternes, N., Radosevic-Robin, N., Klaushen, F., Weber, K., Harbeck, N., Gluz, O., Wienert, S., Cserni, G., Vingiani, A., Criscitiello, C., Solinas, C., Curigliano, G., Konishi, E., Suzuki, E., Yoshikawa, K., Kawaguchi, K., Takada, M., Toi, M., Ishida, M., Shibata, N., Saji, S., Kogawa, T., Sakatani, T., Okamoto, T., Moriya, T., Kataoka, T., Shimoi, T., Sugie, T., Mukohara, T., Shu, Y., Kikawa, Y., Kozuka, Y., Sayed, S., Rahayu, R., Ramsaroop, R., Senkus-Konefka, E., Chmielik, E., Cardoso, F., Ribeiro, J., Chan, J., Dent, R., Martin, M., Hagen, C., Guerrero, A., Rojo, F., Comerma, L., Nuciforo, P., Serrano, V. V., Camaea, V. P., Steenbruggen, T., Ciompi, F., Nederlof, I., Jan, Hudecek, van der Laak, J., van den Berg, J., Voorwerk, L., van de Vijver, M., de Maaker, M., Linn, S., Mckenzie, H., Somaiah, N., Tutt, A., Swanton, C., Hiley, C., Moore, D. A., Hall, J. A., Le Quesne, J., Jabbar, K. A., al Bakir, M., Hills, R., Irshad, S., Yuan, Y., Li, Z., Liu, M., Klein, J., Fadare, O., Thompson, A., Lazar, A. J., Gown, A., Lo, A., Garrido Castro, A. C., Madabhushi, A., Moreira, A., Richardson, A., Beck, A. H., Bellizzi, A. M., Wolff, A., Harbhajanka, A., Sharma, A., Cimino-Mathews, A., Srinivasan, A., Singh, B., Chennubhotla, C. S., Chauhan, C., Dillon, D. A., Zardavas, D., Johnson, D. B., Thompson, A. E., Brogi, E., Reisenbichler, E., Huang, E., Hirsch, F. R., Mcarthur, H., Ziai, J., Brock, J., Kerner, J., Zha, J., Lennerz, J. K., Carter, J. M., Reis-Filho, J., Sparano, J., Balko, J. M., Pogue-Geile, K., Steele, K. E., Blenman, K. R. M., Allison, K. H., Pusztai, L., Cooper, L., Estrada, V. M., Flowers, M., Robson, M., Rebelatto, M. C., Hanna, M. G., Goetz, M. P., Khojasteh, M., Sanders, M. E., Regan, M. M., Misialek, M., Amgad, M., Tung, N., Singh, R., Huang, R., Pierce, R. H., Leon-Ferre, R., Swain, S., Ely, S., Kim, S. -R., Bedri, S., Paik, S., Schnitt, S., D'Alfons, T., Kurkure, U., Bossuyt, V., Tong, W., Wang, Y., Dos Anjos, C. H., Gaire, F., Van Diest, P. J., El Bairi, Khalid [0000-0002-8414-4145], de Freitas, Juliana Ribeiro [0000-0003-4978-7273], Sur, Daniel [0000-0002-0926-4614], Amendola, Luis Claudio [0000-0002-6404-450X], Azmoudeh-Ardalan, Farid [0000-0003-4701-0532], Kirtani, Pawan [0000-0002-2343-7016], Yang, Wenxian [0000-0002-5349-9680], Castillo, Miluska [0000-0002-0111-3176], Provenzano, Elena [0000-0003-3345-3965], Mehrotra, Ravi [0000-0001-9453-1408], Ehinger, Anna [0000-0001-9225-7396], Rimm, David L [0000-0001-5820-4397], Bartlett, John MS [0000-0002-0347-3888], Denkert, Carsten [0000-0002-2249-0982], Hida, Akira I [0000-0002-4486-8819], Sotiriou, Christos [0000-0002-5745-9977], Hewitt, Stephen M [0000-0001-8283-1788], Badve, Sunil [0000-0001-8861-9980], Symmans, William Fraser [0000-0002-1526-184X], Goel, Shom [0000-0001-8329-9084], Francis, Prudence A [0000-0002-7207-9286], Horlings, Hugo [0000-0003-4782-8828], Salgado, Roberto [0000-0002-1110-3801], Demaria, Sandra [0000-0003-4426-0499], Loi, Sherene [0000-0001-6137-9171], Apollo - University of Cambridge Repository, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'anatomie pathologique, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), and UNICANCER
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Oncology ,medicine.medical_treatment ,[SDV]Life Sciences [q-bio] ,TRASTUZUMAB ,Improved survival ,MICROENVIRONMENT ,Review Article ,SUBTYPES ,NEOADJUVANT CHEMOTHERAPY ,0302 clinical medicine ,Breast cancer ,Ecology,Evolution & Ethology ,PROGNOSTIC-SIGNIFICANCE ,Medicine and Health Sciences ,Pharmacology (medical) ,TUMOR-INFILTRATING LYMPHOCYTES ,Stage (cooking) ,RC254-282 ,Chemical Biology & High Throughput ,0303 health sciences ,Human Biology & Physiology ,Genome Integrity & Repair ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,ASSOCIATION ,3. Good health ,030220 oncology & carcinogenesis ,Biomarker (medicine) ,Life Sciences & Biomedicine ,Genetics & Genomics ,medicine.medical_specialty ,chemical and pharmacologic phenomena ,International Immuno-Oncology Biomarker Working Group ,Predictive markers ,03 medical and health sciences ,Signalling & Oncogenes ,SDG 3 - Good Health and Well-being ,Internal medicine ,692/53/2423 ,medicine ,Radiology, Nuclear Medicine and imaging ,In patient ,030304 developmental biology ,Computational & Systems Biology ,Science & Technology ,IDENTIFICATION ,business.industry ,review-article ,Cancer ,03.01. Általános orvostudomány ,Immunotherapy ,Tumour Biology ,medicine.disease ,PREDICTIVE-VALUE ,692/4028/67/1347 ,Programmed death 1 ,business ,FREE SURVIVAL - Abstract
The advent of immune-checkpoint inhibitors (ICI) in modern oncology has significantly improved survival in several cancer settings. A subgroup of women with breast cancer (BC) has immunogenic infiltration of lymphocytes with expression of programmed death-ligand 1 (PD-L1). These patients may potentially benefit from ICI targeting the programmed death 1 (PD-1)/PD-L1 signaling axis. The use of tumor-infiltrating lymphocytes (TILs) as predictive and prognostic biomarkers has been under intense examination. Emerging data suggest that TILs are associated with response to both cytotoxic treatments and immunotherapy, particularly for patients with triple-negative BC. In this review from The International Immuno-Oncology Biomarker Working Group, we discuss (a) the biological understanding of TILs, (b) their analytical and clinical validity and efforts toward the clinical utility in BC, and (c) the current status of PD-L1 and TIL testing across different continents, including experiences from low-to-middle-income countries, incorporating also the view of a patient advocate. This information will help set the stage for future approaches to optimize the understanding and clinical utilization of TIL analysis in patients with BC. ispartof: NPJ BREAST CANCER vol:7 issue:1 ispartof: location:United States status: published
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- 2021
3. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)
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F, CARDOSO, Paluch-Shimon, S, Senkus, E, Curigliano, G, Aapro, M S, F, ANDE, C H, BARRIOS, J, BERGH, Bhattacharyya, G S, Biganzoli, L, F, BOYLE, CARDOSO, M-J, L A, CAREY, J, CORTES, EL SAGHIR, N S, M, ELZAYAT, A, ENIU, L, FALLOWFIED, P A, FRANCIS, Gelmon, K, Gligorov, J, R, HAIDINGER, Harbeck, N, X, HU, Kaufman, B, Kaur, R., B E, KIELY, S-B, KIM, N U, LIN, S A, MERTZ, S, NECIOSUP, Offersen, BV, S, OHNO, O, PAGANI, A, PRAT, Penault-Llorca, F, Rugo, HS, Sledge, GW, Thomssen, C, Vorobiof, DA, Wiseman, T., B, XU, Norton, L, A, COSTA, Winer, EP, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), and UNICANCER
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0303 health sciences ,[SDV]Life Sciences [q-bio] ,COVID-19 ,Hematology ,3. Good health ,metastatic ,Coronavirus ,03 medical and health sciences ,Special Article ,0302 clinical medicine ,breast cancer ,Oncology ,advanced ,ESO-ESMO ,030220 oncology & carcinogenesis ,guidelines ,skin and connective tissue diseases ,ABC ,ComputingMilieux_MISCELLANEOUS ,030304 developmental biology - Abstract
Highlights • This ESO-ESMO ABC 5 Clinical Practice Guideline provides key recommendations for managing advanced breast cancer patients • It provides updates on the management of patients with all breast cancer subtypes, LABC, follow-up, palliative and supportive care • Updated diagnostic and treatment algorithms are also provided • All recommendations were compiled by a multidisciplinary group of international experts • Recommendations are based on available clinical evidence and the collective expert opinion of the authors
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- 2020
4. Pitfalls in assessing stromal tumor infiltrating lymphocytes (sTILs) in breast cancer
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Kos, Z., Roblin, E., Kim, R. S., Michiels, S., Gallas, B. D., Chen, W., van de Vijver, K. K., Goel, S., Adams, S., Demaria, S., Viale, G., Nielsen, T. O., Badve, S. S., Symmans, W. F., Sotiriou, C., Rimm, D. L., Hewitt, S., Denkert, C., Loibl, S., Luen, S. J., Bartlett, J. M. S., Savas, P., Pruneri, G., Dillon, D. A., Cheang, M. C. U., Tutt, A., Hall, J. A., Kok, M., Horlings, H. M., Madabhushi, A., van der Laak, J., Ciompi, F., Laenkholm, A. -V., Bellolio, E., Gruosso, T., Fox, S. B., Araya, J. C., Floris, G., Hudecek, J., Voorwerk, L., Beck, A. H., Kerner, J., Larsimont, D., Declercq, S., Van den Eynden, G., Pusztai, L., Ehinger, A., Yang, W., Abduljabbar, K., Yuan, Y., Singh, R., Hiley, C., Bakir, M., Lazar, A. J., Naber, S., Wienert, S., Castillo, M., Curigliano, G., Dieci, M. -V., Andre, F., Swanton, C., Reis-Filho, J., Sparano, J., Balslev, E., Chen, I. -C., Stovgaard, E. I. S., Pogue-Geile, K., Blenman, K. R. M., Penault-Llorca, F., Schnitt, S., Lakhani, S. R., Vincent-Salomon, A., Rojo, F., Braybrooke, J. P., Hanna, M. G., Soler-Monso, M. T., Bethmann, D., Castaneda, C. A., Willard-Gallo, K., Sharma, A., Lien, H. -C., Fineberg, S., Thagaard, J., Comerma, L., Gonzalez-Ericsson, P., Brogi, E., Loi, S., Saltz, J., Klaushen, F., Cooper, L., Amgad, M., Moore, D. A., Salgado, R., Hyytiainen, A., Hida, A. I., Thompson, A., Lefevre, A., Gown, A., Lo, A., Sapino, A., Moreira, A. M., Richardson, A., Vingiani, A., Bellizzi, A. M., Guerrero, A., Grigoriadis, A., Garrido-Castro, A. C., Cimino-Mathews, A., Srinivasan, A., Acs, B., Singh, B., Calhoun, B., Haibe-Kans, B., Solomon, B., Thapa, B., Nelson, B. H., Ballesteroes-Merino, C., Criscitiello, C., Boeckx, C., Colpaert, C., Quinn, C., Chennubhotla, C. S., Solinas, C., Drubay, D., Sabanathan, D., Peeters, D., Zardavas, D., Hoflmayer, D., Johnson, D. B., Thompson, E. A., Perez, E., Elgabry, E. A., Blackley, E. F., Reisenbichler, E., Chmielik, E., Gaire, F., F. -I., Lu, Azmoudeh-Ardalan, F., Peale, F., Hirsch, F. R., Acosta-Haab, G., Farshid, G., Broeckx, G., Koeppen, H., Haynes, H. R., Mcarthur, H., Joensuu, H., Olofsson, H., Cree, I., Nederlof, I., Frahm, I., Brcic, I., Chan, J., Ziai, J., Brock, J., Weseling, J., Giltnane, J., Lemonnier, J., Zha, J., Ribeiro, J., Lennerz, J. K., Carter, J. M., Hartman, J., Hainfellner, J., Le Quesne, J., Juco, J. W., van den Berg, J., Sanchez, J., Cucherousset, J., Adam, J., Balko, J. M., Saeger, K., Siziopikou, K., Sikorska, K., Weber, K., Steele, K. E., Emancipator, K., El Bairi, K., Allison, K. H., Korski, K., Buisseret, L., Shi, L., Kooreman, L. F. S., Molinero, L., Estrada, M. V., Van Seijen, M., Lacroix-Triki, M., Sebastian, M. M., Balancin, M. L., Mathieu, M. -C., van de Vijver, M., Rebelatto, M. C., Piccart, M., Goetz, M. P., Preusser, M., Khojasteh, M., Sanders, M. E., Regan, M. M., Barnes, M., Christie, M., Misialek, M., Ignatiadis, M., de Maaker, M., Van Bockstal, M., Harbeck, N., Tung, N., Laudus, N., Sirtaine, N., Burchardi, N., Ternes, N., Radosevic-Robin, N., Gluz, O., Grimm, O., Nuciforo, P., Jank, P., Kirtani, P., Watson, P. H., Jelinic, P., Francis, P. A., Russell, P. A., Pierce, R. H., Hills, R., Leon-Ferre, R., de Wind, R., Shui, R., Leung, S., Tabbarah, S., Souza, S. C., O'Toole, S., Swain, S., Dudgeon, S., Willis, S., Ely, S., Bedri, S., Irshad, S., Liu, S., Hendry, S., Bianchi, S., Braganca, S., Paik, S., Luz, S., Gevaert, T., D'Alfons, T., John, T., Sugie, T., Kurkure, U., Bossuyt, V., Manem, V., Camaea, V. P., Tong, W., Tran, W. T., Wang, Y., Allory, Y., Husain, Z., Bago-Horvath, Z., Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Institut Gustave Roussy (IGR), Division of Pathology and Laboratory Medicine, Università degli Studi di Milano [Milano] (UNIMI)-European Institute of Oncology [Milan] (ESMO), Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Charité, Institute of Pathology, Translational Tumorpathology Unit, German Breast Group, University of the Sunshine Coast (USC), European Institute of Oncology [Milan] (ESMO), Breakthrough Breast Cancer Centre, London Institute of Cancer, Department of Pathology, The Netherlands Cancer Institute, Division of Experimental Therapy, The Netherlands Cancer Institute NKI/AvL, Odense University Hospital, Unité de génétique et biologie des cancers (U830), Université Paris Descartes - Paris 5 (UPD5)-Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Breast Medical Oncology [Houston], The University of Texas M.D. Anderson Cancer Center [Houston], Helsingborg Hospital, Division of Experimental Therapeutics [Milan, Italy], Département de médecine oncologique [Gustave Roussy], Cancer Research UK Lung Cancer Centre of Excellence [Londres, Royaume-Uni], University College of London [London] (UCL), Memorial Sloane Kettering Cancer Center [New York], Herlev and Gentofte Hospital, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Southern Queensland (USQ), Pharmacogenomics Unit [Paris], Department of Genetics [Paris], Institut Curie [Paris]-Institut Curie [Paris], Instituto de Física Teórica UAM/CSIC (IFT), Universidad Autonoma de Madrid (UAM)-Consejo Superior de Investigaciones Científicas [Madrid] (CSIC), Ctr Biomol Struct & Org, University of Maryland [College Park], University of Maryland System-University of Maryland System, The University of Sydney, Breast Cancer Translational Research Laboratory, Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB)-Faculté de Médecine [Bruxelles] (ULB), Innovation North - Faculty of Information and Technology, Leeds Metropolitan University, Int Immuno-Oncology Biomarker, Graduate School, CCA - Cancer biology and immunology, Pathology, Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Oncostat (U1018 (Équipe 2)), Institut Gustave Roussy (IGR)-Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Università degli Studi di Milano = University of Milan (UNIMI)-European Institute of Oncology [Milan] (ESMO), German Breast Group (GBG), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Universidad Autónoma de Madrid (UAM)-Consejo Superior de Investigaciones Científicas [Madrid] (CSIC), Gallas, Brandon D [0000-0001-7332-1620], van de Vijver, Koen K [0000-0002-2026-9790], Demaria, Sandra [0000-0003-4426-0499], Badve, Sunil S [0000-0001-8861-9980], Symmans, W Fraser [0000-0002-1526-184X], Rimm, David L [0000-0001-5820-4397], Savas, Peter [0000-0001-5999-428X], Hall, Jacqueline A [0000-0003-0708-1360], Horlings, Hugo M [0000-0003-4782-8828], van der Laak, Jeroen [0000-0001-7982-0754], Bellolio, Enrique [0000-0003-0079-5264], Araya, Juan Carlos [0000-0003-3501-8203], Floris, Giuseppe [0000-0003-2391-5425], Hudeček, Jan [0000-0003-1071-5686], Ehinger, Anna [0000-0001-9225-7396], Lazar, Alexander J [0000-0002-6395-4499], Castillo, Miluska [0000-0002-0111-3176], Curigliano, Giuseppe [0000-0003-1781-2518], Sparano, Joseph [0000-0002-9031-2010], Braybrooke, Jeremy P [0000-0003-1943-7360], Hanna, Matthew G [0000-0002-7536-1746], Willard-Gallo, Karen [0000-0002-1150-1295], Sharma, Ashish [0000-0002-1011-6504], Comerma, Laura [0000-0002-0249-4636], Gonzalez-Ericsson, Paula [0000-0002-6292-6963], Loi, Sherene [0000-0001-6137-9171], Cooper, Lee [0000-0002-3504-4965], Apollo - University of Cambridge Repository, Research Programs Unit, Heikki Joensuu / Principal Investigator, HUS Comprehensive Cancer Center, Department of Oncology, Medicum, Gallas, Brandon D. [0000-0001-7332-1620], van de Vijver, Koen K. [0000-0002-2026-9790], Badve, Sunil S. [0000-0001-8861-9980], Symmans, W. Fraser [0000-0002-1526-184X], Rimm, David L. [0000-0001-5820-4397], Hall, Jacqueline A. [0000-0003-0708-1360], Horlings, Hugo M. [0000-0003-4782-8828], Lazar, Alexander J. [0000-0002-6395-4499], Braybrooke, Jeremy P. [0000-0003-1943-7360], and Hanna, Matthew G. [0000-0002-7536-1746]
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Oncology ,[SDV]Life Sciences [q-bio] ,THERAPY ,Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14] ,Prognostic markers ,0302 clinical medicine ,Breast cancer ,Medicine and Health Sciences ,Pharmacology (medical) ,Lymphocytes ,Stromal tumor ,health care economics and organizations ,0303 health sciences ,CHEMOTHERAPY ,Sciences bio-médicales et agricoles ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,3. Good health ,Women's cancers Radboud Institute for Health Sciences [Radboudumc 17] ,PROGNOSTIC VALUE ,Clinical Practice ,030220 oncology & carcinogenesis ,Educational resources ,Immunosurveillance ,medicine.medical_specialty ,3122 Cancers ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,IMMUNITY ,lcsh:RC254-282 ,Article ,Limfòcits ,Càncer de mama ,03 medical and health sciences ,Gastrointestinal cancer ,SDG 3 - Good Health and Well-being ,Internal medicine ,692/53/2422 ,medicine ,Radiology, Nuclear Medicine and imaging ,Càncer gastrointestinal ,030304 developmental biology ,Predictive biomarker ,Tumor-infiltrating lymphocytes ,business.industry ,Médecine pathologie humaine ,medicine.disease ,Cancérologie ,Human medicine ,business ,SYSTEM ,631/67/580/1884 - Abstract
Stromal tumor-infiltrating lymphocytes (sTILs) are important prognostic and predictive biomarkers in triple-negative (TNBC) and HER2-positive breast cancer. Incorporating sTILs into clinical practice necessitates reproducible assessment. Previously developed standardized scoring guidelines have been widely embraced by the clinical and research communities. We evaluated sources of variability in sTIL assessment by pathologists in three previous sTIL ring studies. We identify common challenges and evaluate impact of discrepancies on outcome estimates in early TNBC using a newly-developed prognostic tool. Discordant sTIL assessment is driven by heterogeneity in lymphocyte distribution. Additional factors include: technical slide-related issues; scoring outside the tumor boundary; tumors with minimal assessable stroma; including lymphocytes associated with other structures; and including other inflammatory cells. Small variations in sTIL assessment modestly alter risk estimation in early TNBC but have the potential to affect treatment selection if cutpoints are employed. Scoring and averaging multiple areas, as well as use of reference images, improve consistency of sTIL evaluation. Moreover, to assist in avoiding the pitfalls identified in this analysis, we developed an educational resource available at www.tilsinbreastcancer.org/pitfalls., info:eu-repo/semantics/published
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- 2020
5. Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials
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Hudecek, J., Voorwerk, L., van Seijen, M., Nederlof, I., de Maaker, M., van den Berg, J., van de Vijver, K. K., Sikorska, K., Adams, S., Demaria, S., Viale, G., Nielsen, T. O., Badve, S. S., Michiels, S., Symmans, W. F., Sotiriou, C., Rimm, D. L., Hewitt, S. M., Denkert, C., Loibl, S., Loi, S., Bartlett, J. M. S., Pruneri, G., Dillon, D. A., Cheang, M. C. U., Tutt, A., Hall, J. A., Kos, Z., Salgado, R., Kok, M., Horlings, H. M., Hyytiainen, A., Hida, A. I., Thompson, A., Lefevre, A., Lazar, A. J., Gown, A., Lo, A., Sapino, A., Madabhushi, A., Moreira, A., Richardson, A., Vingiani, A., Beck, A. H., Bellizzi, A. M., Guerrero, A., Grigoriadis, A., Ehinger, A., Garrido-Castro, A., Vincent-Salomon, A., Laenkholm, A. -V., Sharma, A., Cimino-Mathews, A., Srinivasan, A., Acs, B., Singh, B., Calhoun, B., Haibe-Kans, B., Solomon, B., Thapa, B., Nelson, B. H., Gallas, B. D., Castaneda, C., Ballesteros-Merino, C., Criscitiello, C., Boeckx, C., Colpaert, C., Quinn, C., Chennubhotla, C. S., Swanton, C., Solinas, C., Hiley, C., Drubay, D., Bethmann, D., Moore, D. A., Larsimont, D., Sabanathan, D., Peeters, D., Zardavas, D., Hoflmayer, D., Johnson, D. B., Thompson, E. A., Brogi, E., Perez, E., Elgabry, E. A., Stovgaard, E. S., Blackley, E. F., Roblin, E., Reisenbichler, E., Bellolio, E., Balslev, E., Chmielik, E., Gaire, F., Andre, F., F. -I., Lu, Azmoudeh-Ardalan, F., Rojo, F., Gruosso, T., Ciompi, F., Peale, F., Hirsch, F. R., Klauschen, F., Penault-Llorca, F., Acosta Haab, G., Farshid, G., van den Eynden, G., Curigliano, G., Floris, G., Broeckx, G., Gonzalez-Ericsson, Koeppen, H., Haynes, H. R., Mcarthur, H., Joensuu, H., Olofsson, H., Lien, H. -C., Chen, I. -C., Cree, I., Frahm, I., Brcic, I., Chan, J., Ziai, J., Brock, J., Wesseling, J., Giltnane, J., Kerner, J. K., Thagaard, J., Braybrooke, J. P., van der Laak, J. A. W. M., Lemonnier, J., Zha, J., Ribeiro, J., Lennerz, J. K., Carter, J. M., Saltz, J., Hartman, J., Hainfellner, J., Quesne, J. L., Juco, J. W., Reis-Filho, J., Sanchez, J., Sparano, J., Cucherousset, J., Araya, J. C., Adam, J., Balko, J. M., Saeger, K., Siziopikou, K., Willard-Gallo, K., Weber, K., Pogue-Geile, K. L., Steele, K. E., Emancipator, K., Abduljabbar, K., El Bairi, K., Blenman, K. R. M., Allison, K. H., Korski, K., Pusztai, L., Comerma, L., Buisseret, L., Cooper, L. A. D., Shi, L., Kooreman, L. F. S., Molinero, L., Estrada, M. V., Lacroix-Triki, M., Al Bakir, M., Sebastian, M. M., van de Vijver, M., Balancin, M. L., Dieci, M. V., Mathieu, M. -C., Rebelatto, M. C., Piccart, M., Hanna, M. G., Goetz, M. P., Preusser, M., Khojasteh, M., Sanders, M. E., Regan, M. M., Barnes, M., Christie, M., Misialek, M., Ignatiadis, M., van Bockstal, M., Castillo, M., Amgad, M., Harbeck, N., Tung, N., Laudus, N., Sirtaine, N., Burchardi, N., Ternes, N., Radosevic-Robin, N., Gluz, O., Grimm, O., Nuciforo, P., Jank, P., Gonzalez-Ericsson, P., Kirtani, P., Jelinic, P., Watson, P. H., Savas, P., Francis, P. A., Russell, P. A., Singh, R., Kim, R. S., Pierce, R. H., Hills, R., Leon-Ferre, R., de Wind, R., Shui, R., De Clercq, S., Leung, S., Tabbarah, S., Souza, S. C., O'Toole, S., Swain, S., Dudgeon, S., Willis, S., Ely, S., Kim, S. -R., Bedri, S., Irshad, S., Liu, S. -W., Goel, S., Hendry, S., Bianchi, S., Braganca, S., Paik, S., Wienert, S., Fox, S. B., Luen, S. J., Naber, S., Schnitt, S. J., Sua, L. F., Lakhani, S. R., Fineberg, S., Soler, T., Gevaert, T., D'Alfonso, T., John, T., Sugie, T., Kurkure, U., Bossuyt, V., Manem, V., Camara, V. P., Tong, W., Chen, W., Yang, W., Tran, W. T., Wang, Y., Yuan, Y., Allory, Y., Husain, Z., Bago-Horvath, Z., Division of Pathology and Laboratory Medicine, Università degli Studi di Milano [Milano] (UNIMI)-European Institute of Oncology [Milan] (ESMO), Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Institut Gustave Roussy (IGR), Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Charité, Institute of Pathology, Translational Tumorpathology Unit, German Breast Group, Breast Cancer Translational Research Laboratory, Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB)-Faculté de Médecine [Bruxelles] (ULB), University of the Sunshine Coast (USC), European Institute of Oncology [Milan] (ESMO), Breakthrough Breast Cancer Centre, London Institute of Cancer, Department of Pathology, The Netherlands Cancer Institute, Division of Experimental Therapy, The Netherlands Cancer Institute NKI/AvL, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Hudeček, Jan [0000-0003-1071-5686], van de Vijver, Koen K [0000-0002-2026-9790], Demaria, Sandra [0000-0003-4426-0499], Badve, Sunil S [0000-0001-8861-9980], Symmans, William Fraser [0000-0002-1526-184X], Rimm, David L [0000-0001-5820-4397], Loi, Sherene [0000-0001-6137-9171], Hall, Jacqueline A [0000-0003-0708-1360], Horlings, Hugo M [0000-0003-4782-8828], Apollo - University of Cambridge Repository, van de Vijver, Koen K. [0000-0002-2026-9790], Badve, Sunil S. [0000-0001-8861-9980], Rimm, David L. [0000-0001-5820-4397], Hall, Jacqueline A. [0000-0003-0708-1360], Horlings, Hugo M. [0000-0003-4782-8828], Università degli Studi di Milano = University of Milan (UNIMI)-European Institute of Oncology [Milan] (ESMO), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Oncostat (U1018 (Équipe 2)), Institut Gustave Roussy (IGR)-Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, German Breast Group (GBG), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])
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0301 basic medicine ,Oncology ,medicine.medical_specialty ,[SDV]Life Sciences [q-bio] ,medicine.medical_treatment ,MEDLINE ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,Review Article ,lcsh:RC254-282 ,631/67/1857 ,Tumour biomarkers ,Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14] ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,692/53 ,Internal medicine ,Medicine and Health Sciences ,medicine ,Pharmacology (medical) ,Radiology, Nuclear Medicine and imaging ,692/4028/67/580 ,Stromal tumor ,Biomarkers ,Tumour immunology ,business.industry ,Risk management framework ,review-article ,Médecine pathologie humaine ,631/67/1347 ,Immunotherapy ,Sciences bio-médicales et agricoles ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,medicine.disease ,Women's cancers Radboud Institute for Health Sciences [Radboudumc 17] ,3. Good health ,Review article ,Clinical trial ,Cancérologie ,030104 developmental biology ,030220 oncology & carcinogenesis ,Biomarker (medicine) ,business - Abstract
Stromal tumor-infiltrating lymphocytes (sTILs) are a potential predictive biomarker for immunotherapy response in metastatic triple-negative breast cancer (TNBC). To incorporate sTILs into clinical trials and diagnostics, reliable assessment is essential. In this review, we propose a new concept, namely the implementation of a risk-management framework that enables the use of sTILs as a stratification factor in clinical trials. We present the design of a biomarker risk-mitigation workflow that can be applied to any biomarker incorporation in clinical trials. We demonstrate the implementation of this concept using sTILs as an integral biomarker in a single-center phase II immunotherapy trial for metastatic TNBC (TONIC trial, NCT02499367), using this workflow to mitigate risks of suboptimal inclusion of sTILs in this specific trial. In this review, we demonstrate that a web-based scoring platform can mitigate potential risk factors when including sTILs in clinical trials, and we argue that this framework can be applied for any future biomarker-driven clinical trial setting., info:eu-repo/semantics/published
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- 2020
6. nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial
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Yardley, D A, Coleman, R, Conte, P, Cortes, J, Brufsky, A, Shtivelband, M, Young, R, Bengala, C, Ali, H, Eakel, J, Schneeweiss, A, de la Cruz-Merino, L, Wilks, S, O'Shaughnessy, J, Glück, S, Li, H, Miller, J, Barton, D, Harbeck, N, and tnAcity investigators
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0301 basic medicine ,medicine.medical_treatment ,Triple Negative Breast Neoplasms ,Kaplan-Meier Estimate ,Deoxycytidine ,Gastroenterology ,Carboplatin ,chemistry.chemical_compound ,Triple-negative Breast cancer ,0302 clinical medicine ,Breast Tumors ,Antineoplastic Combined Chemotherapy Protocols ,Mastectomy ,Aged, 80 and over ,Chemotherapy ,Gemcitabine ,Nab-paclitaxel ,Hematology ,Oncology ,Hazard ratio ,Middle Aged ,Chemotherapy regimen ,Metastatic breast cancer ,Progression-Free Survival ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Female ,medicine.drug ,Adult ,medicine.medical_specialty ,Paclitaxel ,Disease-Free Survival ,03 medical and health sciences ,Breast cancer ,Albumins ,Internal medicine ,medicine ,Humans ,Progression-free survival ,Aged ,business.industry ,Original Articles ,medicine.disease ,030104 developmental biology ,chemistry ,business - Abstract
Background Metastatic triple-negative breast cancer (mTNBC) has a poor prognosis and aggressive clinical course. tnAcity evaluated the efficacy and safety of first-line nab-paclitaxel plus carboplatin (nab-P/C), nab-paclitaxel plus gemcitabine (nab-P/G), and gemcitabine plus carboplatin (G/C) in patients with mTNBC. Patients and methods Patients with pathologically confirmed mTNBC and no prior chemotherapy for metastatic BC received (1 : 1 : 1) nab-P 125 mg/m2 plus C AUC 2, nab-P 125 mg/m2 plus G 1000 mg/m2, or G 1000 mg/m2 plus C AUC 2, all on days 1, 8 q3w. Phase II primary end point: investigator-assessed progression-free survival (PFS); secondary end points included overall response rate (ORR), overall survival (OS), percentage of patients initiating cycle 6 with doublet therapy, and safety. Results In total, 191 patients were enrolled (nab-P/C, n = 64; nab-P/G, n = 61; G/C, n = 66). PFS was significantly longer with nab-P/C versus nab-P/G [median, 8.3 versus 5.5 months; hazard ratio (HR), 0.59 [95% CI, 0.38–0.92]; P = 0.02] or G/C (median, 8.3 versus 6.0 months; HR, 0.58 [95% CI, 0.37–0.90]; P = 0.02). OS was numerically longer with nab-P/C versus nab-P/G (median, 16.8 versus 12.1 months; HR, 0.73 [95% CI, 0.47–1.13]; P = 0.16) or G/C (median, 16.8 versus 12.6 months; HR, 0.80 [95% CI, 0.52–1.22]; P = 0.29). ORR was 73%, 39%, and 44%, respectively. In the nab-P/C, nab-P/G, and G/C groups, 64%, 56%, and 50% of patients initiated cycle 6 with a doublet. Grade ≥3 adverse events were mainly hematologic. Conclusions First-line nab-P/C was active in mTNBC and resulted in a significantly longer PFS and improved risk/benefit profile versus nab-P/G or G/C.
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- 2018
7. 3rd ESO–ESMO international consensus guidelines for Advanced Breast Cancer (ABC 3)
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Cardoso, E, Costa, E, Senkus, E., Aapro, B, Andre, D., Barrios, B, Bergh, B, Bhattacharyya, B., Biganzoli, L., Cardoso, L., Carey, L., Corneliussen-James, E, Curigliano, E, Dieras, D, El Saghir, E, Eniu, E, Fallowfield, L., Fenech, E, Francis, D, Gelmon, B, Gennari, D, Harbeck, B, Hudis, B, Kaufman, B., Krop, B, Mayer, B, Meijer, D, Mertz, B, Ohno, B, Pagani, B, Papadopoulos, E., Peccatori, E, Penault-Llorca, L, Piccart, L, Pierga, D, Rugo, B, Shockney, L., Sledge, A, Swain, L, Thomssen, E, Tutt, L, Vorobiof, D., Xu, B., Norton, L., Winer, E., Cardoso, F., Costa, A., Aapro, M., Andre, F., Barrios, C., Bergh, J., Bhattacharyya, G., Cardoso, M.J., Corneliussen-James, D., Curigliano, G., Dieras, V., El Saghir, N., Eniu, A., Fenech, D., Francis, P., Gelmon, K., Gennari, A., Harbeck, N., Hudis, C., Krop, I., Mayer, M., Meijer, H., Mertz, S., Ohno, S., Pagani, O., Peccatori, F., Penault-Llorca, F., Piccart, M.J., Pierga, J.Y., Rugo, H., Sledge, G., Swain, S., Thomssen, C., Tutt, A., Jodrell Bank Centre for Astrophysics, University of Manchester [Manchester], Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Système membranaires, photobiologie, stress et détoxication (SMPSD), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Centre National de la Recherche Scientifique (CNRS), Division of Medical Oncology, and European Institute of Oncology [Milan] (ESMO)
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Male ,0301 basic medicine ,Oncology ,Palliative care ,Receptor, ErbB-2 ,Consensus Development Conferences as Topic ,medicine.medical_treatment ,Triple Negative Breast Neoplasms ,0302 clinical medicine ,030212 general & internal medicine ,ComputingMilieux_MISCELLANEOUS ,Randomized Controlled Trials as Topic ,Palliative Care ,General Medicine ,Hematology ,Corrigenda ,Metastatic breast cancer ,Women's cancers Radboud Institute for Health Sciences [Radboudumc 17] ,3. Good health ,Observational Studies as Topic ,Receptors, Estrogen ,Geriatric oncology ,030220 oncology & carcinogenesis ,Special Articles ,Female ,medicine.medical_specialty ,Breast surgery ,RC0280.B8 ,Antineoplastic Agents ,Breast Neoplasms ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,Breast Neoplasms, Male ,RC0254 ,03 medical and health sciences ,Breast cancer ,Internal medicine ,medicine ,Humans ,Chirurgie ,business.industry ,Evidence-based medicine ,medicine.disease ,Cancérologie ,Clinical trial ,Editor's Choice ,Oncology nursing ,030104 developmental biology ,Family medicine ,Surgery ,business ,Hématologie - Abstract
0, SCOPUS: ar.j, info:eu-repo/semantics/published
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- 2017
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8. 4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)†
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Cardoso, F, Senkus, E., Costa, A, Papadopoulos, E, Aapro, M, André, F, Harbeck, N, Aguilar Lopez, B, Barrios, CH, Bergh, J, Prat, A, Boers-Doets, CB, Cardoso, MJ, Carey, LA, Cortés, J, Curigliano, G, Diéras, V, Saghir NS, EL, Eniu, A, Fallowfield, L, Francis, PA, Gelmon, K, Johnston, SRD, Kaufman, B, Koppikar, S, Krop, IE, Mayer, M, Nakigudde, G, Offersen, BV, Ohno, S, Pagani, O, Paluch-Shimon, S, Penault-Llorca, F, Prat, A., Rugo, HS, Sledge, GW, Spence, D, Thomssen, C, Vorobiof, DA, Xu, B., Norton, L, Winer, EP, Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland, Medical University of Gdansk, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])
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0301 basic medicine ,Consensus Development Conferences as Topic ,Breast Neoplasms ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,Medical Oncology ,03 medical and health sciences ,0302 clinical medicine ,Biomarkers, Tumor ,Humans ,Breast ,Mastectomy ,Societies, Medical ,ComputingMilieux_MISCELLANEOUS ,Neoplasm Staging ,Clinical Trials as Topic ,Integrative Medicine ,Evidence-Based Medicine ,Hematology ,Chemoradiotherapy, Adjuvant ,Neoadjuvant Therapy ,3. Good health ,Europe ,030104 developmental biology ,Treatment Outcome ,Oncology ,030220 oncology & carcinogenesis ,Special article ,Female ,Biopsy, Large-Core Needle - Abstract
International audience
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- 2018
9. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years
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Pan, H, Gray, R, Braybrooke, J, Davies, C, Taylor, C, Mcgale, P, Peto, R, Pritchard, Ki, Bergh, J, Dowsett, M, Hayes, Df, Albain, K, Anderson, S, Arriagada, R, Barlow, W, Bartlett, J, Bergsten‐nordström, E, Bliss, J, Boccardo, F, Bradley, R, Brain, E, Cameron, D, Clarke, M, Coates, A, Coleman, R, Correa, C, Costantino, J, Cuzick, J, Davidson, N, Dodwell, D, Di Leo, A, Ewertz, M, Forbes, J, Gelber, R, Gnant, M, Goldhirsch, A, Goodwin, P, Hill, C, Ingle, J, Jagsi, R, Janni, W, Loibl, S, Mackinnon, E, Martin, M, Mukai, H, Norton, L, Ohashi, Y, Paik, S, Perez, E, Piccart, M, Pierce, L, Poortmans, P, Raina, V, Ravdin, P, Regan, M, Robertson, J, Rutgers, E, Slamon, D, Sparano, J, Swain, S, Tutt, A, Viale, G, Von Minckwitz, G, Wang, X, Whelan, T, Wilcken, N, Winer, E, Wolmark, N, Wood, W, Zambetti, M, Alberro, Ja, Ballester, B, Deulofeu, P, Fábregas, R, Fraile, M, Gubern, Jm, Janer, J, Moral, A, De Pablo Jl, Peñalva, G, Puig, P, Ramos, M, Rojo, R, Santesteban, P, Serra, C, Solà, M, Solarnau, L, Solsona, J, Veloso, E, Vidal, S, Abe, O, Abe, R, Enomoto, K, Kikuchi, K, Koyama, H, Masuda, H, Nomura, Y, Sakai, K, Sugimachi, K, Toi, M, Tominaga, T, Uchino, J, Yoshida, M, Haybittle, Jl, Leonard, Cf, Calais, G, Garaud, P, Collett, V, Delmestri, A, Sayer, J, Harvey, Vj, Holdaway, Im, Kay, Rg, Mason, Bh, Forbes, Jf, Balic, M, Bartsch, R, Fesl, C, Fitzal, F, Fohler, H, Greil, R, Jakesz, R, Marth, C, Mlineritsch, B, Pfeiler, G, Singer, Cf, Steger, Gg, Stöger, H, Canney, P, Yosef, Hma, Focan, C, Peek, U, Oates, Gd, Powell, J, Durand, M, Mauriac, L, Dolci, S, Larsimont, D, Nogaret, Jm, Philippson, C, Piccart, Mj, Masood, Mb, Parker, D, Price, Jj, Lindsay, Ma, Mackey, J, Hupperets, Psgj, Bates, T, Blamey, Rw, Chetty, U, Ellis, Io, Mallon, E, Morgan, Dal, Patnick, J, Pinder, S, Lohrisch, C, Nichol, A, Bramwell, Vh, Chen, Be, Gelmon, K, Goss, Pe, Levine, Mn, Parulekar, W, Pater, Jl, Shepherd, Le, Tu, D, Berry, D, Broadwater, G, Cirrincione, C, Muss, H, Weiss, Rb, Abu‐zahra, Ht, Portnoj, Sm, Bowden, S, Brookes, C, Dunn, J, Fernando, I, Lee, M, Poole, C, Rea, D, Spooner, D, Barrett‐lee, Pj, Mansel, Re, Monypenny, Ij, Gordon, Nh, Davis, Hl, Sestak, I, Lehingue, Y, Romestaing, P, Dubois, Jb, Delozier, T, Griffon, B, Mace Lesec’h, J, De La Lande, B, Mouret‐fourme, E, Mustacchi, G, Petruzelka, L, Pribylova, O, Owen, Jr, Harbeck, N, Jänicke, F, Meisner, C, Schmitt, M, Thomssen, C, Meier, P, Shan, Y, Shao, Yf, Zhao, Db, Chen, Zm, Howell, A, Swindell, R, Boddington, C, Burrett, Ja, Cutter, D, Duane, F, Evans, V, Gettins, L, Godwin, J, James, S, Kerr, A, Liu, H, Mannu, G, Mchugh, T, Morris, P, Read, S, Wang, Y, Wang, Z, Albano, J, De Oliveira Cf, Gervásio, H, Gordilho, J, Ejlertsen, B, Jensen, Mb, Johansen, H, Mouridsen, H, Palshof, T, Gelman, Rs, Harris, Jr, Henderson, C, Shapiro, Cl, Christiansen, P, Mouridsen, Ht, Fehm, T, Trampisch, Hj, Dalesio, O, De Vries Ege, Rodenhuis, S, Van Tinteren, H, Comis, Rl, Davidson, Ne, Robert, N, Sledge, G, Solin, Lj, Sparano, Ja, Tormey, Dc, Dixon, Jm, Forrest, P, Jack, W, Kunkler, I, Rossbach, J, Klijn, Jgm, Treurniet‐donker, Ad, Van Putten Wlj, Rotmensz, N, Veronesi, U, Bartelink, H, Bijker, N, Bogaerts, J, Cardoso, F, Cufer, T, Julien, Jp, Van De Velde Cjh, Cunningham, Mp, Brufsky, Am, Coleman, Re, Llombart, Ha, Huovinen, R, Joensuu, H, Costa, A, Bonadonna, G, Gianni, L, Valagussa, P, Goldstein, Lj, Bonneterre, J, Fargeot, P, Fumoleau, P, Kerbrat, P, Luporsi, E, Namer, M, Carrasco, E, Segui, Ma, Eiermann, W, Hilfrich, J, Jonat, W, Kaufmann, M, Kreienberg, R, Schumacher, M, Bastert, G, Rauschecker, H, Sauer, R, Sauerbrei, W, Schauer, A, Blohmer, Ju, Costa, Sd, Eidtmann, H, Gerber, B, Jackisch, C, De Schryver, A, Vakaet, L, Belfiglio, M, Nicolucci, A, Pellegrini, F, Pirozzoli, Mc, Sacco, M, Valentini, M, Mcardle, Cs, Smith, Dc, Stallard, S, Dent, Dm, Gudgeon, Ca, Hacking, A, Murray, E, Panieri, E, Werner, Id, Galligioni, E, Leone, B, Vallejo, Ct, Zwenger, A, Lopez, M, Erazo, A, Medina, Jy, Horiguchi, J, Takei, H, Fentiman, Is, Hayward, Jl, Rubens, Rd, Skilton, D, Scheurlen, H, Sohn, Hc, Untch, M, Dafni, U, Markopoulos, C, Fountzilas, G, Mavroudis, D, Klefstrom, P, Blomqvist, C, Saarto, T, Gallen, M, Tinterri, C, Margreiter, R, De Lafontan, B, Mihura, J, Roché, H, Asselain, B, Salmon, Rj, Vilcoq, Jr, André, F, Delaloge, S, Koscielny, S, Michiels, S, Rubino, C, A'Hern, R, Ellis, P, Kilburn, L, Yarnold, Jr, Benraadt, J, Kooi, M, Van De Velde Ao, Van Dongen Ja, Vermorken, Jb, Castiglione, M, Colleoni, M, Collins, J, Gelber, Rd, Lindtner, J, Price, Kn, Regan, Mm, Rudenstam, Cm, Senn, Hj, Thuerlimann, B, Bliss, Jm, Chilvers, Ced, Coombes, Rc, Hall, E, Marty, M, Buyse, M, Possinger, K, Schmid, P, Wallwiener, D, Bighin, C, Bruzzi, P, Del Mastro, L, Dozin, B, Pastorino, S, Pronzato, P, Sertoli, Mr, Foster, L, George, Wd, Stewart, Hj, Stroner, P, Borovik, R, Hayat, H, Inbar, Mj, Peretz, T, Robinson, E, Camerini, T, Formelli, F, Martelli, G, Di Mauro Mg, Perrone, F, Amadori, D, Martoni, A, Pannuti, F, Camisa, R, Musolino, A, Passalacqua, R, Iwata, H, Shien, T, Ikeda, T, Inokuchi, K, Sawa, K, Sonoo, H, Sadoon, M, Tulusan, Ah, Kohno, N, Miyashita, M, Takao, S, Ahn, Jh, Jung, Kh, Korzeniowski, S, Skolyszewski, J, Ogawa, M, Yamashita, J, Bastiaannet, E, Liefers, Gj, Christiaens, R, Neven, P, Paridaens, R, Van Den Bogaert, W, Braun, S, Martin, P, Romain, S, Janauer, M, Seifert, M, Sevelda, P, Zielinski, Cc, Hakes, T, Hudis, Ca, Wittes, R, Giokas, G, Kondylis, D, Lissaios, B, De La Huerta, R, Sainz, Mg, Ro, J, Camphausen, K, Danforth, D, Lichter, A, Lippman, M, Smart, D, Steinberg, S, D’Amico, C, Lioce, M, Paradiso, A, Ohno, S, Bass, G, Brown, A, Bryant, J, Dignam, J, Fisher, B, Geyer, C, Mamounas, Ep, Redmond, C, Wickerham, L, Aihara, T, Hozumi, Y, Baum, M, Jackson, Im, Palmer, Mk, Ingle, Jn, Suman, Vj, Bengtsson, No, Emdin, S, Jonsson, H, Venturini, M, Lythgoe, Jp, Kissin, M, Erikstein, B, Hannisdal, E, Jacobsen, Ab, Reinertsen, Kv, Varhaug, Je, Gundersen, S, Hauer‐jensen, M, Høst, H, Nissen‐meyer, R, Mitchell, Ak, Robertson, Jfr, Ueo, H, Di Palma, M, Mathé, G, Misset, Jl, Levine, M, Morimoto, K, Takatsuka, Y, Crossley, E, Harris, A, Talbot, D, Taylor, M, Cocconi, G, Di Blasio, B, Ivanov, V, Paltuev, R, Semiglazov, V, Brockschmidt, J, Cooper, Mr, Falkson, Ci, Hadji, P, A’Hern, R, Makris, A, Parton, M, Pennert, K, Powles, Tj, Smith, Ie, Gazet, Jc, Browne, L, Graham, P, Corcoran, N, Clack, G, Van Poznak, C, Deshpande, N, Di Martino, L, Douglas, P, Lindtner, A, Notter, G, Bryant, Ajs, Ewing, Gh, Firth, La, Krushen‐kosloski, Jl, Anderson, H, Killander, F, Malmström, P, Rydén, L, Arnesson, Lg, Carstensen, J, Dufmats, M, Fohlin, H, Nordenskjöld, B, Söderberg, M, Carpenter, Jt, Murray, N, Royle, Gt, Simmonds, Pd, Crowley, J, Gralow, J, Hortobagyi, G, Livingston, R, Martino, S, Osborne, Ck, Ravdin, Pm, Bondesson, T, Celebioglu, F, Dahlberg, K, Fornander, T, Fredriksson, I, Frisell, J, Göransson, E, Iiristo, M, Johansson, U, Lenner, E, Löfgren, L, Nikolaidis, P, Perbeck, L, Rotstein, S, Sandelin, K, Skoog, L, Svane, G, Af Trampe, E, Wadström, C, Maibach, R, Thürlimann, B, Holli, K, Rouhento, K, Safra, T, Brenner, H, Hercbergs, A, Yoshimoto, M, Paterson, Ahg, Fyles, A, Meakin, Jw, Panzarella, T, Bahi, J, Lemonnier, J, Martin, Al, Reid, M, Spittle, M, Bishop, H, Bundred, Nj, Forsyth, S, Pinder, Se, Deutsch, Gp, Kwong, Dlw, Pai, Vr, Senanayake, F, Rubagotti, A, Hackshaw, A, Houghton, J, Ledermann, J, Monson, K, Tobias, Js, Carlomagno, C, De Laurentiis, M, De Placido, S, Williams, L, Bell, R, Hinsley, S, Marshall, Hc, Pierce, Lj, Solomayer, E, Horsman, Jm, Lester, J, Winter, Mc, Buzdar, Au, Hsu, L, Love, Rr, Ahlgren, J, Garmo, H, Holmberg, L, Liljegren, G, Lindman, H, Wärnberg, F, Asmar, L, Jones, Se, Aft, R, Gluz, O, Liedtke, C, Nitz, U, Litton, A, Wallgren, A, Karlsson, P, Linderholm, Bk, Chlebowski, Rt, Caffier, H., Guided Treatment in Optimal Selected Cancer Patients (GUTS), Other departments, CCA - Cancer Treatment and Quality of Life, Radiotherapy, Pan, Hongchao, Gray, Richard, Braybrooke, Jeremy, Davies, Christina, Taylor, Carolyn, Mcgale, Paul, Peto, Richard, Pritchard, Kathleen I, Bergh, Jona, Dowsett, Mitch, Hayes, Daniel F, De Laurentiis, Michelino, MUMC+: MA Medische Oncologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, and Interne Geneeskunde
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0301 basic medicine ,Oncology ,medicine.medical_treatment ,Kaplan-Meier Estimate ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,Recurrence ,Receptors ,Neoplasm Metastasis ,AMERICAN SOCIETY ,Adjuvant ,CLINICAL-PRACTICE GUIDELINE ,Absolute risk reduction ,Estrogen Antagonists ,General Medicine ,Estrogen Antagonist ,CHEMOTHERAPY ,Middle Aged ,Prognosis ,Neoplasm Metastasi ,Local ,POSTMENOPAUSAL WOMEN ,Receptors, Estrogen ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Meta-analysis ,Lymphatic Metastasis ,Female ,Human ,Estrogen Antagonists/therapeutic use ,Adult ,Risk ,medicine.medical_specialty ,Prognosi ,medicine.drug_class ,DISCONTINUATION ,Breast Neoplasms ,Article ,Drug Administration Schedule ,LATE DISTANT RECURRENCE ,03 medical and health sciences ,Breast cancer ,Breast Neoplasms/drug therapy ,Internal medicine ,SCORE ,medicine ,Humans ,SURGICAL ADJUVANT BREAST ,Aged ,Proportional Hazards Models ,Chemotherapy ,business.industry ,Proportional hazards model ,Lymphatic Metastasi ,TAMOXIFEN THERAPY ,ta3122 ,medicine.disease ,Estrogen ,RANDOMIZED-TRIALS ,Discontinuation ,Surgery ,Neoplasm Recurrence ,030104 developmental biology ,Proportional Hazards Model ,Neoplasm Grading ,Neoplasm Recurrence, Local ,business - Abstract
Background The administration of endocrine therapy for 5 years substantially reduces recurrence rates during and after treatment in women with early-stage, estrogen-receptor (ER)–positive breast cancer. Extending such therapy beyond 5 years offers further protection but has additional side effects. Obtaining data on the absolute risk of subsequent distant recurrence if therapy stops at 5 years could help determine whether to extend treatment. Methods In this meta-analysis of the results of 88 trials involving 62,923 women with ER-positive breast cancer who were disease-free after 5 years of scheduled endocrine therapy, we used Kaplan–Meier and Cox regression analyses, stratified according to trial and treatment, to assess the associations of tumor diameter and nodal status (TN), tumor grade, and other factors with patients’ outcomes during the period from 5 to 20 years. Results Breast-cancer recurrences occurred at a steady rate throughout the study period from 5 to 20 years. The risk of distant recurrence was strongly correlated with the original TN status. Among the patients with stage T1 disease, the risk of distant recurrence was 13% with no nodal involvement (T1N0), 20% with one to three nodes involved (T1N1–3), and 34% with four to nine nodes involved (T1N4–9); among those with stage T2 disease, the risks were 19% with T2N0, 26% with T2N1–3, and 41% with T2N4–9. The risk of death from breast cancer was similarly dependent on TN status, but the risk of contralateral breast cancer was not. Given the TN status, the factors of tumor grade (available in 43,590 patients) and Ki-67 status (available in 7692 patients), which are strongly correlated with each other, were of only moderate independent predictive value for distant recurrence, but the status regarding the progesterone receptor (in 54,115 patients) and human epidermal growth factor receptor type 2 (HER2) (in 15,418 patients in trials with no use of trastuzumab) was not predictive. During the study period from 5 to 20 years, the absolute risk of distant recurrence among patients with T1N0 breast cancer was 10% for low-grade disease, 13% for moderate-grade disease, and 17% for high-grade disease; the corresponding risks of any recurrence or a contralateral breast cancer were 17%, 22%, and 26%, respectively. Conclusions After 5 years of adjuvant endocrine therapy, breast-cancer recurrences continued to occur steadily throughout the study period from 5 to 20 years. The risk of distant recurrence was strongly correlated with the original TN status, with risks ranging from 10 to 41%, depending on TN status and tumor grade. (Funded by Cancer Research UK and others.)
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- 2017
10. Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials
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Alberro, JA, Ballester, B, Deulofeu, P, Fabregas, R, Fraile, M, Gubern, JM, Janer, J, Moral, A, de Pablo, JL, Penalva, G, Puig, P, Ramos, M, Rojo, R, Santesteban, P, Serra, C, Sola, M, Solarnau, L, Solsona, J, Veloso, E, Vidal, S, Abe, O, Abe, R, Enomoto, K, Kikuchi, K, Koyama, H, Masuda, H, Nomura, Y, Ohashi, Y, Sakai, K, Sugimachi, K, Toi, M, Tominaga, T, Uchino, J, Yoshida, M, Coles, CE, Haybittle, JL, Moebus, V, Leonard, CF, Calais, G, Garaud, P, Collett, V, Davies, C, Delmestri, A, Sayer, J, Harvey, VJ, Holdaway, IM, Kay, RG, Mason, BH, Forbe, JF, Franci, PA, Wilcken, N, Balic, M, Bartsch, R, Fesl, C, Fitzal, F, Fohler, H, Gnant, M, Greil, R, Jakesz, R, Marth, C, Mlineritsch, B, Pfeiler, G, Singer, CF, Steger, GG, Stoeger, H, Canney, P, Yosef, HMA, Focan, C, Peek, U, Oates, GD, Powell, J, Durand, M, Mauriac, L, Di Leo, A, Dolci, S, Larsimont, D, Nogaret, JM, Philippson, C, Piccart, MJ, Masood, MB, Parker, D, Price, JJ, Lindsay, MA, Mackey, J, Martin, M, Hupperets, PSGJ, Bates, T, Blamey, RW, Chetty, U, Ellis, IO, Mallon, E, Morgan, DAL, Patnick, J, Pinder, S, Lohrisch, C, Nichol, A, Bartlett, JMS, Bramwell, VH, Chen, BE, Chia, SKL, Gelmon, K, Goss, PE, Levine, MN, Parulekar, W, Pater, JL, Pritchard, KI, Shepherd, LE, Tu, D, Whelan, T, Berry, D, Broadwater, G, Cirrincione, C, Muss, H, Norton, L, Weiss, RB, Abu-Zahara, HT, Karpov, A, Portnoj, SL, Bowden, S, Brookes, C, Dunn, J, Fernando, I, Lee, M, Poole, C, Rea, D, Spooner, D, Barrett-Lee, PJ, Manse, RE, Monypenny, IJ, Gordon, NH, Davis, HL, Cuzick, J, Sestak, I, Lehingue, Y, Romestaing, P, Dubois, JB, Delozier, T, Griffon, B, Lesec'h, J Mace, Mustacchi, G, Petruzelka, L, Pribylova, O, Owen, JR, Meier, P, Shan, Y, Shao, YF, Wang, X, Zhao, DB, Howell, A, Swindell, R, Albano, J, de Oliveira, CF, Gervasio, H, Gordilho, J, Ejlertsen, B, Jensen, M-B, Mouridsen, H, Gelman, RS, Harris, JR, Hayes, D, Henderson, C, Shapiro, CL, Christiansen, P, Ewertz, M, Jensen, MB, Mouridsen, HT, Fehm, T, Trampisch, HJ, Dalesio, O, de Vries, EGE, Rodenhuis, S, van Tinteren, H, Comis, RL, Davidson, NE, Gray, R, Robert, N, Sledge, G, Solin, LJ, Sparano, JA, Tormey, DC, Wood, W, Cameron, D, Dixon, JM, Forrest, P, Jack, W, Kunkler, I, Rossbach, J, Klijn, JGM, Treurniet-Donker, AD, van Putten, WLJ, Rotmensz, N, Veronesi, U, Viale, G, Bartelink, H, Bijker, N, Bogaerts, J, Cardoso, F, Cufer, T, Julien, JP, Poortmans, PM, Rutgers, E, van de Velde, CJH, Cunningham, MP, Huovinen, R, Joensuu, H, Costa, A, Bonadonna, G, Gianni, L, Valagussa, P, Goldstein, LJ, Bonneterre, J, Fargeot, P, Fumoleau, P, Kerbrat, P, Lupors, E, Namer, M, Carrasco, E, Segui, MA, Eierman, W, Hilfrich, J, Jonat, W, Kaufmann, M, Kreienberg, R, Schumacher, M, Bastert, G, Rauschecker, H, Sauer, R, Sauerbrei, W, Schauer, A, Blohmer, JU, Costa, SD, Eidtmann, H, Gerber, B, Jackisch, C, Loib, S, von Minckwitz, G, de Schryver, A, Vakaet, L, Belfiglio, M, Nicolucci, A, Pellegrini, F, Pirozzoli, MC, Sacco, M, Valentini, M, McArdle, CS, Smith, DC, Stallard, S, Dent, DM, Gudgeon, CA, Hacking, A, Murray, E, Panieri, E, Werner, ID, De Salvo, GL, Del Bianco, P, Zavagno, G, Leone, B, Vallejo, CT, Zwenger, A, Galligioni, E, Lopez, M, Erazo, A, Medina, JY, Horiguchi, J, Takei, H, Fentiman, IS, Hayward, JL, Rubens, RD, Skilton, D, Scheurlen, H, Sohn, HC, Untch, M, Dafni, U, Markopoulos, C, Bamia, C, Fountzilas, G, Koliou, G-A, Manousou, K, Mavroudis, D, Klefstrom, P, Blomqvist, C, Saarto, T, Gallen, M, Canavese, G, Tinterri, C, Margreiter, R, de Lafontan, B, Mihura, J, Roche, H, Asselain, B, Salmon, RJ, Vilcoq, JR, Brain, E, de La Lande, B, Mouret-Fourme, E, Andre, F, Arriagada, R, Delaloge, S, Hill, C, Koscienly, S, Michiels, S, Rubino, C, A'Hern, R, Bliss, J, Ellis, P, Kilburn, L, Yarnold, JR, Benraadt, J, Kooi, M, van de Velde, AO, van Dongen, JA, Vermorken, JB, Castiglione, M, Coates, A, Colleoni, M, Collins, J, Forbes, J, Gelbe, RD, Goldhirsch, A, Lindtner, J, Price, KN, Regan, MM, Rudenstam, CM, Senn, HJ, Thuerlimann, B, Bliss, JM, Chilvers, CED, Coombes, RC, Hall, E, Marty, M, Buyse, M, Possinger, K, Schmid, P, Wallwiener, D, Foster, L, George, WD, Stewart, HJ, Stroner, P, Borovik, R, Hayat, H, Inbar, MJ, Peretz, T, Robinson, E, Camerini, T, Formelli, F, Martelli, G, Di Mauro, MG, Perrone, F, Amadori, D, Martoni, A, Pannuti, F, Camisa, R, Musolino, A, Passalacqua, R, Iwata, H, Shien, T, Ikeda, T, Inokuchi, K, Sawa, K, Sonoo, H, Sadoon, M, Tulusan, AH, Kohno, N, Miyashita, M, Takao, S, Ahn, J-H, Jung, KH, Korzeniowski, S, Skolyszewski, J, Ogawa, M, Yamashita, J, Bastiaannet, E, Liefers, GJ, Christiaens, R, Neven, P, Paridaens, R, Van den Bogaert, W, Gazet, JC, Corcoran, N, Deshpande, N, di Martino, L, Douglas, P, Host, H, Lindtner, A, Notter, G, Bryant, AJS, Ewing, GH, Firth, LA, Krushen-Kosloski, JL, Nissen-Meyer, R, Anderson, H, Killander, F, Malmstrom, P, Ryden, L, Arnesson, L-G, Carstense, J, Dufmats, M, Fohlin, H, Nordenskjold, B, Soderberg, M, Sundqvist, M, Carpenter, TJ, Murray, N, Royle, GT, Simmonds, PD, Albain, K, Barlow, W, Crowley, J, Gralow, J, Hortobagyi, G, Livingston, R, Martino, S, Osborne, CK, Ravdin, PM, Bergh, J, Bondesso, T, Celebiogl, F, Dahlberg, K, Fornander, T, Fredriksson, I, Frisell, J, Goransson, E, Iiristo, M, Johansson, U, Lenner, E, Lofgren, L, Nikolaidis, P, Perbeck, L, Rotstein, S, Sandelin, K, Skoog, L, Svane, G, af Trampe, E, Wadstrom, C, Janni, W, Maibach, R, Thurlimann, B, Hadji, P, Hozumi, J, Holli, K, Rouhento, K, Safra, T, Brenner, H, Hercbergs, A, Yoshimoto, M, Paterson, AHG, Fyles, A, Meakin, JW, Panzarella, T, Bahi, J, Lemonnier, J, Martin, AL, Reid, M, Spittle, M, Bishop, H, Bundred, NJ, Forbes, JF, Forsyth, S, George, WS, Pinder, SE, Deutsch, GP, Kwong, DLW, Pai, VR, Peto, R, Senanayake, F, Boccardo, F, Rubagotti, A, Baum, M, Hackshaw, A, Houghton, J, Ledermann, J, Monson, K, Tobias, JS, Carlomagno, C, De Laurentiis, M, De Placido, S, Schem, C, Williams, L, Bell, R, Coleman, RE, Dodwell, D, Hinsley, S, Marshall, HC, Pierce, LJ, Basso, SMM, Lumachi, F, Solomayer, E, Horsman, JM, Lester, J, Winter, MC, Buzdar, AU, Hsu, L, Love, RR, Ahlgren, J, Garmo, H, Holmberg, L, Lindman, H, Warnberg, F, Asmar, L, Jones, SE, Aft, R, Gluz, O, Harbeck, N, Liedtke, C, Nitz, U, Litton, A, Wallgren, A, Karlsson, P, Linderholm, BK, Chlebowski, RT, Caffier, H, Brufsky, AM, Llombart, HA, Asselain, B, Barlow, W, Bartlett, J, Bradley, R, Braybrooke, J, Davies, C, Dodwell, D, Gray, R, Mannu, G, Taylor, C, Peto, R, McGale, P, Pan, H, Wang, Y, Wang, Z, Department of Oncology, Clinicum, HUS Comprehensive Cancer Center, Medical Oncology, Cancer Research UK, and Pfizer Limited
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0301 basic medicine ,Oncology ,Time Factors ,SURGERY ,medicine.medical_treatment ,menopause ,chemotherapy ,Mastectomy, Segmental ,Rate ratio ,THERAPY ,aromatase inhibitors ,CEA ,0302 clinical medicine ,Risk Factors ,Medicine and Health Sciences ,Breast ,Neoplasm Metastasis ,Randomized Controlled Trials as Topic ,RISK ,tamoxifen ,breast tumor ,CA15-3 ,axillary dissection ,mastectomy ,Middle Aged ,Neoadjuvant Therapy ,METHOTREXATE ,3. Good health ,trastuzumab ,Treatment Outcome ,quadrantectomy ,Chemotherapy, Adjuvant ,axillary lymphnodes ,030220 oncology & carcinogenesis ,Meta-analysis ,SURVIVAL ,Disease Progression ,Female ,Life Sciences & Biomedicine ,axillary clearance ,RADIOTHERAPY ,medicine.drug ,Adult ,medicine.medical_specialty ,Anthracycline ,3122 Cancers ,Antineoplastic Agents ,Breast Neoplasms ,axillary nodes ,sentinel node biopsy ,03 medical and health sciences ,breast cancer ,Breast cancer ,SDG 3 - Good Health and Well-being ,HER2 ,Internal medicine ,Journal Article ,medicine ,cancer ,Humans ,Breast, breast cancer, breast diseases, cancer, malignancy, menopause, surgery, mastectomy, quadrantectomy, lumpectomy, axillary nodes, axillary lymphnodes, axillary dissection, axillary clearance, sentinel node biopsy, sentinel node, BRCA1, BRCA2, tamoxifen, aromatase inhibitors, breast tumor, osteoporosis, bisphosphonates, denosumab, trastuzumab, HER2, CEA, CA15-3, tumor marker, chemotherapy, endocrine therapy ,Oncology & Carcinogenesis ,RECURRENCE ,bisphosphonates ,Pathological ,Neoplasm Staging ,lumpectomy ,Chemotherapy ,Science & Technology ,breast diseases ,endocrine therapy ,business.industry ,denosumab ,BRCA1 ,medicine.disease ,BRCA2 ,osteoporosis ,Radiation therapy ,STIMULATING FACTOR ,030104 developmental biology ,sentinel node ,tumor marker ,Methotrexate ,Neoplasm Recurrence, Local ,business ,1112 Oncology And Carcinogenesis ,malignancy - Abstract
BACKGROUND: Neoadjuvant chemotherapy (NACT) for early breast cancer can make breast-conserving surgery more feasible and might be more likely to eradicate micrometastatic disease than might the same chemotherapy given after surgery. We investigated the long-term benefits and risks of NACT and the influence of tumour characteristics on outcome with a collaborative meta-analysis of individual patient data from relevant randomised trials. METHODS: We obtained information about prerandomisation tumour characteristics, clinical tumour response, surgery, recurrence, and mortality for 4756 women in ten randomised trials in early breast cancer that began before 2005 and compared NACT with the same chemotherapy given postoperatively. Primary outcomes were tumour response, extent of local therapy, local and distant recurrence, breast cancer death, and overall mortality. Analyses by intention-to-treat used standard regression (for response and frequency of breast-conserving therapy) and log-rank methods (for recurrence and mortality). FINDINGS: Patients entered the trials from 1983 to 2002 and median follow-up was 9 years (IQR 5-14), with the last follow-up in 2013. Most chemotherapy was anthracycline based (3838 [81%] of 4756 women). More than two thirds (1349 [69%] of 1947) of women allocated NACT had a complete or partial clinical response. Patients allocated NACT had an increased frequency of breast-conserving therapy (1504 [65%] of 2320 treated with NACT vs 1135 [49%] of 2318 treated with adjuvant chemotherapy). NACT was associated with more frequent local recurrence than was adjuvant chemotherapy: the 15 year local recurrence was 21·4% for NACT versus 15·9% for adjuvant chemotherapy (5·5% increase [95% CI 2·4-8·6]; rate ratio 1·37 [95% CI 1·17-1·61]; p=0·0001). No significant difference between NACT and adjuvant chemotherapy was noted for distant recurrence (15 year risk 38·2% for NACT vs 38·0% for adjuvant chemotherapy; rate ratio 1·02 [95% CI 0·92-1·14]; p=0·66), breast cancer mortality (34·4% vs 33·7%; 1·06 [0·95-1·18]; p=0·31), or death from any cause (40·9% vs 41·2%; 1·04 [0·94-1·15]; p=0·45). INTERPRETATION: Tumours downsized by NACT might have higher local recurrence after breast-conserving therapy than might tumours of the same dimensions in women who have not received NACT. Strategies to mitigate the increased local recurrence after breast-conserving therapy in tumours downsized by NACT should be considered-eg, careful tumour localisation, detailed pathological assessment, and appropriate radiotherapy. FUNDING: Cancer Research UK, British Heart Foundation, UK Medical Research Council, and UK Department of Health. ispartof: LANCET ONCOLOGY vol:19 issue:1 pages:27-39 ispartof: location:England status: published
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- 2017
11. Corrigendum to '3rd ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 3)' [Breast 31 (February 2017) 244-259]
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Cardoso, F., Costa, A., Senkus, E., Aapro, M., Andre, F., Barrios, C.H., Bergh, J., Bhattacharyya, G., Biganzoli, L., Cardoso, M.J., Carey, L., Corneliussen-James, D, Curigliano, G, Dieras, V, El Saghir, N, Eniu, E, Fallowfield, L., Fenech, E, Francis, D, Gelmon, B, Gennari, D, Hudis, B, Kaufman, B., Krop, B, Meijer, D, Mertz, B, Ohno, B, Pagani, B, Papadopoulos, E., Peccatori, E, Penault-Llorca, L, Piccart, L, Pierga, D, Rugo, B, Shockney, L., Sledge, A, Swain, L, Thomssen, E, Tutt, L, Vorobiof, D., Xu, B., Norton, L., Winer, E., Eniu, A., Fenech, D., Francis, P., Gelmon, K., Gennari, A., Harbeck, N., Hudis, C., Krop, I., Mayer, M., Meijer, H., Mertz, S., Ohno, S., Pagani, O., Peccatori, F., Penault-Llorca, F., Piccart, M.J., Pierga, J.Y., Rugo, H., Sledge, G., Swain, S., Thomssen, C., Tutt, A., European School of Oncology & Breast Unit, Champalimaud Clinical Center, Lisbon, Portugal, Champalimaud Clinical Center, European Institute of Oncology [Milan] (ESMO), Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland, Medical University of Gdansk, Breast Center, Genolier Cancer Center, Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR), Department of Medicine, PUCRS School of Medicine, Department of Oncology–Pathology, Radiumhemmet, Karolinska University Hospital [Stockholm], Department of Medical Oncology, Fortis Hospital, 'Sandro Pitigliani' Medical Oncology Unit, Department of Oncology, Hospital of Prato, Istituto Toscano Tumori, Breast Unit, Department of Hematology and Oncology, Lineberger Comprehensive Cancer Center (UNC Lineberger), University of North Carolina [Chapel Hill] (UNC), University of North Carolina System (UNC)-University of North Carolina System (UNC)-University of North Carolina [Chapel Hill] (UNC), University of North Carolina System (UNC)-University of North Carolina System (UNC), METAvivor Research and Support, MetaVivor Research and Support, Division of Experimental Therapeutics, Department of Medical Oncology, Institut Curie, Paris 75248, France, Brustzentrum der Universitat München, Universität München, Advanced BC.org, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])
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0301 basic medicine ,Oncology ,medicine.medical_specialty ,business.industry ,Advanced breast ,Cancer ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,General Medicine ,medicine.disease ,3. Good health ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,Surgery ,business ,ComputingMilieux_MISCELLANEOUS - Abstract
International audience
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- 2017
12. Ten-year analysis of the prospective multicentre Chemo-N0 trial validates American Society of Clinical Oncology (ASCO)-recommended biomarkers uPA and PAI-1 for therapy decision making in node-negative breast cancer patients
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Harbeck, N., Schmitt, M., Meisner, C., Friedel, C., Untch, M., Schmidt, M., Sweep, C.G.J., Lisboa, B.W., Lux, M.P., Beck, T., Hasmuller, S., Kiechle, M., Janicke, F., and Thomssen, C.
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Adult ,Oncology ,Cancer Research ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Decision Making ,Breast Neoplasms ,Enzyme-Linked Immunosorbent Assay ,Disease-Free Survival ,Metastasis ,law.invention ,Breast cancer ,Drug Therapy ,Randomized controlled trial ,Risk Factors ,law ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Plasminogen Activator Inhibitor 1 ,Biomarkers, Tumor ,medicine ,Humans ,Prospective Studies ,Prospective cohort study ,Cyclophosphamide ,Aged ,Neoplasm Staging ,Gynecology ,Chemotherapy ,business.industry ,Cancer ,Middle Aged ,Prognosis ,medicine.disease ,Urokinase-Type Plasminogen Activator ,Methotrexate ,Treatment Outcome ,Chemotherapy, Adjuvant ,Hormonal regulation Aetiology, screening and detection [IGMD 6] ,Female ,Fluorouracil ,business ,Risk assessment ,Plasminogen activator - Abstract
Item does not contain fulltext AIM: Final 10-year analysis of the prospective randomised Chemo-N0 trial is presented. Based on the Chemo-N0 interim results and an European Organisation for Research and Treatment of Cancer (EORTC) pooled analysis (n=8377), American Society of Clinical Oncology (ASCO) and Arbeitsgemeinschaft Gynakologische Onkologie (AGO) guidelines recommend invasion and metastasis markers urokinase-type plasminogen activator (uPA)/plasminogen activator inhibitor-1 (PAI-1) for risk assessment and treatment decision in node-negative (N0) breast cancer (BC). METHODS: The final Chemo-N0 trial analysis (recruitment 1993-1998; n=647; 12 centres) comprises 113 (5-167) months of median follow-up. Patients with low-uPA and PAI-1 tumour tissue levels (n=283) were observed. External quality assurance guaranteed uPA/PAI-1 enzyme-linked immunosorbent assay (ELISA) standardisation. Of 364 high uPA and/or PAI-1 patients, 242 agreed to randomisation for CMF chemotherapy (n=117) versus observation (n=125). RESULTS: Actuarial 10-year recurrence rate (without any adjuvant systemic therapy) for high-uPA/PAI-1 observation group patients (randomised and non-randomised) was 23.0%, in contrast to only 12.9% for low-uPA/PAI-1 patients (plog-rank=0.011). High-risk patients randomised to cyclophosphamide-methotrexate-5-fluorouracil (CMF) therapy had a 26.0% lower estimated probability of disease recurrence than those randomised for observation (intention-to-treat (ITT)-analysis: hazard ratio (HR) 0.74 (0.44-1.27); plog-rank=0.28). Per-protocol analysis demonstrated significant treatment benefit: HR 0.48 (0.26-0.88), p=0.019, disease-free survival (DFS) Cox regression, adjusted for tumour stage and grade. CONCLUSIONS: Chemo-N0 is the first prospective biomarker-based therapy trial in early BC defining patients reaching good long-term DFS without adjuvant systemic therapy. Using a standardised uPA/PAI-1 ELISA, almost half of N0-patients could be spared chemotherapy, while high-risk patients benefit from adjuvant chemotherapy. These 10-year results validate the long-term prognostic impact of uPA/PAI-1 and the benefit from adjuvant chemotherapy in the high-uPA/PAI-1 group at highest level of evidence. They thus support the guideline-based routine use of uPA/PAI-1 for risk-adapted individualised therapy decisions in N0 breast cancer.
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- 2013
13. BP50 THERAPY SUPPORT WITH A STANDARDIZED NURSING CONSULTATION FOR PATIENTS UNDER ORALTUMOR THERAPY IN GYNECOLOGICAL ONCOLOGY (BREAST CANCER AND OVARIAN CANCER).
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Winkler, Sophie, Hirschberg, L., Henze, F., Milani, V., Schinkoethe, T., Haidinger, R., Paradies, K., Mahner, S., Trillsch, F., Harbeck, N., and Wuerstlein, R.
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OVARIAN cancer ,BREAST cancer ,NURSES as patients ,NURSE-patient relationships ,ONCOLOGY nursing ,ONCOLOGY - Published
- 2023
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14. uPA und PAI-1 haben nicht nur eine prognostische, sondern auch eine prädiktive Bedeutung und unterstützen klinische Therapieentscheidungen beim primären Mammakarzinom
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Harbeck N and C Thomssen
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Urokinase ,Oncology ,medicine.medical_specialty ,Chemotherapy ,Axillary lymph nodes ,business.industry ,medicine.medical_treatment ,Obstetrics and Gynecology ,medicine.disease ,Primary tumor ,Breast cancer ,medicine.anatomical_structure ,Internal medicine ,Immunology ,medicine ,Carcinoma ,business ,Adjuvant ,Plasminogen activator ,medicine.drug - Abstract
uPA and PAI-1 are the first novel tumor biological prognostic factors in breast cancer for which the prognostic impact has been validated at the highest level of evidence and hence all evaluation criteria for transfer into clinical practice have been fullfilled. Breast cancer patients with high uPA and/or PAI-1 levels in their primary tumor tissue have a significantly lower chance for cure than patients with low levels of both uPA and PAI-1. Our research that was honored with the Schmidt-Matthiesen-Award 2002 shows for the first time that uPA and PAI-1 are not only prognostic factors but also have a predictive impact with regard to response to adjuvant chemotherapy. Patients with high uPA/PAI-1 derive a significantly greater benefit from adjuvant chemotherapy than patients with low uPA/PAI-1. Benefit from adjuvant endocrine therapy is independent of uPA/PAI-1 status. The resulting question about the optimal chemotherapy for patients with high uPA/PAI-1 is currently being addressed in Germany by the NNBC-3 trial in node-negative breast cancer (AGO, EORTC-RBG) as well as the ADEBAR trial in patients with 4 or more involved axillary lymph nodes. Moreover, our results suggest the use of novel therapeutic agents interfering with the uPA system together with conventional chemotherapy in patients with high uPA/PAI-1 already in early stage disease.
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- 2003
15. Adjuvante Chemotherapie beim primären Mammakarzinom
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Harbeck N
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,Adjuvant chemotherapy ,Hematology ,medicine.disease ,Polychemotherapies ,ddc ,Surgery ,Clinical trial ,Breast cancer ,Nodal status ,Relative risk ,Internal medicine ,Adjuvant therapy ,Medicine ,business ,Primary breast cancer - Abstract
Adjuvant Chemotherapy in Primary Breast Cancer Adjuvant chemotherapy reduces the relative risk of relapse by about 25% – independent of the nodal status. Anthracycline-containing regimens are considered standard for adjuvant chemotherapy. In single studies, superiority to CMF has only been shown for anthracyclinecontaining polychemotherapies with at least three substances or a sequential anthracycline-CMF therapy. Recent data show that adding taxanes to anthracyclinecontaining regimens may lead to significant survival advantages. Based on trial results published so far, taxanes are a valid adjuvant therapy option in node-positive breast cancer. In Germany, their optimal use is currently being evaluated in several clinical trials (i.e. NNBC-3, ECDoc, ADEBAR). Up-to-date evidence-based therapy recommendations for adjuvant chemotherapy can be found in the S2 guidelines of the working group on gynecological oncology (AGO) expert panel ’breast‘ (www.agoonline. de) [1].
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- 2003
16. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials
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EARLY BREAST CANCER TRIALISTS' COLLABORATIVE GROUP (EBCTCG), Darby, S., Mcgale, P., Correa, C., Taylor, C., Arriagada, R., Clarke, M., Cutter, D., Davies, C., Ewertz, M., Godwin, J., Gray, R., Pierce, L., Whelan, T., Wang, Y., Peto, R., Albain, K, Anderson, S, Arriagada, R, Barlow, W, Bergh, J, Bliss, J, Buyse, M, Cameron, D, Carrasco, E, Clarke, M, Correa, C, Coates, A, Collins, R, Costantino, J, Cutter, D, Cuzick, J, Darby, S, Davidson, N, Davies, C, Davies, K, Delmestri, A, Di Leo, A, Dowsett, M, Elphinstone, P, Evans, V, Ewertz, M, Gelber, R, Gettins, L, Geyer, C, Goldhirsch, A, Godwin, J, Gray, R, Gregory, C, Hayes, D, Hill, C, Ingle, J, Jakesz, R, James, S, Kaufmann, M, Kerr, A, Mackinnon, E, Mcgale, P, Mchugh, T, Norton, L, Ohashi, Y, Paik, S, Pan, Hc, Perez, E, Peto, R, Piccart, M, Pierce, L, Pritchard, K, Pruneri, G, Raina, V, Ravdin, P, Robertson, J, Rutgers, E, Shao, Yf, Swain, S, Taylor, C, Valagussa, P, Viale, G, Whelan, T, Winer, E, Wang, Y, Wood, W, Abe, O, Abe, R, Enomoto, K, Kikuchi, K, Koyama, H, Masuda, H, Nomura, Y, Sakai, K, Sugimachi, K, Toi, M, Tominaga, T, Uchino, J, Yoshida, M, Haybittle, Jl, Leonard, Cf, Calais, G, Geraud, P, Collett, V, Sayer, J, Harvey, Vj, Holdaway, Im, Kay, Rg, Mason, Bh, Forbes, Jf, Wilcken, N, Bartsch, R, Dubsky, P, Fesl, C, Fohler, H, Gnant, M, Greil, R, Lang, A, Luschin-Ebengreuth, G, Marth, C, Mlineritsch, B, Samonigg, H, Singer, Cf, Steger, Gg, Stöger, H, Canney, P, Yosef, Hm, Focan, C, Peek, U, Oates, Gd, Powell, J, Durand, M, Mauriac, L, Dolci, S, Larsimont, D, Nogaret, Jm, Philippson, C, Piccart, Mj, Masood, Mb, Parker, D, Price, Jj, Lindsay, Ma, Mackey, J, Martin, M, Hupperets, Ps, Bates, T, Blamey, Rw, Chetty, U, Ellis, Io, Mallon, E, Morgan, Da, Patnick, J, Pinder, S, Olivotto, I, Ragaz, J, Berry, D, Broadwater, G, Cirrincione, C, Muss, H, Weiss, Rb, Abu-Zahra, Ht, Portnoj, Sm, Bowden, S, Brookes, C, Dunn, J, Fernando, I, Lee, M, Poole, C, Rea, D, Spooner, D, Barrett-Lee, Pj, Mansel, Re, Monypenny, Ij, Gordon, Nh, Davis, Hl, Lehingue, Y, Romestaing, P, Dubois, Jb, Delozier, T, Griffon, B, Mace Lesec'h, J, Rambert, P, Mustacchi, G, Petruzelka, Pribylova, O, Owen, Jr, Harbeck, N, Jänicke, F, Meisner, C, Schmitt, M, Thomssen, C, Meier, P, Shan, Y, Wang, X, Zhao, Db, Chen, Zm, Howell, A, Swindell, R, Burrett, Ja, Hermans, D, Hicks, C, Lay, M, Albano, J, de Oliveira CF, Gervásio, H, Gordilho, J, Johansen, H, Mouridsen, Ht, Gelman, Rs, Harris, Jr, Henderson, C, Shapiro, Cl, Christiansen, P, Ejlertsen, B, Jensen, Mb, Møller, S, Carstensen, B, Palshof, T, Trampisch, Hj, Dalesio, O, de Vries EG, Rodenhuis, S, van Tinteren, H, Comis, Rl, Davidson, Ne, Robert, N, Sledge, G, Solin, Lj, Sparano, Ja, Tormey, Dc, Dixon, Jm, Forrest, P, Jack, W, Kunkler, I, Rossbach, J, Klijn, Jg, Treurniet-Donker, Ad, van Putten WL, Rotmensz, N, Veronesi, U, Bartelink, H, Bijker, N, Bogaerts, J, Cardoso, F, Cufer, T, Julien, Jp, van de Velde CJ, Cunningham, Mp, Huovinen, R, Joensuu, H, Costa, A, Tinterri, C, Bonadonna, G, Gianni, L, Goldstein, Lj, Bonneterre, J, Fargeot, P, Fumoleau, P, Kerbrat, P, Luporsi, E, Namer, M, Eiermann, W, Hilfrich, J, Jonat, W, Kreienberg, R, Schumacher, M, Bastert, G, Rauschecker, H, Sauer, R, Sauerbrei, W, Schauer, A, Blohmer, Ju, Costa, Sd, Eidtmann, H, Gerber, G, Jackisch, C, Loibl, S, von Minckwitz, G, de Schryver, A, Vakaet, L, Belfiglio, M, Nicolucci, A, Pellegrini, F, Pirozzoli, Mc, Sacco, M, Valentini, M, Mcardle, Cs, Smith, Dc, Stallard, S, Dent, Dm, Gudgeon, Ca, Hacking, A, Murray, E, Panieri, E, Werner, Id, Segui, Ma, Galligioni, E, Lopez, M, Erazo, A, Medina, Jy, Horiguchi, J, Takei, H, Fentiman, Is, Hayward, Jl, Rubens, Rd, Skilton, D, Scheurlen, H, Sohn, Hc, Untch, M, Dafni, U, Markopoulos, C, Dafni, D, Fountzilas, G, Mavroudis, D, Klefstrom, P, Saarto, T, Gallen, M, Margreiter, R, de Lafontan, B, Mihura, J, Roché, H, Asselain, B, Salmon, Rj, Vilcoq, Jr, Bourgier, C, Koscielny, S, Laplanche, A, Lê, Mg, Spielmann, M, A'Hern, R, Ellis, P, Kilburn, L, Yarnold, Jr, Benraadt, J, Kooi, M, van de Velde AO, van Dongen JA, Vermorken, Jb, Castiglione, M, Colleoni, M, Collins, J, Forbes, J, Gelber, Rd, Lindtner, J, Price, Kn, Regan, Mm, Rudenstam, Cm, Senn, Hj, Thuerlimann, B, Bliss, Jm, Chilvers, Ce, Coombes, Rc, Hall, E, Marty, M, Possinger, K, Schmid, P, Wallwiener, D, Foster, L, George, Wd, Stewart, Hj, Stroner, P, Borovik, R, Hayat, H, Inbar, Mj, Robinson, E, Bruzzi, P, Del Mastro, L, Pronzato, P, Sertoli, Mr, Venturini, M, Camerini, T, De Palo, G, Di Mauro MG, Formelli, F, Amadori, D, Martoni, A, Pannuti, F, Camisa, R, Cocconi, G, Colozza, A, Passalacqua, R, Aogi, K, Takashima, S, Ikeda, T, Inokuchi, K, Sawa, K, Sonoo, H, Korzeniowski, S, Skolyszewski, J, Ogawa, M, Yamashita, J, Bastiaannet, E, van de Water, W, van Nes JG, Christiaens, R, Neven, P, Paridaens, R, Van den Bogaert, W, Braun, S, Janni, W, Martin, P, Romain, S, Janauer, M, Seifert, M, Sevelda, P, Zielinski, Cc, Hakes, T, Hudis, Ca, Wittes, R, Giokas, G, Kondylis, D, Lissaios, B, de la Huerta, R, Sainz, Mg, Altemus, R, Camphausen, K, Cowan, K, Danforth, D, Lichter, A, Lippman, M, O'Shaughnessy, J, Pierce, Lj, Steinberg, S, Venzon, D, Zujewski, Ja, D'Amico, C, Lioce, M, Paradiso, A, Chapman, Ja, Gelmon, K, Goss, Pe, Levine, Mn, Meyer, R, Parulekar, W, Pater, Jl, Pritchard, Ki, Shepherd, Le, Tu, D, Ohno, S, Anderson, A, Bass, G, Brown, A, Bryant, J, Dignam, J, Fisher, B, Mamounas, Ep, Redmond, C, Wickerham, L, Wolmark, N, Baum, M, Jackson, Im, Palmer, Mk, Ingle, Jn, Suman, Vj, Bengtsson, No, Emdin, S, Jonsson, H, Lythgoe, Jp, Kissin, M, Erikstein, B, Hannisdal, E, Jacobsen, Ab, Varhaug, Je, Gundersen, S, Hauer-Jensen, M, Høst, H, Nissen-Meyer, R, Mitchell, Ak, Robertson, Jf, Ueo, H, Di Palma, M, Mathé, G, Misset, Jl, Levine, M, Morimoto, K, Takatsuka, Y, Crossley, E, Harris, A, Talbot, D, Taylor, M, Martin, Al, di Blasio, B, Ivanov, V, Paltuev, R, Semiglazov, V, Brockschmidt, J, Cooper, Mr, Falkson, Ci, Ashley, S, Makris, A, Powles, Tj, Smith, Ie, Gazet, Jc, Browne, L, Graham, P, Corcoran, N, Deshpande, N, di Martino, L, Douglas, P, Lindtner, A, Notter, G, Bryant, Aj, Ewing, Gh, Firth, La, Krushen-Kosloski, Jl, Anderson, H, Killander, F, Malmström, P, Rydén, L, Arnesson, Lg, Carstensen, J, Dufmats, M, Fohlin, H, Nordenskjöld, B, Söderberg, M, Carpenter, Jt, Murray, N, Royle, Gt, Simmonds, Pd, Crowley, J, Gralow, J, Green, S, Hortobagyi, G, Livingston, R, Martino, S, Osborne, Ck, Adolfsson, J, Bondesson, T, Celebioglu, F, Dahlberg, K, Fornander, T, Fredriksson, I, Frisell, J, Göransson, E, Iiristo, M, Johansson, U, Lenner, E, Löfgren, L, Nikolaidis, P, Perbeck, L, Rotstein, S, Sandelin, K, Skoog, L, Svane, G, af Trampe, E, Wadström, C, Maibach, R, Thürlimann, B, Hakama, M, Holli, K, Isola, J, Rouhento, K, Saaristo, R, Brenner, H, Hercbergs, A, Yoshimoto, M, Paterson, Ah, Fyles, A, Meakin, Jw, Panzarella, T, Bahi, J, Reid, M, Spittle, M, Bishop, H, Bundred, Nj, Forsyth, S, Pinder, Se, Sestak, I, Deutsch, Gp, Kwong, Dl, Pai, Vr, Senanayake, F, Boccardo, F, Rubagotti, A, Hackshaw, A, Houghton, J, Ledermann, J, Monson, K, Tobias, Js, Carlomagno, C, De Laurentiis, M, De Placido, S, Williams, L, Broglio, K, Buzdar, Au, Love, Rr, Ahlgren, J, Garmo, H, Holmberg, L, Liljegren, G, Lindman, H, Wärnberg, F, Asmar, L, Jones, Se, Gluz, O, Liedtke, C, Nitz, U, Litton, A, Wallgren, A, Karlsson, P, Linderholm, Bk, Chlebowski, Rt, Caffier, H, Mcgale, P, Correa, C, Taylor, C, Arriagada, R, Clarke, M, Cutter, D, Davies, C, Ewertz, M, Godwin, J, Gray, R, Pierce, L, Whelan, T, Wang, Y, Peto, R, Early Breast Cancer Trialists' Collaborative, Group, DE LAURENTIIS, Michelino, DE PLACIDO, Sabino, Carlomagno, Chiara, Darby, S, McGale, P, Interne Geneeskunde, RS: GROW - School for Oncology and Reproduction, Other departments, CCA -Cancer Center Amsterdam, and Radiotherapy
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Oncology ,medicine.medical_specialty ,Neoplasm Recurrence, Local - epidemiology ,medicine.medical_treatment ,Population ,Breast Neoplasms ,Mastectomy, Segmental ,Breast cancer ,breast cancer ,Internal medicine ,medicine ,Breast-conserving surgery ,Humans ,education ,skin and connective tissue diseases ,radiotherapy ,Randomized Controlled Trials as Topic ,education.field_of_study ,business.industry ,Estrogen Antagonists - therapeutic use ,Mortality rate ,Age Factors ,Estrogen Antagonists ,General Medicine ,Breast Neoplasms - mortality - therapy ,medicine.disease ,Surgery ,Unilateral Breast Neoplasms ,Radiation therapy ,Clinical trial ,meta-analysis ,Tamoxifen ,Receptors, Estrogen ,Lymphatic Metastasis ,Female ,Radiotherapy, Adjuvant ,Neoplasm Grading ,Neoplasm Recurrence, Local ,business ,Mastectomy - Abstract
BACKGROUND: After breast-conserving surgery, radiotherapy reduces recurrence and breast cancer death, but it may do so more for some groups of women than for others. We describe the absolute magnitude of these reductions according to various prognostic and other patient characteristics, and relate the absolute reduction in 15-year risk of breast cancer death to the absolute reduction in 10-year recurrence risk. METHODS: We undertook a meta-analysis of individual patient data for 10,801 women in 17 randomised trials of radiotherapy versus no radiotherapy after breast-conserving surgery, 8337 of whom had pathologically confirmed node-negative (pN0) or node-positive (pN+) disease. FINDINGS: Overall, radiotherapy reduced the 10-year risk of any (ie, locoregional or distant) first recurrence from 35.0% to 19.3% (absolute reduction 15.7%, 95% CI 13.7-17.7, 2p/=20%), intermediate (10-19%), or lower (, link_to_OA_fulltext
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- 2011
17. Pooled analysis of prognostic impact of uPA and PAI-1 in breast cancer patients
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Look M, van Putten W, Duffy M, Harbeck N, Ij, Christensen, Thomssen C, Kates R, Spyratos F, Fernö M, Eppenberger-Castori S, Cg, Fred Sweep, Ulm K, Jp, Peyrat, Pm, Martin, Magdelenat H, Brünner N, Catherine Duggan, Bw, Lisboa, Po, Bendahl, Quillien V, Daver A, Ricolleau G, Meijer-van Gelder M, Manders P, Edward Fiets W, Blankenstein M, Broët P, Romain S, Daxenbichler G, Windbichler G, Cufer T, Borstnar S, Kueng W, Beex L, Klijn J, O'Higgins N, Eppenberger U, Jänicke F, Schmitt M, Foekens J, Po, Bendah, Medical Oncology, and Internal Medicine
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Oncology ,medicine.medical_specialty ,Prognostic factor ,Mammary gland ,Breast Neoplasms ,Risk Assessment ,Sensitivity and Specificity ,Disease-Free Survival ,Metastasis ,chemistry.chemical_compound ,Risk groups ,Breast cancer ,SDG 3 - Good Health and Well-being ,Predictive Value of Tests ,Internal medicine ,Nodal status ,Plasminogen Activator Inhibitor 1 ,medicine ,Humans ,Neoplasm Metastasis ,Molecular diagnosis, prognosis and monitoring [UMCN 1.2] ,Endocrinology and reproduction [UMCN 5.2] ,business.industry ,Hematology ,Prognosis ,medicine.disease ,Survival Analysis ,Urokinase-Type Plasminogen Activator ,medicine.anatomical_structure ,Pooled analysis ,chemistry ,Plasminogen activator inhibitor-1 ,Multivariate Analysis ,Immunology ,Female ,Lymph Nodes ,business - Abstract
Item does not contain fulltext In this report we present an extension of the pooled analysis of the prognostic impact of urokinase-type plasminogen activator (uPA) and its inhibitor PAI-I in breast cancer patients. We analyzed a different endpoint, metastasis-free survival (MFS). We checked the consistency of the estimates for uPA and PAI-1 for relapse-free survival (RFS) and MFS exploring possible sources of heterogeneity. Nodal status, the most important prognostic factor for breast cancer, introduced heterogeneity in the uPA/PAI-1 survival analyses, reflecting the interaction between nodal status and uPA/PAI-1. The estimates for uPA and PAI-1 were found to be consistent, even when a different transformation of their values was used. The heterogeneity of the separate data sets decreased if the levels of uPA and PAI-1 were ranked, data sets were pooled, and the analyses corrected for the base model that included all traditional prognostic factors, and stratified by data set. We conclude that uPA and PAI-1 are ready to be used in the clinic to help classify breast cancer patients into high and low risk groups.
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- 2003
18. 216 (PB-040) Poster - AI-based smartphone App using a single-lead ECG for automated QTc diagnostics in oncology.
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Tonk, C.H., Schinköthe, T., Harbeck, N., Carmelo, V., Gomes Feliciano, J., Wuerstlein, R., Kümmel, S., and Schmidt, A.
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LONG QT syndrome diagnosis , *MOBILE apps , *ARTIFICIAL intelligence , *CONFERENCES & conventions , *SHORT QT syndrome , *ELECTROCARDIOGRAPHY , *AUTOMATION , *ONCOLOGY - Published
- 2022
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19. Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial
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J.Y. Hsu, Na Cui, Susan Dent, Sofia Sousa, Timothy R. Wilson, Véronique Diéras, William Jacot, Ian E. Krop, Frauke Schimmoller, M. De Laurentiis, Nadia Harbeck, Yunjoo Im, Jing He, J. Cortes, Pamela Drullinsky, Dent, S., Cortes, J., Im, Y. -H., Dieras, V., Harbeck, N., Krop, I. E., Wilson, T. R., Cui, N., Schimmoller, F., Hsu, J. Y., He, J., De Laurentiis, M., Sousa, S., Drullinsky, P., and Jacot, W.
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0301 basic medicine ,Receptor, ErbB-2 ,PIK3CA mutation ,Gastroenterology ,law.invention ,Phosphatidylinositol 3-Kinases ,0302 clinical medicine ,Randomized controlled trial ,law ,Antineoplastic Combined Chemotherapy Protocols ,Clinical endpoint ,Fulvestrant ,Class I Phosphatidylinositol 3-Kinase ,advanced breast cancer ,education.field_of_study ,Hazard ratio ,Imidazoles ,Hematology ,Receptors, Estrogen ,Oncology ,030220 oncology & carcinogenesis ,Female ,Breast Neoplasm ,Human ,medicine.drug ,medicine.medical_specialty ,Class I Phosphatidylinositol 3-Kinases ,medicine.drug_class ,Population ,Breast Neoplasms ,PI3K inhibitor ,Placebo ,03 medical and health sciences ,Internal medicine ,taselisib ,medicine ,Humans ,education ,Adverse effect ,Imidazole ,Antineoplastic Combined Chemotherapy Protocol ,Aromatase inhibitor ,Oxazepine ,business.industry ,Oxazepines ,030104 developmental biology ,Quality of Life ,Phosphatidylinositol 3-Kinase ,Neoplasm Recurrence, Local ,business - Abstract
Background The phase III SANDPIPER study assessed taselisib (GDC-0032), a potent, selective PI3K inhibitor, plus fulvestrant in estrogen receptor-positive, HER2-negative, PIK3CA-mutant locally advanced or metastatic breast cancer. Patients and methods Postmenopausal women with disease recurrence/progression during/after an aromatase inhibitor were randomized 2 : 1 to receive taselisib (4 mg; taselisib arm) or placebo (placebo arm) plus fulvestrant (500 mg). Stratification factors were visceral disease, endocrine sensitivity, and geographic region. Patients with PIK3CA-mutant tumors (central cobas® PIK3CA Mutation Test) were randomized separately from those without detectable mutations. The primary endpoint was investigator-assessed progression-free survival (INV-PFS) in patients with PIK3CA-mutant tumors. Secondary endpoints included objective response rate, overall survival, clinical benefit rate, duration of objective response, PFS by blinded independent central review (BICR-PFS), safety, and time to deterioration in health-related quality of life. Results The PIK3CA-mutant intention-to-treat population comprised 516 patients (placebo arm: n = 176; taselisib arm: n = 340). INV-PFS was significantly improved in the taselisib {7.4 months [95% confidence interval (CI), 7.26-9.07]} versus placebo arm (5.4 months [95% CI, 3.68-7.29]) (stratified hazard ratio [HR] 0.70; 95% CI, 0.56-0.89; P = 0.0037) and confirmed by BICR-PFS (HR 0.66). Secondary endpoints, including objective response rate, clinical benefit rate, and duration of objective response, showed consistent improvements in the taselisib arm. Safety was assessed in all randomized patients who received at least one dose of taselisib/placebo or fulvestrant regardless of PIK3CA-mutation status (n = 629). Serious adverse events were lower in the placebo versus taselisib arm (8.9% versus 32.0%). There were more discontinuations (placebo arm: 2.3%; taselisib arm: 16.8%) and dose reductions (placebo arm: 2.3%; taselisib arm: 36.5%) in the taselisib arm. Conclusion SANDPIPER met its primary endpoint; however, the combination of taselisib plus fulvestrant has no clinical utility given its safety profile and modest clinical benefit.
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- 2021
20. Gene signatures in patients with early breast cancer and relapse despite pathologic complete response
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Simona Bruzas, Oleg Gluz, Nadia Harbeck, Peter Schmid, Javier Cortés, Jens Blohmer, Christine Seiberling, Ouafaa Chiari, Hakima Harrach, Beyhan Ataseven, Satyendra Shenoy, Mark H. Dyson, Eugen Traut, Ingo Theuerkauf, Daniel Gebauer, Sherko Kuemmel, Mattea Reinisch, Institut Català de la Salut, [Bruzas S] Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Essen, Germany. [Gluz O] West German Study Group, Moenchengladbach, Germany. Breast Center Niederrhein, Evangelical Hospital Bethesda, Moenchengladbach, Germany. [Harbeck N] Breast Center, Dept. OB&GYN and CCCLMU, University of Munich (LMU), Munich, Germany. [Schmid P] Barts Cancer Institute, Queen Mary University London, London, United Kingdom. [Cortés J] International Breast Cancer Centre (IBCC), Quiron Group, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain. Medica Scientia Innovation Research (MEDSIR), Ridgewood, NJ, USA. [Blohmer J] Klinik für Gynäkologie mit Brustzentrum, Charité-Universitätsmedizin Berlin, Berlin, Germany, and Vall d'Hebron Barcelona Hospital Campus
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neoplasias::neoplasias por localización::neoplasias de la mama [ENFERMEDADES] ,neoplasias::procesos neoplásicos::recurrencia neoplásica local [ENFERMEDADES] ,Oncology ,Otros calificadores::Otros calificadores::/genética [Otros calificadores] ,Neoplasms::Neoplasms by Site::Breast Neoplasms [DISEASES] ,Other subheadings::Other subheadings::/genetics [Other subheadings] ,Neoplasms::Neoplastic Processes::Neoplasm Recurrence, Local [DISEASES] ,Mama - Càncer - Aspectes genètics ,Mama - Càncer - Recaiguda ,Pharmacology (medical) ,Radiology, Nuclear Medicine and imaging - Abstract
A substantial minority of early breast cancer (EBC) patients relapse despite their tumors achieving pathologic complete response (pCR) after neoadjuvant therapy. We compared gene expression (BC360; nCounter® platform; NanoString) between primary tumors of patients with post-pCR relapse (N = 14) with: (i) matched recurrent tumors from same patient (intraindividual analysis); and (ii) primary tumors from matched controls with pCR and no relapse (N = 41; interindividual analysis). Intraindividual analysis showed lower estrogen receptor signaling signature expression in recurrent tumors versus primaries (logFC = −0.595; P = 0.022). Recurrent tumors in patients with distant metastases also exhibited reduced expression of immune-related expression parameters. In interindividual analyses, primary tumor major histocompatibility complex class II expression was lower versus controls in patients with any relapse (logFC = −0.819; P = 0.030) or distant relapse (logFC = −1.151; P = 0.013). Primaries with later distant relapse also had greater homologous recombination deficiency than controls (logFC = 0.649; P = 0.026). Although no associations remained statistically significant following adjustment for false discovery rate, our results show that transcriptomic analyses have potential for prognostic value and may help in selecting optimal treatment regimens for EBC at risk of relapse and warrant further investigation.
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- 2022
21. Time-Dependent COVID-19 Mortality in Patients With Cancer: An Updated Analysis of the OnCovid Registry
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Gianpiero Rizzo, Eudald Felip, Annalisa Guida, Alessio Cortellini, Francesca Mazzoni, Rachel Sharkey, Alice Baggi, Emeline Colomba, Sabrina Rossi, Salvatore Grisanti, Federica Zoratto, David J. Pinato, Daniela Ferrante, Claudia Andrea Cruz, Giampero Porzio, Lorenzo Chiudinelli, Alessandra Gennari, Alexia Bertuzzi, Gianluca Gaidano, Joan Brunet, Johann Colomba, Alessia Dalla Pria, Nadia Harbeck, Raffaele Giusti, Alberto Zambelli, Angela Loizidou, Clara Martinez-Vila, Daniele Generali, Matteo Lambertini, Isabel Ruiz-Camps, Paola Queirolo, Michela Libertini, Ana Sanchez de Torre, Ailsa Sita-Lumsden, Laura Fox, Federica Biello, Javier Marco-Hernández, Nikolaos Diamantis, Elia Seguí, Lorenza Rimassa, Nadia Saoudi-Gonzalez, Ariadna Roqué Lloveras, Armando Santoro, John D. Chester, Mieke Van Hemelrijck, Carlo Tondini, Marco Krengli, Saoirse Dolly, Raquel Liñan, Elisa Roldán, Charlotte Moss, Diego Ottaviani, Fanny Pommeret, Uma Mukherjee, Andrea Patriarca, Aleix Prat, Joanne Evans, Rossana Berardi, Meera Patel, Mark Bower, Marco Tagliamento, Paolo Pedrazzoli, Juan Aguilar-Company, Lorenza Scotti, Bruno Vincenzi, Irina Earnshaw, M Carmen Carmona-García, Anna Pous, Thomas Newsom-Davis, Riccardo Bruna, Krishnie Srikandarajah, Rossella Bertulli, Josep Tabernero, Vittoria Fotia, Alessandro Parisi, Anna Sureda, Ramon Salazar, Beth Russell, Michela Franchi, Roxana Reyes, Pinato, D. J., Patel, M., Scotti, L., Colomba, E., Dolly, S., Loizidou, A., Chester, J., Mukherjee, U., Zambelli, A., Dalla Pria, A., Aguilar-Company, J., Bower, M., Salazar, R., Bertuzzi, A., Brunet, J., Lambertini, M., Tagliamento, M., Pous, A., Sita-Lumsden, A., Srikandarajah, K., Colomba, J., Pommeret, F., Segui, E., Generali, D., Grisanti, S., Pedrazzoli, P., Rizzo, G., Libertini, M., Moss, C., Evans, J. S., Russell, B., Harbeck, N., Vincenzi, B., Biello, F., Bertulli, R., Ottaviani, D., Linan, R., Rossi, S., Carmona-Garcia, M. C., Tondini, C., Fox, L., Baggi, A., Fotia, V., Parisi, A., Porzio, G., Queirolo, P., Cruz, C. A., Saoudi-Gonzalez, N., Felip, E., Roque Lloveras, A., Newsom-Davis, T., Sharkey, R., Roldan, E., Reyes, R., Zoratto, F., Earnshaw, I., Ferrante, D., Marco-Hernandez, J., Ruiz-Camps, I., Gaidano, G., Patriarca, A., Bruna, R., Sureda, A., Martinez-Vila, C., Sanchez De Torre, A., Berardi, R., Giusti, R., Mazzoni, F., Guida, A., Rimassa, L., Chiudinelli, L., Franchi, M., Krengli, M., Santoro, A., Prat, A., Tabernero, J., Van Hemelrijck, M., Diamantis, N., Gennari, A., and Cortellini, A.
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Male ,Cancer Research ,medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,solid cancer ,Internal medicine ,Neoplasms ,Tumor stage ,COVID-19 ,real-world data ,hematologic cancer ,medicine ,Humans ,In patient ,Registries ,Pandemics ,Aged ,Original Investigation ,business.industry ,SARS-CoV-2 ,Hazard ratio ,Outbreak ,Cancer ,Infant ,medicine.disease ,Female ,Oncology ,business ,Case series - Abstract
IMPORTANCE Whether the severity and mortality of COVID-19 in patients with cancer have improved in terms of disease management and capacity is yet to be defined. OBJECTIVE To test whether severity and mortality from COVID-19 among patients with cancer have improved during the course of the pandemic. DESIGN, SETTING, AND PARTICIPANTS OnCovid is a European registry that collects data on consecutive patients with solid or hematologic cancer and COVID-19. This multicenter case series study included real-world data from 35 institutions across 6 countries (UK, Italy, Spain, France, Belgium, and Germany). This update included patients diagnosed between February 27, 2020, and February, 14, 2021. Inclusion criteria were confirmed diagnosis of SARS-CoV-2 infection and a history of solid or hematologic cancer. EXPOSURES SARS-CoV-2 infection. MAIN OUTCOMES AND MEASURES Deaths were differentiated at 14 days and 3 months as the 2 landmark end points. Patient characteristics and outcomes were compared by stratifying patients across 5 phases (February to March 2020, April to June 2020, July to September 2020, October to December 2020, and January to February 2021) and across 2 major outbreaks (February to June 2020 and July 2020 to February 2021). RESULTS At data cutoff, 2795 consecutive patients were included, with 2634 patients eligible for analysis (median [IQR] age, 68 [18-77] years ; 52.8% men). Eligible patients demonstrated significant time-dependent improvement in 14-day case-fatality rate (CFR) with estimates of 29.8% (95% CI, 0.26-0.33) for February to March 2020; 20.3% (95% CI, 0.17-0.23) for April to June 2020;12.5% (95% Cl, 0.06-22.90) for July to September 2020; 17.2% (95% CI, 0.15-0.21) for October to December 2020; and 14.5% (95% CI, 0.09-0.21) for January to February 2021(all P < .001) across the predefined phases. Compared with the second major outbreak, patients diagnosed in the first outbreak were more likely to be 65 years or older (974 of 1626 [60.3%] vs 564 of 1008 [56.1%]; P = .03), have at least 2 comorbidities (793 of 1626 [48.8%) vs 427 of 1008 [42.4%); P = .001), and have advanced tumors (708 of 1626 [46.4%) vs 536 of 1008 [56.1%]: P < .001). Complications of COVID-19 were more likely to be seen (738 of 1626 [45.4%) vs 342 of 1008 [33.9%]; P < .001) and require hospitalization (969 of 1626 [59.8%) vs 418 of 1008 [42.1%); P < .001) and anti-COVID-19 therapy (1004 of 1626 [61.7%) vs 501of 1008 [49.7%); P < .001) during the first major outbreak. The 14-day CFRs for the first and second major outbreaks were 25.6% (95% CI, 0.23-0.28) vs 16.2% (95% CI, 0.13-0.19; P < .001), respectively. After adjusting for country, sex, age, comorbidities, tumor stage and status, anti-COVID-19 and anticancer therapy, and COVID-19 complications, patients diagnosed in the first outbreak had an increased risk of death at 14 days (hazard ratio [HR], 1.85; 95% CI, 1.47-2.32) and 3 months (HR, 1.28; 95% CI, 1.08-1.51) compared with those diagnosed in the second outbreak. CONCLUSIONS AND RELEVANCE The findings of this registry-based study suggest that mortality in patients with cancer diagnosed with COVID-19 has improved in Europe; this improvement may be associated with earlier diagnosis, improved management, and dynamic changes in community transmission over time.
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- 2021
22. Prevalence and impact of COVID-19 sequelae on treatment and survival of patients with cancer who recovered from SARS-CoV-2 infection: evidence from the OnCovid retrospective, multicentre registry study
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David J Pinato, Josep Tabernero, Mark Bower, Lorenza Scotti, Meera Patel, Emeline Colomba, Saoirse Dolly, Angela Loizidou, John Chester, Uma Mukherjee, Alberto Zambelli, Alessia Dalla Pria, Juan Aguilar-Company, Diego Ottaviani, Amani Chowdhury, Eve Merry, Ramon Salazar, Alexia Bertuzzi, Joan Brunet, Matteo Lambertini, Marco Tagliamento, Anna Pous, Ailsa Sita-Lumsden, Krishnie Srikandarajah, Johann Colomba, Fanny Pommeret, Elia Seguí, Daniele Generali, Salvatore Grisanti, Paolo Pedrazzoli, Gianpiero Rizzo, Michela Libertini, Charlotte Moss, Joanne S Evans, Beth Russell, Nadia Harbeck, Bruno Vincenzi, Federica Biello, Rossella Bertulli, Raquel Liñan, Sabrina Rossi, Maria Carmen Carmona-García, Carlo Tondini, Laura Fox, Alice Baggi, Vittoria Fotia, Alessandro Parisi, Giampero Porzio, Maristella Saponara, Claudia Andrea Cruz, David García-Illescas, Eudald Felip, Ariadna Roqué Lloveras, Rachel Sharkey, Elisa Roldán, Roxana Reyes, Irina Earnshaw, Daniela Ferrante, Javier Marco-Hernández, Isabel Ruiz-Camps, Gianluca Gaidano, Andrea Patriarca, Riccardo Bruna, Anna Sureda, Clara Martinez-Vila, Ana Sanchez de Torre, Luca Cantini, Marco Filetti, Lorenza Rimassa, Lorenzo Chiudinelli, Michela Franchi, Marco Krengli, Armando Santoro, Aleix Prat, Mieke Van Hemelrijck, Nikolaos Diamantis, Thomas Newsom-Davis, Alessandra Gennari, Alessio Cortellini, Judith Swallow, Chris Chung, Gino Dettorre, Neha Chopra, Alvin JX Lee, Christopher CT Sng, Yien Ning Sophia Wong, Myria Galazi, Sarah Benafif, Palma Dileo, Grisma Patel, Anjui Wu, Alasdair Sinclair, Gehan Soosaipillai, Eleanor Jones, Amanda Jackson, Martine Piccart, Emeline Colomba-Blameble, Claudia A Cruz, Elia Segui, David Garcia Illescas, Oriol Mirallas, Anna Carbó, Isabel Garcia, Rachel Wuerstlein, Ricard Mesia, Clara Maluquer, Francesca D'Avanzo, Giuseppe Tonini, Salvatore Provenzano, Valeria Tovazzi, Corrado Ficorella, Paola Queirolo, Raffaele Giusti, Francesca Mazzoni, Federica Zoratto, Marco Tucci, Rossana Berardi, Annalisa Guida, Sergio Bracarda, Maria Iglesias, Pinato, D. J., Tabernero, J., Bower, M., Scotti, L., Patel, M., Colomba, E., Dolly, S., Loizidou, A., Chester, J., Mukherjee, U., Zambelli, A., Dalla Pria, A., Aguilar-Company, J., Ottaviani, D., Chowdhury, A., Merry, E., Salazar, R., Bertuzzi, A., Brunet, J., Lambertini, M., Tagliamento, M., Pous, A., Sita-Lumsden, A., Srikandarajah, K., Colomba, J., Pommeret, F., Segui, E., Generali, D., Grisanti, S., Pedrazzoli, P., Rizzo, G., Libertini, M., Moss, C., Evans, J. S., Russell, B., Harbeck, N., Vincenzi, B., Biello, F., Bertulli, R., Linan, R., Rossi, S., Carmona-Garcia, M. C., Tondini, C., Fox, L., Baggi, A., Fotia, V., Parisi, A., Porzio, G., Saponara, M., Cruz, C. A., Garcia-Illescas, D., Felip, E., Roque Lloveras, A., Sharkey, R., Roldan, E., Reyes, R., Earnshaw, I., Ferrante, D., Marco-Hernandez, J., Ruiz-Camps, I., Gaidano, G., Patriarca, A., Bruna, R., Sureda, A., Martinez-Vila, C., Sanchez de Torre, A., Cantini, L., Filetti, M., Rimassa, L., Chiudinelli, L., Franchi, M., Krengli, M., Santoro, A., Prat, A., Van Hemelrijck, M., Diamantis, N., Newsom-Davis, T., Gennari, A., Cortellini, A., Swallow, J., Chung, C., Dettorre, G., Chopra, N., Lee, A. J., Sng, C. C., Wong, Y. N. S., Galazi, M., Benafif, S., Dileo, P., Patel, G., Wu, A., Sinclair, A., Soosaipillai, G., Jones, E., Jackson, A., Piccart, M., Colomba-Blameble, E., Garcia Illescas, D., Mirallas, O., Carbo, A., Garcia, I., Wuerstlein, R., Mesia, R., Maluquer, C., D'Avanzo, F., Tonini, G., Provenzano, S., Tovazzi, V., Ficorella, C., Queirolo, P., Giusti, R., Mazzoni, F., Zoratto, F., Tucci, M., Berardi, R., Guida, A., Bracarda, S., and Iglesias, M.
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Adult ,Aged ,Aged, 80 and over ,Antineoplastic Agents ,Belgium ,COVID-19 ,Disease Progression ,Female ,France ,Germany ,Hospitalization ,Humans ,Italy ,Kaplan-Meier Estimate ,Male ,Middle Aged ,Neoplasms ,Prevalence ,Registries ,Retrospective Studies ,Spain ,United Kingdom ,medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,Registry study ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,OnCovid ,cancer treatment ,Post-Acute COVID-19 Syndrome ,Internal medicine ,medicine ,80 and over ,In patient ,business.industry ,Cancer ,Retrospective cohort study ,Articles ,medicine.disease ,Oncology ,Research centre ,Population study ,business - Abstract
Background: The medium-term and long-term impact of COVID-19 in patients with cancer is not yet known. In this study, we aimed to describe the prevalence of COVID-19 sequelae and their impact on the survival of patients with cancer. We also aimed to describe patterns of resumption and modifications of systemic anti-cancer therapy following recovery from SARS-CoV-2 infection. Methods: OnCovid is an active European registry study enrolling consecutive patients aged 18 years or older with a history of solid or haematological malignancy and who had a diagnosis of RT-PCR confirmed SARS-CoV-2 infection. For this retrospective study, patients were enrolled from 35 institutions across Belgium, France, Germany, Italy, Spain, and the UK. Patients who were diagnosed with SARS-CoV-2 infection between Feb 27, 2020, and Feb 14, 2021, and entered into the registry at the point of data lock (March 1, 2021), were eligible for analysis. The present analysis was focused on COVID-19 survivors who underwent clinical reassessment at each participating institution. We documented prevalence of COVID-19 sequelae and described factors associated with their development and their association with post-COVID-19 survival, which was defined as the interval from post-COVID-19 reassessment to the patients’ death or last follow-up. We also evaluated resumption of systemic anti-cancer therapy in patients treated within 4 weeks of COVID-19 diagnosis. The OnCovid study is registered in ClinicalTrials.gov, NCT04393974. Findings: 2795 patients diagnosed with SARS-CoV-2 infection between Feb 27, 2020, and Feb 14, 2021, were entered into the study by the time of the data lock on March 1, 2021. After the exclusion of ineligible patients, the final study population consisted of 2634 patients. 1557 COVID-19 survivors underwent a formal clinical reassessment after a median of 22·1 months (IQR 8·4–57·8) from cancer diagnosis and 44 days (28–329) from COVID-19 diagnosis. 234 (15·0%) patients reported COVID-19 sequelae, including respiratory symptoms (116 [49·6%]) and residual fatigue (96 [41·0%]). Sequelae were more common in men (vs women; p=0·041), patients aged 65 years or older (vs other age groups; p=0·048), patients with two or more comorbidities (vs one or none; p=0·0006), and patients with a history of smoking (vs no smoking history; p=0·0004). Sequelae were associated with hospitalisation for COVID-19 (p
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- 2021
23. Anthracyclines Strike Back: Rediscovering Non-Pegylated Liposomal Doxorubicin in Current Therapeutic Scenarios of Breast Cancer
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Javier Cortes, Mariavittoria Locci, Daniele Generali, Diana Lüftner, Sergio Venturini, Lucia Del Mastro, Nadia Harbeck, Matteo Lambertini, Guy Jerusalem, Concetta Elisa Onesti, Francesco Schettini, Alessandra Gennari, Miguel Martin, Vivianne C. G. Tjan-Heijnen, Mario Giuliano, Rupert Bartsch, Giorgio Mustacchi, David J. Pinato, Khalil Zaman, Ahmad Awada, Sylvie Rottey, Mario Campone, Sabino De Placido, Ida Paris, Peter van Dam, Joseph Gligorov, Hans Wildiers, Giuseppe Curigliano, Institut Català de la Salut, [Schettini F] Translational Genomics and Targeted Therapies in Solid Tumors Research Group, Barcelona, Spain. Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain. [Giuliano M] Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy. [Lambertini M] Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Genova, Italy. Department of Medical Oncology, U.O.C Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Genova, Italy. [Bartsch R] Division of Oncology, Department of Medicine 1, Medical University of Vienna, Vienna, Austria. [Pinato DJ] Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK. Department of Translational Medicine, Università del Piemonte Orientale 'A. Avogadro', Novara, Italy. [Onesti CE] Clinical and Oncological Research Department, IRCCS Regina Elena National Cancer Institute, Rome, Italy. [Cortes J] Oncology Department, IOB Institute of Oncology, Quiron Group, 08023 Madrid, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus, Schettini, Francesco, Giuliano, Mario, Lambertini, Matteo, Bartsch, Rupert, Pinato, David Jame, Onesti, Concetta Elisa, Harbeck, Nadia, Lüftner, Diana, Rottey, Sylvie, van Dam, Peter A, Zaman, Khalil, Mustacchi, Giorgio, Gligorov, Joseph, Awada, Ahmad, Campone, Mario, Wildiers, Han, Gennari, Alessandra, Tjan-Heijnen, Vivianne C G, Cortes, Javier, Locci, Mariavittoria, Paris, Ida, Del Mastro, Lucia, De Placido, Sabino, Martín, Miguel, Jerusalem, Guy, Venturini, Sergio, Curigliano, Giuseppe, Generali, Daniele, Schettini, F., Giuliano, M., Lambertini, M., Bartsch, R., Pinato, D. J., Onesti, C. E., Harbeck, N., Luftner, D., Rottey, S., van Dam, P. A., Zaman, K., Mustacchi, G., Gligorov, J., Awada, A., Campone, M., Wildiers, H., Gennari, A., Tjan-heijnen, V. C. G., Cortes, J., Locci, M., Paris, I., Mastro, L. D., De Placido, S., Martin, M., Jerusalem, G., Venturini, S., Curigliano, G., and Generali, D.
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Oncology ,Cancer Research ,medicine.medical_treatment ,Non‐pegylated liposomal doxorubicin ,Neoplasms::Neoplasms by Site::Breast Neoplasms [DISEASES] ,EPIRUBICIN ,Review ,Anthracycline ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,Oncología ,Breast cancer ,CYCLOPHOSPHAMIDE ,Medicine and Health Sciences ,Endocrinología ,Other subheadings::/therapeutic use [Other subheadings] ,NAB-PACLITAXEL ,RC254-282 ,MULTICENTER TRIAL ,anthracyclines ,neoplasias::neoplasias por localización::neoplasias de la mama [ENFERMEDADES] ,PRIMARY ,TRASTUZUMAB PLUS DOCETAXEL ,terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,PHASE-III TRIAL ,Sciences bio-médicales et agricoles ,CHEMOTHERAPY ,metastatic ,Settore SECS-S/01 - STATISTICA ,Metastatic ,Epirubicin ,medicine.drug ,medicine.medical_specialty ,Cyclophosphamide ,Side effect ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,anthracycline ,Hormone receptor ,Quimioteràpia combinada ,triple negative ,Therapeutic index ,breast cancer ,Internal medicine ,Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,CONVENTIONAL DOXORUBICIN ,medicine ,Doxorubicin ,Chemotherapy ,Cardiotoxicity ,business.industry ,PRIMARY CHEMOTHERAPY ,Otros calificadores::/uso terapéutico [Otros calificadores] ,ENCAPSULATED DOXORUBICIN ,hormone receptor ,medicine.disease ,Anthracyclines ,Triple negative ,Cancérologie ,Mama - Càncer - Tractament ,Human medicine ,1ST-LINE THERAPY ,business ,non-pegylated liposomal doxorubicin - Abstract
Anthracyclines are among the most active chemotherapies (CT) in breast cancer (BC). However, cardiotoxicity is a risk and peculiar side effect that has been limiting their use in clinical practice, especially after the introduction of taxanes. Non‐pegylated liposomal doxorubicin (NPLD) has been developed to optimize the toxicity profile induced by anthracyclines, while maintaining its unquestionable therapeutic index, thanks to its delivering characteristics that increase its diffusion in tumor tissues and reduce it in normal tissues. This feature allows NPLD to be safely administered beyond the standard doxorubicin maximum cumulative dose of 450–480 mg/m2. Following three pivotal first‐line phase III trials in HER2‐negative metastatic BC (MBC), this drug was finally approved in combination with cyclophosphamide in this specific setting. Given the increasing complexity of the therapeutic scenario of HER2‐negative MBC, we have carefully revised the most updated literature on the topic and dissected the potential role of NPLD in the evolving therapeutic algorithms., SCOPUS: re.j, info:eu-repo/semantics/published
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- 2021
24. Adjuvant bisphosphonates in early breast cancer: consensus guidance for clinical practice from a European Panel.
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Hadji, P., Coleman, R. E., Wilson, C., Powles, T. J., Clézardin, P., Aapro, M., Costa, L., Body, J.-J., Markopoulos, C., Santini, D., Diel, I., Di Leo, A., Cameron, D., Dodwell, D., Smith, I., Gnant, M., Gray, R., Harbeck, N., Thurlimann, B., and Untch, M.
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BREAST cancer , *DIPHOSPHONATES , *BREAST cancer surgery , *COMEDO carcinoma , *CANCER , *TUMORS , *ONCOLOGY - Abstract
Bisphosphonates have been studied in randomised trials in early breast cancer to investigate their ability to prevent cancer treatment-induced bone loss (CTIBL) and reduce the risk of disease recurrence and metastasis. Treatment benefits have been reported but bisphosphonates do not currently have regulatory approval for either of these potential indications. This consensus paper provides a review of the evidence and offers guidance to breast cancer clinicians on the use of bisphosphonates in early breast cancer. Using the nominal group methodology for consensus, a systematic review of the literature was augmented by a workshop held in October 2014 for breast cancer and bone specialists to present and debate the available pre-clinical and clinical evidence for the use of adjuvant bisphosphonates. This was followed by a questionnaire to all members of the writing committee to identify areas of consensus. The panel recommended that bisphosphonates should be considered as part of routine clinical practice for the prevention of CTIBL in all patients with a T score of <-2.0 or ⩾2 clinical risk factors for fracture. Compelling evidence from a meta-analysis of trial data of >18 000 patients supports clinically significant benefits of bisphosphonates on the development of bone metastases and breast cancer mortality in post-menopausal women or those receiving ovarian suppression therapy. Therefore, the panel recommends that bisphosphonates (either intravenous zoledronic acid or oral clodronate) are considered as part of the adjuvant breast cancer treatment in this population and the potential benefits and risks discussed with relevant patients. [ABSTRACT FROM AUTHOR]
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- 2016
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25. Increasing the dose intensity of chemotherapy by more frequent administration or sequential scheduling: a patient-level meta-analysis of 37 298 women with early breast cancer in 26 randomised trials
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Richard Gray, Rosie Bradley, Jeremy Braybrooke, Zulian Liu, Richard Peto, Lucy Davies, David Dodwell, Paul McGale, Hongchao Pan, Carolyn Taylor, William Barlow, Judith Bliss, Paolo Bruzzi, David Cameron, George Fountzilas, Sibylle Loibl, John Mackey, Miguel Martin, Lucia Del Mastro, Volker Möbus, Valentina Nekljudova, Sabino De Placido, Sandra Swain, Michael Untch, Kathleen I Pritchard, Jonas Bergh, Larry Norton, Clare Boddington, Julie Burrett, Mike Clarke, Christina Davies, Fran Duane, Vaughan Evans, Lucy Gettins, Jon Godwin, Robert Hills, Sam James, Hui Liu, Elizabeth MacKinnon, Gurdeep Mannu, Theresa McHugh, Philip Morris, Simon Read, Yaochen Wang, Zhe Wang, Peter Fasching, Nadia Harbeck, Pascal Piedbois, Michael Gnant, Guenther Steger, Angelo Di Leo, Stella Dolci, Prue Francis, Denis Larsimont, Jean Marie Nogaret, Catherine Philippson, Martine Piccart, Sabine Linn, Petronella Peer, Vivianne Tjan-Heijnen, Sonja Vliek, Dennis Slamon, John Bartlett, Vivien H Bramwell, Bingshu Chen, Stephen Chia, Karen Gelmon, Paul Goss, Mark Levine, Wendy Parulekar, Joseph Pater, Eileen Rakovitch, Lois Shepherd, Dongsheng Tu, Tim Whelan, Don Berry, Gloria Broadwater, Constance Cirrincione, Hyman Muss, Raymond Weiss, Yi Shan, Yong Fu Shao, Xiang Wang, Binghe Xu, Dong-Bing Zhao, Harry Bartelink, Nina Bijker, Jan Bogaerts, Fatima Cardoso, Tanja Cufer, Jean-Pierre Julien, Philip Poortmans, Emiel Rutgers, Cornelis van de Velde, Eva Carrasco, Miguel Angel Segui, Jens Uwe Blohmer, Serban Costa, Bernd Gerber, Christian Jackisch, Gunter von Minckwitz, Mario Giuliano, Michele De Laurentiis, Christina Bamia, Georgia-Angeliki Koliou, Dimitris Mavroudis, Roger A'Hern, Paul Ellis, Lucy Kilburn, James Morden, John Yarnold, Mohammad Sadoon, Augustinus H Tulusan, Stewart Anderson, Gordon Bass, Joe Costantino, James Dignam, Bernard Fisher, Charles Geyer, Eleftherios P Mamounas, Soon Paik, Carol Redmond, D Lawrence Wickerham, Marco Venturini, Claudia Bighin, Simona Pastorino, Paolo Pronzato, Mario Roberto Sertoli, Theodorus Foukakis, Kathy Albain, Rodrigo Arriagada, Elizabeth Bergsten Nordström, Francesco Boccardo, Etienne Brain, Lisa Carey, Alan Coates, Robert Coleman, Candace Correa, Jack Cuzick, Nancy Davidson, Mitch Dowsett, Marianne Ewertz, John Forbes, Richard Gelber, Aron Goldhirsch, Pamela Goodwin, Daniel Hayes, Catherine Hill, James Ingle, Reshma Jagsi, Wolfgang Janni, Hirofumi Mukai, Yasuo Ohashi, Lori Pierce, Vinod Raina, Peter Ravdin, Daniel Rea, Meredith Regan, John Robertson, Joseph Sparano, Andrew Tutt, Giuseppe Viale, Nicholas Wilcken, Norman Wolmark, Wiliam Wood, Milvia Zambetti, Gray, R., Bradley, R., Braybrooke, J., Liu, Z., Peto, R., Davies, L., Dodwell, D., Mcgale, P., Pan, H., Taylor, C., Barlow, W., Bliss, J., Bruzzi, P., Cameron, D., Fountzilas, G., Loibl, S., Mackey, J., Martin, M., Del Mastro, L., Mobus, V., Nekljudova, V., De Placido, S., Swain, S., Untch, M., Pritchard, K. I., Bergh, J., Norton, L., Boddington, C., Burrett, J., Clarke, M., Davies, C., Duane, F., Evans, V., Gettins, L., Godwin, J., Hills, R., James, S., Liu, H., Mackinnon, E., Mannu, G., Mchugh, T., Morris, P., Read, S., Wang, Y., Wang, Z., Fasching, P., Harbeck, N., Piedbois, P., Gnant, M., Steger, G., Di Leo, A., Dolci, S., Francis, P., Larsimont, D., Nogaret, J. M., Philippson, C., Piccart, M., Linn, S., Peer, P., Tjan-Heijnen, V., Vliek, S., Slamon, D., Bartlett, J., Bramwell, V. H., Chen, B., Chia, S., Gelmon, K., Goss, P., Levine, M., Parulekar, W., Pater, J., Rakovitch, E., Shepherd, L., Tu, D., Whelan, T., Berry, D., Broadwater, G., Cirrincione, C., Muss, H., Weiss, R., Shan, Y., Shao, Y. F., Wang, X., Xu, B., Zhao, D. -B., Bartelink, H., Bijker, N., Bogaerts, J., Cardoso, F., Cufer, T., Julien, J. -P., Poortmans, P., Rutgers, E., van de Velde, C., Carrasco, E., Segui, M. A., Blohmer, J. U., Costa, S., Gerber, B., Jackisch, C., von Minckwitz, G., Giuliano, M., De Laurentiis, M., Bamia, C., Koliou, G. -A., Mavroudis, D., A'Hern, R., Ellis, P., Kilburn, L., Morden, J., Yarnold, J., Sadoon, M., Tulusan, A. H., Anderson, S., Bass, G., Costantino, J., Dignam, J., Fisher, B., Geyer, C., Mamounas, E. P., Paik, S., Redmond, C., Wickerham, D. L., Venturini, M., Bighin, C., Pastorino, S., Pronzato, P., Sertoli, M. R., Foukakis, T., Albain, K., Arriagada, R., Bergsten Nordstrom, E., Boccardo, F., Brain, E., Carey, L., Coates, A., Coleman, R., Correa, C., Cuzick, J., Davidson, N., Dowsett, M., Ewertz, M., Forbes, J., Gelber, R., Goldhirsch, A., Goodwin, P., Hayes, D., Hill, C., Ingle, J., Jagsi, R., Janni, W., Mukai, H., Ohashi, Y., Pierce, L., Raina, V., Ravdin, P., Rea, D., Regan, M., Robertson, J., Sparano, J., Tutt, A., Viale, G., Wilcken, N., Wolmark, N., Wood, W., and Zambetti, M.
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Oncology ,treatment schedule ,medicine.medical_specialty ,Anthracycline ,medicine.medical_treatment ,novotvorbe dojk ,Antineoplastic Agents ,Breast Neoplasms ,režim zdravljenja ,Disease ,randomized trials ,030204 cardiovascular system & hematology ,chemotherapy ,meta-analiza ,klinični protokoli ,Drug Administration Schedule ,randomizirane raziskave ,Antineoplastic Agent ,03 medical and health sciences ,breast cancer ,0302 clinical medicine ,Breast cancer ,Internal medicine ,breast neoplasms ,medicine ,Humans ,clinical protocols ,terapija z zdravili ,030212 general & internal medicine ,Early breast cancer ,Chemotherapy ,Taxane ,business.industry ,rak dojk ,kemoterapija ,General Medicine ,medicine.disease ,Dose intensity ,udc:618.19-006 ,drug therapy ,meta-analysis ,Meta-analysis ,Female ,women ,ženske ,business ,Breast Neoplasm - Abstract
Background Increasing the dose intensity of cytotoxic therapy by shortening the intervals between cycles, or by giving individual drugs sequentially at full dose rather than in lower-dose concurrent treatment schedules, might enhance efficacy. Methods To clarify the relative benefits and risks of dose-intense and standard-schedule chemotherapy in early breast cancer, we did an individual patient-level meta-analysis of trials comparing 2-weekly versus standard 3-weekly schedules, and of trials comparing sequential versus concurrent administration of anthracycline and taxane chemotherapy. The primary outcomes were recurrence and breast cancer mortality. Standard intention-to-treat log-rank analyses, stratified by age, nodal status, and trial, yielded dose-intense versus standard-schedule first-event rate ratios (RRs). Findings Individual patient data were provided for 26 of 33 relevant trials identified, comprising 37 298 (93%) of 40 070 women randomised. Most women were aged younger than 70 years and had node-positive disease. Total cytotoxic drug usage was broadly comparable in the two treatment arms; colony-stimulating factor was generally used in the more dose-intense arm. Combining data from all 26 trials, fewer breast cancer recurrences were seen with dose-intense than with standard-schedule chemotherapy (10-year recurrence risk 28·0% vs 31·4%; RR 0·86, 95% CI 0·82–0·89; p Interpretation Increasing the dose intensity of adjuvant chemotherapy by shortening the interval between treatment cycles, or by giving individual drugs sequentially rather than giving the same drugs concurrently, moderately reduces the 10-year risk of recurrence and death from breast cancer without increasing mortality from other causes.
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- 2019
26. COVID-19 in breast cancer patients: a subanalysis of the OnCovid registry
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Laia Garrigós, Cristina Saura, Clara Martinez-Vila, Alberto Zambelli, Mark Bower, Barbara Pistilli, Matteo Lambertini, Diego Ottaviani, Nikolaos Diamantis, Ailsa Lumsden, Sonia Pernas, Daniele Generali, Elia Seguí, Gemma Viñas, Eudald Felip, Ana Sanchez, Gianpiero Rizzo, Armando Santoro, Alessio Cortellini, Ylenia Perone, John Chester, Maria Iglesias, Marta Betti, Bruno Vincenzi, Michela Libertini, Francesca Mazzoni, Federica Zoratto, Rossana Berardi, Annalisa Guida, Rachel Wuerstlein, Angela Loizidou, Rachel Sharkey, Juan Aguilar Company, Marta Matas, Chiara Saggia, Lorenzo Chiudinelli, Emeline Colomba-Blameble, Myria Galazi, Uma Mukherjee, Mieke Van Hemelrijck, Mar Marin, Carla Strina, Aleix Prat, Helena Pla, Eva Maria Ciruelos, Alexia Bertuzzi, Lucia del Mastro, Giampiero Porzio, Thomas Newsom-Davis, Isabel Ruiz, Maria Belen Delany, Marco Krengli, Vittoria Fotia, Alessandro Viansone, Neha Chopra, Margarita Romeo, Ramon Salazar, Ignacio Perez, Francesca d’Avanzo, Michela Franchi, Manuela Milani, Fanny Pommeret, Marco Tucci, Paolo Pedrazzoli, Nadia Harbeck, Daniela Ferrante, David J. Pinato, Alessandra Gennari, Garrigos, L., Saura, C., Martinez-Vila, C., Zambelli, A., Bower, M., Pistilli, B., Lambertini, M., Ottaviani, D., Diamantis, N., Lumsden, A., Pernas, S., Generali, D., Segui, E., Vinas, G., Felip, E., Sanchez, A., Rizzo, G., Santoro, A., Cortellini, A., Perone, Y., Chester, J., Iglesias, M., Betti, M., Vincenzi, B., Libertini, M., Mazzoni, F., Zoratto, F., Berardi, R., Guida, A., Wuerstlein, R., Loizidou, A., Sharkey, R., Aguilar Company, J., Matas, M., Saggia, C., Chiudinelli, L., Colomba-Blameble, E., Galazi, M., Mukherjee, U., Van Hemelrijck, M., Marin, M., Strina, C., Prat, A., Pla, H., Ciruelos, E. M., Bertuzzi, A., del Mastro, L., Porzio, G., Newsom-Davis, T., Ruiz, I., Delany, M. B., Krengli, M., Fotia, V., Viansone, A., Chopra, N., Romeo, M., Salazar, R., Perez, I., D'Avanzo, F., Franchi, M., Milani, M., Pommeret, F., Tucci, M., Pedrazzoli, P., Harbeck, N., Ferrante, D., Pinato, D. J., Gennari, A., Institut Català de la Salut, [Garrigós L] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Saura C] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Head Breast Cancer Unit, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Martinez-Vila C] Department of Oncology, Hospital Althaia Manresa, Barcelona, Spain. [Zambelli A] Oncology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy. [Bower M] Department of Oncology and National Centre for HIV Malignancy, Chelsea and Westminster Hospital, London, UK. [Pistilli B] Department of Medical Oncology, Institute Gustave-Roussy, Villejuif, France. [Aguilar Company J] Servei d’Oncologia Mèdica i Servei de Malalties Infeccioses, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Ruiz I] Servei de Malalties Infeccioses, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Pla H] Departament d'Oncologia Institut Català d'Oncologia, Hospital Universitari de Girona Doctor Josep Trueta, Institut Català de la Salut (ICS), Girona, Spain, and Vall d'Hebron Barcelona Hospital Campus
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medicine.medical_specialty ,Outcome assessment (Medical care) ,breast cancer ,COVID-19 ,COVID-19 outcomes ,OnCovid ,SARS-CoV-2 ,Neoplasms::Neoplasms by Site::Breast Neoplasms [DISEASES] ,Population ,Context (language use) ,COVID-19 (Malaltia) - Mortalitat ,Disease ,técnicas de investigación::métodos epidemiológicos::recopilación de datos::estadísticas vitales::mortalidad [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Càncer de mama ,Otros calificadores::Otros calificadores::/complicaciones [Otros calificadores] ,Breast cancer ,Mama - Càncer ,Internal medicine ,virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES] ,Medicine ,education ,COVID-19 outcome ,RC254-282 ,COVID-19 (Malaltia) - Complicacions ,Original Research ,education.field_of_study ,neoplasias::neoplasias por localización::neoplasias de la mama [ENFERMEDADES] ,business.industry ,Mortality rate ,Cancer ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES] ,medicine.disease ,Comorbidity ,Oncology ,Investigative Techniques::Epidemiologic Methods::Data Collection::Vital Statistics::Mortality [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Avaluació de resultats (Assistència mèdica) ,business ,Complication ,Other subheadings::Other subheadings::/complications [Other subheadings] - Abstract
COVID-19; SARS-CoV-2; Cáncer de mama COVID-19; SARS-CoV-2; Càncer de mama COVID-19; SARS-CoV-2; Breast cancer Background: Cancer patients are at higher risk of COVID-19 complications and mortality than the rest of the population. Breast cancer patients seem to have better prognosis when infected by SARS-CoV-2 than other cancer patients. Methods: We report a subanalysis of the OnCovid study providing more detailed information in the breast cancer population. Results: We included 495 breast cancer patients with a SARS-CoV-2 infection. Mean age was 62.6 years; 31.5% presented more than one comorbidity. The most frequent breast cancer subtype was luminal-like (n = 245, 49.5%) and 177 (35.8%) had metastatic disease. A total of 332 (67.1%) patients were receiving active treatment, with radical intent in 232 (47.6%) of them. Hospitalization rate was 58.2% and all-cause mortality rate was 20.3%. One hundred twenty-nine (26.1%) patients developed one COVID-19 complication, being acute respiratory failure the most common (n = 74, 15.0%). In the multivariable analysis, age older than 70 years, presence of COVID-19 complications, and metastatic disease were factors correlated with worse outcomes, while ongoing anticancer therapy at time of COVID-19 diagnosis appeared to be a protective factor. No particular oncological treatment was related to higher risk of complications. In the context of SARS-CoV-2 infection, 73 (18.3%) patients had some kind of modification on their oncologic treatment. At the first oncological reassessment (median time: 46.9 days ± 36.7), 255 (51.6%) patients reported to be fully recovered from the infection. There were 39 patients (7.9%) with long-term SARS-CoV-2-related complications. Conclusion: In the context of COVID-19, our data confirm that breast cancer patients appear to have lower complications and mortality rate than expected in other cancer populations. Most breast cancer patients can be safely treated for their neoplasm during SARS-CoV-2 pandemic. Oncological treatment has no impact on the risk of SARS-CoV-2 complications, and, especially in the curative setting, the treatment should be modified as little as possible. D.J. Pinato is supported by grant funding from the Wellcome Trust Strategic Fund (PS3416) and acknowledges grant support from the Cancer Treatment and Research Trust (CTRT), infrastructural and grant support by the Cancer Research UK Imperial Centre and the NIHR Imperial Biomedical Research Centre. A. Gennari is supported by the AIRC IG Grant, No. 14230, Associazione Italiana per la Ricerca sul Cancro Foundation, Milan, Italy and acknowledge also support from the UPO Aging Project.
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- 2021
27. Systemic pro-inflammatory response identifies patients with cancer with adverse outcomes from SARS-CoV-2 infection: the OnCovid Inflammatory Score
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Dettorre, Gino M., Dolly, Saoirse, Loizidou, Angela, Chester, John, Jackson, Amanda, Mukherjee, Uma, Zambelli, Alberto, Aguilar Company, Juan, Bower, Mark, Sng, Christopher C. T., Salazar Soler, Ramón, Bertuzzi, Alexia, Brunet, Joan, Mesia, Ricard, Sita-Lumsden, Ailsa, Seguí, Elia, Biello, Federica, Generali, Daniele, Grisanti, Salvatore, Seeva, Pavetha, Rizzo, Gianpiero, Libertini, Michela, Maconi, Antonio, Moss, Charlotte, Russell, Beth, Harbeck, Nadia, Vincenzi, Bruno, Bertulli, Rossella, Ottaviani, Diego, Liñan, Raquel, Marrari, Andrea, Carmona García, M. Carmen, Chopra, Neha, Tondini, Carlo Alberto, Mirallas, Oriol, Tovazzi, Valeria, Fotia, Vittoria, Cruz, Claudia Andrea, Saoudi González, Nadia, Felip, Eudald, Roqué, Ariadna, Lee, Alvin J. X., Newsom-Davis, Tom, García Illescas, David, Reyes, Roxana, Wong, Yien Ning Sophia, Ferrante, Daniela, Scotti, Lorenza, Marco Hernández, Javier, Ruiz Camps, Isabel, Patriarca, Andrea, Rimassa, Lorenza, Chiudinelli, Lorenzo, Franchi, Michela, Santoro, Armando, Prat Aparicio, Aleix, Gennari, Alessandra, Van Hemelrijck, Mieke, Tabernero Caturla, Josep, Diamantis, Nikolaos, Pinato, David J., OnCovid study group, Dettorre, G. M., Dolly, S., Loizidou, A., Chester, J., Jackson, A., Mukherjee, U., Zambelli, A., Aguilar-Company, J., Bower, M., Sng, C. C. T., Salazar, R., Bertuzzi, A., Brunet, J., Mesia, R., Sita-Lumsden, A., Segui, E., Biello, F., Generali, D., Grisanti, S., Seeva, P., Rizzo, G., Libertini, M., Maconi, A., Moss, C., Russell, B., Harbeck, N., Vincenzi, B., Bertulli, R., Ottaviani, D., Linan, R., Marrari, A., Carmen Carmona-Garcia, M., Chopra, N., Tondini, C. A., Mirallas, O., Tovazzi, V., Fotia, V., Cruz, C. A., Saoudi-Gonzalez, N., Felip, E., Roque, A., Lee, A. J. X., Newsom-Davis, T., Garcia-Illescas, D., Reyes, R., Wong, Y. N. S., Ferrante, D., Scotti, L., Marco-Hernandez, J., Ruiz-Camps, I., Patriarca, A., Rimassa, L., Chiudinelli, L., Franchi, M., Santoro, A., Prat, A., Gennari, A., Van Hemelrijck, M., Tabernero, J., Diamantis, N., Pinato, D. J., Wellcome Trust, Institut Català de la Salut, [Dettorre GM] Department of Surgery and Cancer, Imperial College London, Hammersmith Hospital, London, UK. [Dolly S] Medical Oncology, Guy’s and St Thomas’ NHS Foundation Trust (GSTT), London, UK. [Loizidou A] Department of Infectious Diseases, Internal Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium. [Chester J] Medical Oncology, School of Medicine, Cardiff University, Cardiff, UK. Medical Oncology, Velindre Cancer Centre, Cardiff, UK. [Jackson A] Clinical Trials, Velindre Cancer Centre, Cardiff, UK. [Mukherjee U] Medical Oncology, Barts Health NHS Trust, London, UK. [Aguilar-Company J] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Servei de Malalties Infeccioses, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Mirallas O, Saoudi-Gonzalez N, García-Illescas D] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Ruiz-Camps I] Servei de Malalties Infeccioses, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Tabernero J] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. IOB-Quiron, UVic-UCC, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
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Male ,0301 basic medicine ,Oncology ,Cancer Research ,Comorbidity ,Systemic inflammation ,Otros calificadores::Otros calificadores::/complicaciones [Otros calificadores] ,COVID-19 Testing ,0302 clinical medicine ,Neoplasms ,Immunotherapy Biomarkers ,virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES] ,80 and over ,Immunology and Allergy ,Medicine ,Hypoalbuminemia ,Young adult ,Càncer ,Multivariate Analysi ,RC254-282 ,COVID-19 (Malaltia) - Complicacions ,Cancer ,Aged, 80 and over ,OnCovid study group ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES] ,Middle Aged ,Prognosis ,Inflamació ,Systemic Inflammatory Response Syndrome ,030220 oncology & carcinogenesis ,Cohort ,Pathological Conditions, Signs and Symptoms::Pathologic Processes::Inflammation::Systemic Inflammatory Response Syndrome [DISEASES] ,Molecular Medicine ,Female ,medicine.symptom ,Life Sciences & Biomedicine ,Human ,Adult ,medicine.medical_specialty ,Prognosi ,Càncer - Epidemiologia ,Immunology ,neoplasias [ENFERMEDADES] ,inflammation mediator ,Young Adult ,03 medical and health sciences ,Internal medicine ,Humans ,afecciones patológicas, signos y síntomas::procesos patológicos::inflamación::síndrome de respuesta inflamatoria sistémica [ENFERMEDADES] ,Aged ,Pharmacology ,Science & Technology ,business.industry ,SARS-CoV-2 ,COVID-19 ,medicine.disease ,inflammation ,inflammation mediators ,Blood Cell Count ,Multivariate Analysis ,Neoplasms [DISEASES] ,Systemic inflammatory response syndrome ,030104 developmental biology ,Neoplasm ,Lymphocytopenia ,business ,Other subheadings::Other subheadings::/complications [Other subheadings] - Abstract
Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Inflamació; Mediadors d'inflamació Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Inflamación; Mediadores de la inflamación Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Inflammation; Inflammation mediators Background Patients with cancer are particularly susceptible to SARS-CoV-2 infection. The systemic inflammatory response is a pathogenic mechanism shared by cancer progression and COVID-19. We investigated systemic inflammation as a driver of severity and mortality from COVID-19, evaluating the prognostic role of commonly used inflammatory indices in SARS-CoV-2-infected patients with cancer accrued to the OnCovid study. Methods In a multicenter cohort of SARS-CoV-2-infected patients with cancer in Europe, we evaluated dynamic changes in neutrophil:lymphocyte ratio (NLR); platelet:lymphocyte ratio (PLR); Prognostic Nutritional Index (PNI), renamed the OnCovid Inflammatory Score (OIS); modified Glasgow Prognostic Score (mGPS); and Prognostic Index (PI) in relation to oncological and COVID-19 infection features, testing their prognostic potential in independent training (n=529) and validation (n=542) sets. Results We evaluated 1071 eligible patients, of which 625 (58.3%) were men, and 420 were patients with malignancy in advanced stage (39.2%), most commonly genitourinary (n=216, 20.2%). 844 (78.8%) had ≥1 comorbidity and 754 (70.4%) had ≥1 COVID-19 complication. NLR, OIS, and mGPS worsened at COVID-19 diagnosis compared with pre-COVID-19 measurement (p
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- 2021
28. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study
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N. Harbeck, P. Rastogi, M. Martin, S.M. Tolaney, Z.M. Shao, P.A. Fasching, C.S. Huang, G.G. Jaliffe, A. Tryakin, M.P. Goetz, H.S. Rugo, E. Senkus, L. Testa, M. Andersson, K. Tamura, L. Del Mastro, G.G. Steger, H. Kreipe, R. Hegg, J. Sohn, V. Guarneri, J. Cortés, E. Hamilton, V. André, R. Wei, S. Barriga, S. Sherwood, T. Forrester, M. Munoz, A. Shahir, B. San Antonio, S.C. Nabinger, M. Toi, S.R.D. Johnston, J. O’Shaughnessy, M.M. Jimenez, S. Johnston, F. Boyle, P. Neven, Z. Jiang, M. Campone, J. Huober, C. Shimizu, I. Cicin, A. Wardley, G.G. Abuin, J. Zarba, E. Lim, P. Sant, N. Liao, B. Christiansen, N. Eigeliene, J. Martin-Babau, J. Ettl, D. Mavroudis, J. Chiu, K. Boer, R. Nagarkar, S. Paluch-Shimon, L. Moscetti, Y. Sagara, S.-B. Kim, M.M. Maciel, V. Tjan-Heijnen, R. Broom, A. Lacko, M. Schenker, N. Volkov, Y. Sim Yap, M. Coccia-Portugal, J. Ángel García Sáenz, A. Andersson, T.-Y. Chao, E. Gokmen, H. Harputluoglu, O. Berzoy, D. Patt, H. McArthur, H. Chew, P. Chalasani, P. Kaufman, K. Tedesco, S.L. Graff, Institut Català de la Salut, [Harbeck N] Breast Center, Department of OB & GYN and CCC Munich, LMU University Hospital, Munich, Germany. [Rastogi P] University of Pittsburgh/UPMC, NSABP Foundation, Pittsburgh, USA. [Martin M] Hospital General Universitario Gregorio Marañon, Universidad Complutense, CIBERONC, GEICAM, Madrid, Spain. [Tolaney SM] Dana-Farber Cancer Institute, Boston, USA. [Shao ZM] Fudan University Shanghai Cancer Center, Shanghai, China. [Fasching PA] University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany. [Cortés J] International Breast Cancer Center (IBCC), Madrid & Barcelona. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine, Madrid, Spain, and Vall d'Hebron Barcelona Hospital Campus
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Oncology ,Receptor, ErbB-2 ,abemaciclib ,adjuvant ,CDK4/6 ,early breast cancer ,Ki-67 ,Aminopyridines ,Antineoplastic Combined Chemotherapy Protocols ,Benzimidazoles ,Chemotherapy, Adjuvant ,Disease-Free Survival ,Female ,Humans ,Ki-67 Antigen ,Neoplasm Recurrence, Local ,Breast Neoplasms ,medicine.medical_treatment ,Neoplasms::Neoplasms by Site::Breast Neoplasms [DISEASES] ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,chemistry.chemical_compound ,Tratamiento médico ,ErbB-2 ,Clinical endpoint ,Other subheadings::/therapeutic use [Other subheadings] ,Abemaciclib ,education.field_of_study ,neoplasias::neoplasias por localización::neoplasias de la mama [ENFERMEDADES] ,biology ,terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Hematology ,Cáncer ,medicine.anatomical_structure ,Local ,Cohort ,Neoplasias de la mama ,Adjuvant ,Receptor ,medicine.medical_specialty ,Axillary lymph nodes ,Mujer ,Population ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,Quimioteràpia combinada ,Internal medicine ,Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,medicine ,Chemotherapy ,education ,business.industry ,Otros calificadores::/uso terapéutico [Otros calificadores] ,Interim analysis ,Neoplasm Recurrence ,chemistry ,Mama - Càncer - Tractament ,biology.protein ,business - Abstract
Abemaciclib; Adjuvant; Early breast cancer Abemaciclib; Adjuvant; Càncer de mama precoç Abemaciclib; Adyuvante; Cáncer de mama precoz Background Adjuvant abemaciclib combined with endocrine therapy (ET) previously demonstrated clinically meaningful improvement in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) in hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer at the second interim analysis, however follow-up was limited. Here, we present results of the prespecified primary outcome analysis and an additional follow-up analysis. Patients and methods This global, phase III, open-label trial randomized (1 : 1) 5637 patients to adjuvant ET for ≥5 years ± abemaciclib for 2 years. Cohort 1 enrolled patients with ≥4 positive axillary lymph nodes (ALNs), or 1-3 positive ALNs and either grade 3 disease or tumor ≥5 cm. Cohort 2 enrolled patients with 1-3 positive ALNs and centrally determined high Ki-67 index (≥20%). The primary endpoint was IDFS in the intent-to-treat population (cohorts 1 and 2). Secondary endpoints were IDFS in patients with high Ki-67, DRFS, overall survival, and safety. Results At the primary outcome analysis, with 19 months median follow-up time, abemaciclib + ET resulted in a 29% reduction in the risk of developing an IDFS event [hazard ratio (HR) = 0.71, 95% confidence interval (CI) 0.58-0.87; nominal P = 0.0009]. At the additional follow-up analysis, with 27 months median follow-up and 90% of patients off treatment, IDFS (HR = 0.70, 95% CI 0.59-0.82; nominal P < 0.0001) and DRFS (HR = 0.69, 95% CI 0.57-0.83; nominal P < 0.0001) benefit was maintained. The absolute improvements in 3-year IDFS and DRFS rates were 5.4% and 4.2%, respectively. Whereas Ki-67 index was prognostic, abemaciclib benefit was consistent regardless of Ki-67 index. Safety data were consistent with the known abemaciclib risk profile. Conclusion Abemaciclib + ET significantly improved IDFS in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer, with an acceptable safety profile. Ki-67 index was prognostic, but abemaciclib benefit was observed regardless of Ki-67 index. Overall, the robust treatment benefit of abemaciclib extended beyond the 2-year treatment period. This work was supported by the sponsor (Eli Lilly and Company) and designed together with the study Executive Committee (no grant number).
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- 2021
29. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE)
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Masakazu Toi, Joyce O'Shaughnessy, Investigators, Valentina Guarneri, Ran Wei, Maarten Hulstijn, Irfan Cicin, Mario Campone, Frances M. Boyle, Jens Huober, Patrick Neven, Erika Hamilton, Belen San Antonio, Morihito Okada, Sara M. Tolaney, Andrew M Wardley, Roberto Hegg, Desiree Headley, Stephen R. D. Johnston, Martin Frenzel, Q. Zhang, Priya Rastogi, Zhi Min Shao, Jorge Luis Martinez Rodriguez, Miguel Martín, Javier Cortes, Ian C. Smith, Nadia Harbeck, Joohyuk Sohn, Joanne Cox, Institut Català de la Salut, [Johnston SRD] Royal Marsden NHS Foundation Trust, London, United Kingdom. [Harbeck N] Department of Obstetrics and Gynecology, Breast Center, LMU University Hospital, Munich, Germany. [Hegg R] Clinica Pesquisas e Centro São Paulo, São Paulo, Brazil. [Toi M] Kyoto University Hospital, Kyoto, Japan. [Martin M] Hospital General Universitario Gregorio Marañon, Universidad Complutense, Ciberonc, GEICAM, Madrid, Spain. [Shao ZM] Fudan University Shanghai Cancer Center, Shanghai, China. [Cortés J] IOB Institute of Oncology, Quiron Group, Madrid, Barcelona. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
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0301 basic medicine ,Oncology ,Cancer Research ,acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos::antineoplásicos hormonales [COMPUESTOS QUÍMICOS Y DROGAS] ,Receptor, ErbB-2 ,Neoplasms::Neoplasms by Site::Breast Neoplasms [DISEASES] ,medicine.medical_treatment ,Medicaments antineoplàstics - Ús terapèutic ,Aminopyridines ,law.invention ,Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents::Antineoplastic Agents, Hormonal [CHEMICALS AND DRUGS] ,chemistry.chemical_compound ,0302 clinical medicine ,Mama - Càncer ,Randomized controlled trial ,law ,Antineoplastic Combined Chemotherapy Protocols ,Breast ,Young adult ,Abemaciclib ,Early breast cancer ,Aged, 80 and over ,neoplasias::neoplasias por localización::neoplasias de la mama [ENFERMEDADES] ,Middle Aged ,Therapeutics::Combined Modality Therapy::Neoadjuvant Therapy [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Receptors, Estrogen ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Lymphatic Metastasis ,Female ,Receptors, Progesterone ,Adjuvant ,Adult ,medicine.medical_specialty ,Antineoplastic Agents, Hormonal ,Breast Neoplasms ,Disease-Free Survival ,monarchE Committee Members and Investigators ,03 medical and health sciences ,Young Adult ,Internal medicine ,RAPID COMMUNICATIONS ,Breast Cancer ,medicine ,Humans ,Protein Kinase Inhibitors ,Aged ,Chemotherapy ,business.industry ,Endocrine therapy ,Clinical trial ,030104 developmental biology ,chemistry ,terapéutica::tratamiento combinado::tratamiento neoadyuvante [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Benzimidazoles ,Neoplasm Recurrence, Local ,business - Abstract
Càncer de mama precoç; Teràpia endocrina; Abemaciclib Cáncer de mama precoz; Terapia endocrina; Abemaciclib Early Breast Cancer; Endocrine Therapy; Abemaciclib PURPOSE Many patients with HR+, HER2− early breast cancer (EBC) will not experience recurrence or have distant recurrence with currently available standard therapies. However, up to 30% of patients with high-risk clinical and/or pathologic features may experience distant recurrence, many in the first few years. Superior treatment options are needed to prevent early recurrence and development of metastases for this group of patients. Abemaciclib is an oral, continuously dosed, CDK4/6 inhibitor approved for HR+, HER2− advanced breast cancer (ABC). Efficacy and safety of abemaciclib in ABC supported evaluation in the adjuvant setting. METHODS This open-label, phase III study included patients with HR+, HER2−, high-risk EBC, who had surgery and, as indicated, radiotherapy and/or adjuvant/neoadjuvant chemotherapy. Patients with four or more positive nodes, or one to three nodes and either tumor size ≥ 5 cm, histologic grade 3, or central Ki-67 ≥ 20%, were eligible and randomly assigned (1:1) to standard-of-care adjuvant endocrine therapy (ET) with or without abemaciclib (150 mg twice daily for 2 years). The primary end point was invasive disease-free survival (IDFS), and secondary end points included distant relapse–free survival, overall survival, and safety. RESULTS At a preplanned efficacy interim analysis, among 5,637 randomly assigned patients, 323 IDFS events were observed in the intent-to-treat population. Abemaciclib plus ET demonstrated superior IDFS versus ET alone (P = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93), with 2-year IDFS rates of 92.2% versus 88.7%, respectively. Safety data were consistent with the known safety profile of abemaciclib. CONCLUSION Abemaciclib when combined with ET is the first CDK4/6 inhibitor to demonstrate a significant improvement in IDFS in patients with HR+, HER2− node-positive EBC at high risk of early recurrence. Funded and sponsored by Eli Lilly and Company. Additional support provided by National Institute for Health Research funding to the Royal Marsden and Institute of Cancer Research Biomedical Research Center.
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- 2020
30. Clinical portrait of the SARS-CoV-2 epidemic in european patients with cancer
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David J. Pinato, Alberto Zambelli, Juan Aguilar-Company, Mark Bower, Christopher C.T. Sng, Ramon Salazar, Alexia Bertuzzi, Joan Brunet, Ricard Mesia, Elia Seguí, Federica Biello, Daniele Generali, Salvatore Grisanti, Gianpiero Rizzo, Michela Libertini, Antonio Maconi, Nadia Harbeck, Bruno Vincenzi, Rossella Bertulli, Diego Ottaviani, Anna Carbó, Riccardo Bruna, Sarah Benafif, Andrea Marrari, Rachel Wuerstlein, M. Carmen Carmona-Garcia, Neha Chopra, Carlo Tondini, Oriol Mirallas, Valeria Tovazzi, Marta Betti, Salvatore Provenzano, Vittoria Fotia, Claudia Andrea Cruz, Alessia Dalla Pria, Francesca D'Avanzo, Joanne S. Evans, Nadia Saoudi-Gonzalez, Eudald Felip, Myria Galazi, Isabel Garcia-Fructuoso, Alvin J.X. Lee, Thomas Newsom-Davis, Andrea Patriarca, David García-Illescas, Roxana Reyes, Palma Dileo, Rachel Sharkey, Yien Ning Sophia Wong, Daniela Ferrante, Javier Marco-Hernández, Anna Sureda, Clara Maluquer, Isabel Ruiz-Camps, Gianluca Gaidano, Lorenza Rimassa, Lorenzo Chiudinelli, Macarena Izuzquiza, Alba Cabirta, Michela Franchi, Armando Santoro, Aleix Prat, Josep Tabernero, Alessandra Gennari, Gian Carlo Avanzi, Mattia Bellan, Luigi Mario Castello, Maria Martinez, Meritxell Mollà, Mario Pirisi, Lorenza Scotti, Judith Swallow, Pinato, D. J., Zambelli, A., Aguilar-Company, J., Bower, M., Sng, C. C. T., Salazar, R., Bertuzzi, A., Brunet, J., Mesia, R., Segui, E., Biello, F., Generali, D., Grisanti, S., Rizzo, G., Libertini, M., Maconi, A., Harbeck, N., Vincenzi, B., Bertulli, R., Ottaviani, D., Carbo, A., Bruna, R., Benafif, S., Marrari, A., Wuerstlein, R., Carmona-Garcia, M. C., Chopra, N., Tondini, C., Mirallas, O., Tovazzi, V., Betti, M., Provenzano, S., Fotia, V., Cruz, C. A., Pria, A. D., D'Avanzo, F., Evans, J. S., Saoudi-Gonzalez, N., Felip, E., Galazi, M., Garcia-Fructuoso, I., Lee, A. J. X., Newsom-Davis, T., Patriarca, A., Garcia-Illescas, D., Reyes, R., Dileo, P., Sharkey, R., Wong, Y. N. S., Ferrante, D., Marco-Hernandez, J., Sureda, A., Maluquer, C., Ruiz-Camps, I., Gaidano, G., Rimassa, L., Chiudinelli, L., Izuzquiza, M., Cabirta, A., Franchi, M., Santoro, A., Prat, A., Tabernero, J., and Gennari, A.
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0301 basic medicine ,medicine.medical_specialty ,medicine.medical_treatment ,Population ,MEDLINE ,risk stratification ,Targeted therapy ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,SARS-CoV-2 pandemic ,oncology practice ,Internal medicine ,Pandemic ,medicine ,education ,education.field_of_study ,Chemotherapy ,Research Briefs ,business.industry ,Mortality rate ,Cancer ,medicine.disease ,3. Good health ,030104 developmental biology ,Oncology ,030220 oncology & carcinogenesis ,business - Abstract
Higher risk of death from COVID-19 among patients with cancer was correlated with male sex, greater age, presence of multiple comorbidities, advanced-stage disease, and active disease; there was no association between risk and anticancer treatment., The SARS-CoV-2 pandemic significantly affected oncology practice across the globe. There is uncertainty as to the contribution of patients' demographics and oncologic features to severity and mortality from COVID-19 and little guidance as to the role of anticancer and anti–COVID-19 therapy in this population. In a multicenter study of 890 patients with cancer with confirmed COVID-19, we demonstrated a worsening gradient of mortality from breast cancer to hematologic malignancies and showed that male gender, older age, and number of comorbidities identify a subset of patients with significantly worse mortality rates from COVID-19. Provision of chemotherapy, targeted therapy, or immunotherapy did not worsen mortality. Exposure to antimalarials was associated with improved mortality rates independent of baseline prognostic factors. This study highlights the clinical utility of demographic factors for individualized risk stratification of patients and supports further research into emerging anti–COVID-19 therapeutics in SARS-CoV-2–infected patients with cancer. Significance: In this observational study of 890 patients with cancer diagnosed with SARS-CoV-2, mortality was 33.6% and predicted by male gender, age ≥65, and comorbidity burden. Delivery of cancer therapy was not detrimental to severity or mortality from COVID-19. These patients should be the focus of shielding efforts during the SARS-CoV-2 pandemic. This article is highlighted in the In This Issue feature, p. 1426
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- 2020
31. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial
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Keun Seok Lee, Louis W.C. Chow, Joohyuk Sohn, Debu Tripathy, Seock-Ah Im, Saúl Campos-Gómez, Mei Ching Liu, Paul Wheatley-Price, Aditya Bardia, K Govind Babu, Yen-Shen Lu, Rafael Villanueva Vazquez, Fabio Franke, Sara A. Hurvitz, Samit Hirawat, C. Germa, Gary Carlson, Kyung Hae Jung, I Diaz-Padilla, Young-Hyuck Im, Sherko Kuemmel, Nadia Harbeck, Gareth Hughes, Nagi S. El-Saghir, Michelino De Laurentiis, Marco Colleoni, Tripathy, D., Im, S. -A., Colleoni, M., Franke, F., Bardia, A., Harbeck, N., Hurvitz, S. A., Chow, L., Sohn, J., Lee, K. S., Campos-Gomez, S., Villanueva Vazquez, R., Jung, K. H., Babu, K. G., Wheatley-Price, P., De Laurentiis, M., Im, Y. -H., Kuemmel, S., El-Saghir, N., Liu, M. -C., Carlson, G., Hughes, G., Diaz-Padilla, I., Germa, C., Hirawat, S., and Lu, Y. -S.
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Adult ,0301 basic medicine ,medicine.medical_specialty ,Internationality ,Antineoplastic Agents, Hormonal ,medicine.drug_class ,Administration, Oral ,Aminopyridines ,Breast Neoplasms ,Kaplan-Meier Estimate ,Placebo ,Disease-Free Survival ,Drug Administration Schedule ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,Double-Blind Method ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Neoplasm Invasiveness ,Neoplasm Staging ,Proportional Hazards Models ,Aromatase inhibitor ,Dose-Response Relationship, Drug ,business.industry ,Letrozole ,Goserelin ,Cancer ,Middle Aged ,Prognosis ,medicine.disease ,Survival Analysis ,Tamoxifen ,Treatment Outcome ,030104 developmental biology ,Premenopause ,Oncology ,Purines ,Response Evaluation Criteria in Solid Tumors ,030220 oncology & carcinogenesis ,business ,medicine.drug - Abstract
Background: In MONALEESA-2, ribociclib plus letrozole showed improved progression-free survival compared with letrozole alone as first-line treatment for postmenopausal patients with hormone receptor (HR)-positive, HER2-negative, advanced breast cancer. MONALEESA-7 aimed to assess the efficacy and safety of ribociclib plus endocrine therapy in premenopausal women with advanced, HR-positive breast cancer. Methods: This phase 3, randomised, double-blind, placebo-controlled trial was done at 188 centres in 30 countries. Eligible patients were premenopausal women aged 18–59 years who had histologically or cytologically confirmed HR-positive, HER2-negative, advanced breast cancer; an Eastern Cooperative Oncology Group performance status of 0 or 1; measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria, or at least one predominantly lytic bone lesion; and had not received previous treatment with cyclin-dependent kinases 4 and 6 inhibitors. Endocrine therapy and chemotherapy in the adjuvant or neoadjuvant setting was permitted, as was up to one line of chemotherapy for advanced disease. Patients were randomly assigned (1:1) via interactive response technology to receive oral ribociclib (600 mg/day on a 3-weeks-on, 1-week-off schedule) or matching placebo with either oral tamoxifen (20 mg daily) or a non-steroidal aromatase inhibitor (letrozole 2·5 mg or anastrozole 1 mg, both oral, daily), all with goserelin (3·6 mg administered subcutaneously on day 1 of every 28-day cycle). Patients and investigators were masked to treatment assignment. Efficacy analyses were by intention to treat, and safety was assessed in all patients who received at least one dose of any study treatment. The primary endpoint was investigator-assessed progression-free survival. MONALEESA-7 is registered with ClinicalTrials.gov, NCT02278120 and is ongoing, but no longer enrolling patients. Findings: Between Dec 17, 2014, and Aug 1, 2016, 672 patients were randomly assigned: 335 to the ribociclib group and 337 to the placebo group. Per investigator's assessment, median progression-free survival was 23·8 months (95% CI 19·2–not reached) in the ribociclib group compared with 13·0 months (11·0–16·4) in the placebo group (hazard ratio 0·55, 95% CI 0·44–0·69; p
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- 2018
32. LBA76_PR Expected medium and long term impact of the COVID-19 outbreak in oncology.
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Jerusalem, G., Onesti, C.E., Generali, D.G., Harbeck, N., Wildiers, H., Curigliano, G., Campone, M., Tjan-Heijnen, V., Martin, M., Cristofanilli, M., Pusztai, L., Bartsch, R., Peeters, M., Berchem, G., Tagliamento, M., Cortés, J., Ruhstaller, T., Ciruelos, E.M., Rottey, S., and Rugo, H.S.
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- *
COVID-19 pandemic , *ONCOLOGY - Published
- 2020
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33. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer
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Fatima, Cardoso, Laura J, van't Veer, Jan, Bogaerts, Leen, Slaets, Giuseppe, Viale, Suzette, Delaloge, Jean-Yves, Pierga, Etienne, Brain, Sylvain, Causeret, Mauro, DeLorenzi, Annuska M, Glas, Vassilis, Golfinopoulos, Theodora, Goulioti, Susan, Knox, Erika, Matos, Bart, Meulemans, Peter A, Neijenhuis, Ulrike, Nitz, Rodolfo, Passalacqua, Peter, Ravdin, Isabel T, Rubio, Mahasti, Saghatchian, Tineke J, Smilde, Christos, Sotiriou, Lisette, Stork, Carolyn, Straehle, Geraldine, Thomas, Alastair M, Thompson, Jacobus M, van der Hoeven, Peter, Vuylsteke, René, Bernards, Konstantinos, Tryfonidis, Emiel, Rutgers, Martine, Piccart, Marc, Buyse, Commission of the European Communities, MINDACT Investigators, Benn, K., Bogaerts, J., Cardoso, F., Ciruelos, E., Corochan, S., Cuny, J., de la Pena, L., Delaloge, S., DeLorenzi, M., Dudek-Peric, A., Eekhout, I., Gluz, O., Golfinopoulos, V., Goulioti, T., Harbeck, N., Hilal, V., Knox, S., Lemonnier, J., Ławniczak, M., Marini, L., Matos, E., Morales, P., Murray, K., Nitz, U., Passalaqua, R., Piccart, M., Remmelzwaal, J., Rubio, I., Rutgers, E., Saghatchian, M., Slaets, L., Sotiriou, C., Straehle, C., Straley, M., Theron, N., Thompson, A., Tryfonidis, K., Todeschini, R., Urunkar, M., van 't Veer, L., Viale, G., Aalders, K., Bines, J., Bedard, P., Bozovic, I., Braga, S., Castaneda, C., Celebic, A., Colichi, C., Criscitiello, C., Dal Lago, L., Demonty, G., Drukker, C., Fei, F., Lia, M., Loi, S., Messina, C., Mook, S., Moulin, C., Sreseli, R., Therasse, P., Werutsky, G., Corachan, S., Wheeler, L., Dif, N., Rizzetto, G., Beauvois, M., Meirsman, L., Breyssens, H., Decker, N., Engelen, K., Akropovic, A., Harrison, J., Henot, F., Celis, M., De Jongh, B., Delmotte, I., Daubie, V., Goossens, R., Helsen, N., Hourt, L., Janssen, S., Soete, V., Vansevenant, K., Hermans, C., Hart, G., Brink, G., Floore, A., Sixt, B., and Buyse, M.
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0301 basic medicine ,Oncology ,medicine.medical_treatment ,Gene Expression ,Kaplan-Meier Estimate ,law.invention ,0302 clinical medicine ,MammaPrint ,Randomized controlled trial ,law ,Prospective Studies ,Neoplasm Metastasis ,Prospective cohort study ,Mastectomy ,Oligonucleotide Array Sequence Analysis ,medicine.diagnostic_test ,11 Medical And Health Sciences ,General Medicine ,Middle Aged ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Female ,Adult ,Aged ,Antineoplastic Agents/therapeutic use ,Breast Neoplasms/drug therapy ,Breast Neoplasms/genetics ,Breast Neoplasms/mortality ,Breast Neoplasms/surgery ,Disease-Free Survival ,Gene Expression Profiling ,Genetic Predisposition to Disease ,Genetic Testing ,Humans ,Neoplasm Metastasis/prevention & control ,Neoplasm Staging ,Risk ,Risk Assessment ,Risk assessment ,medicine.medical_specialty ,Antineoplastic Agents ,Breast Neoplasms ,03 medical and health sciences ,Breast cancer ,General & Internal Medicine ,Internal medicine ,medicine ,Gynecology ,business.industry ,Gene signature ,medicine.disease ,Clinical trial ,030104 developmental biology ,business - Abstract
BACKGROUND: The 70-gene signature test (MammaPrint) has been shown to improve prediction of clinical outcome in women with early-stage breast cancer. We sought to provide prospective evidence of the clinical utility of the addition of the 70-gene signature to standard clinical-pathological criteria in selecting patients for adjuvant chemotherapy. METHODS: In this randomized, phase 3 study, we enrolled 6693 women with early-stage breast cancer and determined their genomic risk (using the 70-gene signature) and their clinical risk (using a modified version of Adjuvant! Online). Women at low clinical and genomic risk did not receive chemotherapy, whereas those at high clinical and genomic risk did receive such therapy. In patients with discordant risk results, either the genomic risk or the clinical risk was used to determine the use of chemotherapy. The primary goal was to assess whether, among patients with high-risk clinical features and a low-risk gene-expression profile who did not receive chemotherapy, the lower boundary of the 95% confidence interval for the rate of 5-year survival without distant metastasis would be 92% (i.e., the noninferiority boundary) or higher. RESULTS: A total of 1550 patients (23.2%) were deemed to be at high clinical risk and low genomic risk. At 5 years, the rate of survival without distant metastasis in this group was 94.7% (95% confidence interval, 92.5 to 96.2) among those not receiving chemotherapy. The absolute difference in this survival rate between these patients and those who received chemotherapy was 1.5 percentage points, with the rate being lower without chemotherapy. Similar rates of survival without distant metastasis were reported in the subgroup of patients who had estrogen-receptor-positive, human epidermal growth factor receptor 2-negative, and either node-negative or node-positive disease. CONCLUSIONS: Among women with early-stage breast cancer who were at high clinical risk and low genomic risk for recurrence, the receipt of no chemotherapy on the basis of the 70-gene signature led to a 5-year rate of survival without distant metastasis that was 1.5 percentage points lower than the rate with chemotherapy. Given these findings, approximately 46% of women with breast cancer who are at high clinical risk might not require chemotherapy. (Funded by the European Commission Sixth Framework Program and others; ClinicalTrials.gov number, NCT00433589; EudraCT number, 2005-002625-31.).
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- 2016
34. Oncological care organisation during COVID-19 outbreak
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Khalil Zaman, Miguel Martin, Daniele Generali, Massimo Cristofanilli, Marc Peeters, Sabino De Placido, Javier Cortes, Sylvie Rottey, Thomas Ruhstaller, Hope S. Rugo, Concetta Elisa Onesti, Rupert Bartsch, Ahmad Awada, Guy Jerusalem, Sara A. Hurvitz, Jean Pascal Machiels, Volkmar Müller, Fabio Puglisi, Nadia Harbeck, Guy Berchem, Marco Tagliamento, Pierfranco Conte, Mario Campone, Hans Wildiers, Vivianne C. G. Tjan-Heijnen, Institut Català de la Salut, [Onesti CE] Department of Medical Oncology, CHU de Liège, Liege, Belgium. Laboratory of Human Genetics, GIGA Research Institute and University of Liège, Liège, Belgium. [Rugo HS] Department of Medicine and Division of Oncology, University of California San Francisco, Comprehensive Cancer Center, San Francisco, California, USA. [Generali D] UO Patologia Mammaria e Ricerca Traslazionale, Breast Unit, Azienda Socio Sanitaria Territoriale di Cremona, Cremona, Italy. University of Trieste, Trieste, Italy. [Peeters M] Oncology Department, University Hospital Antwerp (UZA), Antwerp, Belgium. [Zaman K] Oncology Department, CHUV - Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. [Wildiers H] Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium. [Cortes J] Servei d’Oncologia, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. IOB Institute of Oncology, Madrid, Spain, Vall d'Hebron Barcelona Hospital Campus, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Onesti, Concetta Elisa, Rugo, Hope S, Generali, Daniele, Peeters, Marc, Zaman, Khalil, Wildiers, Han, Harbeck, Nadia, Martin, Miguel, Cristofanilli, Massimo, Cortes, Javier, Tjan-Heijnen, Vivianne, Hurvitz, Sara A, Berchem, Guy, Tagliamento, Marco, Campone, Mario, Bartsch, Rupert, De Placido, Sabino, Puglisi, Fabio, Rottey, Sylvie, Müller, Volkmar, Ruhstaller, Thoma, Machiels, Jean-Pascal, Conte, Pierfranco, Awada, Ahmad, Jerusalem, Guy, Onesti, C. E., Rugo, H. S., Generali, D., Peeters, M., Zaman, K., Wildiers, H., Harbeck, N., Martin, M., Cristofanilli, M., Cortes, J., Tjan-Heijnen, V., Hurvitz, S. A., Berchem, G., Tagliamento, M., Campone, M., Bartsch, R., De Placido, S., Puglisi, F., Rottey, S., Muller, V., Ruhstaller, T., Machiels, J. -P., Conte, P., Awada, A., and Jerusalem, G.
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Cancer Research ,Oncologia ,Day care ,Medical Oncology ,COVID-19 (Malaltia) ,RECOMMENDATIONS ,Assistència sanitària ,Neoplasms ,Health care ,Medicine and Health Sciences ,virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES] ,Medicine ,Viral ,Health Occupations::Medicine::Internal Medicine::Medical Oncology [DISCIPLINES AND OCCUPATIONS] ,Cancer ,COVID-19 ,oncological care ,Betacoronavirus ,Cancer Care Facilities ,Coronavirus Infections ,Delivery of Health Care ,Disinfection ,Europe ,Health Care Surveys ,Humans ,Pandemics ,Personal Protective Equipment ,Pneumonia, Viral ,SARS-CoV-2 ,Triage ,United States ,Visitors to Patients ,Health Care (Public Health) [PUBLIC HEALTH] ,Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES] ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,CANCER ,Oncology ,Medical emergency ,Human ,United State ,Telemedicine ,Cancer Care Facilities/organization & administration ,Cancer Care Facilities/statistics & numerical data ,Coronavirus Infections/diagnosis ,Coronavirus Infections/epidemiology ,Coronavirus Infections/prevention & control ,Europe/epidemiology ,Medical Oncology/statistics & numerical data ,Neoplasms/therapy ,Pandemics/prevention & control ,Pneumonia, Viral/diagnosis ,Pneumonia, Viral/epidemiology ,Pneumonia, Viral/prevention & control ,United States/epidemiology ,atención a la salud (salud pública) [SALUD PÚBLICA] ,SARS-COV-2 ,lcsh:RC254-282 ,profesiones sanitarias::medicina::medicina interna::oncología médica [DISCIPLINAS Y OCUPACIONES] ,Clinical Research ,Behavioral and Social Science ,Personal protective equipment ,Betacoronaviru ,Pandemic ,Cancer Care Facilitie ,Coronavirus Infection ,business.industry ,Prevention ,Généralités ,Pneumonia ,medicine.disease ,Good Health and Well Being ,Health Care Survey ,Neoplasm ,Observational study ,Human medicine ,business ,Patient education - Abstract
Background COVID-19 appeared in late 2019, causing a pandemic spread. This led to a reorganisation of oncology care in order to reduce the risk of spreading infection between patients and healthcare staff. Here we analysed measures taken in major oncological units in Europe and the USA. Methods A 46-item survey was sent by email to representatives of 30 oncological centres in 12 of the most affected countries. The survey inquired about preventive measures established to reduce virus spread, patient education and processes employed for risk reduction in each oncological unit. Results Investigators from 21 centres in 10 countries answered the survey between 10 April and 6 May 2020. A triage for patients with cancer before hospital or clinic visits was conducted by 90.5% of centres before consultations, 95.2% before day care admissions and in 100% of the cases before overnight hospitalisation by means of phone calls, interactive online platforms, swab test and/or chest CT scan. Permission for caregivers to attend clinic visits was limited in many centres, with some exceptions (ie, for non-autonomous patients, in the case of a new diagnosis, when bad news was expected and for terminally ill patients). With a variable delay period, the use of personal protective equipment was unanimously mandatory, and in many centres, only targeted clinical and instrumental examinations were performed. Telemedicine was implemented in 76.2% of the centres. Separated pathways for COVID-19-positive and COVID-19-negative patients were organised, with separate inpatient units and day care areas. Self-isolation was required for COVID-19-positive or symptomatic staff, while return to work policies required a negative swab test in 76.2% of the centres. Conclusion Many pragmatic measures have been quickly implemented to deal with the health emergency linked to COVID-19, although the relative efficacy of each intervention should be further analysed in large observational studies., SCOPUS: ar.j, info:eu-repo/semantics/published
- Published
- 2020
35. Epigenome-based cancer risk prediction: rationale, opportunities and challenges
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Daniel Reisel, Andrew E. Teschendorff, Michal Zikan, E.W. Steyerberg, Odette Wegwarth, Ineke Bolt, Frank Dudbridge, Martin Widschwendter, Line Bjørge, Yann Joly, Anne-Marie Tassé, Yvonne Vergouwe, Gaby Sroczynski, Joakim Dillner, Allison Jones, Uwe Siebert, Karin Sundström, Inez de Beaufort, Bartha Maria Knoppers, Nicoletta Colombo, Felix G. Rebitschek, Iona Evans, Nora Pashayan, Nadia Harbeck, David Cibula, Public Health, Widschwendter, M, Jones, A, Evans, I, Reisel, D, Dillner, J, Sundström, K, Steyerberg, E, Vergouwe, Y, Wegwarth, O, Rebitschek, F, Siebert, U, Sroczynski, G, De Beaufort, I, Bolt, I, Cibula, D, Zikan, M, Bjørge, L, Colombo, N, Harbeck, N, Dudbridge, F, Tasse, A, Knoppers, B, Joly, Y, Teschendorff, A, Pashayan, N, and the FORECEE (4C) Consortium
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0301 basic medicine ,Epigenomics ,Risk Assessment ,03 medical and health sciences ,SDG 3 - Good Health and Well-being ,Risk Factors ,Primary prevention ,Neoplasms ,Medicine ,Humans ,Epigenetics ,business.industry ,Genome, Human ,Epigenome ,DNA Methylation ,Human genetics ,3. Good health ,030104 developmental biology ,Oncology ,Risk analysis (engineering) ,Cellular heterogeneity ,Oncology, cancer incidence, risk-predictive test, prevention strategies, epigenome ,DNA methylation ,Cancer risk ,Risk assessment ,business - Abstract
The incidence of cancer is continuing to rise and risk-tailored early diagnostic and/or primary prevention strategies are urgently required. The ideal risk-predictive test should: integrate the effects of both genetic and nongenetic factors and aim to capture these effects using an approach that is both biologically stable and technically reproducible; derive a score from easily accessible biological samples that acts as a surrogate for the organ in question; and enable the effectiveness of risk-reducing measures to be monitored. Substantial evidence has accumulated suggesting that the epigenome and, in particular, DNA methylation-based tests meet all of these requirements. However, the development and implementation of DNA methylation-based risk-prediction tests poses considerable challenges. In particular, the cell type specificity of DNA methylation and the extensive cellular heterogeneity of the easily accessible surrogate cells that might contain information relevant to less accessible tissues necessitates the use of novel methods in order to account for these confounding issues. Furthermore, the engagement of the scientific community with health-care professionals, policymakers and the public is required in order to identify and address the organizational, ethical, legal, social and economic challenges associated with the routine use of epigenetic testing.
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- 2018
36. De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017
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Bahadir M. Gulluoglu, A. Di Leo, Jonas Bergh, Jens Huober, Kent Osborne, Bo Xu, Beat Thürlimann, Chiun-Sheng Huang, Masakazu Toi, Eric P. Winer, Pamela J. Goodwin, Toshihiro Watanabe, Roberto Orecchia, Andrew Tutt, Ann H. Partridge, Nadia Harbeck, Felix Sedlmayer, Sara Y. Brucker, H.-J. Senn, José Baselga, Michael Gnant, Timothy J. Whelan, Jack Cuzick, Zefei Jiang, Zhimin Shao, Bent Ejlertsen, Emiel J. Th. Rutgers, Sibylle Loibl, Daniel F. Hayes, Meredith M. Regan, Jungsil Ro, Olivia Pagani, Prudence A. Francis, Vladimir Semiglazov, Judy Garber, Carsten Denkert, H. Khaled, Lisa A. Carey, Viviana Galimberti, Giuseppe Curigliano, Giuseppe Viale, I.E. Smith, Marco Colleoni, Monica Morrow, Harold J. Burstein, Eva Ciruelos, Hervé Bonnefoi, Per Karlsson, Fabrice Andre, Jacek Jassem, Martine Piccart-Gebhart, Peter Dubsky, Fatima Cardoso, Kathleen I. Pritchard, Curigliano, G., Burstein, H. J., Winer, E. P., Gnant, M., Dubsky, P., Loibl, S., Colleoni, M., Regan, M. M., Piccart-Gebhart, M., Senn, H. -J., Thurlimann, B., Andre, F., Baselga, J., Bergh, J., Bonnefoi, H., Brucker, S. Y., Cardoso, F., Carey, L., Ciruelos, E., Cuzick, J., Denkert, C., Di Leo, A., Ejlertsen, B., Francis, P., Galimberti, V., Garber, J., Gulluoglu, B., Goodwin, P., Harbeck, N., Hayes, D. F., Huang, C. -S., Huober, J., Khaled, H., Jassem, J., Jiang, Z., Karlsson, P., Morrow, M., Orecchia, R., Osborne, K. C., Pagani, O., Partridge, A. H., Pritchard, K., Ro, J., Rutgers, E. J. T., Sedlmayer, F., Semiglazov, V., Shao, Z., Smith, I., Toi, M., Tutt, A., Viale, G., Watanabe, T., Whelan, T. J., and Xu, B.
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0301 basic medicine ,Oncology ,medicine.medical_treatment ,Systemic therapy ,radiation therapy ,Primary therapy ,surgery ,NEOADJUVANT CHEMOTHERAPY ,DOUBLE-BLIND ,0302 clinical medicine ,Stage (cooking) ,Neoadjuvant therapy ,Early breast cancer ,DISTANT RECURRENCE ,Hematology ,CONSERVING SURGERY ,Corrigenda ,Chemotherapy regimen ,Combined Modality Therapy ,Neoadjuvant Therapy ,LYMPH-NODE BIOPSY ,POSTMENOPAUSAL WOMEN ,CARCINOMA IN-SITU ,030220 oncology & carcinogenesis ,Austria ,Surgical Procedures, Operative ,Special Articles ,Female ,medicine.medical_specialty ,Antineoplastic Agents ,Breast Neoplasms ,systemic adjuvant therapies ,03 medical and health sciences ,Breast cancer ,Adjuvants, Immunologic ,Internal medicine ,St Gallen Consensus ,Adjuvant therapy ,medicine ,Humans ,early breast cancer ,ENDOCRINE THERAPY ,Radiotherapy ,business.industry ,Carcinoma in situ ,Cancer ,Expert consensus ,medicine.disease ,Radiation therapy ,030104 developmental biology ,Annals ,Early Diagnosis ,AXILLARY DISSECTION ,21-GENE RECURRENCE SCORE ,business - Abstract
The 15th St. Gallen International Breast Cancer Conference 2017 in Vienna, Austria reviewed substantial new evidence on loco-regional and systemic therapies for early breast cancer. Treatments were assessed in light of their intensity, duration and side-effects, seeking where appropriate to escalate or de-escalate therapies based on likely benefits as predicted by tumor stage and tumor biology. The Panel favored several interventions that may reduce surgical morbidity, including acceptance of 2 mm margins for DCIS, the resection of residual cancer (but not baseline extent of cancer) in women undergoing neoadjuvant therapy, acceptance of sentinel node biopsy following neoadjuvant treatment of many patients, and the preference for neoadjuvant therapy in HER2 positive and triple-negative, stage II and III breast cancer. The Panel favored escalating radiation therapy with regional nodal irradiation in high-risk patients, while encouraging omission of boost in low-risk patients. The Panel endorsed gene expression signatures that permit avoidance of chemotherapy in many patients with ER positive breast cancer. For women with higher risk tumors, the Panel escalated recommendations for adjuvant endocrine treatment to include ovarian suppression in premenopausal women, and extended therapy for postmenopausal women. However, low-risk patients can avoid these treatments. Finally, the Panel recommended bisphosphonate use in postmenopausal women to prevent breast cancer recurrence. The Panel recognized that recommendations are not intended for all patients, but rather to address the clinical needs of the majority of common presentations. Individualization of adjuvant therapy means adjusting to the tumor characteristics, patient comorbidities and preferences, and managing constraints of treatment cost and access that may affect care in both the developed and developing world.
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- 2017
37. Cardiovascular complications of conventional and targeted adjuvant breast cancer therapy
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Thomas M. Suter, M. De Laurentiis, Michael S. Ewer, Steven M. Ewer, Nadia Harbeck, Harbeck, N, Ewer, M, DE LAURENTIIS, Michelino, Suter, Tm, and Ewer, Sm
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Oncology ,medicine.medical_specialty ,Antineoplastic Agents ,Breast Neoplasms ,Disease ,Breast cancer ,Trastuzumab ,Internal medicine ,medicine ,Adjuvant therapy ,Humans ,Adverse effect ,Cardiotoxicity ,business.industry ,Cancer ,Heart ,Hematology ,medicine.disease ,Cardiovascular Diseases ,Chemotherapy, Adjuvant ,Immunology ,Female ,Breast disease ,business ,Biomarkers ,medicine.drug - Abstract
Adjuvant therapy has improved the survival of women with early breast cancer (BC). Meta-analyses suggest that anthracycline-based regimens reduced the annual BC death rate by 40% in women below the age of 50 and 20% in older women. Novel agents designed to modulate abnormal growth factor signaling in and around the BC cell further increase patients' chances of survival. However, both conventional chemotherapeutic agents as well as some of the novel signaling inhibitors can induce important cardiovascular side-effects, potentially attenuating the progress made in recent years. The mechanism of cancer drug-induced cardiovascular complications varies greatly with some compounds inducing irreversible myocardial cell damage, while others lead to temporary cell dysfunction. The challenge of the future will be to prospectively discriminate between irreversible damage which can lead to progressive cardiovascular disease and reversible cardiovascular dysfunctions without further prognostic implications. Since adjuvant therapy for BC is potentially curative, emphasis must be placed on finding treatments combining maximum efficacy with the minimum of long-term side-effects in order to achieve survival with preserved quality of life.
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- 2011
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38. Multicenter study using paraffin-embedded tumor tissue testing PITX2 DNA methylation as a marker for outcome prediction in tamoxifen-treated, node-negative breast cancer patients
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Jörg Nährig, Sabine Maier, John W.M. Martens, Arndt Hartmann, Inko Nimmrich, Angelo Paradiso, Ina Schwope, John A. Foekens, Volkmar Müller, Manfred Schmitt, Astrid Margossian, Tanja Cufer, Karin Milde-Langosch, Nadia Harbeck, Jeffrey S. Ross, Robert Grützmann, Antje Lukas, Oliver Hartmann, Glen Kristiansen, Ralf Lesche, University of Zurich, Harbeck, N, and Medical Oncology
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Oncology ,Cancer Research ,Pathology ,Time Factors ,Polymerase Chain Reaction ,Frozen Sections ,1306 Cancer Research ,Neoplasm Metastasis ,Aged, 80 and over ,Paraffin Embedding ,Methylation ,Middle Aged ,Europe ,Gene Expression Regulation, Neoplastic ,Treatment Outcome ,DNA methylation ,Biomarker (medicine) ,Female ,2730 Oncology ,Breast disease ,medicine.drug ,Adult ,Selective Estrogen Receptor Modulators ,medicine.medical_specialty ,Argentina ,New York ,Breast Neoplasms ,610 Medicine & health ,Breast cancer ,SDG 3 - Good Health and Well-being ,Predictive Value of Tests ,Internal medicine ,10049 Institute of Pathology and Molecular Pathology ,Biomarkers, Tumor ,medicine ,Humans ,Aged ,Homeodomain Proteins ,business.industry ,Reproducibility of Results ,Cancer ,DNA Methylation ,medicine.disease ,Antiestrogen ,Tamoxifen ,Lymph Nodes ,business ,Transcription Factors - Abstract
Purpose We recently reported DNA methylation of the paired-like homeodomain transcription factor 2 (PITX2) gene to be strongly correlated with increased risk of recurrence in node-negative, hormone receptor–positive, tamoxifen-treated breast cancer patients using fresh frozen specimens. Aims of the present study were to establish determination of PITX2 methylation for routine analysis in formalin-fixed paraffin-embedded (FFPE) breast cancer tissue and to test PITX2 DNA methylation as a biomarker for outcome prediction in an independent patient cohort. Patients and Methods Real-time polymerase chain reaction (PCR) technology was validated for FFPE tissue by comparing methylation measurements in FFPE specimens with those in fresh frozen specimens from the same tumor. The impact of PITX2 methylation on time to distant metastasis was then evaluated in FFPE specimens from hormone receptor–positive, node-negative breast cancer patients (n = 399, adjuvant tamoxifen monotherapy). Results Reproducibility of the PCR assay in replicate measurements (rs ≥ 0.95; n = 150) and concordant measurements between fresh frozen and FFPE tissues (rs = 0.81; n = 89) were demonstrated. In a multivariate model, PITX2 methylation added significant information (hazard ratio = 2.35; 95% CI, 1.20 to 4.60) to established prognostic factors (tumor size, grade, and age). Conclusion PITX2 methylation can be reliably assessed by real-time PCR technology in FFPE tissue. Together with our earlier studies, we have accumulated substantial evidence that PITX2 methylation analysis holds promise as a practical assay for routine clinical use to predict outcome in node-negative, tamoxifen-treated breast cancer, which might allow, based on future validation studies, the identification of low-risk patients who may be treated by tamoxifen alone.
- Published
- 2008
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