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633 results on '"Pavic, M."'

1. Interobserver agreement on definition of the target volume in stereotactic radiotherapy for pancreatic adenocarcinoma using different imaging modalities

Author

Gkika, E., Kostyszyn, D., Fechter, T., Moustakis, C., Ernst, F., Boda-Heggemann, J., Sarria, G., Dieckmann, K., Dobiasch, S., Duma, M. N., Eberle, F., Kroeger, K., Häussler, B., Izaguirre, V., Jazmati, D., Lautenschläger, S., Lohaus, F., Mantel, F., Menzel, J., Pachmann, S., Pavic, M., Radlanski, K., Riesterer, O., Gerum, S., Röder, F., Willner, J., Barczyk, S., Imhoff, D., Blanck, O., Wittig, A., Guckenberger, M., Grosu, Anca-L., and Brunner, T. B.

Published
2023
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3. Assessment of the management of carcinomatous meningitis from breast cancer globally: a study by the Breast International Group Brain Metastasis Task Force

Author

Razis, E., Escudero, M.J., Palmieri, C., Mueller, V., Bartsch, R., Rossi, G., Gampenrieder, S.P., Kolberg, H.C., Zdenkowski, N., Pavic, M., Connolly, R.M., Rosset, L., Arcuri, J., Tesch, H., Vallejos, C., Retamales, J., Musolino, A., Del Mastro, L., Christodoulou, C., Aebi, S., Paluch-Shimon, S., Gupta, S., Ohno, S., Macpherson, I., Ekholm, M., Zaman, K., Vidal, M., Chakiba, C., Fumagalli, D., Thulin, A., Witzel, I., Kotecki, N., Gil-Gil, M., and Linderholm, B.

Published
2022
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5. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer

Author

Zhang, Q., Xu, B., Shao, Z., Wang, X., Geng, C., Yan, X., Tong, Z., Shen, K., Yin, Y., Sun, T., Yang, J., Feng, J., Yan, M., Wang, Y., Liu, Q., Zhang, S., De Laurentiis, M., Santoro, A., Guarneri, V., Colleoni, M., Natoli, C., Cortesi, L., Placido, S., Gianni, L., Ferrau, F., Livi, L., Zambelli, A., Del Mastro, L., Tonini, G., Montemurro, F., Bianchi, G., Pedersini, R., Prete, S., Allegrini, G., Naso, G., Vici, P., Loirat, D., Mailliez, A., Priou, F., Tredan, O., Dalenc, F., Perrin, C., Gligorov, J., Timar David, M., Dohollou, N., Teixeira, L., Brocard, F., Arnaud, A., Delaloge, S., Spano, J.-P., Mansi, L., Andrade, L., Damian, F., Pedrini, J., Aleixo, S., Hegg, R., Junior, R., Reinisch, M., Schmidt, M., Wenzel, C., Grischke, E.-M., Schneeweiss, A., Just, M., Harbeck, N., Schumacher, C., Peters, U., Fischer, D., Forstbauer, H., Liersch, R., Warner, E., Bouganim, N., Doyle, C., Price Hiller, J., Vandenberg, T., Pavic, M., Robinson, A., Roldan Urgoiti, G., Califaretti, N., Alacacioglu, A., Gumus, M., Yalcin, B., Cicin, I., Kose, F., Uygun, K., Kaplan, M., Cubukcu, E., Wardley, A., Harries, M., Miles, D., Doval, D., Gupta, S., Mohapatra, P., Chatterjee, S., Ghadyalpatil, N., Singhal, M., Nag, S., Agarwal, A., Wolf, I., Gal Yam, E., Yerushalmi, R., Peretz, T., Fried, G., Ben Baruch, N., Katz, D., Hamilton, E., Kayali, F., Brufsky, A., Telli, M., Wright, G., Oyola, R., Rakowski, T., Graff, S., Tjulandin, S., Semiglazov, V., Aparicio, A., Ruiz Borrego, M., Merino, L., Guerra Martinez, J., Lopez, E., Yamashita, T., Ohtani, S., Inoue, K., Ito, Y., Niikura, N., Nakayama, T., Sagara, Y., Yanagita, Y., Kamada, Y., Kaneko, K., Kaen, D., Nervo, A., Eniu, A., Schenker, M., Priester, P., Melichar, B., Zimovjanova, M., Sormova, P., Sufliarsky, J., Kakalejcik, M., Belbaraka, R., Errihani, H., Le Than, D., Pham, D., Aravantinos, G., Papadimitriou, C., Koumakis, G., Papandreou, C., Podolski, P., Tabane, K., André, F., Cameron, D., Barrios, C., Patel, S., Patre, M., Morales, L., Patel, S.L., Kaul, M., Barata, T., and O’Shaughnessy, J.

Published
2021
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8. Asteroids' physical models from combined dense and sparse photometry and scaling of the YORP effect by the observed obliquity distribution

Author

Hanuš, J., Ďurech, J., Brož, M., Marciniak, A., Warner, B. D., Pilcher, F., Stephens, R., Behrend, R., Carry, B., Čapek, D., Antonini, P., Audejean, M., Augustesen, K., Barbotin, E., Baudouin, P., Bayol, A., Bernasconi, L., Borczyk, W., Bosch, J. -G., Brochard, E., Brunetto, L., Casulli, S., Cazenave, A., Charbonnel, S., Christophe, B., Colas, F., Coloma, J., Conjat, M., Cooney, W., Correira, H., Cotrez, V., Coupier, A., Crippa, R., Cristofanelli, M., Dalmas, Ch., Danavaro, C., Demeautis, C., Droege, T., Durkee, R., Esseiva, N., Esteban, M., Fagas, M., Farroni, G., Fauvaud, M., Fauvaud, S., Del Freo, F., Garcia, L., Geier, S., Godon, C., Grangeon, K., Hamanowa, H., Heck, N., Hellmich, S., Higgins, D., Hirsch, R., Husarik, M., Itkonen, T., Jade, O., Kamiński, K., Kankiewicz, P., Klotz, A., Koff, R. A., Kryszczyńska, A., Kwiatkowski, T., Laffont, A., Leroy, A., Lecacheux, J., Leonie, Y., Leyrat, C., Manzini, F., Martin, A., Masi, G., Matter, D., Michałowski, J., Michałowski, M. J., Michałowski, T., Michelet, J., Michelsen, R., Morelle, E., Mottola, S., Naves, R., Nomen, J., Oey, J., Ogloza, W., Oksanen, A., Oszkiewicz, D., Pääkkönen, P., Paiella, M., Pallares, H., Paulo, J., Pavic, M., Payet, B., Polińska, M., Polishook, D., Poncy, R., Revaz, Y., Rinner, C., Rocca, M., Roche, A., Romeuf, D., Roy, R., Saguin, H., Salom, P. A., Sanchez, S., Santacana, G., Santana-Ros, T., Sareyan, J. -P., Sobkowiak, K., Sposetti, S., Starkey, D., Stoss, R., Strajnic, J., Teng, J. -P., Tregon, B., Vagnozzi, A., Velichko, F. P., Waelchli, N., Wagrez, K., and Wücher, H.

Subjects
Astrophysics - Earth and Planetary Astrophysics
Abstract

The larger number of models of asteroid shapes and their rotational states derived by the lightcurve inversion give us better insight into both the nature of individual objects and the whole asteroid population. With a larger statistical sample we can study the physical properties of asteroid populations, such as main-belt asteroids or individual asteroid families, in more detail. Shape models can also be used in combination with other types of observational data (IR, adaptive optics images, stellar occultations), e.g., to determine sizes and thermal properties. We use all available photometric data of asteroids to derive their physical models by the lightcurve inversion method and compare the observed pole latitude distributions of all asteroids with known convex shape models with the simulated pole latitude distributions. We used classical dense photometric lightcurves from several sources and sparse-in-time photometry from the U.S. Naval Observatory in Flagstaff, Catalina Sky Survey, and La Palma surveys (IAU codes 689, 703, 950) in the lightcurve inversion method to determine asteroid convex models and their rotational states. We also extended a simple dynamical model for the spin evolution of asteroids used in our previous paper. We present 119 new asteroid models derived from combined dense and sparse-in-time photometry. We discuss the reliability of asteroid shape models derived only from Catalina Sky Survey data (IAU code 703) and present 20 such models. By using different values for a scaling parameter cYORP (corresponds to the magnitude of the YORP momentum) in the dynamical model for the spin evolution and by comparing synthetics and observed pole-latitude distributions, we were able to constrain the typical values of the cYORP parameter as between 0.05 and 0.6., Comment: Accepted for publication in A&A, January 15, 2013

Published
2013
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10. OC-0270 Metastases-directed SRT and systemic therapy: EORTC-ESTRO OligoCare delphi consensus recommendations

Author

Kroeze, S., primary, Pavic, M., additional, Stellamans, K., additional, Lievens, Y., additional, Becherini, C., additional, Scorsetti, M., additional, Alongi, F., additional, Ricardi, U., additional, Jereczek, B., additional, Westhoff, P., additional, But-Hadzic, J., additional, Widder, J., additional, Geets, X., additional, Bral, S., additional, Lambrecht, M., additional, Billiet, C., additional, Sirak, I., additional, Ramella, S., additional, Battista, I.G., additional, Benavente, S., additional, Zapatero, A., additional, Romero, F., additional, Zilli, T., additional, Khanfir, K., additional, Hemmatazad, H., additional, De Bari, B., additional, Klass, D., additional, Adnan, S., additional, Peulen, H., additional, Salinas Ramos, J., additional, Strijbos, M., additional, Popat, S., additional, Ost, P., additional, and Guckenberger, M., additional

Published
2023
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11. Metastases-directed stereotactic body radiotherapy in combination with targeted therapy or immunotherapy: systematic review and consensus recommendations by the EORTC-ESTRO OligoCare consortium.

Author

Kroeze, S.G.C., Pavic, M., Stellamans, K., Lievens, Y., Becherini, C., Scorsetti, M., Alongi, F., Ricardi, U., Jereczek-Fossa, Barbara A., Westhoff, P.G., But-Hadzic, J., Widder, J., Geets, X., Bral, S., Lambrecht, M., Billiet, C., Sirak, I., Ramella, S., Giovanni Battista, I., Benavente, S., Zapatero, A., Romero, F., Zilli, T., Khanfir, K., Hemmatazad, H., Bari, B. De, Klass, D.N., Adnan, S., Peulen, H., Salinas Ramos, J., Strijbos, M., Popat, S., Ost, P., Guckenberger, M., Kroeze, S.G.C., Pavic, M., Stellamans, K., Lievens, Y., Becherini, C., Scorsetti, M., Alongi, F., Ricardi, U., Jereczek-Fossa, Barbara A., Westhoff, P.G., But-Hadzic, J., Widder, J., Geets, X., Bral, S., Lambrecht, M., Billiet, C., Sirak, I., Ramella, S., Giovanni Battista, I., Benavente, S., Zapatero, A., Romero, F., Zilli, T., Khanfir, K., Hemmatazad, H., Bari, B. De, Klass, D.N., Adnan, S., Peulen, H., Salinas Ramos, J., Strijbos, M., Popat, S., Ost, P., and Guckenberger, M.

Abstract

Item does not contain fulltext, Stereotactic body radiotherapy (SBRT) for patients with metastatic cancer, especially when characterised by a low tumour burden (ie, oligometastatic disease), receiving targeted therapy or immunotherapy has become a frequently practised and guideline-supported treatment strategy. Despite the increasing use in routine clinical practice, there is little information on the safety of combining SBRT with modern targeted therapy or immunotherapy and a paucity of high-level evidence to guide clinical management. A systematic literature review was performed to identify the toxicity profiles of combined metastases-directed SBRT and targeted therapy or immunotherapy. These results served as the basis for an international Delphi consensus process among 28 interdisciplinary experts who are members of the European Society for Radiotherapy and Oncology (ESTRO) and European Organisation for Research and Treatment of Cancer (EORTC) OligoCare consortium. Consensus was sought about risk mitigation strategies of metastases-directed SBRT combined with targeted therapy or immunotherapy; a potential need for and length of interruption to targeted therapy or immunotherapy around SBRT delivery; and potential adaptations of radiation dose and fractionation. Results of this systematic review and consensus process compile the best available evidence for safe combination of metastases-directed SBRT and targeted therapy or immunotherapy for patients with metastatic or oligometastatic cancer and aim to guide today's clinical practice and the design of future clinical trials.

Published
2023

12. Interobserver agreement on definition of the target volume in stereotactic radiotherapy for pancreatic adenocarcinoma using different imaging modalities

Author

Gkika, E; https://orcid.org/0000-0001-5455-252X, Kostyszyn, D, Fechter, T, Moustakis, C, Ernst, F, Boda-Heggemann, J, Sarria, G, Dieckmann, K, Dobiasch, S, Duma, M N, Eberle, F, Kroeger, K, Häussler, B, Izaguirre, V, Jazmati, D, Lautenschläger, S, Lohaus, F, Mantel, F, Menzel, J, Pachmann, S, Pavic, M, Radlanski, K, Riesterer, O, Gerum, S, Röder, F, Willner, J, Barczyk, S, Imhoff, D, Blanck, O, Wittig, A, et al, Guckenberger, M, Gkika, E; https://orcid.org/0000-0001-5455-252X, Kostyszyn, D, Fechter, T, Moustakis, C, Ernst, F, Boda-Heggemann, J, Sarria, G, Dieckmann, K, Dobiasch, S, Duma, M N, Eberle, F, Kroeger, K, Häussler, B, Izaguirre, V, Jazmati, D, Lautenschläger, S, Lohaus, F, Mantel, F, Menzel, J, Pachmann, S, Pavic, M, Radlanski, K, Riesterer, O, Gerum, S, Röder, F, Willner, J, Barczyk, S, Imhoff, D, Blanck, O, Wittig, A, et al, and Guckenberger, M

Abstract

PURPOSE The aim of this study was to evaluate interobserver agreement (IOA) on target volume definition for pancreatic cancer (PACA) within the Radiosurgery and Stereotactic Radiotherapy Working Group of the German Society of Radiation Oncology (DEGRO) and to identify the influence of imaging modalities on the definition of the target volumes. METHODS Two cases of locally advanced PACA and one local recurrence were selected from a large SBRT database. Delineation was based on either a planning 4D CT with or without (w/wo) IV contrast, w/wo PET/CT, and w/wo diagnostic MRI. Novel compared to other studies, a combination of four metrics was used to integrate several aspects of target volume segmentation: the Dice coefficient (DSC), the Hausdorff distance (HD), the probabilistic distance (PBD), and the volumetric similarity (VS). RESULTS For all three GTVs, the median DSC was 0.75 (range 0.17-0.95), the median HD 15 (range 3.22-67.11) mm, the median PBD 0.33 (range 0.06-4.86), and the median VS was 0.88 (range 0.31-1). For ITVs and PTVs the results were similar. When comparing the imaging modalities for delineation, the best agreement for the GTV was achieved using PET/CT, and for the ITV and PTV using 4D PET/CT, in treatment position with abdominal compression. CONCLUSION Overall, there was good GTV agreement (DSC). Combined metrics appeared to allow a more valid detection of interobserver variation. For SBRT, either 4D PET/CT or 3D PET/CT in treatment position with abdominal compression leads to better agreement and should be considered as a very useful imaging modality for the definition of treatment volumes in pancreatic SBRT. Contouring does not appear to be the weakest link in the treatment planning chain of SBRT for PACA.

Published
2023

13. Exclusion of Patients with a Severe T-Cell Defect Improves the Definition of Common Variable Immunodeficiency

Author

Oksenhendler, E., Fieschi, C., Malphettes, M., Galicier, L., Boutboul, D., Fermand, J.P., Viallard, J.F., Jaccard, A., Hoarau, C., Lebranchu, Y., Bérezné, A., Mouthon, L., Karmochkine, M., Schleinitz, N., Durieu, I., Nove-Josserand, R., Chanet, V., Le-Moing, V., Just, N., Salanoubat, C., Jaussaud, R., Suarez, F., Hermine, O., Solal-Celigny, P., Hachulla, E., Sanhes, L., Gardembas, M., Pellier, I., Tisserant, P., Pavic, M., Bonnotte, B., Haroche, J., Amoura, Z., Alric, L., Thiercelin, M.F., Tetu, L., Adoue, D., Bordigoni, P., Perpoint, T., Sève, P., Rohrlich, P., Pasquali, J.L., Korganow, A.S., Soulas, P., Couderc, L.J., Catherinot, E., Giraud, P., Baruchel, A., Deleveau, I., Chaix, F., Donadieu, J., Tron, F., Larroche, C., Blanc, A.P., Masseau, A., Hamidou, M., Kanny, G., Morisset, M., Millot, F., Fain, O., Borie, R., Perlat, A., Bienvenue, B., Autran, B., Gorochov, G., Garnier, J.L., Moins, H., Maki, G., Gérard, L., Bertinchamp, Rémi, Gérard, Laurence, Boutboul, David, Malphettes, Marion, Fieschi, Claire, and Oksenhendler, Eric

Published
2016
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17. Interobserver agreement on definition of the target volume in stereotactic radiotherapy for pancreatic adenocarcinoma using different imaging modalities

Author

Gkika, E, Kostyszyn, D, Fechter, T, Moustakis, C, Ernst, F, Boda-Heggemann, J, Sarria, G, Dieckmann, K, Dobiasch, S, Duma, M N, Eberle, F, Kroeger, K, Häussler, B, Izaguirre, V, Jazmati, D, Lautenschläger, S, Lohaus, F, Mantel, F, Menzel, J, Pachmann, S, Pavic, M, Radlanski, K, Riesterer, O, Gerum, S, Röder, F, Willner, J, Barczyk, S, Imhoff, D, Blanck, O, Wittig, A, et al, and Guckenberger, M

Published
2023
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20. PET/CT radiomics for prediction of hyperprogression in metastatic melanoma patients treated with immune checkpoint inhibitors

Author

Gabryś, H. S., primary, Basler, L., additional, Burgermeister, S., additional, Hogan, S., additional, Ahmadsei, M., additional, Pavic, M., additional, Bogowicz, M., additional, Vuong, D., additional, Tanadini-Lang, S., additional, Förster, R., additional, Kudura, K., additional, Huellner, M., additional, Dummer, R., additional, Levesque, M. P., additional, and Guckenberger, M., additional

Published
2022
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26. 437TiP An open-label, multicenter, phase II study to evaluate the safety and efficacy of BB-1701, a novel antibody drug conjugate (ADC) targeting HER2, in previously treated patients (pts) with HER2+ or HER2-low unresectable or metastatic (M) breast cancer (BC)

Author

George, M., Frenel, J-S., Cortés, J., Schmidt, M., Saenz, J.Á. García, Blau, S., Abdulla, N.E., Nishimura, M., Sakai, H., Babu, S., McAndrew, N.P., Ali, A., Pavic, M., Jhaveri, K., Jones, J.M., Rugo, H.S., Mody, K., Smith, A.D., and Yamashita, T.

Published
2024
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29. PD-0083 Benefit of replanning in MR-guided online adaptive radiation therapy in liver metastasis treatment

Author

Mayinger, M., primary, Ludwig, R., additional, Christ, S., additional, Dal Bello, R., additional, Ryu, A., additional, Weitkamp, N., additional, Pavic, M., additional, Garcia Schüler, H., additional, Wilke, L., additional, Guckenberger, M., additional, Unkelbach, J., additional, Tanadini-Lang, S., additional, and Andratschke, N., additional

Published
2022
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30. Guide de recommandations d’utilisation des bisphosphonates dans les lésions osseuses malignes des tumeurs solides et du myélome multiple

Author

Brantus, J.-F., Roemer-Becuwe, C., Cony-Makhoul, P., Salino, S., Fontana, A., Debourdeau, P., Thomas, T., Guastalla, J.-P., Ghesquieres, H., Sebban, C., Pavic, M., Collet, P., Larbre, J.-P., Martinon, S., Brocard, F., Bodard, A.-G., Blanc, G., Balestrière, V., Favier, B., Farsi, F., Krakowski, I., and Biron, P.

Published
2011
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33. Prospective Neurocognitive Functions of Patients Treated With Concurrent Nivolumab and Stereotactic Brain Radiosurgery for NSCLC and RCC Brain Metastases

Author

Masucci, G.L., primary, Boucher, O., additional, Marie, F., additional, Plourde, M.E., additional, Panet-Raymond, V., additional, Pavic, M., additional, Owen, S., additional, Masson-Cote, L., additional, Menard, C., additional, Routy, B., additional, Tehfe, M., additional, Blais, N., additional, Roberge, D., additional, and Wong, P., additional

Published
2021
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37. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer

Author

Miles, D., primary, Gligorov, J., additional, André, F., additional, Cameron, D., additional, Schneeweiss, A., additional, Barrios, C., additional, Xu, B., additional, Wardley, A., additional, Kaen, D., additional, Andrade, L., additional, Semiglazov, V., additional, Reinisch, M., additional, Patel, S., additional, Patre, M., additional, Morales, L., additional, Patel, S.L., additional, Kaul, M., additional, Barata, T., additional, O’Shaughnessy, J., additional, Zhang, Q., additional, Shao, Z., additional, Wang, X., additional, Geng, C., additional, Yan, X., additional, Tong, Z., additional, Shen, K., additional, Yin, Y., additional, Sun, T., additional, Yang, J., additional, Feng, J., additional, Yan, M., additional, Wang, Y., additional, Liu, Q., additional, Zhang, S., additional, De Laurentiis, M., additional, Santoro, A., additional, Guarneri, V., additional, Colleoni, M., additional, Natoli, C., additional, Cortesi, L., additional, Placido, S., additional, Gianni, L., additional, Ferrau, F., additional, Livi, L., additional, Zambelli, A., additional, Del Mastro, L., additional, Tonini, G., additional, Montemurro, F., additional, Bianchi, G., additional, Pedersini, R., additional, Prete, S., additional, Allegrini, G., additional, Naso, G., additional, Vici, P., additional, Loirat, D., additional, Mailliez, A., additional, Priou, F., additional, Tredan, O., additional, Dalenc, F., additional, Perrin, C., additional, Timar David, M., additional, Dohollou, N., additional, Teixeira, L., additional, Brocard, F., additional, Arnaud, A., additional, Delaloge, S., additional, Spano, J.-P., additional, Mansi, L., additional, Damian, F., additional, Pedrini, J., additional, Aleixo, S., additional, Hegg, R., additional, Junior, R., additional, Schmidt, M., additional, Wenzel, C., additional, Grischke, E.-M., additional, Just, M., additional, Harbeck, N., additional, Schumacher, C., additional, Peters, U., additional, Fischer, D., additional, Forstbauer, H., additional, Liersch, R., additional, Warner, E., additional, Bouganim, N., additional, Doyle, C., additional, Price Hiller, J., additional, Vandenberg, T., additional, Pavic, M., additional, Robinson, A., additional, Roldan Urgoiti, G., additional, Califaretti, N., additional, Alacacioglu, A., additional, Gumus, M., additional, Yalcin, B., additional, Cicin, I., additional, Kose, F., additional, Uygun, K., additional, Kaplan, M., additional, Cubukcu, E., additional, Harries, M., additional, Miles, D., additional, Doval, D., additional, Gupta, S., additional, Mohapatra, P., additional, Chatterjee, S., additional, Ghadyalpatil, N., additional, Singhal, M., additional, Nag, S., additional, Agarwal, A., additional, Wolf, I., additional, Gal Yam, E., additional, Yerushalmi, R., additional, Peretz, T., additional, Fried, G., additional, Ben Baruch, N., additional, Katz, D., additional, Hamilton, E., additional, Kayali, F., additional, Brufsky, A., additional, Telli, M., additional, Wright, G., additional, Oyola, R., additional, Rakowski, T., additional, Graff, S., additional, Tjulandin, S., additional, Aparicio, A., additional, Ruiz Borrego, M., additional, Merino, L., additional, Guerra Martinez, J., additional, Lopez, E., additional, Yamashita, T., additional, Ohtani, S., additional, Inoue, K., additional, Ito, Y., additional, Niikura, N., additional, Nakayama, T., additional, Sagara, Y., additional, Yanagita, Y., additional, Kamada, Y., additional, Kaneko, K., additional, Nervo, A., additional, Eniu, A., additional, Schenker, M., additional, Priester, P., additional, Melichar, B., additional, Zimovjanova, M., additional, Sormova, P., additional, Sufliarsky, J., additional, Kakalejcik, M., additional, Belbaraka, R., additional, Errihani, H., additional, Le Than, D., additional, Pham, D., additional, Aravantinos, G., additional, Papadimitriou, C., additional, Koumakis, G., additional, Papandreou, C., additional, Podolski, P., additional, and Tabane, K., additional

Published
2021
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38. Pomalidomide, bortezomib, and dexamethasone for multiple myeloma previously treated with lenalidomide (OPTIMISMM): outcomes by prior treatment at first relapse

Author

Dimopoulos, M. Weisel, K. Moreau, P. Anderson, L.D., Jr. White, D. San-Miguel, J. Sonneveld, P. Engelhardt, M. Jenner, M. Corso, A. Dürig, J. Pavic, M. Salomo, M. Casal, E. Srinivasan, S. Yu, X. Nguyen, T.V. Biyukov, T. Peluso, T. Richardson, P.

Subjects
hemic and lymphatic diseases
Abstract

In the phase 3 OPTIMISMM trial, pomalidomide, bortezomib, and dexamethasone (PVd) demonstrated superior efficacy vs bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma previously treated with lenalidomide, including those refractory to lenalidomide. This analysis evaluated outcomes in patients at first relapse (N = 226) by lenalidomide-refractory status, prior bortezomib exposure, and prior stem cell transplant (SCT). Second-line PVd significantly improved PFS vs Vd in lenalidomide-refractory (17.8 vs 9.5 months; P = 0.0276) and lenalidomide-nonrefractory patients (22.0 vs 12.0 months; P = 0.0491), patients with prior bortezomib (17.8 vs 12.0 months; P = 0.0068), and patients with (22.0 vs 13.8 months; P = 0.0241) or without (16.5 vs 9.5 months; P = 0.0454) prior SCT. In patients without prior bortezomib, median PFS was 20.7 vs 9.5 months (P = 0.1055). Significant improvement in overall response rate was also observed with PVd vs Vd in lenalidomide-refractory (85.9% vs 50.8%; P < 0.001) and lenalidomide-nonrefractory (95.7% vs 60.0%; P < 0.001) patients, with similar results regardless of prior bortezomib or SCT. No new safety signals were observed. These data demonstrate the benefit of PVd at first relapse, including immediately after upfront lenalidomide treatment failure and other common first-line treatments. © 2020, The Author(s).

Published
2021

39. Pomalidomide, bortezomib, and dexamethasone for multiple myeloma previously treated with lenalidomide (OPTIMISMM): outcomes by prior treatment at first relapse

Author

Dimopoulos, M, Weisel, K, Moreau, P, Anderson, LD, White, D, San-Miguel, J, Sonneveld, P, Engelhardt, M, Jenner, M, Corso, A, Duerig, J, Pavic, M, Salomo, M, Casal, E, Srinivasan, S, Yu, X, Nguyen, TV, Biyukov, T, Peluso, T, Richardson, P, Dimopoulos, M, Weisel, K, Moreau, P, Anderson, LD, White, D, San-Miguel, J, Sonneveld, P, Engelhardt, M, Jenner, M, Corso, A, Duerig, J, Pavic, M, Salomo, M, Casal, E, Srinivasan, S, Yu, X, Nguyen, TV, Biyukov, T, Peluso, T, and Richardson, P

Abstract

In the phase 3 OPTIMISMM trial, pomalidomide, bortezomib, and dexamethasone (PVd) demonstrated superior efficacy vs bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma previously treated with lenalidomide, including those refractory to lenalidomide. This analysis evaluated outcomes in patients at first relapse (N = 226) by lenalidomide-refractory status, prior bortezomib exposure, and prior stem cell transplant (SCT). Second-line PVd significantly improved PFS vs Vd in lenalidomide-refractory (17.8 vs 9.5 months; P = 0.0276) and lenalidomide-nonrefractory patients (22.0 vs 12.0 months; P = 0.0491), patients with prior bortezomib (17.8 vs 12.0 months; P = 0.0068), and patients with (22.0 vs 13.8 months; P = 0.0241) or without (16.5 vs 9.5 months; P = 0.0454) prior SCT. In patients without prior bortezomib, median PFS was 20.7 vs 9.5 months (P = 0.1055). Significant improvement in overall response rate was also observed with PVd vs Vd in lenalidomide-refractory (85.9% vs 50.8%; P < 0.001) and lenalidomide-nonrefractory (95.7% vs 60.0%; P < 0.001) patients, with similar results regardless of prior bortezomib or SCT. No new safety signals were observed. These data demonstrate the benefit of PVd at first relapse, including immediately after upfront lenalidomide treatment failure and other common first-line treatments.

Published
2021

40. Patterns of integrating palliative care into standard oncology in an early ESMO designated center: a 10-year experience

Author

Blum, D, Seiler, A, Schmidt, E, Pavic, M, Strasser, F, Blum, D, Seiler, A, Schmidt, E, Pavic, M, and Strasser, F

Abstract

BACKGROUND Integration of specialist palliative care (PC) into standard oncology care is recommended. This study investigated how integration at the Cantonal Hospital St. Gallen (KSSG) was manifested 10 years after initial accreditation as a European Society for Medical Oncology (ESMO) Designated Center (ESMO-DC) of Integrated Oncology and Palliative Care. METHODS A chart review covering the years 2006-2009 and 2016 was carried out in patients with an incurable malignancy receiving PC. Visual graphic analysis was utilized to identify patterns of integration of PC into oncology based on the number and nature of medical consultations recorded for both specialties. A follow-up cohort collected 10 years later was analyzed and changes in patterns of integrating specialist PC into oncology were compared. RESULTS Three hundred and forty-five patients from 2006 to 2009 and 64 patients from 2016 were included into analyses. Four distinct patterns were identified using visual graphic analysis. The 'specialist PC-led pattern' (44.9%) and the 'oncology-led pattern' (20.3%) represent disciplines that took primary responsibility for managing patients, with occasional and limited involvement from other disciplines. Patients in the 'concurrent integrated care pattern' (18.3%) had medical consultations that frequently bounced between specialist PC and oncology. In the 'segmented integrated care pattern' (16.5%), patients had sequences of continuous consultations provided by one discipline before alternating to a stretch of consultations provided by the other specialty. In the 2016 follow-up, while the 'oncology-led pattern' occurred significantly less frequently relative to the 'specialist PC-led pattern' and the 'segmented integrated care pattern', the 'concurrent integrated care pattern' emerged more frequently when compared with the 2006-2009 follow-up. CONCLUSION The 'specialist PC-led pattern' was the most prominent pattern in this data. The 2016 follow-up showed that a growing

Published
2021

45. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial

Author

Richardson, Paul G, Oriol, Albert, Beksac, Meral, Liberati, Anna Marina, Galli, Monica, Schjesvold, Fredrik, Lindsay, Jindriska, Weisel, Katja, White, Darrell, Facon, Thierry, San Miguel, Jesus, Sunami, Kazutaka, O'Gorman, Peter, Sonneveld, Pieter, Robak, Pawel, Semochkin, Sergey, Schey, Steve, Yu, Xin, Doerr, Thomas, Bensmaine, Amine, Biyukov, Tsvetan, Peluso, Teresa, Zaki, Mohamed, Anderson, Kenneth, Dimopoulos, Meletios, OPTIMISMM trial investigators, Abildgaard N, Adler H, Altuntas F, Akay OM, Amin B, Anagnostopoulos A, Anderson L, Anttila P, Araujo C, Arce-Lara C, Aydin Y, Basu S, Battini R, Beeker T, Benboubker L, Ben-Yehuda D, Bladé J, Blau IW, Boccia R, Burke L, Byeff P, Cascavilla N, Cavo M, Chantry A, Charles Y, Chaudhry A, Corso A, Coyne M, De Arriba F, Delimpasi S, Desjardins P, Dhakal B, Di Bartolomeo P, Di Raimondo F, Dürig J, Engelhardt M, Escoffre-Barbe M, Esteves G, Flogegard M, Gabrail N, Gamberi B, Garrison M, Gay J, Gisslinger H, Goldschmidt H, Goncalves C, Gressot L, Grosicki S, Hanna W, Hayden P, Henriques Bernardo MM, Hermann R, Holden V, Honkalehto K, Huben M, Huffman J, Hunter H, Hus M, Jagasia M, Jagganath S, Janakiram M, Jaiyesimi I, Jenner M, João C, Johnson P, Jurcyszyn A, Kalayoğlu Beşişik S, Kambhampati S, Kanate A, Karadoğan I, Khojasteh A, Kirkel D, Komarnicki M, Krauth MT, Kuriakose P, Larocca A, Lauri B, Leleu X, Lucio P, Luppi M, Mangiacavalli S, Mariette C, Matsue K, Mellqvist UH, Mendeleeva L, Meshad M, Miller C, Mohrbacher A, Moreau P, Morelli AM, Müldür E, Naassan A, Nahi H, Nair R, O'Dwyer M, Öngören Aydin S, Openshaw T, O'Rourke T, Osswald M, Overton L, Pati A, Pavic M, Pegourie B, Pehlivan M, Pierola AA, Plesner T, Pluta A, Rabin N, Ramasamy K, Rambaldi A, Rodriguez P, Röllig C, Rosenblatt J, Rosenbluth J, Salomo M, Samoylova O, Sastre Moral J, Sati H, Selleri C, Shafeek S, Shinagawa A, Sleckman B, Smith C, Sonmez M, Stone C, Streetly M, Suzuki K, Taetle R, Tafuri A, Takezako N, Teke HÜ, Vapaatalo M, Vassilopoulos G, Verma A, Vidito S, Viterbo L, Vural F, Wang XS, Yağci M, Yee A., Richardson, Paul G, Oriol, Albert, Beksac, Meral, Liberati, Anna Marina, Galli, Monica, Schjesvold, Fredrik, Lindsay, Jindriska, Weisel, Katja, White, Darrell, Facon, Thierry, San Miguel, Jesu, Sunami, Kazutaka, O'Gorman, Peter, Sonneveld, Pieter, Robak, Pawel, Semochkin, Sergey, Schey, Steve, Yu, Xin, Doerr, Thoma, Bensmaine, Amine, Biyukov, Tsvetan, Peluso, Teresa, Zaki, Mohamed, Anderson, Kenneth, Dimopoulos, Meletio, OPTIMISMM trial investigator, Abildgaard N, Adler H, Altuntas F, Akay OM, Amin B, Anagnostopoulos A, Anderson L, Anttila P, Araujo C, Arce-Lara C, Aydin Y, Basu S, Battini R, Beeker T, Benboubker L, Ben-Yehuda D, Bladé J, Blau IW, Boccia R, Burke L, Byeff P, Cascavilla N, Cavo M, Chantry A, Charles Y, Chaudhry A, Corso A, Coyne M, De Arriba F, Delimpasi S, Desjardins P, Dhakal B, Di Bartolomeo P, Di Raimondo F, Dürig J, Engelhardt M, Escoffre-Barbe M, Esteves G, Flogegard M, Gabrail N, Gamberi B, Garrison M, Gay J, Gisslinger H, Goldschmidt H, Goncalves C, Gressot L, Grosicki S, Hanna W, Hayden P, Henriques Bernardo MM, Hermann R, Holden V, Honkalehto K, Huben M, Huffman J, Hunter H, Hus M, Jagasia M, Jagganath S, Janakiram M, Jaiyesimi I, Jenner M, João C, Johnson P, Jurcyszyn A, Kalayoğlu Beşişik S, Kambhampati S, Kanate A, Karadoğan I, Khojasteh A, Kirkel D, Komarnicki M, Krauth MT, Kuriakose P, Larocca A, Lauri B, Leleu X, Lucio P, Luppi M, Mangiacavalli S, Mariette C, Matsue K, Mellqvist UH, Mendeleeva L, Meshad M, Miller C, Mohrbacher A, Moreau P, Morelli AM, Müldür E, Naassan A, Nahi H, Nair R, O'Dwyer M, Öngören Aydin S, Openshaw T, O'Rourke T, Osswald M, Overton L, Pati A, Pavic M, Pegourie B, Pehlivan M, Pierola AA, Plesner T, Pluta A, Rabin N, Ramasamy K, Rambaldi A, Rodriguez P, Röllig C, Rosenblatt J, Rosenbluth J, Salomo M, Samoylova O, Sastre Moral J, Sati H, Selleri C, Shafeek S, Shinagawa A, Sleckman B, Smith C, Sonmez M, Stone C, Streetly M, Suzuki K, Taetle R, Tafuri A, Takezako N, Teke HÜ, Vapaatalo M, Vassilopoulos G, Verma A, Vidito S, Viterbo L, Vural F, Wang XS, Yağci M, Yee A., and Hematology

Subjects
Oncology, Adult, Male, medicine.medical_specialty, Adolescent, Population, Dexamethasone, Bortezomib, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Internal medicine, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, education, Survival rate, Lenalidomide, Multiple myeloma, Aged, Salvage Therapy, education.field_of_study, business.industry, Pomalidomide, bortezomib, dexamethasone, Middle Aged, Pomalidomide, medicine.disease, Prognosis, Thalidomide, Survival Rate, Regimen, Drug Resistance, Neoplasm, 030220 oncology & carcinogenesis, Female, Neoplasm Recurrence, Local, business, Multiple Myeloma, 030215 immunology, medicine.drug, Follow-Up Studies
Abstract

Background As lenalidomide becomes increasingly established for upfront treatment of multiple myeloma, patients refractory to this drug represent a population with an unmet need. The combination of pomalidomide, bortezomib, and dexamethasone has shown promising results in phase 1/2 trials of patients with relapsed or refractory multiple myeloma. We aimed to assess the efficacy and safety of this triplet regimen in patients with relapsed or refractory multiple myeloma who previously received lenalidomide. Methods We did a randomised, open-label, phase 3 trial at 133 hospitals and research centres in 21 countries. We enrolled patients (aged >= 18 years) with a diagnosis of multiple myeloma and measurable disease, an Eastern Cooperative Oncology Group performance status of 0-2, who received one to three previous regimens, including a lenalidomide-containing regimen for at least two consecutive cycles. We randomly assigned patients (1:1) to bortezomib and dexamethasone with or without pomalidomide using a permutated blocked design in blocks of four, stratified according to age, number of previous regimens, and concentration of beta(2) microglobulin at screening. Bortezomib (1.3 mg/m(2)) was administered intravenously until protocol amendment 1 then either intravenously or subcutaneously on days 1,4, 8, and 11 for the first eight cycles and subsequently on days 1 and 8. Dexamethasone (20 mg [10 mg if age >75 years]) was administered orally on the same days as bortezomib and the day after. Patients allocated pomalidomide received 4 mg orally on days 1-14. Treatment cycles were every 21 days. The primary endpoint was progression-free survival in the intention-to-treat population, as assessed by an independent review committee. Safety was assessed in all patients who received at least one dose of study medication. This trial is registered at ClinicalTrials.gov, number NCT01734928; patients are no longer being enrolled. Findings Between Jan 7, 2013, and May 15,2017,559 patients were enrolled. 281 patients were assigned pomalidomide, bortezomib, and dexamethasone and 278 were allocated bortezomib and dexamethasone. Median follow-up was 15.9 months (IQR 9.9-21.7). Pomalidomide, bortezomib, and dexamethasone significantly improved progression-free survival compared with bortezomib and dexamethasone (median 11.20 months [95% CI 9.66-13-73] vs 7.10 months [5.88-8-48]; hazard ratio 0.61, 95% CI 0.49-0-77; p

Published
2019
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48. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial

Author

Powles, T. van der Heijden, M.S. Castellano, D. Galsky, M.D. Loriot, Y. Petrylak, D.P. Ogawa, O. Park, S.H. Lee, J.-L. De Giorgi, U. Bögemann, M. Bamias, A. Eigl, B.J. Gurney, H. Mukherjee, S.D. Fradet, Y. Skoneczna, I. Tsiatas, M. Novikov, A. Suárez, C. Fay, A.P. Duran, I. Necchi, A. Wildsmith, S. He, P. Angra, N. Gupta, A.K. Levin, W. Bellmunt, J. van der Heijden, M.S. Lee, J.L. Eigl, B.J. Mukherjee, S.D. Suarez, C. Westgeest, H. Flechon, A. Ou, Y.-C. Park, I. Matveev, V. Pérez-Valderrama, B. Cheng, S. Frank, S. Anido, U. Hamzaj, A. Retz, M. Sridhar, S. Scagliotti, G.V. Voortman, J. Alekseev, B. Alyasova, A. Komyakov, B. Dumez, H. Pavic, M. Kimura, G. Mizokami, A. Osanto, S. Arranz, J.A. Piersma, D. Shin, S.J. Karyakin, O. Delgado, I. Gonzalez, J.L. Pang, S.-T. Tran, A. Lipatov, O. Su, W.-P. Flaig, T. Alva, A. Park Kyong, H. Kopyltsov, E. Almagro, E. Domenech, M. Chang, Y.-H. Sautois, B. Ravaux, A. Aravantinos, G. Georgoulias, V. Mulder, S. Kim, Y.J. Kater, F. Chevreau, C. Tagawa, S. Zalewski, P. Joly, F. Hatiboglu, G. Gianni, L. Morelli, F. Tambaro, R. Hashimoto, Y. Nosov, A. Font, A. Rodriguez-Vida, A.M. Jones, R. Vasudev, N. Srinivas, S. Zhang, J. Gil, T. Finch, D. Grimm, M.-O. Su, Y.-L. Chowdhury, S. Hocking, C. Plas, E. North, S. Jensen, N.V. Theodore, C. Imkamp, F. Peer, A. Kobayashi, T. Sakai, H. Sassa, N. Yoshimura, K. Aarts, M. Ferreira Castro, A. Topuzov, M. Rodriguez, J.F. Vazquez, F.J. Tsai, Y.-C. Crabb, S. Hussain, S. Bendell, J. Gross-Goupil, M. Gwenaelle, G. Berger, R. Statsenko, G. Evans, L. Drakaki, A. Somer, B. Davis, I. Lynam, J. Borges, G. Dettino, A. Fay, A.P. Martins, G. Zucca, L.E. Agerbaek, M. Kalofonos, H. Rosenbaum, E. Enokida, H. Kikukawa, H. Nishimura, K. Tamada, S. Uemura, M. Lopez, Y. Gietema, J. Slojewski, M. Fernandes, I. Smolin, A. Mazhar, D. Kalebasty, A.R. Carthon, B. Loidl, W. Franke, F. Girotto, G. Alimohamed, N. Macfarlane, R. Pappot, H. Niegisch, G. Mavroudis, D. Sella, A. Porta, C. Ebara, S. Nakamura, M. Obara, W. Okuno, N. Shinohara, N. Sugimoto, M. Suzuki, A. Tokuda, N. Uemura, H. Yamaguchi, A. Ramirez, F. Rozanowski, P. Wiechno, P. Keam, B. Kislov, N. Plaksin, D. Cicin, I. Kumar, S. Galsky, M.D. Petrylak, D.P. Rosales, J. Vaishampayan, U. Culine, S. Papandreou, C. Nara, T. Erman, M. Kreiger, L. Janoski, J. Rosa, D. Siqueira, M. Canil, C. Sengelov, L. Tourani, J.-M. Arai, G. Hashine, K. Kawakita, M. Nakaigawa, N. Nomi, H. Shiina, H. Suzuki, H. Yonese, J. Kuri, R. Macedo, E. Rivera, S. Villalobos Prieto, A. Polakiewicz-Gilowska, A. Zaucha, R. Lopes, F. Ponomarev, R. Pomerantz, M. Shariat, S. Luk, C. Lesniewski-Kmak, K.

Abstract

Background: Survival outcomes are poor for patients with metastatic urothelial carcinoma who receive standard, first-line, platinum-based chemotherapy. We assessed the overall survival of patients who received durvalumab (a PD-L1 inhibitor), with or without tremelimumab (a CTLA-4 inhibitor), as a first-line treatment for metastatic urothelial carcinoma. Methods: DANUBE is an open-label, randomised, controlled, phase 3 trial in patients with untreated, unresectable, locally advanced or metastatic urothelial carcinoma, conducted at 224 academic research centres, hospitals, and oncology clinics in 23 countries. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1. We randomly assigned patients (1:1:1) to receive durvalumab monotherapy (1500 mg) administered intravenously every 4 weeks; durvalumab (1500 mg) plus tremelimumab (75 mg) administered intravenously every 4 weeks for up to four doses, followed by durvalumab maintenance (1500 mg) every 4 weeks; or standard-of-care chemotherapy (gemcitabine plus cisplatin or gemcitabine plus carboplatin, depending on cisplatin eligibility) administered intravenously for up to six cycles. Randomisation was done through an interactive voice–web response system, with stratification by cisplatin eligibility, PD-L1 status, and presence or absence of liver metastases, lung metastases, or both. The coprimary endpoints were overall survival compared between the durvalumab monotherapy versus chemotherapy groups in the population of patients with high PD-L1 expression (the high PD-L1 population) and between the durvalumab plus tremelimumab versus chemotherapy groups in the intention-to-treat population (all randomly assigned patients). The study has completed enrolment and the final analysis of overall survival is reported. The trial is registered with ClinicalTrials.gov, NCT02516241, and the EU Clinical Trials Register, EudraCT number 2015-001633-24. Findings: Between Nov 24, 2015, and March 21, 2017, we randomly assigned 1032 patients to receive durvalumab (n=346), durvalumab plus tremelimumab (n=342), or chemotherapy (n=344). At data cutoff (Jan 27, 2020), median follow-up for survival was 41·2 months (IQR 37·9–43·2) for all patients. In the high PD-L1 population, median overall survival was 14·4 months (95% CI 10·4–17·3) in the durvalumab monotherapy group (n=209) versus 12·1 months (10·4–15·0) in the chemotherapy group (n=207; hazard ratio 0·89, 95% CI 0·71–1·11; p=0·30). In the intention-to-treat population, median overall survival was 15·1 months (13·1–18·0) in the durvalumab plus tremelimumab group versus 12·1 months (10·9–14·0) in the chemotherapy group (0·85, 95% CI 0·72–1·02; p=0·075). In the safety population, grade 3 or 4 treatment-related adverse events occurred in 47 (14%) of 345 patients in the durvalumab group, 93 (27%) of 340 patients in the durvalumab plus tremelimumab group, and in 188 (60%) of 313 patients in the chemotherapy group. The most common grade 3 or 4 treatment-related adverse event was increased lipase in the durvalumab group (seven [2%] of 345 patients) and in the durvalumab plus tremelimumab group (16 [5%] of 340 patients), and neutropenia in the chemotherapy group (66 [21%] of 313 patients). Serious treatment-related adverse events occurred in 30 (9%) of 345 patients in the durvalumab group, 78 (23%) of 340 patients in the durvalumab plus tremelimumab group, and 50 (16%) of 313 patients in the chemotherapy group. Deaths due to study drug toxicity were reported in two (1%) patients in the durvalumab group (acute hepatic failure and hepatitis), two (1%) patients in the durvalumab plus tremelimumab group (septic shock and pneumonitis), and one (

Published
2020

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