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1. Triple-negative breast cancer: treatment challenges and solutions

Author

Collignon J, Lousberg L, Schroeder H, and Jerusalem G

Subjects
triple-negative breast cancer, molecular subtype, platinum-based chemotherapy, targeted therapy, androgen receptor, BRCA1/2 mutation, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Joëlle Collignon,1 Laurence Lousberg,1 Hélène Schroeder,1 Guy Jerusalem,1,21Medical Oncology Department, CHU Sart Tilman Liege, Domaine Universitaire du Sart Tilman, Liege, Belgium; 2University of Liege, Liege, Belgium Abstract: Triple-negative breast cancers (TNBCs) are defined by the absence of estrogen and progesterone receptors and the absence of HER2 overexpression. These cancers represent a heterogeneous breast cancer subtype with a poor prognosis. Few systemic treatment options exist besides the use of chemotherapy (CT). The heterogeneity of the disease has limited the successful development of targeted therapy in unselected patient populations. Currently, there are no approved targeted therapies for TNBC. However, intense research is ongoing to identify specific targets and develop additional and better systemic treatment options. Standard adjuvant and neoadjuvant regimens include anthracyclines, cyclophosphamide, and taxanes. Platinum-based CT has been proposed as another CT option of interest in TNBC. We review the role of this therapy in general, and particularly in patients carrying BRCA germ-line mutations. Available data concerning the role of platinum-based CT in TNBC were acquired primarily in the neoadjuvant setting. The routine use of platinum-based CT is not yet recommended by available guidelines. Many studies have reported the molecular characterization of TNBCs. Several actionable targets have been identified. Novel therapeutic strategies are currently being tested in clinical trials based on promising results observed in preclinical studies. These targets include androgen receptor, EGFR, PARP, FGFR, and the angiogenic pathway. We review the recent data on experimental drugs in this field. We also discuss the recent data concerning immunologic checkpoint inhibitors. Keywords: triple-negative breast cancer, molecular subtype, platinum-based chemotherapy, targeted therapy, androgen receptor, BRCA1/2 mutation

Published
2016

2. Ageism and its clinical impact in oncogeriatry: state of knowledge and therapeutic leads

Author

Schroyen S, Adam S, Jerusalem G, and Missotten P

Subjects
Oncogeriatry, clinical approaches, stigmatization, ageism, Geriatrics, RC952-954.6
Abstract

Sarah Schroyen,1 Stéphane Adam,1 Guy Jerusalem,2,3 Pierre Missotten1 1University of Liège, Psychology of Aging Unit, 2University of Liège, Laboratory of Medical Oncology, 3CHU Sart Tilman Liege, Department of Medical Oncology, Liège, Belgium Abstract: Cancer is a major health problem that is widespread in elderly people. Paradoxically, older people suffering from cancer are often excluded from clinical trials and are undertreated when compared to younger patients. One explanation for these observations is age stigma (ie, stereotypes linked to age, and thus ageism). These stigmas can result in deleterious consequences for elderly people’s mental and physical health in “normal” aging. What, then, is the impact in a pathological context, such as oncology? Moreover, health care professionals’ attitudes can be tainted with ageism, thus leading to undesirable consequences for patients. To counter these stigmas, we can apply some possible interventions emerging from research on normal aging and from social psychology, such as intergenerational contact, activation of positive stereotypes, self-affirmation, and so on; these tools can improve opinions of aging among the elderly people themselves, as well as health care professionals, thus affecting patients’ mental and physical health. Keywords: oncogeriatry, clinical approaches, stigmatization, ageism

Published
2014

3. Use of mTOR inhibitors in the treatment of breast cancer: an evaluation of factors that influence patient outcomes

Author

Jerusalem G, Rorive A, and Collignon J

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Guy Jerusalem, Andree Rorive, Joelle Collignon Medical Oncology, CHU Sart Tilman Liege, Domaine Universitaire du Sart Tilman, Liege, Belgium Abstract: Many systemic treatment options are available for advanced breast cancer, including endocrine therapy, chemotherapy, anti-human epidermal growth factor receptor 2 (HER2) therapy, and other targeted agents. Recently, everolimus, a mammalian target of rapamycin (mTOR) inhibitor, combined with exemestane, an aromatase inhibitor, has been approved in Europe and the USA for patients suffering from estrogen receptor-positive, HER2-negative advanced breast cancer previously treated by a nonsteroidal aromatase inhibitor, based on the results of BOLERO-2 (Breast cancer trials of OraL EveROlimus). This study showed a statistically significant and clinically meaningful improvement in median progression-free survival. Results concerning the impact on overall survival are expected in the near future. This clinically oriented review focuses on the use of mTOR inhibitors in breast cancer. Results reported with first-generation mTOR inhibitors (ridaforolimus, temsirolimus, everolimus) are discussed. The current and potential role of mTOR inhibitors is reported according to breast cancer subtype (estrogen receptor-positive HER2-negative, triple-negative, and HER2-positive ER-positive/negative disease). Everolimus is currently being evaluated in the adjuvant setting in high-risk estrogen receptor-positive, HER2-negative early breast cancer. Continuing mTOR inhibition or alternatively administering other drugs targeting the phosphatidylinositol-3-kinase/protein kinase B-mTOR pathway after progression on treatments including an mTOR inhibitor is under evaluation. Potential biomarkers to select patients showing a more pronounced benefit are reviewed, but we are not currently using these biomarkers in routine practice. Subgroup analysis of BOLERO 2 has shown that the benefit is consistent in all subgroups and that it is impossible to select patients not benefiting from addition of everolimus to exemestane. Side effects and impact on quality of life are other important issues discussed in this review. Second-generation mTOR inhibitors and dual mTOR-phosphatidylinositol-3-kinase inhibitors are currently being evaluated in clinical trials. Keywords: breast cancer, treatment, everolimus, mTOR inhibitors, biomarkers, phosphatidylinositol-3-kinase/protein kinase B-mTOR pathway

Published
2014

7. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

Bachelot, T., Bouzid, K., Campone, M., Desmoulins, I., Coudert, B., Bondarenko, I., Nowecki, Z., Glogowska, I., Ciruelos Gil, E., Errihani, H., Dalenc, F., Ricci, F., Dieras, V., Kaufman, B., Paluch-Shimon, S., Wardley, A., Schneeweiss, A., Ferreira, A., Mano, M., Kalofonos, H., Andreetta, C., Puglisi, F., Montemurro, F., Barrett, S., Zhang, Q., Mavroudis, D., Matus, J., Villarreal Garza, C., Beato, C., Ismael, G., Hu, X., Abdel Azeem, H., Gaafar, R., Perrin, C., Kerbrat, P., Ettl, J., Paepke, S., Hitre, E., Lang, I., Trudeau, M., Verma, S., Li, H., Hoffmann, O., Aktas, B., Cariello, A., Cruciani, G., Tienghi, A., Tondini, C., Al-Twegieri, T., Loman, N., Laing, R., Miles, D., Brain, E., Fasching, P., Lux, M., Frassoldati, A., Aziz, Z., Salas, J., Streb, J., Krzemieniecki, K., Wronski, A., Garcia Garcia, J., Menjon Beltran, S., Cicin, I., Schmid, P., Gallagher, C., Turner, N., Tong, Z., Boer, K., Juhász, B., Horvath, Z., Bianchini, G., Gianni, L., Curigliano, G., Juarez Ramiro, A., Susnjar, S., Matos, E., Sevillano, E., Garcia Estevez, L., Gokmen, E., Uslu, R., Wildiers, H., Schutz, F., Cruz, M., Bourgeois, H., von Schumann, R., Stemmer, S., Dominguez, A., Morales-Vásques, F., Wojtukiewicz, M., Trifunovic, J., Echarri Gonzalez, M.J., Illarramendi Mañas, J., Martinez De Dueñas, E., Voitko, N., Hicks, J., Waters, S., Barrett-Lee, P., Wheatley, D., De Boer, R., Cocquyt, V., Jerusalem, G., Barrios, C., Panasci, L., Mattson, J., Tanner, M., Gozy, M., Vasilopoulos, G., Papandreou, C., Revesz, J., Battelli, N., Benedetti, G., Latini, L., Gridelli, C., Lazaro Leon, J., Alarcón Company, J., Arance Fernandez, A., Barnadas Molins, A., Calvo Plaza, I., Bratos, R., Gonzalez Martin, A., Izarzugaza Peron, Y., Klint, L., Kovalev, A., McCarthy, N., Yeo, B., Kee, D., Thomson, J., White, S., Greil, R., Wang, S., Artignan, X., Juhasz-Böess, I., Rody, A., Ngan, R., Dourleshter, F., Goldberg, H., Doni, L., Di Costanzo, F., Ferraù, F., Drobniene, M., Aleknavicius, E., Rashid, K., Costa, L., de la Cruz Merino, L., Garcia Saenz, J., López, R., Del Val Munoz, O., Ozyilkan, O., Azribi, F., Jaafar, H., Baird, R., Verrill, M., Beith, J., Petzer, A., Moreira de Andrade, J., Bernstein, V., Macpherson, N., Rayson, D., Saad Eldin, I., Achille, M., Augereau, P., Müller, V., Rasco, A., Evron, E., Katz, D., Berardi, R., Cascinu, S., De Censi, A., Gennari, A., El-Saghir, N., Ghosn, M., Oosterkamp, H.M., Van den Bosch, J., Kukulska, M., Kalinka, E., Alonso, J., Dalmau Portulas, E., Del Mar Gordon Santiago, M., Pelaez Fernandez, I., Aksoy, S., Altundag, K., Senol Coskun, H., Bozcuk, H., Shparyk, Y., Barraclough, L., Levitt, N., Panwar, U., Kelly, S., Rigg, A., Varughese, M., Castillo, C., Fein, L., Malik, L., Stuart-Harris, R., Singer, C., Stoeger, H., Samonigg, H., Feng, J., Cedeño, M., Ruohola, J., Berdah, J.-F., Goncalves, A., Orfeuvre, H., Grischke, E.-M., Simon, E., Wagner, S., Koumakis, G., Papazisis, K., Ben Baruch, N., Fried, G., Geffen, D., Karminsky, N., Peretz, T., Cavanna, L., Pedrazzioli, P., Grasso, D., Ruggeri, E., D’Auria, G., Moscetti, L., Juozaityte, E., Rodriguez Cid, J., Roerdink, H., Siddiqi, N., Passos Coelho, J., Arcediano Del Amo, A., Garcia Garre, E., García Gonzalez, M., Garcia-Palomo Perez, A., Herenandez Perez, C., Lopez Alvarez, P., Lopez De Ceballos, M.H., Martínez Jañez, N., Mele Olive, M., McAdam, K., Perren, T., Dunn, G., Humphreys, A., Taylor, W., Vera, R., Kaen, L., Andel, J., Steger, G., De Grève, J., Huizing, M., Hegg, R., Joy, A., Kuruvilla, P., Sehdev, S., Smiljanic, S., Kütner, R., Alexandre, J., Grosjean, J., Laplaige, P., Largillier, R., Maes, P., Martin, P., Pottier, V., Christensen, B., Khandan, F., Lück, H.-J., Zahm, D.-M., Fountzilas, G., Karavasilis, V., Safra, T., Inbar, M., Ryvo, L., Bonetti, A., Seles, E., Giacobino, A., Chavarri Guerra, Y., de Jongh, F., van der Velden, A., van Warmerdam, L., Vrijaldenhoven, S., Smorenburg, C.H., Cavero, M., Andres Conejero, R., Oltra Ferrando, A., Redondo Sanchez, A., Ribelles Entrena, N., Saura Grau, S., Viñas Vilaro, G., Bachmeier, K., Beresford, M., Butt, M., Joffe, J., Poole, C., Woodings, P., Chakraborti, P., Yordi, G., Woodward, N., Nobre, A., Luiz Amorim, G., Califaretti, N., Fox, S., Robidoux, A., Li, E., Li, N., Jiang, J., Soria, T., Padrik, P., Lahdenpera, O., Barletta, H., Dohollou, N., Genet, D., Prulhiere, K., Coeffic, D., Facchini, T., Vieillot, S., Catala, S., Teixeira, L., Hesse, T., Kühn, T., Ober, A., Repp, R., Schröder, W., Pectasides, D., Bodoky, G., Kahan, Z., Jiveliouk, I., Rosengarten, O., Rossi, V., Alabiso, O., Pérez Martínez, M., van de Wouw, A.J., Smok-Kalwat, J., Damasecno, M., Augusto, I., Sousa, G., Saadein, A., Abdelhafiez, N., Abulkhair, O., Antón Torres, A., Corbellas Aparicio, M., Llorente Domenech, R., Florián Jerico, J., Garcia Mata, J., Gil Raga, M., Galan Brotons, A., Llombart Cussac, A., Llorca Ferrandiz, C., Martinez Del Prado, P., Olier Garate, C., Rodriguez Sanchez, C., Sanchez Gomez, R., Santisteban Eslava, M., Soberino, J., Vidal Losada Garcia, M., Soto de Prado, D., Torrego Garcia, J., Vicente Rubio, E., Garcia, M., Murias Rosales, A., Granstam Björneklett, H., Narbe, U., Jafri, M., Rea, D., Newby, J., Jones, A., Westwell, S., Ring, A., Alonso, I., Rodríguez, R., Ciruelos, E., Peretz-Yablonski, T., Merot, J.-L., Trask, P., du Toit, Y., Pena-Murillo, C., Revelant, V., and Klingbiel, D.

Published
2021
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8. Continuous versus intermittent extended adjuvant letrozole for breast cancer: final results of randomized phase III SOLE (Study of Letrozole Extension) and SOLE Estrogen Substudy

Author

Jerusalem, G., Farah, S., Courtois, A., Chirgwin, J., Aebi, S., Karlsson, P., Neven, P., Hitre, E., Graas, M.P., Simoncini, E., Abdi, E., Kamby, C., Thompson, A., Loibl, S., Gavilá, J., Kuroi, K., Marth, C., Müller, B., O’Reilly, S., Gombos, A., Ruhstaller, T., Burstein, H.J., Rabaglio, M., Ruepp, B., Ribi, K., Viale, G., Gelber, R.D., Coates, A.S., Loi, S., Goldhirsch, A., Regan, M.M., and Colleoni, M.

Published
2021
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9. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival

Author

Slamon, D.J., Neven, P., Chia, S., Jerusalem, G., De Laurentiis, M., Im, S., Petrakova, K., Valeria Bianchi, G., Martín, M., Nusch, A., Sonke, G.S., De la Cruz-Merino, L., Beck, J.T., Ji, Y., Wang, C., Deore, U., Chakravartty, A., Zarate, J.P., Taran, T., and Fasching, P.A.

Published
2021
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12. Determining clinically important differences in health-related quality of life in older patients with cancer undergoing chemotherapy or surgery

Author

Quinten, C., Kenis, C., Decoster, L., Debruyne, P. R., De Groof, I., Focan, C., Cornelis, F., Verschaeve, V., Bachmann, C., Bron, D., Luce, S., Debugne, G., Van den Bulck, H., Goeminne, J. C., Baitar, A., Geboers, K., Petit, B., Langenaeken, C., Van Rijswijk, R., Specenier, P., Jerusalem, G., Praet, J. P., Vandenborre, K., Lycke, M., Flamaing, J., Milisen, K., Lobelle, J. P., and Wildiers, H.

Published
2019

14. End-of-life healthcare utilization in older patients with cancer: a large Belgian data linkage study

Author

Depoorter, V., primary, Vanschoenbeek, K., additional, Decoster, L., additional, Silversmit, G., additional, Debruyne, P., additional, De Groof, I., additional, Bron, D., additional, Cornélis, F., additional, Luce, S., additional, Focan, C., additional, Verschaeve, V., additional, Debugne, G., additional, Langenaeken, C., additional, Van Den Bulck, H., additional, Goeminne, J.C., additional, Teurfs, W., additional, Jerusalem, G., additional, Schrijvers, D., additional, Petit, B., additional, Rasschaert, M., additional, Praet, J.P., additional, Vandenborre, K., additional, De Schutter, H., additional, Milisen, K., additional, Flamaing, J., additional, Kenis, C., additional, Verdoodt, F., additional, and Wildiers, H., additional

Published
2023
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15. Palliative care at the end-of-life in older patients with cancer and associated age-related factors

Author

Depoorter, V., primary, Vanschoenbeek, K., additional, Decoster, L., additional, Silversmit, G., additional, Debruyne, P., additional, De Groof, I., additional, Bron, D., additional, Cornélis, F., additional, Luce, S., additional, Focan, C., additional, Verschaeve, V., additional, Debugne, G., additional, Langenaeken, C., additional, Van Den Bulck, H., additional, Goeminne, J.C., additional, Teurfs, W., additional, Jerusalem, G., additional, Schrijvers, D., additional, Petit, B., additional, Rasschaert, M., additional, Praet, J.P., additional, Vandenborre, K., additional, De Schutter, H., additional, Milisen, K., additional, Flamaing, J., additional, Kenis, C., additional, Verdoodt, F., additional, and Wildiers, H., additional

Published
2023
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16. A randomized phase II study evaluating different maintenance schedules of nab-paclitaxel in the first-line treatment of metastatic breast cancer: final results of the IBCSG 42-12/BIG 2-12 SNAP trial

Author

Gennari, A., Sun, Z., Hasler-Strub, U., Colleoni, M., Kennedy, M.J., Von Moos, R., Cortés, J., Vidal, M.J., Hennessy, B., Walshe, J., Parraga, K. Amillano, Ribi, K., Bernhard, J., Murillo, S. Morales, Pagani, O., Barbeaux, A., Borstnar, S., Rabaglio-Poretti, M., Maibach, R., Regan, M.M., and Jerusalem, G.

Published
2018
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18. Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrant

Author

Universidad de Sevilla. Departamento de Medicina, Universidad de Sevilla. CTS151: Bioquímica médica., Neven, P., Fasching, P. A., Chia, S., Jerusalem, G., De Laurentiis, M., Im, S. A., Cruz Merino, Luis de la, Slamon, D. J., Universidad de Sevilla. Departamento de Medicina, Universidad de Sevilla. CTS151: Bioquímica médica., Neven, P., Fasching, P. A., Chia, S., Jerusalem, G., De Laurentiis, M., Im, S. A., Cruz Merino, Luis de la, and Slamon, D. J.

Abstract

Background The phase III MONALEESA-3 trial included frst- (1L) and second-line (2L) patients and demonstrated a signifcant overall survival (OS) beneft for ribociclib+fulvestrant in patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2−) advanced breast cancer (ABC) in the fnal protocol-specifed and exploratory (longer follow-up) OS analyses. At the time of these analyses, the full OS beneft of 1L ribociclib was not completely characterized because the median OS (mOS) was not reached. As CDK4/6 inhibi‑ tor (CDK4/6i)+endocrine therapy (ET) is now a preferred option for 1L HR+/HER2− ABC, we report an exploratory analysis (median follow-up, 70.8 months; 14.5 months longer than the prior analysis) to fully elucidate the OS beneft in the MONALEESA-3 1L population. Methods Postmenopausal patients with HR+/HER2− ABC were randomized 2:1 to 1L/2L fulvestrant+riboci‑ clib or placebo. OS in 1L patients (de novo disease or relapse>12 months from completion of [neo]adjuvant ET) was assessed by Cox proportional hazards model and Kaplan–Meier methods. Progression-free survival 2 (PFS2) and chemotherapy-free survival (CFS) were analyzed. MONALEESA-3 is registered with ClinicalTrials.gov (NCT02422615). Results At data cutof (January 12, 2022; median follow-up time, 70.8 months), mOS was 67.6 versus 51.8 months with 1L ribociclib versus placebo (hazard ratio (HR) 0.67; 95% CI 0.50–0.90); 16.5% and 8.6% of ribociclib and placebo patients, respectively, were still receiving treatment. PFS2 (HR 0.64) and CFS (HR 0.62) favored ribociclib versus pla‑ cebo. Among those who discontinued treatment, 16.7% and 35.0% on ribociclib or placebo, respectively, received a subsequent CDK4/6i. No new safety signals were observed. This analysis of MONALEESA-3 reports the longest mOS thus far (67.6 months) for 1L patients in a phase III ABC trial. These results in a 1L population show that the OS beneft of ribociclib was maintained through extended follow-u

Published
2023

19. Safety of everolimus plus exemestane in patients with hormone-receptor–positive, HER2–negative locally advanced or metastatic breast cancer progressing on prior non-steroidal aromatase inhibitors: primary results of a phase IIIb, open-label, single-arm, expanded-access multicenter trial (BALLET)

Author

Jerusalem, G., Mariani, G., Ciruelos, E.M., Martin, M., Tjan-Heijnen, V.C.G., Neven, P., Gavila, J.G., Michelotti, A., Montemurro, F., Generali, D., Simoncini, E., Lang, I., Mardiak, J., Naume, B., Camozzi, M., Lorizzo, K., Bianchetti, S., and Conte, P.

Published
2016
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21. 201P Phase II study of taminadenant (A2AR antagonist) + spartalizumab (anti PD-1 antibody) in patients with triple-negative breast cancer (TNBC)

Author

Jerusalem, G., primary, De Braud, F.G.M., additional, de Jonge, M.J.A., additional, Grell, P., additional, Gonçalves, A., additional, Tan, T.J.Y., additional, Greil, R., additional, Yap, T.A., additional, Lin, C-C., additional, Kornbluth, K.A., additional, Yang, X., additional, Vong, C., additional, Choudhury, S., additional, Mataraza, J., additional, Lee, L.H., additional, Otero, J.A., additional, and Garralda, E., additional

Published
2022
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22. Hospitalizations, emergency department visits and home care in older patients after cancer diagnosis: results from a large data linkage study with 3 year follow-up

Author

Depoorter, V., primary, Vanschoenbeek, K., additional, Decoster, L., additional, De Schutter, H., additional, Debruyne, P.R., additional, De Groof, I., additional, Bron, D., additional, Cornélis, F., additional, Luce, S., additional, Focan, C., additional, Verschaeve, V., additional, Debugne, G., additional, Langenaeken, C., additional, Van Den Bulck, H., additional, Goeminne, J.C., additional, Teurfs, W., additional, Jerusalem, G., additional, Schrijvers, D., additional, Petit, B., additional, Rasschaert, M., additional, Praet, J.P., additional, Vandenborre, K., additional, Milisen, K., additional, Flamaing, J., additional, Kenis, C., additional, Verdoodt, F., additional, and Wildiers, H., additional

Published
2022
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23. 273TiP ACE-Breast-03: A phase II study patients with HER2-positive metastatic breast cancer whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens treated with ARX788

Author

Hurvitz, S.A., primary, Kalinsky, K., additional, Tripathy, D., additional, Sledge, G., additional, Gradishar, W.J., additional, O'Shaughnessy, J., additional, Modi, S., additional, Park, H., additional, McCartney, A., additional, Frentzas, S., additional, Shannon, C., additional, Cuff, K., additional, Eek, R.W., additional, Martin Jimenez, M., additional, Curigliano, G., additional, Jerusalem, G., additional, Huang, C., additional, Press, M., additional, and Lu, J., additional

Published
2022
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24. OA03.04 Phase I A Study to Evaluate GDC-6036 Monotherapy in Patients with Non-small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation

Author

Sacher, A., primary, Patel, M.R., additional, Miller, W.H., additional, Desai, J., additional, Garralda, E., additional, Bowyer, S., additional, Kim, T.W., additional, De Miguel, M., additional, Falcon, A., additional, Krebs, M.G., additional, Lee, J., additional, Cheng, M., additional, Han, S.-W., additional, Shacham-Shmueli, E., additional, Forster, M., additional, Jerusalem, G., additional, Massarelli, E., additional, Paz-Ares Rodriguez, L., additional, Prenen, H., additional, Walpole, I., additional, Arbour, K., additional, Choi, Y., additional, Dharia, N.V., additional, Lin, M., additional, Mandlekar, S., additional, Royer Joo, S., additional, Shi, Z., additional, Schutzman, J., additional, and LoRusso, P., additional

Published
2022
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26. LBA18 Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ advanced/metastatic breast cancer (mBC) with or without brain metastases (BM): DESTINYBreast-12 primary results

Author

Lin, N., Ciruelos, E.M., Jerusalem, G., Mueller, V., Niikura, N., Viale, G., Bartsch, R., Kurzeder, C., Connolly, R., Baron-Hay, S.E., Gion Cortes, M., Guarneri, V., Bianchini, G., Wildiers, H., Escrivá-de-Romaní, S., Prahladan, M., Bridge, H., Verma, S., and Harbeck, N.

Published
2024
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27. 1072TiP Phase I/II dose escalation/expansion trial to evaluate safety and preliminary efficacy of DuoBody-EpCAM×4-1BB (BNT314/GEN1059) alone or in combination with an immune checkpoint inhibitor in patients with malignant solid tumors

Author

Melero, I., Lakhani, N.J., Powderly, J., Adjei, A.A., Lopez, J.S., Paz-Ares, L.G., Moreno Candilejo, I., Thistlethwaite, F., Rohrberg, K.S., Jerusalem, G., Malmberg, A., Ioan-Facsinay, A., Upadhyay, P.J., Tan, B., Bartz, R., Gaziel, T.B.B., Forssmann, U., Celik, I., Gann, C., and De Mattos-Arruda, L.

Published
2024
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31. List of Contributors

Author

Abellás-Sequeiros, R.A., primary, Alcidi, G., additional, Alonso Salinas, G.L., additional, Arpino, G., additional, Ayach, B., additional, Boni, R., additional, Bours, V., additional, Brown, J., additional, Bucciarelli-Ducci, C., additional, Cardinale, D., additional, Coppola, C., additional, Cosyns, B., additional, Dulgheru, R., additional, Edvardsen, T., additional, Erba, P.A., additional, Freres, P., additional, Galderisi, M., additional, González-Juanatey, J.R., additional, Hinojar, R., additional, Ilardi, F., additional, Jerusalem, G., additional, Kerkhove, D., additional, Lancellotti, P., additional, López Fernández, T., additional, López López, A., additional, López Sendón, J., additional, Manrique, C.R., additional, Maurea, N., additional, Monagham, M.J., additional, Moonen, M., additional, Oury, C., additional, Paciolla, I., additional, Plana, J.C., additional, Ramos, J., additional, Rienzo, A., additional, Rigo, F., additional, Rodríguez Muñoz, D., additional, Sánchez, V., additional, Santoro, C., additional, Scherrer-Crosbie, M., additional, Sicari, R., additional, Sollini, M., additional, Sorrentino, R., additional, Tiwari, N., additional, and Zamorano Gómez, J.L., additional

Published
2017
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32. A Belgian survey on geriatric assessment in oncology focusing on large-scale implementation and related barriers and facilitators

Author

Kenis, C., Heeren, P., Decoster, L., Van Puyvelde, K., Conings, G., Cornelis, F., Cornette, P., Moor, R., Luce, S., Libert, Y., Van Rijswijk, R., Jerusalem, G., Rasschaert, M., Langenaeken, C., Baitar, A., Specenier, P., Geboers, K., Vandenborre, K., Debruyne, P.R., Vanoverbeke, K., Van Den Bulck, H., Praet, J.-P., Focan, C., Verschaeve, V., Nols, N., Goeminne, J.-C., Petit, B., Lobelle, J.-P., Flamaing, J., Milisen, K., and Wildiers, Hans

Published
2016
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33. Multiple Bayesian network meta-analyses to establish therapeutic algorithms for metastatic triple negative breast cancer

Author

Schettini, F., Venturini, Sergio, Giuliano, M., Lambertini, M., Pinato, D. J., Onesti, C. E., De Placido, P., Harbeck, N., Luftner, D., Denys, H., Van Dam, P., Arpino, G., Zaman, K., Mustacchi, G., Gligorov, J., Awada, A., Campone, M., Wildiers, H., Gennari, Alessandro, Tjan-Heijnen, V., Bartsch, R., Cortes, J., Paris, Ida, Martin, M., De Placido, S., Del Mastro, L., Jerusalem, G., Curigliano, G., Prat, A., Generali, Daniele, Venturini S. (ORCID:0000-0002-6574-3337), Gennari A., Paris I., Generali D. (ORCID:0000-0003-2480-3855), Schettini, F., Venturini, Sergio, Giuliano, M., Lambertini, M., Pinato, D. J., Onesti, C. E., De Placido, P., Harbeck, N., Luftner, D., Denys, H., Van Dam, P., Arpino, G., Zaman, K., Mustacchi, G., Gligorov, J., Awada, A., Campone, M., Wildiers, H., Gennari, Alessandro, Tjan-Heijnen, V., Bartsch, R., Cortes, J., Paris, Ida, Martin, M., De Placido, S., Del Mastro, L., Jerusalem, G., Curigliano, G., Prat, A., Generali, Daniele, Venturini S. (ORCID:0000-0002-6574-3337), Gennari A., Paris I., and Generali D. (ORCID:0000-0003-2480-3855)

Abstract

Metastatic triple-negative breast cancer (mTNBC) is a poor prognostic disease with limited treatments and un-certain therapeutic algorithms. We performed a systematic review and multiple Bayesian network meta-analyses according to treatment line to establish an optimal therapeutic sequencing strategy for this lethal disease. We included 125 first-line trials (37,812 patients) and 33 s/further-lines trials (11,321 patients). The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall response rates (ORR), overall survival (OS) and safety, for first and further lines, separately. We also estimated separate treatment rankings for the first and subsequent lines according to each endpoint, based on (surface under the cumulative ranking curve) SUCRA values. No first-line treatment was associated with superior PFS and OS than paclitaxel +/- bevacizumab. Platinum-based polychemotherapies were generally superior in terms of ORR, at the cost of higher toxicity.. PARP-inhibitors in germline-BRCA1/2-mutant patients, and immunotherapy + chemotherapy in PD-L1 -positive mTNBC, performed similar to paclitaxel +/- bevacizumab. In PD-L1-positive mTNBC, pembrolizumab + chemotherapy was better than atezolizumab + nab-paclitaxel in terms of OS according to SUCRA values. In second/further-lines, sacituzumab govitecan outperformed all other treatments on all endpoints, followed by PARP-inhibitors in germline-BRCA1/2-mutant tumors. Trastuzumab deruxtecan in HER2-low mTNBC performed similarly and was the best advanced-line treatment in terms of PFS and OS after sacituzumab govitecan, ac-cording to SUCRA values. Moreover, comparisons with sacituzumab govitecan, talazoparib and olaparib were not statistically significant. The most effective alternatives or candidates for subsequent lines were represented by nab-paclitaxel (in ORR), capecitabine (in PFS) and eribulin (in PFS and OS).

Published
2022

34. 92MO Neoadjuvant nivolumab (NIVO) + palbociclib (PALBO) + anastrozole (ANA) for estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) primary breast cancer (BC): CheckMate 7A8

Author

Jerusalem, G., primary, Prat, A., additional, Salgado, R.F., additional, Reinisch, M., additional, Saura, C., additional, Ruiz Borrego, M., additional, Nikolinakos, P., additional, Filian, J., additional, Ades, F., additional, Huang, N., additional, Mazzei-Abba, A., additional, and Tolaney, S.M., additional

Published
2022
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35. LBA4 Updated overall survival (OS) results from the first-line (1L) population in the phase III MONALEESA-3 trial of postmenopausal patients (PTS) with HR+/HER2− advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL)

Author

Neven, P., primary, Fasching, P.A., additional, Chia, S., additional, Jerusalem, G., additional, De Laurentiis, M., additional, Im, S.-A., additional, Petrakova, K., additional, Bianchi, G.V., additional, Martin Jimenez, M., additional, Nusch, A., additional, Sonke, G.S., additional, de la Cruz Merino, L., additional, Beck, J.T., additional, Zarate, J.P., additional, Wang, Y., additional, Chakravartty, A., additional, Wang, C., additional, and Slamon, D., additional

Published
2022
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36. Clinical PET in Oncology

Author

Rigo, P., Paulus, P., Bury, T., Jerusalem, G., Hustinx, R., Benoit, T., Larock, M. P., Foidart, J., Bergmann, H., editor, Kroiss, A., editor, and Sinzinger, H., editor

Published
1997
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37. Geriatric screening and assessment among older patients with cancer: evaluation of long-term outcomes in a multicentric cohort of > 7, 000 patients

Author

Depoorter, V., primary, Vanschoenbeek, K., additional, Decoster, L., additional, De Schutter, H., additional, Debruyne, P.R., additional, De Groof, I., additional, Bron, D., additional, Cornélis, F., additional, Luce, S., additional, Focan, C., additional, Verschaeve, V., additional, Debugne, G., additional, Langenaeken, C., additional, Van Den Bulck, H., additional, Goeminne, J.C., additional, Teurfs, W., additional, Jerusalem, G., additional, Schrijvers, D., additional, Petit, B., additional, Geboers, K., additional, Forceville, K., additional, Praet, J.P., additional, Vandenborre, K., additional, Milisen, K., additional, Flamaing, J., additional, Kenis, C., additional, Verdoodt, F., additional, and Wildiers, H., additional

Published
2021
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40. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

Miles, D., primary, Ciruelos, E., additional, Schneeweiss, A., additional, Puglisi, F., additional, Peretz-Yablonski, T., additional, Campone, M., additional, Bondarenko, I., additional, Nowecki, Z., additional, Errihani, H., additional, Paluch-Shimon, S., additional, Wardley, A., additional, Merot, J.-L., additional, Trask, P., additional, du Toit, Y., additional, Pena-Murillo, C., additional, Revelant, V., additional, Klingbiel, D., additional, Bachelot, T., additional, Bouzid, K., additional, Desmoulins, I., additional, Coudert, B., additional, Glogowska, I., additional, Ciruelos Gil, E., additional, Dalenc, F., additional, Ricci, F., additional, Dieras, V., additional, Kaufman, B., additional, Ferreira, A., additional, Mano, M., additional, Kalofonos, H., additional, Andreetta, C., additional, Montemurro, F., additional, Barrett, S., additional, Zhang, Q., additional, Mavroudis, D., additional, Matus, J., additional, Villarreal Garza, C., additional, Beato, C., additional, Ismael, G., additional, Hu, X., additional, Abdel Azeem, H., additional, Gaafar, R., additional, Perrin, C., additional, Kerbrat, P., additional, Ettl, J., additional, Paepke, S., additional, Hitre, E., additional, Lang, I., additional, Trudeau, M., additional, Verma, S., additional, Li, H., additional, Hoffmann, O., additional, Aktas, B., additional, Cariello, A., additional, Cruciani, G., additional, Tienghi, A., additional, Tondini, C., additional, Al-Twegieri, T., additional, Loman, N., additional, Laing, R., additional, Miles, D., additional, Brain, E., additional, Fasching, P., additional, Lux, M., additional, Frassoldati, A., additional, Aziz, Z., additional, Salas, J., additional, Streb, J., additional, Krzemieniecki, K., additional, Wronski, A., additional, Garcia Garcia, J., additional, Menjon Beltran, S., additional, Cicin, I., additional, Schmid, P., additional, Gallagher, C., additional, Turner, N., additional, Tong, Z., additional, Boer, K., additional, Juhász, B., additional, Horvath, Z., additional, Bianchini, G., additional, Gianni, L., additional, Curigliano, G., additional, Juarez Ramiro, A., additional, Susnjar, S., additional, Matos, E., additional, Sevillano, E., additional, Garcia Estevez, L., additional, Gokmen, E., additional, Uslu, R., additional, Wildiers, H., additional, Schutz, F., additional, Cruz, M., additional, Bourgeois, H., additional, von Schumann, R., additional, Stemmer, S., additional, Dominguez, A., additional, Morales-Vásques, F., additional, Wojtukiewicz, M., additional, Trifunovic, J., additional, Echarri Gonzalez, M.J., additional, Illarramendi Mañas, J., additional, Martinez De Dueñas, E., additional, Voitko, N., additional, Hicks, J., additional, Waters, S., additional, Barrett-Lee, P., additional, Wheatley, D., additional, De Boer, R., additional, Cocquyt, V., additional, Jerusalem, G., additional, Barrios, C., additional, Panasci, L., additional, Mattson, J., additional, Tanner, M., additional, Gozy, M., additional, Vasilopoulos, G., additional, Papandreou, C., additional, Revesz, J., additional, Battelli, N., additional, Benedetti, G., additional, Latini, L., additional, Gridelli, C., additional, Lazaro Leon, J., additional, Alarcón Company, J., additional, Arance Fernandez, A., additional, Barnadas Molins, A., additional, Calvo Plaza, I., additional, Bratos, R., additional, Gonzalez Martin, A., additional, Izarzugaza Peron, Y., additional, Klint, L., additional, Kovalev, A., additional, McCarthy, N., additional, Yeo, B., additional, Kee, D., additional, Thomson, J., additional, White, S., additional, Greil, R., additional, Wang, S., additional, Artignan, X., additional, Juhasz-Böess, I., additional, Rody, A., additional, Ngan, R., additional, Dourleshter, F., additional, Goldberg, H., additional, Doni, L., additional, Di Costanzo, F., additional, Ferraù, F., additional, Drobniene, M., additional, Aleknavicius, E., additional, Rashid, K., additional, Costa, L., additional, de la Cruz Merino, L., additional, Garcia Saenz, J., additional, López, R., additional, Del Val Munoz, O., additional, Ozyilkan, O., additional, Azribi, F., additional, Jaafar, H., additional, Baird, R., additional, Verrill, M., additional, Beith, J., additional, Petzer, A., additional, Moreira de Andrade, J., additional, Bernstein, V., additional, Macpherson, N., additional, Rayson, D., additional, Saad Eldin, I., additional, Achille, M., additional, Augereau, P., additional, Müller, V., additional, Rasco, A., additional, Evron, E., additional, Katz, D., additional, Berardi, R., additional, Cascinu, S., additional, De Censi, A., additional, Gennari, A., additional, El-Saghir, N., additional, Ghosn, M., additional, Oosterkamp, H.M., additional, Van den Bosch, J., additional, Kukulska, M., additional, Kalinka, E., additional, Alonso, J., additional, Dalmau Portulas, E., additional, Del Mar Gordon Santiago, M., additional, Pelaez Fernandez, I., additional, Aksoy, S., additional, Altundag, K., additional, Senol Coskun, H., additional, Bozcuk, H., additional, Shparyk, Y., additional, Barraclough, L., additional, Levitt, N., additional, Panwar, U., additional, Kelly, S., additional, Rigg, A., additional, Varughese, M., additional, Castillo, C., additional, Fein, L., additional, Malik, L., additional, Stuart-Harris, R., additional, Singer, C., additional, Stoeger, H., additional, Samonigg, H., additional, Feng, J., additional, Cedeño, M., additional, Ruohola, J., additional, Berdah, J.-F., additional, Goncalves, A., additional, Orfeuvre, H., additional, Grischke, E.-M., additional, Simon, E., additional, Wagner, S., additional, Koumakis, G., additional, Papazisis, K., additional, Ben Baruch, N., additional, Fried, G., additional, Geffen, D., additional, Karminsky, N., additional, Peretz, T., additional, Cavanna, L., additional, Pedrazzioli, P., additional, Grasso, D., additional, Ruggeri, E., additional, D’Auria, G., additional, Moscetti, L., additional, Juozaityte, E., additional, Rodriguez Cid, J., additional, Roerdink, H., additional, Siddiqi, N., additional, Passos Coelho, J., additional, Arcediano Del Amo, A., additional, Garcia Garre, E., additional, García Gonzalez, M., additional, Garcia-Palomo Perez, A., additional, Herenandez Perez, C., additional, Lopez Alvarez, P., additional, Lopez De Ceballos, M.H., additional, Martínez Jañez, N., additional, Mele Olive, M., additional, McAdam, K., additional, Perren, T., additional, Dunn, G., additional, Humphreys, A., additional, Taylor, W., additional, Vera, R., additional, Kaen, L., additional, Andel, J., additional, Steger, G., additional, De Grève, J., additional, Huizing, M., additional, Hegg, R., additional, Joy, A., additional, Kuruvilla, P., additional, Sehdev, S., additional, Smiljanic, S., additional, Kütner, R., additional, Alexandre, J., additional, Grosjean, J., additional, Laplaige, P., additional, Largillier, R., additional, Maes, P., additional, Martin, P., additional, Pottier, V., additional, Christensen, B., additional, Khandan, F., additional, Lück, H.-J., additional, Zahm, D.-M., additional, Fountzilas, G., additional, Karavasilis, V., additional, Safra, T., additional, Inbar, M., additional, Ryvo, L., additional, Bonetti, A., additional, Seles, E., additional, Giacobino, A., additional, Chavarri Guerra, Y., additional, de Jongh, F., additional, van der Velden, A., additional, van Warmerdam, L., additional, Vrijaldenhoven, S., additional, Smorenburg, C.H., additional, Cavero, M., additional, Andres Conejero, R., additional, Oltra Ferrando, A., additional, Redondo Sanchez, A., additional, Ribelles Entrena, N., additional, Saura Grau, S., additional, Viñas Vilaro, G., additional, Bachmeier, K., additional, Beresford, M., additional, Butt, M., additional, Joffe, J., additional, Poole, C., additional, Woodings, P., additional, Chakraborti, P., additional, Yordi, G., additional, Woodward, N., additional, Nobre, A., additional, Luiz Amorim, G., additional, Califaretti, N., additional, Fox, S., additional, Robidoux, A., additional, Li, E., additional, Li, N., additional, Jiang, J., additional, Soria, T., additional, Padrik, P., additional, Lahdenpera, O., additional, Barletta, H., additional, Dohollou, N., additional, Genet, D., additional, Prulhiere, K., additional, Coeffic, D., additional, Facchini, T., additional, Vieillot, S., additional, Catala, S., additional, Teixeira, L., additional, Hesse, T., additional, Kühn, T., additional, Ober, A., additional, Repp, R., additional, Schröder, W., additional, Pectasides, D., additional, Bodoky, G., additional, Kahan, Z., additional, Jiveliouk, I., additional, Rosengarten, O., additional, Rossi, V., additional, Alabiso, O., additional, Pérez Martínez, M., additional, van de Wouw, A.J., additional, Smok-Kalwat, J., additional, Damasecno, M., additional, Augusto, I., additional, Sousa, G., additional, Saadein, A., additional, Abdelhafiez, N., additional, Abulkhair, O., additional, Antón Torres, A., additional, Corbellas Aparicio, M., additional, Llorente Domenech, R., additional, Florián Jerico, J., additional, Garcia Mata, J., additional, Gil Raga, M., additional, Galan Brotons, A., additional, Llombart Cussac, A., additional, Llorca Ferrandiz, C., additional, Martinez Del Prado, P., additional, Olier Garate, C., additional, Rodriguez Sanchez, C., additional, Sanchez Gomez, R., additional, Santisteban Eslava, M., additional, Soberino, J., additional, Vidal Losada Garcia, M., additional, Soto de Prado, D., additional, Torrego Garcia, J., additional, Vicente Rubio, E., additional, Garcia, M., additional, Murias Rosales, A., additional, Granstam Björneklett, H., additional, Narbe, U., additional, Jafri, M., additional, Rea, D., additional, Newby, J., additional, Jones, A., additional, Westwell, S., additional, Ring, A., additional, Alonso, I., additional, and Rodríguez, R., additional

Published
2021
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41. Corrigendum to ‘Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival’

Author

Slamon, D.J., primary, Neven, P., additional, Chia, S., additional, Jerusalem, G., additional, De Laurentiis, M., additional, Im, S., additional, Petrakova, K., additional, Valeria Bianchi, G., additional, Martín, M., additional, Nusch, A., additional, Sonke, G.S., additional, De la Cruz-Merino, L., additional, Beck, J.T., additional, Ji, Y., additional, Wang, C., additional, Deore, U., additional, Chakravartty, A., additional, Zarate, J.P., additional, Taran, T., additional, and Fasching, P.A., additional

Published
2021
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42. 436P Phase (Ph) II study of taminadenant (NIR178) + spartalizumab (PDR001) in patients (pts) with microsatellite stable (MSS) colorectal cancer (CRC)

Author

Saavedra Santa Gadea, O., primary, Greil, R., additional, de Jonge, M.J.A., additional, Tan, D., additional, Jerusalem, G., additional, Damian, S., additional, Grell, P., additional, Wainberg, Z., additional, Wolf, J., additional, Joerger, M., additional, Carlino, M.S., additional, Kasper, S., additional, Yap, T.A., additional, Otero, J., additional, Yang, X., additional, Nesbitt, V., additional, Kim, J., additional, Lee, L. Ho, additional, Choudhury, S., additional, and Leal, T.A., additional

Published
2021
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43. 131P Impact of body mass (BMI) and weight change after adjuvant treatment in patients (pts) with HER2-positive early breast cancer

Author

Franzoi, M.A., primary, Martel, S., additional, Agbor-Tarh, D., additional, Piccart, M., additional, Bines, J., additional, Loibl, S., additional, Di Cosimo, S., additional, Vaz-Luis, I., additional, Di Meglio, A., additional, Del Mastro, L., additional, Gombos, A., additional, Desmedt, C., additional, Jerusalem, G., additional, Reaby, L., additional, Pienkowski, T., additional, Lambertini, M., additional, and de Azambuja, E., additional

Published
2021
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44. 275P A phase II study of LAG525 in combination with spartalizumab (PDR001), PDR001 and carboplatin (Carbo), or Carbo, as first- or second-line therapy in patients (Pts) with advanced (Adv) triple-negative breast cancer (tnbc)

Author

Carey, L.A., primary, Pierga, J-Y., additional, Kümmel, S., additional, Jerusalem, G., additional, De Laurentiis, M., additional, Miller, M., additional, Li, Z., additional, Kaper, M., additional, Su, F., additional, and Loi, S., additional

Published
2021
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45. 233P Association of quality of life (QOL) with overall survival (OS) in patients (pts) with HR+/HER2− advanced breast cancer (ABC) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA-3 (ML-3) and ML-7 trials

Author

Fasching, P.A., primary, Harbeck, N., additional, Jerusalem, G., additional, Colleoni, M.A., additional, Neven, P., additional, Franke, F., additional, De Laurentiis, M., additional, Tripathy, D., additional, Martin, M., additional, Babu, G., additional, Yardley, D., additional, Wheatley-Price, P., additional, Chan, A., additional, Villanueva Vazquez, R., additional, Nusch, A., additional, Gu, E., additional, Hu, H., additional, Pathak, P., additional, Thuerigen, A., additional, and Bardia, A., additional

Published
2021
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46. 335TiP Open-label, multinational, multicenter, phase IIIb/IV study of trastuzumab deruxtecan (T-DXd) in patients with or without baseline brain metastasis with previously treated advanced/metastatic human epidermal growth factor receptor 2–positive breast cancer (HER2+ BC): DESTINY-Breast12

Author

Lin, N.U., primary, Ciruelos, E., additional, Jerusalem, G., additional, Müller, V., additional, Niikura, N., additional, Viale, G., additional, Oscroft, E., additional, Anand, S., additional, Walker, G., additional, and Harbeck, N., additional

Published
2021
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47. Neoadjuvant treatment with docetaxel plus lapatinib, trastuzumab, or both followed by an anthracycline-based chemotherapy in HER2-positive breast cancer: results of the randomised phase II EORTC 10054 study

Author

Bonnefoi, H., Jacot, W., Saghatchian, M., Moldovan, C., Venat-Bouvet, L., Zaman, K., Matos, E., Petit, T., Bodmer, A., Quenel-Tueux, N., Chakiba, C., Vuylsteke, P., Jerusalem, G., Brain, E., Tredan, O., Messina, C. G. M., Slaets, L., and Cameron, D.

Published
2015
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49. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival

Author

Slamon, D. J., Neven, P., Chia, S., Jerusalem, G., De Laurentiis, M., Im, S., Cruz Merino, Luis de la, Fasching, P. A., and Universidad de Sevilla. Departamento de Medicina

Subjects
Ribociclib, Advanced breast cancer, Overall survival, CDK4/6 inhibitor
Abstract

Background: Ribociclib plus fulvestrant demonstrated significant progression-free survival (PFS) and overall survival (OS) benefits in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC). Here we present a new landmark in survival follow-up for a phase III cyclin-dependent kinases 4 and 6 inhibitor clinical trial in patients with ABC (median, 56.3 months). Patients and methods: This phase III, randomized, double-blind, placebo-controlled trial was conducted at 174 sites (30 countries). Patients were men and postmenopausal women (age ≥18 years) with histologically/cytologically confirmed HR+/HER2- ABC. Patients could have received ≤1 line of endocrine therapy (ET) but no chemotherapy for ABC. Patients, assigned 2:1, were stratified by the presence/absence of liver/lung metastases and previous ET. Patients received intramuscular fulvestrant (500 mg, day 1 of each 28-day cycle plus day 15 of cycle 1) with oral ribociclib (600 mg/day, 3 weeks on, 1 week off) or placebo. Efficacy analyses were by intention to treat. Safety was assessed in patients receiving ≥1 dose study treatment. OS was a secondary endpoint. MONALEESA-3 is registered with ClinicalTrials.gov (NCT02422615; no longer enrolling). Results: Between 18 June 2015 and 10 June 2016, 726 patients were randomly assigned (484, ribociclib; 242, placebo). At data cut-off (30 October 2020), median OS (mOS) was 53.7 months (ribociclib) versus 41.5 months (placebo) [hazard ratio (HR), 0.73; 95% confidence interval (CI) 0.59-0.90]. Subgroup analyses were consistent with overall population. In the first-line setting, most patients in the ribociclib arm (∼60%) lived longer than median follow-up; mOS was 51.8 months in the placebo arm (HR, 0.64; 95% CI 0.46-0.88). In the second-line setting, mOS was 39.7 months (ribociclib) versus 33.7 months (placebo) (HR, 0.78; 95% CI 0.59-1.04). No apparent drug-drug interaction between ribociclib and fulvestrant or new safety signals were observed. Conclusions: This analysis reported extended OS follow-up in MONALEESA-3. mOS was ∼12 months longer in patients with HR+/HER2- ABC treated with ribociclib plus fulvestrant compared with fulvestrant monotherapy.

Published
2021

50. A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer

Author

Schmid P, Sablin M, Bergh J, Im S, Lu Y, Martinez N, Neven P, Lee K, Morales S, Perez-Fidalgo J, Adamson D, Goncalves A, Prat A, Jerusalem G, Schlieker L, Espadero R, Bogenrieder T, Huang D, Crown J, and Cortes J

Subjects
Breast cancer, Hormone receptor-positive, Xentuzumab, Insulin-like growth factor, HER2-negative
Abstract

Background: Xentuzumab-a humanised IgG1 monoclonal antibody-binds IGF-1 and IGF-2, inhibiting their growth-promoting signalling and suppressing AKT activation by everolimus. This phase Ib/II exploratory trial evaluated xentuzumab plus everolimus and exemestane in hormone receptor-positive, locally advanced and/or metastatic breast cancer (LA/MBC). Methods: Patients with hormone receptor-positive/HER2-negative LA/MBC resistant to non-steroidal aromatase inhibitors were enrolled. Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of xentuzumab/everolimus/exemestane were determined in phase I (single-arm, dose-escalation). In phase II (open-label), patients were randomised 1:1 to the RP2D of xentuzumab/everolimus/exemestane or everolimus/exemestane alone. Randomisation was stratified by the presence of visceral metastases. Primary endpoint was progression-free survival (PFS). Results: MTD was determined as xentuzumab 1000 mg weekly plus everolimus 10 mg/day and exemestane 25 mg/day. A total of 140 patients were enrolled in phase II (70 to each arm). Further recruitment was stopped following an unfavourable benefit-risk assessment by the internal Data Monitoring Committee appointed by the sponsor. Xentuzumab was discontinued; patients could receive everolimus/exemestane if clinically indicated. Median PFS was 7.3 months (95% CI 3.3-not calculable) in the xentuzumab/everolimus/exemestane group and 5.6 months (3.7-9.1) in the everolimus/exemestane group (hazard ratio 0.97, 95% CI 0.57-1.65; P = 0.9057). In a pre-specified subgroup of patients without visceral metastases at screening, xentuzumab/everolimus/exemestane showed evidence of PFS benefit versus everolimus/exemestane (hazard ratio 0.21 [0.05-0.98]; P = 0.0293). Most common any-cause adverse events in phase II were diarrhoea (29 [41.4%] in the xentuzumab/everolimus/exemestane group versus 20 [29.0%] in the everolimus/exemestane group), mucosal inflammation (27 [38.6%] versus 21 [30.4%]), stomatitis (24 [34.3%] versus 24 [34.8%]), and asthenia (21 [30.0%] versus 24 [34.8%]). Conclusions: Addition of xentuzumab to everolimus/exemestane did not improve PFS in the overall population, leading to early discontinuation of the trial. Evidence of PFS benefit was observed in patients without visceral metastases when treated with xentuzumab/everolimus/exemestane, leading to initiation of the phase II XENERA (TM)-1 trial (NCT03659136).

Published
2021

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