Standard anthracycline based versus docetaxel-capecitabine in early high clinical and/or genomic risk breast cancer in the EORTC 10041/BIG 3-04 MINDACT phase III trial

Suzette Delaloge, Martine Piccart, Emiel Rutgers, Saskia Litière, Laura J. van’t Veer, Franchette van den Berkmortel, Etienne Brain, Aleksandra Dudek-Peric, Miguel Gil-Gil, Patricia Gomez, Florentine S. Hilbers, Zaman Khalil, Susan Knox, Sherko Kuemmel, Georg Kunz, Anne Lesur, Jean Yves Pierga, Peter Ravdin, Isabel T. Rubio, Mahasti SaghatchianTineke J. Smilde, Alastair M. Thompson, Giuseppe Viale, Gabriele Zoppoli, Peter Vuylsteke, Konstantinos Tryfonidis, Coralie Poncet, Jan Bogaerts, Fatima Cardoso, Karen Benn, Eva Ciruelos, Sabine Corochan, Julia Cuny, Lorena de la Pena, Mauro DeLorenzi, Inge Eekhout, Oleg Gluz, Vassilis Golfinopoulos, Theodora Goulioti, Nadia Harbeck, Valérie Hilal, Jerome Lemonnier, Michał Ławniczak, Luca Marini, Erika Matos, Peppi Morales, Kirsten Murray, Urlike Nitz, Rodolfo Passalaqua, Jolanda Remmelzwaal, Leen Slaets, Christos Sotiriou, Carolyn Straehle, Mark Straley, Nathalie Theron, Renata Todeschini, Milanka Urunkar, Kim Aalders, Jacques Bines, Philippe Bedard, Ivana Bozovic, Sofia Braga, Carlos Castaneda, Aleksandar Celebic, Camelia Colichi, Carmen Criscitiello, Lissandra Dal Lago, Gaston Demonty, Caroline Drukker, Fei Fei, Michela Lia, Sherene Loi, Stella Mook, Camilo Moulin, Roman Sreseli, Gustavo Werutsky, Sabine Corachan, Aleksandra Dudek-Peric, Lorraine Wheeler, Nicolas Dif, Giovanna Rizzetto, Melanie Beauvois, Livia Meirsman, Hilde Breyssens, Nuria Decker, Kristel Engelen, Anita Akropovic, Jillian Harrison, Frederic Henot, Miet Celis, Britt de Jongh, Inge Delmotte, Valéry Daubie, Roel Goossens, Nils Helsen, Laetitia Hourt, Sven Janssen, Virginie Soete, Kaat Vansevenant, Catherine Hermans

Research output: Contribution to journalArticle

Abstract

© 2020 by American Society of Clinical Oncology PURPOSE MINDACT demonstrated that 46% of patients with early breast cancer at high clinical but low genomic risk on the basis of MammaPrint may safely avoid adjuvant chemotherapy. A second random assignment (R-C) compared docetaxel-capecitabine with an anthracycline-based regimen. PATIENTS AND METHODS R-C randomly assigned patients 1:1 between standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m2 intravenously plus oral capecitabine 825 mg/m2 two times per day for 14 days (DC) every 3 weeks for 6 cycles. The primary end point was disease-free survival (DFS). Secondary end points included overall survival and safety. RESULTS Of 2,832 patients, 1,301 (45%) were randomly assigned, and 97% complied with R-C assignment. In the control arm, 29.6% only received taxanes (0.5% of N0 patients). DFS events (n = 148) were much less than required (n = 422) as a result of a lower-than-expected accrual and event rate. At 5 years of median follow-up, DFS was not different between DC (n = 652) and control (n = 649; 90.7% [95% CI, 88% to 92.8%] v 88.8% [95% CI, 85.9% to 91.1%]; hazard ratio [HR], 0.83 [95% CI, 0.60 to 1.15]; P = .26). Overall survival (HR, 0.91 [95% CI, 0.54 to 1.53]) and DFS in the clinical high and genomic high-risk subgroup (86.1% v 88.1%; HR, 0.83 [95% CI, 0.58 to 1.21]) were similar in both arms. DC led to more grade 1 neuropathy (27.1% v 11.2%) and more grade 2 hand/foot syndrome (28.5% v 3.3%) and diarrhea (13.7% v 5.8%). Serious cardiac events occurred in 9 patients (control, n = 4; DC, n = 5). Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2 v 1). Five treatment-related deaths occurred (control, 2 [0.3%]; DC, 3 [0.5%]). CONCLUSION Although underpowered, this second randomization in MINDACT did not show any improvement in outcome or safety with the use of DC compared with anthracycline-based chemotherapy.
Original languageAmerican English
Pages (from-to)1186-1197
Number of pages12
JournalJournal of Clinical Oncology
DOIs
StatePublished - 10 Apr 2020

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    Delaloge, S., Piccart, M., Rutgers, E., Litière, S., van’t Veer, L. J., van den Berkmortel, F., Brain, E., Dudek-Peric, A., Gil-Gil, M., Gomez, P., Hilbers, F. S., Khalil, Z., Knox, S., Kuemmel, S., Kunz, G., Lesur, A., Pierga, J. Y., Ravdin, P., Rubio, I. T., ... Hermans, C. (2020). Standard anthracycline based versus docetaxel-capecitabine in early high clinical and/or genomic risk breast cancer in the EORTC 10041/BIG 3-04 MINDACT phase III trial. Journal of Clinical Oncology, 1186-1197. https://doi.org/10.1200/JCO.19.01371