Abstract
Purpose
A major question when treating HR+/HER2− metastatic breast cancer (MBC) is whether early introduction of chemotherapy (CT) increases endocrine resistance. We aimed to describe progression-free survival (PFS) under first endocrine therapy (ET) depending on whether given before or after CT in a large nationwide cohort, in the pre-CDK era.
Methods
The real-life retrospective ESME database includes all patients with MBC whose first-line treatment was initiated between 2008 and 2014 in one of the 18 French Comprehensive Cancer Centres. Our primary objective was to compare PFS from start of first ET in patients with HR+/HER2− MBC who received ET or CT first.
Results
We identified 6293 patients who received at least one ET line during their first two therapeutic lines for MBC. As first-line therapy, 3832 (60.9%) received ET alone (ET1 1st group), whilst 2461 (39.1%) received CT, including 2024 patients (32.2%) with maintenance ET after CT (ET1 after CT group). Median PFS under first ET was 12.4 months (95% CI 11.9–13.1) in ET 1st group vs. 12.6 months in ET1 after CT group (95% CI 12.1–13.4), HR 0.96 (95% CI 0.90–1.01, P = 0.1277).
Conclusions
PFS under first ET appears identical whether prescribed before or after chemotherapy. These data suggest chemotherapy does not promote endocrine resistance.
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Data availability
All data are contained in the ESME data warehouse, which is managed by Unicancer. However, the ESME database is not publicly available for the following reason: in the ESME Research programme, public data sharing is not automatic to ensure that only trained users can analyse the ESME datasets. The analysis datasets will be made available only under data transfer and use agreements executed between Unicancer, and the potential licensee. Interested parties should contact the corresponding author.
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Acknowledgements
The authors thank all patients who participated to the ESME MBC real-life cohort. They also thank the 18 French Comprehensive Cancer Centres for providing the data and each ESME local coordinator for managing the project at the local level. Moreover, they thank the ESME Scientific Group and Strategic Committee for their ongoing support
18 Participating French Comprehensive Cancer Centres (FCCC): I. Curie, Paris/Saint-Cloud; G. Roussy, Villejuif; I. Cancérologie de l’Ouest, Angers/Nantes; C. F. Baclesse, Caen; ICM Montpellier; C. L. Bérard, Lyon; C. G-F Leclerc, Dijon; C. H. Becquerel, Rouen; I. C. Regaud, Toulouse; C. A. Lacassagne, Nice; Institut de Cancérologie de Lorraine, Nancy; C. E. Marquis, Rennes; I. Paoli-Calmettes, Marseille; C. J. Perrin, Clermont Ferrand; I. Bergonié, Bordeaux; C. P. Strauss, Strasbourg; I. J. Godinot, Reims; C. O. Lambret, Lille
ESME central coordinating staff: Programme director: Anne-Laure Martin. Data Management team: Coralie Courtinard, Emilie Nguyen, Olivier Payen, Irwin Piot, Dominique Schwob and Olivier Villacroux. Operational team: Nathalie Bouyer, Michaël Chevrot, Daniel Couch, Patricia D’Agostino, Pascale Danglot, Levent Dinc, Tahar Guesmia, Elodie Kupfer, Harmonie Oulie, Frédéric Roy, Gaëtane Simon and Toihiri Said. Software designer Team: Matou Diop, Blaise Fulpin, Fréja Messo, José Paredes and Alexandre Vanni
ESME local coordinators: Thomas Bachelot, Delphine Berchery, Etienne Brain, Mathias Breton, Loïc Campion, Emmanuel Chamorey, Sandrine Dabakuyo, Valérie Dejean, Stéphanie Delaine, Anne-Valérie Guizard, Anne Jaffré, Lilian Laborde, Carine Laurent, Marie-Paule Lebitasy, Agnès Loeb, Damien Parent, Geneviève Perrocheau, Marie-Ange Mouret-Reynier and Michel Velten.
Funding
This work was supported by R&D UNICANCER. The ESME MBC database is supported by an industrial consortium (Roche, Pierre Fabre, Pfizer, AstraZeneca, MSD, Eisai and Daiichi Sankyo). No Grant Numbers apply. Data collection, analyses and publications are managed entirely by UNICANCER independently of the industrial funding partners.
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Conception and design: TB, MC. Statistical analyses: ALC. Data analysis and interpretation: PC, TB. Manuscript writing: PC, ALC. Critical revision of the manuscript: MA, MF, CL, AAV, AM, MD, AG, FLD, FL, JMF, JCE, MAMR, TP, JSF, FD, CC, TB. Supervision: TB.
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Dr Ledu has received compensation for her advisory role for Novartis, Lilly, Pfizer, Seatlle Genetics, Daiichi and Roche. She also has received research support from Pfizer, AstraZeneca, Novartis and Daiichi. Dr Frenel has received compensation for his advisory role for Novartis, Pfizer, Astra Zeneca, Lilly, Roche, Biocad, Daiichi, Tessaro, GSK and Pierre Fabre. Dr Bachelot has received compensation for his advisory role for Astra Zeneca, Novartis, Pfizer, Roche and SeaGen. He also has received research support from Roche, Pfizer, SeaGen and Astra Zeneca. Dr Corbaux, A. Lardy-Cléaud, Dr Alexandre, Dr Fontanilles, Dr Lévy, Dr Viansone, Dr Mailliez, Dr Debled, Dr Goncalves, Dr Lerebours, Dr Ferrero, Dr Eymard, Dr Mouret-Reynier, Dr Petit, Dr Dalenc, C. Courtinard and Dr Chaix declare no potential competing interests.
Ethical approval
The ESME database received approval from the French Data Protection Authority (Commission Nationale de l’Informatique et des Libertés, registration ID 1704113, authorization N DE-2013.-117). This work was approved by an independent ethics committee (Comité de Protection des Personnes Sud-Est II- 2015-79) which waived the requirement for dedicated informed consent. Approval of all patients for the use of their electronically recorded data had previously been obtained.
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Corbaux, P., Lardy-Cleaud, A., Alexandre, M. et al. Progression-free survival on endocrine therapy, before or after chemotherapy, in hormone receptor-positive HER2-negative metastatic breast cancer. Breast Cancer Res Treat 191, 191–207 (2022). https://doi.org/10.1007/s10549-021-06382-6
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DOI: https://doi.org/10.1007/s10549-021-06382-6