Contemporary outcomes of metastatic breast cancer among 22,000 women from the multicentre ESME cohort 2008-2016.

Real-world data inform the outcome comparisons and help the development of new therapeutic strategies. To this end, we aimed to describe the full characteristics and outcomes in the Epidemiological Strategy and Medical Economics (ESME) cohort, a large national contemporary observational database of patients with metastatic breast cancer (MBC). Women aged ≥18 years with newly diagnosed MBC and who initiated MBC treatment between January 2008 and December 2016 in one of the 18 French Comprehensive Cancer Centers (N = 22,109) were included. We assessed the full patients' characteristics, first-line treatments, overall survival (OS) and first-line progression-free survival, as well as updated prognostic factors in the whole cohort and among the 3 major subtypes: hormone receptor positive and HER2-negative (HR+/HER2-, n = 13,656), HER2-positive (HER2+, n = 4017) and triple-negative (n = 2963) tumours. The median OS of the whole cohort was 39.5 months (95% confidence interval [CI], 38.7-40.3). Five-year OS was 33.8%. OS differed significantly between the 3 subtypes (p < 0.0001) with a median OS of 43.3 (95% CI, 42.5-44.5) in HR+/HER2-; 50.1 (95% CI, 47.6-53.1) in HER2+; and 14.8 months (95% CI, 14.1-15.5) in triple-negative subgroups, respectively. Beyond performance status, the following variables had a constant significant negative prognostic impact on OS in the whole cohort and among subtypes: older age at diagnosis of metastases (except for the triple-negative subtype), metastasis-free interval between 6 and 24 months, presence of visceral metastases and number of metastatic sites ≥ 3. The ESME program represents a unique large-scale real-life cohort on MBC. This study highlights important situations of high medical need within MBC patients. DATABASE REGISTRATION: clinicaltrials.gov Identifier NCT032753.

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Conflict of interest statement S.D. reports personal fees and non-financial support from Roche/Genentech; grants, personal fees and non-financial support from Pfizer; personal fees and non-financial support from Puma; grants, personal fees and non-financial support from AstraZeneca; grants, personal fees and non-financial support from Novartis; personal fees and non-financial support from Amgen. T.B. reports grants, personal fees and non-financial support from Novartis, Pfizer and AstraZeneca; personal fees from Seattle Genetics and personal fees and non-financial support from Roche. E.B. reports personal fees from Pfizer, Roche, Mylan, BMS, Clinigen, TLC Pharma Chem, G1 Therapeutics and Samsung and non-financial support from Roche, Pierre Fabre, Novartis, AstraZeneca and Pfizer. W.J. reports personal fees and non-financial support from Eisai, Novartis, Roche, Pfizer and Lilly; grants, personal fees and non-financial support from AstraZeneca; personal fees from MSD; non-financial support from Chugai. M.-A.M.-R. reports other from Novartis, Lilly, Pfizer, Roche, Pierre Fabre and MSD, outside the submitted work. F.D. reports boards from Novartis, Lilly, Pfizer and AstraZeneca. C.L-P. reports non-financial support from Novartis, Roche, Pfizer, AstraZeneca and Fabre. C.C. reports grants from Pfizer, Roche, MSD, AstraZeneca, Eisai and Daiichi. A.G. reports non-financial support from Roche, Novartis, AstraZeneca and Pfizer. M.R. reports other from Roche, Astra Zeneca, MSD, Pfizer, Daiichi Sankyo and Lilly. D.P. reports personal fees from Roche; personal fees and non-financial support from AstraZeneca; and grants from MSD, outside the submitted work. The other authors declare that they have no conflict of interest to disclose.