Enrollment of older metastatic breast cancer patients in first-line clinical trials: 9-year experience of the large-scale real-life multicenter French ESME cohort

Purpose: Older cancer patients are underrepresented in clinical trials. We aimed to evaluate the enrollment of older women aged 70 years old (yo) or over with metastatic breast cancer (MBC) in clinical trials. Methods: We used the national Epidemio-Strategy and Medical Economics MBC Data Platform, a French multi-center real-life database. We selected MBC women over 70yo, without central nervous system metastases, with at least one line of systemic treatment, between January 1st, 2008 and December 31st, 2016, and had no other cancer in the 5 years before MBC. The primary objective was to evaluate the proportion of patients enrolled in clinical trials according to their age. Secondary objective was to identify variables associated with enrollment in older ones. Results: 5552 women were aged ≥ 70 (median 74yo; IQR 72–77). 14,611 were less than 70. Of the older ones, 239 (4%) were enrolled in a clinical trial during first line of treatment, compared with 1529 (10.5%) for younger ones. Multivariable analysis of variables predicting for enrollment during first line of treatment in older patients were younger age (OR 0.50 [95%CI 0.33–0.76] for the 80–85yo class; OR 0.17 [95%CI 0.06–0.39] for the 85yo and more class), good ECOG Performance Status (PS 0–1) (OR 0.15 [95%CI 0.08–0.27] for the PS 2–4 class), HER2 + disease (OR 1.78 [95%CI 1.27–2.48]), type of treatment (chemotherapy/targeted therapy/immunotherapy OR 5.01 [95%CI 3.13–8.18]), and period (OR 1.65 [95%CI 1.22–2.26] for 2012–2016, compared to 2008–2011). Conclusion: In this large database, few older MBC patients were enrolled in a trial compared with younger ones.