351P - Safety of Everolimus For Women Over 65 Years of Age With Advanced Breast Cancer: 18-Mo Follow-Up of BOLERO-2

Abstract

ABSTRACT Background Hormone-receptor–positive (HR+) breast cancer (BC) refractory/resistant to nonsteroidal aromatase inhibitor (NSAI) may be treated with the steroidal AI exemestane (EXE), although there is no approved treatment standard. The BOLERO-2 trial showed that adding everolimus (EVE) to EXE significantly improved clinical benefit beyond that of EXE alone (Hortobagyi et al, SABCS 2011, Abstract S3-7). As many women with advanced BC are elderly (≥ 65 years), the efficacy and tolerability of EVE + EXE in this population are of interest. Methods BOLERO-2 is a phase 3, randomized trial comparing EVE (10 mg once daily) vs placebo (PBO), both plus EXE (25 mg once daily) in postmenopausal women with advanced HR+ BC progressing or recurring after NSAIs. Results Baseline disease and prior treatment characteristics were balanced between study arms (N = 724). At 18 months' median follow-up, adding EVE to EXE significantly improved progression-free survival in patients Conclusions Adding EVE to EXE was effective and well tolerated overall and, in elderly patients with advanced BC, grade 3/4 AEs were uncommon and manageable. Overall, AEs were consistent with the known safety profile of EVE. Disclosure M. Gnant: Research support from GSK, Sanofi-Aventis, Novartis, and Roche, consultant to Merrion and Novartis, and received honoraria & travel support from Amgen, Pfizer, Novartis, GSK, Bayer, Sandoz, AstraZeneca, and GenomicHealth. S. Noguchi: S. Noguchi received grant support from AstraZeneca, BMS, Chugai, GSK, Novartis, Pfizer, Sanofi-Aventis, and Takeda, and honoraria (speaking, advisory boards, etc.) from AstraZeneca, Chugai, GSK, Novartis, Pfizer, Sanofi-Aventis, and Takeda. M. Piccart: Board for PharmaMar, consultant Sanofi-Aventis, Amgen, BMS, GSK, Boehringer, Roche, & Bayer, grant support Pfizer, Amgen, Bayer, Boehringer, BMS, GSK, Roche, & Sanofi-Aventis, honoraria Bayer, BMS, GSK, Boehringer, Roche, Amgen, & AstraZeneca. J. Baselga: J. Baselga is a consultant to Novartis, Roche, Merck, Sanofi-Aventis, Verastem, Bayer, Chugai, Exelixis, Onyx, and Constellation. A. Panneerselvam: Employee of Novartis with stock/stock options. T. Taran: Employee of Novartis with stock/stock options. T. Sahmoud: Employee of Novartis with stock/stock options. G.N. Hortobagyi: Member of the Scientific Advisory Board of Allergan, is a consultant to Allergan, Novartis, Genentech, and Sanofi-Aventis, has received grant support from Novartis, and has received travel expense reimbursement from Novartis, Genentech, and Sanofi-Aventis. K. Pritchard: Consult sanaven AZE Roche PFE NVR ABR AMG GSK res funding NCICCT Grp contracted AZE BMS SanAven AMG PFE NVR GSK & OrthoBio honoraria & Spkr B SanAven AZE PFE Roche NVR & AMG paid expert test SanAven AZE & GSK AdCom SanAven AZE Roche PFE NVR GSK & AMG. All other authors have declared no conflicts of interest.