Clinical Effectiveness of Everolimus and Exemestane in Advanced Breast Cancer Patients from Asia and Africa: First Efficacy and Updated Safety Results from the Phase IIIb EVEREXES Study.

e11579 Background: BOLERO-2 phase III trial clearly demonstrated the efficacy of everolimus (EVE) plus exemestane (EXE) for the treatment of postmenopausal patients with hormone receptor (HR)-positive, HER2-negative, advanced breast cancer (aBC). However, in this study only a minority ( < 10%) of patients were recruited from African and Asia Pacific countries (except Japan). Considering the potential effects of ethnic and cultural differences on treatment effectiveness, it remains compelling to confirm the safety and efficacy profile of EVE+EXE in these populations. Methods: EVEREXES is an open-label phase IIIb, single arm, multi-center trial, which enrolled 251 post-menopausal, HR-positive and HER2-negative, aBC patients who were treated with EVE+EXE across 13 Asia Pacific and African countries. Its primary objective was to investigate the safety and tolerability profile of EVE+EXE. Secondary objectives were the evaluation of efficacy (assessed by PFS, ORR, and CBR based on RECIST 1.1 criteria) and change in ECOG performance status. Results: From March 2013 to October 2014, 251 patients were enrolled across Asia Pacific, Middle East, North and South Africa. At data cut off of 30st of November 2014, a majority of grade 1/2 adverse events (AEs) was reported, with a small proportion ( < 10%) of ≥ grade (G) 3 AEs. In particular, 66% of patients developed stomatitis (9% G3), 53% skin toxicity (2% G3), 32% infections (4% ≥ G3), 26% hyperlipidemia (2% G3), 17% elevated liver enzymes (6% G3), 14% hyperglycemia (5% G3) and 10% noninfectious pneumonitis (with just 1 case ≥ G3). Overall, 47% of patients underwent dose adjustments/temporary interruptions and 7% permanently discontinued treatment due to AEs. Conclusions: These results are in line with those previously reported in BOLERO-2 trial, with EVE+EXE safety profile being predictable and manageable. Efficacy and safety data of EVE+EXE at January 31, 2015 data cut off will be presented for the first time in the above mentioned patient population with a median follow up of approximately 11 months, fostering further evaluation of the impact of ethnic and cultural differences on treatment outcomes.