, Volume 143, Issue 3, pp 459-467,
Open Access This content is freely available online to anyone, anywhere at any time.
Date: 21 Dec 2013

Everolimus plus exemestane as first-line therapy in HR+, HER2 advanced breast cancer in BOLERO-2


The present exploratory analysis examined the efficacy, safety, and quality-of-life effects of everolimus (EVE) + exemestane (EXE) in the subgroup of patients in BOLERO-2 whose last treatment before study entry was in the (neo)adjuvant setting. In BOLERO-2, patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2) advanced breast cancer recurring/progressing after a nonsteroidal aromatase inhibitor (NSAI) were randomly assigned (2:1) to receive EVE (10 mg/day) + EXE (25 mg/day) or placebo (PBO) + EXE. The primary endpoint was progression-free survival (PFS) by local assessment. Overall, 137 patients received first-line EVE + EXE (n = 100) or PBO + EXE (n = 37). Median PFS by local investigator assessment nearly tripled to 11.5 months with EVE + EXE from 4.1 months with PBO + EXE (hazard ratio = 0.39; 95 % CI 0.25–0.62), while maintaining quality of life. This was confirmed by central assessment (15.2 vs 4.2 months; hazard ratio = 0.32; 95 % CI 0.18–0.57). The marked PFS improvement in patients receiving EVE + EXE as first-line therapy for disease recurrence during or after (neo)adjuvant NSAI therapy supports the efficacy of this combination in the first-line setting. Furthermore, the results highlight the potential benefit of early introduction of EVE + EXE in the management of HR+, HER2 advanced breast cancer in postmenopausal patients.

Presented in part at: The St. Gallen International Breast Cancer Conference (SGBCC), March 13–16, 2013, St. Gallen, Switzerland. The American Society of Clinical Oncology (ASCO), May 31–June 04, 2013, Chicago, IL, USA. The European Society for Medical Oncology (ESMO), September 27–October 01, 2013, Amsterdam, The Netherlands.