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

  • Author(s): Beck, J Thaddeus;
  • Hortobagyi, Gabriel N;
  • Campone, Mario;
  • Lebrun, Fabienne;
  • Deleu, Ines;
  • Rugo, Hope S;
  • Pistilli, Barbara;
  • Masuda, Norikazu;
  • Hart, Lowell;
  • Melichar, Bohuslav;
  • Dakhil, Shaker;
  • Geberth, Matthias;
  • Nunzi, Martina;
  • Heng, Daniel YC;
  • Brechenmacher, Thomas;
  • El-Hashimy, Mona;
  • Douma, Shyanne;
  • Ringeisen, Francois;
  • Piccart, Martine
  • et al.
Abstract

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.

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