Safety and Efficacy of Everolimus With Exemestane vs. Exemestane Alone in Elderly Patients With HER2-Negative, Hormone Receptor–Positive Breast Cancer in BOLERO-2 Academic Article uri icon

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  • BACKGROUND: Postmenopausal women with hormone receptor-positive (HR(+)) breast cancer in whom disease progresses or there is recurrence while taking a nonsteroidal aromatase inhibitor (NSAI) are usually treated with exemestane (EXE), but no single standard of care exists in this setting. The BOLERO-2 trial demonstrated that adding everolimus (EVE) to EXE improved progression-free survival (PFS) while maintaining quality of life when compared with EXE alone. Because many women with HR(+) advanced breast cancer are elderly, the tolerability profile of EVE plus EXE in this population is of interest. PATIENTS AND METHODS: BOLERO-2, a phase III randomized trial, compared EVE (10 mg/d) and placebo (PBO), both plus EXE (25 mg/d), in 724 postmenopausal women with HR(+) advanced breast cancer recurring/progressing after treatment with NSAIs. Safety and efficacy data in elderly patients are reported at 18-month median follow-up. RESULTS: Baseline disease characteristics and treatment histories among the elderly subsets (≥ 65 years, n = 275; ≥ 70 years, n = 164) were generally comparable with younger patients. The addition of EVE to EXE improved PFS regardless of age (hazard ratio, 0.59 [≥ 65 years] and 0.45 [≥ 70 years]). Adverse events (AEs) of special interest (all grades) that occurred more frequently with EVE than with PBO included stomatitis, infections, rash, pneumonitis, and hyperglycemia. Elderly EVE-treated patients had similar incidences of these AEs as did younger patients but had more on-treatment deaths. CONCLUSION: Adding EVE to EXE offers substantially improved PFS over EXE and was generally well tolerated in elderly patients with HR(+) advanced breast cancer. Careful monitoring and appropriate dose reductions or interruptions for AE management are recommended during treatment with EVE in this patient population.


  • Pritchard, Kathleen
  • Burris, Howard A
  • Ito, Yoshinori
  • Rugo, Hope S
  • Dakhil, Shaker
  • Hortobagyi, Gabriel N
  • Campone, Mario
  • Csöszi, Tibor
  • Baselga, José
  • Puttawibul, Puttisak
  • Piccart, Martine
  • Heng, Daniel
  • Noguchi, Shinzaburo
  • Srimuninnimit, Vichien
  • Bourgeois, Hugues
  • Gonzalez Martin, Antonio
  • Osborne, Karen
  • Panneerselvam, Ashok
  • Taran, Tetiana
  • Sahmoud, Tarek
  • Gnant, Michael

publication date

  • December 2013

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