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.
RCT Entities:
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.
Authors: Jared C Foster; Jennifer G Le-Rademacher; Josephine L Feliciano; Ajeet Gajra; Drew K Seisler; Ronald DeMatteo; Jacqueline M Lafky; Arti Hurria; Hyman B Muss; Harvey J Cohen; Aminah Jatoi Journal: Cancer Date: 2017-07-12 Impact factor: 6.860
Authors: F Cardoso; E Senkus; A Costa; E Papadopoulos; M Aapro; F André; N Harbeck; B Aguilar Lopez; C H Barrios; J Bergh; L Biganzoli; C B Boers-Doets; M J Cardoso; L A Carey; J Cortés; G Curigliano; V Diéras; N S El Saghir; A Eniu; L Fallowfield; P A Francis; K Gelmon; S R D Johnston; B Kaufman; S Koppikar; I E Krop; M Mayer; G Nakigudde; B V Offersen; S Ohno; O Pagani; S Paluch-Shimon; F Penault-Llorca; A Prat; H S Rugo; G W Sledge; D Spence; C Thomssen; D A Vorobiof; B Xu; L Norton; E P Winer Journal: Ann Oncol Date: 2018-08-01 Impact factor: 32.976
Authors: Philipp Ivanyi; Thomas Fuehner; Meike Adam; Christian Eichelberg; Edwin Herrmann; Axel Stuart Merseburger; Arnold Ganser; Viktor Grünwald Journal: Med Oncol Date: 2014-08-15 Impact factor: 3.064
Authors: Kathleen I Pritchard; Stephen K Chia; Christine Simmons; Deanna McLeod; Alexander Paterson; Louise Provencher; Daniel Rayson Journal: Oncologist Date: 2016-11-18