Everolimus plus exemestane as first-line therapy in HR⁺, HER2⁻ advanced breast cancer in BOLERO-2.
Everolimus plus exemestane as first-line therapy in HR⁺, HER2⁻ advanced breast cancer in BOLERO-2.
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DOI：
10.1007/s10549-013-2814-5
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发表时间：
2014-02
影响因子：
3.8
通讯作者：
Piccart, Martine
中科院分区：
文献类型：
--
作者：
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 Y. C.;Brechenmacher, Thomas;El-Hashimy, Mona;Douma, Shyanne;Ringeisen, Francois;Piccart, Martine
本探索性分析检查了依维莫司（EVE）+阿司美坦（EXE）在BOLERO-2中入组研究前末次治疗为（新）辅助治疗的患者亚组中的疗效、安全性和生活质量影响。在BOLERO-2中，接受非甾体芳香化酶抑制剂（NSAI）治疗后复发/进展的HER 2受体阳性（HR+）、人表皮生长因子受体2阴性（HER 2 −）晚期乳腺癌患者被随机分配（2：1）接受EVE（10 mg/天）+ EXE（25 mg/天）或安慰剂（PBO）+ EXE。主要终点是当地评估的无进展生存期（PFS）。总体而言，137例患者接受一线EVE + EXE（n = 100）或PBO + EXE（n = 37）。当地研究者评估的EVE + EXE组中位PFS从PBO + EXE组的4.1个月增至11.5个月（风险比= 0.39; 95% CI 0.25-0.62），几乎增加了两倍，同时维持了生活质量。中心评估证实了这一点（15.2 vs 4.2个月;风险比= 0.32; 95% CI 0.18-0.57）。在（新）辅助NSAI治疗期间或之后接受EVE + EXE作为疾病复发一线治疗的患者的PFS显著改善支持该联合治疗在一线环境中的疗效。此外，研究结果强调了早期引入EVE + EXE治疗绝经后HR+、HER 2 −晚期乳腺癌患者的潜在获益。
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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影响因子：
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