Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies.
Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies.
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DOI：
10.1007/s10549-014-3144-y
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发表时间：
2014-12
影响因子：
3.8
通讯作者：
Awada, Ahmad
中科院分区：
文献类型：
--
作者：
Twelves, Chris;Cortes, Javier;Vahdat, Linda;Olivo, Martin;He, Yi;Kaufman, Peter A.;Awada, Ahmad
在最初由欧洲药品管理局要求的分析中汇总了来自艾日布林的两项III期研究的数据，以评估既往接受蒽环类药物和紫杉烷类药物治疗的特定患者亚组是否从艾日布林中获益。研究305/EMBRACE纳入了接受2 - 5线化疗的晚期乳腺癌女性，她们随机接受甲磺酸艾日布林（1.4 mg/m2，第1天和第8天，每21天）或医生选择的治疗。在研究301中，既往接受过最多2种化疗方案治疗晚期疾病的患者随机接受艾日布林（如上所述）或卡培他滨（1.25 g/m2 b.i.d.第1 - 14天，每21天一次）。在汇总人群中，分析了意向治疗人群和选定亚组的总生存期（OS）、无进展生存期和缓解率。总体而言，1，062例患者随机接受艾日布林治疗，802例患者随机接受对照治疗。艾日布林组的中位OS为15.2个月，对照组为12.8个月（风险比[HR] 0.85; 95% CI 0.77，0.95; P = 0.003）。在评估的所有亚组中，OS数据支持艾日布林;在一些亚组中出现显著改善，特别是在人类表皮生长因子受体2（HER2）阴性疾病的女性中（HR 0.82; P = 0.002），尽管在HER2阴性但EGFR阳性疾病患者中的效果未达到统计学显著性;除其他外，在雌激素受体阴性和三阴性疾病患者中也观察到了益处。艾日布林改善了先前接受过蒽环类药物和紫杉烷类药物治疗的晚期/转移性乳腺癌患者亚组的OS。患有HER2阴性疾病的女性可能从艾日布林中获益。本文的在线版本（doi：10.1007/s10549 - 014 - 3144-y）包含补充材料，可供授权用户使用。
Data from two phase 3 studies of eribulin were pooled in analyses initially requested by the European Medicines Agency to assess whether specific patient subgroups, previously treated with an anthracycline and a taxane, benefited from eribulin. Study 305/EMBRACE included women after two-to-five lines of chemotherapy for advanced breast cancer who were randomized to eribulin mesylate (1.4 mg/m2 on days 1 and 8 every 21 days) or treatment of physician’s choice. In Study 301, patients who had received up to two prior chemotherapy regimens for advanced disease were randomized to eribulin (as above) or capecitabine (1.25 g/m2 b.i.d. on days 1–14 every 21 days). In the pooled population, overall survival (OS), progression-free survival and response rates were analysed in the intent-to-treat population and selected subgroups. Overall, 1,062 patients were randomized to eribulin and 802 patients to control. Median OS was 15.2 months with eribulin versus 12.8 months with control (hazard ratio [HR] 0.85; 95 % CI 0.77, 0.95; P = 0.003). In all subgroups assessed, OS data favoured eribulin; significant improvements occurred in some subgroups, notably in women with human epidermal growth factor receptor 2 (HER2)-negative disease (HR 0.82; P = 0.002), although the effect in those with HER2-negative but hormone-receptor-positive disease did not reach statistical significance; benefits were also seen, among others, in those with estrogen-receptor-negative and triple-negative disease. Eribulin improves OS in various patient subgroups with advanced/metastatic breast cancer who had previously received an anthracycline and a taxane. Women with HER2-negative disease are among those who may obtain benefit from eribulin. The online version of this article (doi:10.1007/s10549-014-3144-y) contains supplementary material, which is available to authorized users.
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影响因子：
8.8
作者：
Al-Batran, S-E;Guentner, M.;Jaeger, E.
通讯作者：
Jaeger, E.
影响因子：
168.9
作者：
Cortes, Javier;O'Shaughnessy, Joyce;Twelves, Chris
通讯作者：
Twelves, Chris
DOI：
10.1016/0021-9681(82)90019-4
发表时间：
1982-01-01
期刊：
JOURNAL OF CHRONIC DISEASES
影响因子：
--
作者：
CHANG, IM;GELMAN, R;PAGANO, M
通讯作者：
PAGANO, M
影响因子：
8.8
作者：
Yoshida, T.;Ozawa, Y.;Kimura, T.;Sato, Y.;Kuznetsov, G.;Xu, S.;Uesugi, M.;Agoulnik, S.;Taylor, N.;Funahashi, Y.;Matsui, J.
通讯作者：
Matsui, J.
影响因子：
10.3
作者：
Howlader, Nadia;Altekruse, Sean F.;Cronin, Kathleen A.
通讯作者：
Cronin, Kathleen A.