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贝伐珠单抗联合化疗一线治疗 HER2 阴性转移性乳腺癌:来自 2447 例患者数据的汇总和亚组分析。

First-line bevacizumab in combination with chemotherapy for HER2-negative metastatic breast cancer: pooled and subgroup analyses of data from 2447 patients.

机构信息

Department of Medical Oncology, Mount Vernon Cancer Centre, London, UK.

出版信息

Ann Oncol. 2013 Nov;24(11):2773-80. doi: 10.1093/annonc/mdt276. Epub 2013 Jul 25.

Abstract

BACKGROUND

Bevacizumab has consistently demonstrated improved progression-free survival (PFS) and response rate when combined with first-line chemotherapy for HER2-negative metastatic breast cancer (mBC). However, the lack of a significant overall survival (OS) difference continues to attract debate, and identification of patients deriving greatest benefit from bevacizumab remains elusive.

PATIENTS AND METHODS

Individual patient data from three randomised phase III trials in the first-line HER2-negative mBC setting were analysed, focusing specifically on efficacy in poor-prognosis patients.

RESULTS

The meta-analysis (n = 2447) demonstrated a PFS hazard ratio (HR) of 0.64 (95% confidence interval [CI] 0.57-0.71; median 9.2 months with bevacizumab versus 6.7 months with non-bevacizumab therapy) and response rate of 49% versus 32%, respectively. The OS HR was 0.97 (95% CI 0.86-1.08); median 26.7 versus 26.4 months, respectively. In patients with triple-negative mBC, the HRs for PFS and OS were 0.63 (95% CI 0.52-0.76) and 0.96 (95% CI 0.79-1.16), respectively. Median PFS was 8.1 months with bevacizumab versus 5.4 months with chemotherapy alone, median OS was 18.9 versus 17.5 months, respectively, and 1-year OS rates were 71% versus 65%.

CONCLUSIONS

Bevacizumab improves efficacy, including 1-year OS rates, both overall and in subgroups of poor-prognosis patients with limited treatment options.

摘要

背景

贝伐珠单抗联合一线化疗治疗 HER2 阴性转移性乳腺癌(mBC)可显著提高无进展生存期(PFS)和缓解率。然而,总生存期(OS)的改善并无显著差异,仍存在争议,并且确定哪些患者能从贝伐珠单抗治疗中获益最大仍不明确。

方法

分析了一线治疗 HER2 阴性 mBC 背景下三项随机 III 期试验的个体患者数据,重点关注预后不良患者的疗效。

结果

meta 分析(n = 2447)显示,PFS 风险比(HR)为 0.64(95%置信区间 [CI] 0.57-0.71;贝伐珠单抗组中位 PFS 为 9.2 个月,非贝伐珠单抗组为 6.7 个月),缓解率分别为 49%和 32%。OS HR 为 0.97(95%CI 0.86-1.08);中位 OS 分别为 26.7 和 26.4 个月。在三阴性 mBC 患者中,PFS 和 OS 的 HR 分别为 0.63(95%CI 0.52-0.76)和 0.96(95%CI 0.79-1.16)。贝伐珠单抗组中位 PFS 为 8.1 个月,化疗组为 5.4 个月,中位 OS 分别为 18.9 和 17.5 个月,1 年 OS 率分别为 71%和 65%。

结论

贝伐珠单抗可提高疗效,包括整体和预后不良、治疗选择有限的患者亚组的 1 年 OS 率。

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