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在卵巢癌患者中,将贝伐单抗添加到化疗方案中:一项随机试验的系统评价和荟萃分析。

Addition of bevacizumab to chemotherapy in patients with ovarian cancer: a systematic review and meta-analysis of randomized trials.

作者信息

Li J, Zhou L, Chen X, Ba Y

机构信息

Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, Huanhuxi Rd., Tiyuanbei, Tianjin, 300060, China.

出版信息

Clin Transl Oncol. 2015 Sep;17(9):673-83. doi: 10.1007/s12094-015-1293-z. Epub 2015 May 20.

Abstract

BACKGROUND

This systematic review and meta-analysis analyzed randomized controlled trials (RCTs) assessing the efficacy and tolerance of incorporating bevacizumab into chemotherapy in patients with advanced ovarian cancer.

METHODS

MEDLINE, Web of Science, EMBASE and the Cochrane Central Register of Controlled Trials were reviewed for RCTs evaluating add-on bevacizumab in advanced ovarian cancer. Progression-free survival (PFS), overall survival (OS), objective response rate and adverse events were obtained from RCTs comparing first- and second-line bevacizumab plus chemotherapy with chemotherapy alone for advanced ovarian cancer. Meta-analyses were performed to determine hazard ratios for time-to-event variables and odds ratios for dichotomous outcomes using random-effects or fixed-effects model based on the heterogeneity of included studies.

RESULTS

Four RCTs, including 4246 patients, were identified and analyzed. Two trials, GOG218 and ICON7, assessing bevacizumab in first-line chemotherapy, found that bevacizumab significantly extended PFS (HR 0.82; 95% CI 0.75-0.89) and OS (HR 0.86; 95% CI 0.75-0.99). The other two trials, OCEANS and AURELIA, analyzing second-line bevacizumab, found that this agent extended PFS (HR 0.48; 95% CI 0.41-0.57), but did not enhance OS (HR 0.93; 95% CI 0.78-1.12). The most common adverse events associated with bevacizumab included hypertension, proteinuria and gastrointestinal perforation.

CONCLUSION

The addition of bevacizumab to chemotherapy followed by bevacizumab significantly improved PFS and OS in frontline setting and PFS in recurrent settings compared with that of chemotherapy alone in patients with advanced ovarian cancer.

摘要

背景

本系统评价和荟萃分析分析了评估贝伐单抗联合化疗治疗晚期卵巢癌患者的疗效和耐受性的随机对照试验(RCT)。

方法

检索MEDLINE、科学网、EMBASE和Cochrane对照试验中心注册库,以查找评估晚期卵巢癌中添加贝伐单抗的RCT。无进展生存期(PFS)、总生存期(OS)、客观缓解率和不良事件来自于比较一线和二线贝伐单抗联合化疗与单纯化疗治疗晚期卵巢癌的RCT。根据纳入研究的异质性,采用随机效应或固定效应模型进行荟萃分析,以确定事件发生时间变量的风险比和二分结果的比值比。

结果

共识别并分析了4项RCT,包括4246例患者。两项评估一线化疗中贝伐单抗的试验GOG218和ICON7发现,贝伐单抗显著延长了PFS(风险比0.82;95%置信区间0.75 - 0.89)和OS(风险比0.86;95%置信区间0.75 - 0.99)。另外两项分析二线贝伐单抗的试验OCEANS和AURELIA发现,该药物延长了PFS(风险比0.48;95%置信区间0.41 - 0.57),但未提高OS(风险比0.93;95%置信区间0.78 - 1.12)。与贝伐单抗相关的最常见不良事件包括高血压、蛋白尿和胃肠道穿孔。

结论

与单纯化疗相比,在晚期卵巢癌患者中,化疗后加用贝伐单抗显著改善了一线治疗的PFS和OS以及复发治疗的PFS。

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