目的 系统评价依维莫司联合内分泌治疗激素受体阳性晚期乳腺癌的疗效和安全性。方法 计算机检索PubMed、MEDLINE、CENTRAL、EMBASE、 Cochrane图书馆,CNKI等电子数据库,检索建库至2017年3月发表的依维莫司联合内分泌治疗或依维莫司治疗内分泌失败的激素受体阳性晚期乳腺癌的随机对照试验(randomized controlled trial,RCT)。对符合纳入标准的RCT,进行质量评价,并使用Rev Man 5.3软件进行Meta分析。结果 初检出文献518篇,最终纳入7个RCT,共1 823例患者。Meta分析结果显示,与单用内分泌治疗比较,依维莫司联合内分泌治疗可延长无进展生存期(HR=0.53,95%CI:0.45~0.62,P＜0.001),提高临床获益率(OR=2.31,95%CI:1.49~3.59,P=0.000 2),提高患者生活质量(HR=0.75,95%CI:0.60~0.94,P=0.01),但未能提高客观反映率(OR=1.22,95%CI:0.61~2.48,P=0.57)。在安全性方面,依维莫司联合内分泌治疗最常见的不良反应主要有疲劳、口腔炎、厌食、潮热、皮疹、腹泻、肺炎和高血糖。结论 依维莫司联合内分泌治疗激素受体阳性晚期乳腺癌的疗效显著优于单纯内分泌治疗,但不良反应也显著增加。
Abstract
OBJECTIVE To systematically review the effect and safety of everolimus combined with endocrine therapy for hormone receptor-positive advanced breast cancer.METHODS The randomized controlled trails (RCTs) on everolimus combined with endocrine therapy or everolimus in the treatment of endocrine failure were searched in PubMed,MEDLINE,CENTRAL,EMBASE, the Cochrane Library and CNKI from the date of their establishment to March 2017. According to the inclusion criteria,assessed the quality for the requirements of RCT and Meta analysis were performed with Rev-Man 5.3 software.RESULTS Of 518 articles collected,a total of 7 RCTs involving 1 823 patients were included. The results of Meta-analyses showed that: compared with endocrine therapy alone,everolimus combined with endocrine therapy could prolong the progression-free survival (PFS) for patients with HR+ breast cancer(HR=0.53,95%CI:0.45-0.62,P＜0.001),improve the clinical benefit rate(OR=2.31,95%CI:1.49~3.59,P=0.000 2), improve the quality of life(HR=0.75,95%CI:0.60-0.94,P=0.01),but it could not improve objective response rate(OR=1.22,95%CI:0.61-2.48,P=0.57). The most common adverse effects of everolimus combined with endocrine therapy are fatigue,stomatitis,anorexia,hot flashes,rash,diarrhea,pneumonia and hyperglycemia.CONCLUSION The curative effect of everolimus combined with endocrine therapy is significantly better than endocrine therapy alone in hormone-positive breast cancer with adverse effects increased.
关键词
依维莫司 /
内分泌治疗 /
乳腺癌 /
随机对照试验 /
系统评价
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Key words
everolimus /
endocrine therapy /
breast cancer /
randomized controlled trial /
systematic review
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中图分类号：
R969.3
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参考文献
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脚注
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基金
湖南省人民医院仁术基金项目资助(2013-07)
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