贝伐珠单抗联合化疗治疗晚期乳腺癌疗效及安全性的Meta分析  

Efficacy and safety of bevacizumab combined chemotherapy in metastatic breast cancer:a Meta-analysis

作　　者：杜林娟 刘霜 李明[1] 王春光[1] DU Linjuan;LIU Shuang;LI Ming;WANG Chunguang(Department of Oncology,Affiliated Yongchuan Hospital of Chongqing Medical University,Chongqing 402160,China)

机构地区：[1]重庆医科大学附属永川医院肿瘤内科,重庆402160

出　　处：《肿瘤》2021年第3期197-205,共9页Tumor

基　　金：重庆市永川区科委自然科学基金资助项目(编号:Ycstc2018nb0208)。

摘　　要：目的:系统评价贝伐珠单抗联合化疗治疗晚期乳腺癌的疗效及安全性。方法:计算机检索PubMed、The Cochrane Library、EMbase、维普、中国知网和万方等数据库,检索时间为建库至2020年9月,按照严格的纳入和排除标准筛选文献和提取资料后,采用RevMan 5.3软件进行Meta分析。最终纳入10篇包括5210例患者。主要研究终点为中位无进展生存期(median progression free survival,mPFS)、中位总生存期(median overvall survival,mOS)、客观缓解率(objective response rate,ORR)及安全性。结果:系统评价结果显示,贝伐珠单抗联合化疗较单纯化疗能有效改善晚期乳腺癌的ORR[比值比(odds ratio,OR)=1.79,95%可信区间(confidence interval,CI)为1.56~2.05,P<0.00001]和mPFS[风险比(hazard ratio,HR)=0.70,95%CI为0.63~0.78,P<0.00001],但在mOS中并未表现出优势,差异无统计学意义(HR=0.94,95%CI为0.84~1.05,P=0.28)。安全性方面,Ⅲ级及以上不良反应,联合治疗组中蛋白尿(OR=10.87,95%CI为4.68~25.22,P<0.00001)、高血压(OR=8.39,95%CI为3.56~19.78,P<0.00001)和神经毒性(OR=1.36,95%CI为1.03~1.79,P=0.03)的发生率均高于单纯化疗组,差异有统计学意义;而粒细胞减少(OR=1.25,95%CI为0.95~1.65,P=0.11)及出血事件(OR=1.95,95%CI为0.96~3.95,P=0.07)的发生率差异无统计学意义。结论:相较于单纯化疗,联合贝伐珠单抗能有效改善晚期乳腺癌患者ORR及mPFS,但高血压、蛋白尿和神经毒性不良反应发生率较高。Objective:To evaluate the efficacy and safety of chemotherapy plus bevacizumab versus chemotherapy alone in the treatment of advanced breast cancer systematically.Methods:A computer-based online search was performed by using PubMed,Cochrane Library,Excerpta Medica Database(EMbase),VIP,China National Knowlege Infrastructure(CNKI)and WANFANG databases.The search time ranged from the establishment of the database to September,2020.After screening those articles and extracting data strictly,Meta-analysis was performed by RevMan 5.3.The main endpoints of this study were median progression-free survival(mPFS),median overall survival(mOS),objective response rate(ORR),and safety.Results:A total of 10 articles were included,including 5210 patients.Meta-analysis showed that the treatment of chemotherapy plus bevacizumab could effectively improve ORR[odds ratio(OR)=1.79,95%confidence interval(CI)=1.56-2.05,P<0.00001]and mPFS[hazard ratio(HR)=0.70,95%CI=0.63-0.78,P<0.00001]in metastatic breast cancer compared with the treatment of chemoterapy alone,but they did not show an advantage in mOS,and the difference was not statistically significant(HR=0.94,95%CI=0.84-1.05,P=0.28).In terms of safety,GradeⅢand above adverse reactions,the chemotherapy plus bevacizumab group had higher rate of proteinuria(OR=10.87,95%CI=4.68-25.22,P<0.00001),hypertension(OR=8.39,95%CI=3.56-19.78,P<0.00001),neuropathy(OR=1.36,95%CI=1.03-1.70,P=0.03).There was no significant difference in neutropenia(OR=1.25,95%CI=0.95-1.65,P=0.11],and bleeding(OR=1.95,95%CI=0.96-3.95,P=0.07)between two groups.Conclusion:Compared with chemotherapy alone,the combination of bevacizumab could effectively improve ORR and mPFS in patients with advanced breast cancer,but the incidence of hypertension,proteinuria,and neurotoxicity is high.

关 键 词：乳腺肿瘤 抗肿瘤联合化疗方案 分子靶向治疗 META分析 

分 类 号：R737.9[医药卫生—肿瘤]