贝伐单抗联合化疗一线治疗转移性实体瘤有效性和安全性的Meta分析  

Combination of bevacizumab with first-line chemotherapy for metastatic solid tumors: a Meta-analysis of efficacy and safety

作　　者：张旭东[1] 董昱[1] 米坤[2] 杨晓军[3] 

机构地区：[1]四川省肿瘤医院国家药物临床试验机构,成都610041 [2]四川省肿瘤医院肿瘤基础研究部,成都610041 [3]四川省肿瘤医院胸外科,成都610041

出　　处：《第三军医大学学报》2013年第21期2352-2358,共7页Journal of Third Military Medical University

基　　金：国家自然科学基金(81201826);四川省科技支撑项目(2011FZ0069)~~

摘　　要：目的评价贝伐单抗联合化疗一线治疗转移性实体瘤的有效性和安全性。方法计算机检索Cochrane图书馆、PubMed、EMbase、CNKI、万方等数据库,收集贝伐单抗联合化疗一线治疗转移性实体瘤的随机对照试验,由2名研究者独立评价纳入研究的质量,采用RevMan 5.2软件进行Meta分析,主要结局指标包括无进展生存期（progression free survival,PFS）、总生存期（overall survival,OS）及毒性反应。结果共计16项随机对照试验纳入分析,包括6种恶性肿瘤和10917例病例;结果显示,与单纯化疗方案比较,贝伐单抗联合化疗一线治疗可以降低转移性实体瘤患者疾病进展风险（HR=0.70,95%CI：0.67~0.73,P〈0.001）和疾病死亡风险（HR=0.89,95%CI：0.85~0.94,P〈0.001）,差异有统计学意义;在3~4级毒性反应方面,2组高血压（RR=6.58,95%CI：4.97~8.71,P〈0.001）、蛋白尿（RR=10.85,95%CI：6.33~18.61,P〈0.001）和出血（RR=1.76,95%CI：1.34~2.32,P〈0.001）的发生率差异具有统计学意义,而静脉血栓栓塞（RR=1.00,95%CI：0.76~1.31,P=0.98）和动脉血栓栓塞（RR=1.28,95%CI：0.90~1.82,P=0.17）的发生率差异无统计学意义。结论贝伐单抗联合化疗一线治疗转移性实体瘤可延长患者无进展生存期和总生存期,但出现高血压、蛋白尿和出血的危险性更高,而不增加血栓栓塞的发生率。Objective To evaluate the efficacy and safety of combination of bevacizumab with first-line chemotherapy in the treatment of metastatic solid tumors.Methods Randomized controlled trials on combination of bevacizumab with first-line chemotherapy for metastatic solid tumors were searched in the Cochrane Library,PubMed,EMbase,CNKI,Wangfang Data,etc.The quality of trials was evaluated by 2reviewers independently,and the software RevMan5.2 was used for Meta-analysis.The outcomes included progression-free survival（PFS）,overall survival（OS） and toxicity.Results Sixteen randomized trials with6 different types of malignancies and 10 917 patients were included in this Meta-analysis.Meta-analysis results suggested that compared with chemotherapy alone,bevacizumab combined with chemotherapy decreased the risk of disease progression（HR=0.70,95% CI：0.67 to 0.73,P0.001） and the risk of disease death（HR=0.89,95% CI：0.85 to 0.94,P0.001）.The 3 /4 grade toxicity analysis showed significant differences were found between the 2 groups in hypertension（RR=6.58,95% CI：4.97 to 8.71,P0.001）,proteinuria（RR=10.85,95%CI：6.33 to 18.61,P 0.001） and bleeding（RR=1.76,95% CI：1.34 to 2.32,P 0.001）,but no significant difference was seen in vein thromboembolic events（RR=1.00,95% CI：0.76 to1.31,P=0.98） and artery thromboembolic events（RR=1.28,95% CI：0.90 to 1.82,P=0.17）.Conclusion Bevacizumab plus first-line chemotherapy improves PFS and OS in patients with metastatic solid tumor,but with increased risks in hypertension,proteinuria and bleeding,though without significant increase in thromboembolic events.

关 键 词：贝伐单抗 实体瘤 肿瘤转移 系统评价 

分 类 号：R181.23[医药卫生—流行病学] R730.53[医药卫生—公共卫生与预防医学]