贝伐珠单抗联合化疗一线治疗转移性乳腺癌的Meta分析

Combination of bevacizumab to chemotherapy as a front-line therapy for metastatic breast cancer patients:meta-analysis of randomized trials

目的:通过Meta分析,探讨贝伐珠单抗联合化疗一线治疗转移性乳腺癌(MBC)的有效性和安全性。方法:通过PubMed、Medline、EMBASE、Cochrane图书馆、ASCO论文集、中国期刊全文数据库、万方数据库等数据库检索国内外已发表和未发表的相关文献。由2位评价者分别按检索策略收集资料,按纳入标准入选,主要对无疾病进展生存期(PFS)、总生存期(OS)、客观缓解率(ORR)和3～4级不良反应事件的发生率进行Meta分析。结果:共纳入5个随机对照临床研究(RCT),联合使用贝伐珠单抗一线化疗组PFS(RR=1.50;95%CI:1.31～1.72,P<0.001),OS(RR=1.06;95%CI:1.02～1.11,P=0.005)和ORR(RR=1.37;95%CI:1.26～1.49,P<0.001)与单药化疗组相比差异有统计学意义,3～4级高血压(RR=7.74;95%CI:1.33～45.00,P<0.001)和蛋白尿(RR=4.59;95%CI:2.15～9.79,P<0.001)的发生率与单药化疗组相比差异有统计学意义,而出血和血栓事件的发生率差异无统计学意义。结论:联合使用贝伐珠单抗一线治疗能显著提高MBC患者PFS、OS和ORR,可能增加高血压和蛋白尿的发生率,但不显著增加出血和血栓事件的发生率。

OBJECTIVE： Conducted meta-analysis to verify the clinical efficacy of bevacizumab for the front-line treatment of metastatic breast cancer. METHODS： All available literature of randomized clinical controlled trails about bevacizumab and MBC was pooled from PubMed, Medline, EMBASE, Coehrane library database, ASCO, CNKI. Wang- fang database and so on. The meta-analysis compared the progression free survival, overall survival, objective release rate and incidence of WHO 3/4 grade adverse events in MBC patients. RESULTS.. Five randomized controlled trials were in- cluded by two reviewers. There was statistical differences between the study group（bevacizumab combination group） and the control group （monotherapy group） in PFS（RR=1. 50; 95%CI： 1. 31-1. 72, P〈0.001） and OS（RR=I. 06; 95%CI： 1.02-1.11, P=0.005） and ORR（RR=1. 37; 95GCI： 1.26--1.49, P%0.001）. There was statistical differences between the study group and control group in 3-4 grade hypertension （RR=7.74; 95%CI： 1.33-45.00, P〈0. 001） and proteinuria （RR= 4.59; 95%CI： 2. 15-9.79, P〈0. 001）, but no statistical differences in bleeding and thromboembolic events. CONCLUSIONS：Combination of bevacizumab shows a significant improvement in PFS and OS and ORR in MBC patients,may increase the incidence of hypertension and proteinuria, but no significant increase in bleeding and thrombotic events.