呋喹替尼与瑞戈非尼治疗转移性结直肠癌疗效与安全性Meta分析

目的系统评价呋喹替尼与瑞戈非尼治疗转移性结直肠癌的疗效与安全性。方法计算机检索中国知网、万方、维普等中文数据库和PubMed,Elsevier ScienceDirect,Embase,Springer等外文数据库,收集国内外公开发表的呋喹替尼和瑞戈非尼治疗转移性结直肠癌的随机对照试验(RCT),检索时间为自建库至2018年12月31日。按Jadad评分系统对纳入研究进行质量评价,采用RevMan 5.3软件和加拿大药物和卫生技术局(CADTH)发布的间接比较软件进行效应量合并和间接Meta分析。结果共纳入4个RCTs,呋喹替尼组325例,瑞戈非尼组641例。Meta分析结果显示,与安慰剂比较,呋喹替尼和瑞戈非尼均显著提高患者的总生存期、无进展生存期、客观缓解率和疾病控制率;在安全性方面,虽总不良事件发生率、3级或4级不良事件发生率均高于安慰剂组,但多数可通过减量或停药得到控制;两组患者的总生存期[HR=1,95%CI(0.668,1.496)]、无疾病生存期[HR=0.65,95%CI(0.395,1.068)]、总缓解率[OR=1.99,95%CI(0.14,28.381)]、疾病控制率[OR=1.646,95%CI(0.454,5.964)]、总不良事件发生率[OR=0.714,95%CI(0.132,3.868)]、3级或4级不良事件发生率[OR=0.775,95%CI(0.442,1.357)]比较,差异均无统计学意义(P>0.05)。结论呋喹替尼与瑞戈非尼治疗转移性结肠癌的有效性和安全性均相当。

Meta-Analysis for the Efficacy and Safety of Fruquintinib and Regorafenib in the Treatment of Metastatic Colorectal Cancer

Objective To evaluate the efficacy and safety of fruquintinib and regorafenib in the treatment of metastatic colorectal cancer.Methods Published studies of randomized controlled trials(RCT)concerning fruquintinib and regorafenib for metastatic colorectal cancer were searched systemically in Chinese databases such as CNKI,Wanfang,and VIP,as well as foreign databases such as PubMed,Elsevier,ScienceDirect,Embase,Springer,etc.;the retrieval time was from database establishment to December 31,2018;the quality of the included studies was evaluated according to the Jadad scoring system;RevMan 5.3 software and the indirect comparison software released by the Canadian Agency for Drugs and Technologies in Health(CADTH)were used for effect size consolidation and indirect meta-analysis.Results A total of 4 RCT studies were included,involving 325 patients for fruquintinib and 641 patients for regorafenib.Meta-analysis results showed that compared with placebo,fruquintinib and regorafenib significantly improved the patients’overall survival,progression-free survival,objective response rate,and disease control rate;in terms of safety,although the incidence of total adverse events and grade 3 or 4 adverse events were higher than those in the placebo group,most could be controlled by reduction or discontinuation.Compared between the two groups,for the overall survival of the two groups[HR=1,95%CI(0.668,1.496)],disease-free survival[HR=0.65,95%CI(0.395,1.068)],total response rate[OR=1.99,95%CI(0.14,28.381)],disease control rate[OR=1.646,95%CI(0.445,5.964)],the total incidence of adverse events[OR=0.714,95%CI(0.132,3.868)],incidence of grade 3 or 4 adverse events[OR=0.775,95%CI(0.442,1.357)],the differences were not statistically significant(P>0.05).Conclusion The efficacy and safety of fruquntinib and regorafenib for metastatic colorectal cancer are equal.