呋喹替尼与TAS-102治疗晚期结直肠癌疗效与安全性的间接比较

An indirect comparison of the efficacy and safety of fruquintinib and TAS-102 in the treatment of advanced colorectal cancer

【目的】间接比较呋喹替尼与TAS-102治疗晚期结直肠癌的疗效与安全性。【方法】检索美国国立医学图书馆生物医学信息检索系统(PubMed)、荷兰医学文摘(EMBASE/SCOPUS)、Cochrane图书馆,以及中国知网中国知识基础设施工程(CNKI)、万方数据库等数据库发表的关于呋喹替尼与TAS-102治疗晚期结直肠癌的临床随机对照实验,检索时间从1990年1月1日截止2020年9月5日。按照Jadad评分对纳入研究进行质量评价,采用Stata 16.0软件和加拿大药物和卫生技术局发布的ITC软件进行Meta分析和间接比较。【结果】共纳入5项随机对照实验(RCT),包括1862名患者,实验组1242名患者接受呋喹替尼/TAS-102治疗,对照组620名患者接受安慰剂治疗。Meta分析显示:呋喹替尼和TAS-102皆可以提高患者的中位生存期(mOS),中位无进展生存期(mPFS)和疾病控制率(DCR),但不能改善患者的客观缓解率(ORR)。安全性方面,呋喹替尼可增加患者严重不良事件数,但血小板减少、疲劳及腹泻较安慰剂组无明显变化;TAS-102的严重不良事件数及疲劳较安慰剂组无明显变化,但血小板减少和腹泻较安慰剂组增加。间接比较显示:呋喹替尼对比TAS-102,mOS的HR为0.957(95%CI:0.72~1.26,P=0.87),mPFS的HR为0.578(95%CI:0.44~0.76,P=0.292),ORR的RR为1.447(95%CI:0.341~6.15,P=0.84),DCR的RR为1.45(95%CI:1.02~2.06,P=0.22),血小板减少的RR为0.347(95%CI:0.157~0.764,P=0.47),疲劳的RR为12.43(95%CI:7.95~19.44,P=0.14),腹泻的RR为0.97(95%CI:0.223~4.222,P=0.985),皆无统计学意义。但呋喹替尼对比TAS-102可增加严重不良事件数的发生,[RR=17(95%CI:4.96~58.28,P=0.00)]。【结论】呋喹替尼对比TAS-102治疗晚期结肠癌疗效相当,严重不良事件数的发生会增加。

【Objective】To evaluate the effficacy and safety of fruquintinib and TAS-102 in the treatment of advanced colorectal cancer.【Methods】We searched databases such as PubMed,EMBASE/SCOPUS,The Cochrane Library,CNKI and Wanfang Data to collect randomized controlled trials(RCTs)of Fruquintinib and TAS-102 treating advanced colorectal cancer of origin from January 1,1990 to September 5,2020.According to the Jadad score,the quality of the included studies was evaluated.Meta analysis was performed using Stata 16.0 software and ITC software designed by the Canadian Medicines and Health Technology Agency.【Results】A total of 5 RCT studies were included,involving 1862 patients.1242 patients in the experimental group were treated with fruquintinib/TAS-102,and 620 patients in the control group were treated with placebo.Meta-analysis showed that both fruquintinib and TAS-102 could improve patients'mOS,mPFS and DCR,but they couldnot improve the patient's ORR.In the terms of safety,fruquintinib could increase the serious adverse events(SAEs),but there were no significant changes in thrombocytopenia,fatigue,and diarrhea compared with placebo;TAS-102 did not increase SAEs and fatigue,but thrombocytopenia and diarrhea were increased compared with the placebo group.Indirect comparisons showed that:furacinib compared with TAS-102,mOS HR was 0.957(95%CI:0.72~1.26,P=0.87),mPFS HR was 0.578(95%CI:0.44~0.76,P=0.292),The RR of ORR was 1.447(95%CI:0.341 to 6.15,P=0.84),the RR of DCR was 1.45(95%CI:1.02 to 2.06,P=0.22),and the RR of thrombocytopenia was 0.347(95%CI:0.157~0.764,P=0.47),the fatigue RR was 12.43(95%CI:7.95~19.44,P=0.14),the diarrhea RR was 0.97(95%CI:0.223~4.222,P=0.985).no statistics Learn meaning.These were not statistically significant.However,fruquintinib compared with TAS-102 could increase the SAEs[RR=17(95%CI:4.96~58.28,P=0.00)].【Conclusion】Fruquintinib was equivalent to TAS-102 in the treatment of advanced colorectal cancer,but it could increase the number of SAEs.