卡培他滨联合伊立替康对比氟尿嘧啶联合伊立替康治疗晚期结直肠癌疗效与安全性的Meta分析

A Meta-analysis of Capacitance Combined with Irinotecan versus Fluorouracil Combined with Irinotecan for Advanced Metastatic Colorectal Cancer

目的评价卡培他滨联合伊立替康(CAPIRI)方案与氟尿嘧啶联合伊立替康(FOLFIRI)方案对照治疗晚期结直肠癌的疗效与安全性。方法运用计算机在Pub Med、Embase数据库、万方数据库、中国知网、Cochran图书馆上进行检索。检索时间均从2000年1月-2015年10月,对符合纳入标准的随机对照试验进行质量评价、数据提取并应用Rev Man 5.2进行Meta分析。结果纳入8个随机对照试验,共计1 634例患者,CAPIRI在完全缓解率[RR=1.17,95%CI(0.70,1.96),P=0.56]、总有效率[RR=0.90,95%CI(0.79,1.03),P=0.12]、疾病控制率[RR=0.93,95%CI(0.87,1.00),P=0.06]、中位无疾病进展期[HR=1.00,95%CI(0.72,1.37),P=0.99]、中位总生存期[HR=0.94,95%CI(0.63,1.40),P=0.77]方面表现出与FOLFIRI相似的效果。安全性方面,CAPIRI有较高的Ⅲ/Ⅳ级呕吐[RR=1.91,95%CI(1.13,3.22),P=0.02]、腹泻[RR=2.84,95%CI(2.22,3.63),P<0.000 01]、手足综合征[RR=4.55,95%CI(2.15,9.61),P<0.000 1]发生风险;而恶心[RR=0.77,95%CI(0.64,0.93),P=0.005]、疲劳[RR=1.19,95%CI(0.73,1.94),P=0.47]、发热性中性粒细胞减少[RR=1.59,95%CI(0.89,2.87),P=0.12]、贫血[RR=1.74,95%CI(0.59,5.18),P=0.32]、白细胞减少[RR=1.23,95%CI(0.86,1.77),P=0.25]、嗜中性粒细胞减少症[RR=0.77,95%CI(0.64,0.93),P=0.005]两组方案则相似。结论 CAPIRI治疗晚期结直肠癌是有效的,毒性反应是可以接受及处理的。

Objective To assess the effectiveness and safety of capacitance combined with irinotecan（CAPIRI） versus fluorouracil combined with irinotecan（FOLFIRI） for patients with advanced metastatic colorectal cancer. Methods Databases such as Pubmed, Embase, Wanfang data, CNKI, Cochran Library were searched from January 2000 to October 2015. We evaluated the quality of randomized controlled trials（RCTs） and then extracted data from them. Rev Man 5.2 software was used to perform the meta-analysis. Results Eight RCTs studies with 1 634 advanced metastatic colorectal cancer patients were included based on our standard. CAPIRI regimen was equal to FOLFIRI regimen in complete response rate [RR=1.17, 95%CI（0.70, 1.96）, P=0.56], overall respond rate [RR=0.90, 95%CI（0.79, 1.03）, P=0.12], disease control rate [RR=0.93, 95%CI（0.87, 1.00）, P=0.06], median progression-free survival [HR=1.00, 95%CI（0.72, 1.37）, P=0.99], and median overall survival [HR=0.94, 95%CI（0.63, 1.40）, P=0.77]. For safety, higher incidence rate of grade 3/4 vomiting [RR=1.91, 95%CI（1.13, 3.22）, P=0.02], diarrhea [RR=2.84, 95%CI（2.22, 3.63）, P〈0.000 01], hand-foot syndrome [RR=4.55, 95%CI（2.15, 9.61）, P〈0.000 1] were confirmed for CAPIRI. The two methods had similar toxicities： nausea [RR=0.77, 95%CI（0.64, 0.93）, P=0.005], fatigue [RR=1.19, 95%CI（0.73, 1.94）, P=0.47], febrile neutropenia [RR=1.59, 95%CI（0.89, 2.87）, P=0.12], anemia [RR=1.74, 95%CI（0.59, 5.18）, P=0.32], and leukopenia [RR=0.77, 95%CI（0.64, 0.93）, P=0.005]. Conclusion Capecitabine combined with irinotecan treatment for advanced colorectal cancer is effective and its toxicity is acceptable.