Objective To compare the efficacy and safety of S‐1‐based combination chemotherapy with S‐1 monotherapy in patients with advanced gastric cancer (AGC) .Methods We performed a Meta‐analysis to com‐pare the efficacy and safety of S‐1‐based combination chemotherapy with S‐1 monotherapy in AGC patients .Stud‐ies stratifying overall survival (OS) ,progression‐free survival (PFS) ,objective response rate (ORR) ,and grade 3 or 4 adverse events (AEs) in AGC patients in an S‐1‐based therapy versus an S‐1 monotherapy setting were eligi‐ble for analysis by systematic computerized PubMed ,EMBASE ,Cochrane Library ,MEDLINE and CNKI sear‐ches .Data from these studies were pooled using Stata package version 12 .0 .Results Six studies involved 913 AGC patients were ultimately identified ,of which 443 (48 .5% ) received S‐1‐based combination chemotherapy and 470 (51 .5% ) received S‐1 monotherapy .Median OS and median PFS were significantly prolonged in AGC patients receiving S‐1‐based combination chemotherapy compared with those receiving S‐1 monotherapy (HR=0.775 ;95%CI:0.652 ,0.899 ;P<0.01 ;HR=0.656 ;95% CI:0 .556 ,0 .756 ;P<0.01 ,respectively) .The ORR favored pa‐tients with S‐1‐based combination chemotherapy (OR=1.535 ;95% CI:1.189 ,1.880 ;P< 0.01) .Higher inci‐dence of grade 3/4 AEs was found in patients with S‐1‐based combination chemotherapy (P<0.01) .Conclusion For the Asian population ,S‐1‐based combination chemotherapy significantly improved OS and PFS and enhanced ORR in comparison to S‐1 monotherapy .The incidence of grade 3/4 AEs was higher in patients with S‐1‐based combination chemotherapy ,compared with S‐1 monotherapy group .%目的：比较S‐1为基础的联合化疗与S‐1单独治疗晚期胃癌患者的疗效与安全性。方法通过检索PubMed、EMBASE、Cochrane Library、MEDLINE和CNKI等数据库，全面收集S‐1为基础的联合化疗与S‐1单独治疗晚期胃癌患者比较的研究，并用Stata12．0软件对其进行Meta分析，以总生存期、无病生存期、客观缓解率和3级以上不良反应为结局指标。结果纳入6项研究包括913例患者，其中接受S‐1为基础的联合化疗患者443例（48.5％），接受S‐1单独疗法的患者470例（51.5％）。与S‐1单独治疗组比较，S‐1为基础的联合化疗组患者的总生存期中位数（ H R＝0.775；95％ C I：0.652，0.899；P＜0.01）和无病生存期中位数（ H R＝0.656；95％CI：0.556，0.756；P＜0.01）显著延长；而且，S‐1为基础的联合化疗组患者的客观缓解率也更优（OR＝1.535；95％ C I：1.189，1.880；P＜0.01）；但是，S‐1为基础的联合化疗组患者的3级以上不良反应发生率更高。结论与S‐1单独治疗比较，S‐1为基础的联合化疗可以显著改善亚洲人群的总生存期、无病生存期和提高客观缓解率；但S‐1为基础的联合化疗可能增加3级以上不良反应发生风险。
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