进展期胃癌S-1与5-FU基础化疗有效性和安全性Meta分析

目的 S-1被应用于进展期胃癌一线化疗中,其疗效也备受关注.本研究评估S-1基础化疗对比5-氟尿嘧啶(5-Fluorouracil,5-FU)基础化疗方案在进展期胃癌一线化疗中的有效性和安全性.方法 用“胃癌、替吉奥或S-1、5-氟尿嘧啶和随机对照研究”等检索词,在Pubmed、Embase、Cochrane Library、ASCO会议摘要、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)和中文科技期刊全文数据库(VIP)等检索相关的临床随机对照试验,检索时间截止至2016-10.提取总生存期、无疾病进展生存期、有效率、3～4级不良反应等数据.采用Revman 5.3和STATA 12.0进行数据分析.结果 共纳入18个随机对照研究,3 581例患者.结果显示,S-1基础化疗在总生存期(HR=0.92,95％CI为0.84～1.01,P=0.07)及无疾病进展生存期(HR=0.90,95％CI为0.76～1.07,P=0.25)方面与5-FU基础化疗方案差异无统计学意义,但有更高的有效率,RR=1.46,95％CI为1.22～1.74,P＜0.001.S-1基础化疗方案3～4级中性粒细胞减少(P＜0.001)、白细胞减少(P＜0.001)、血小板减少(P=0.01)、口腔炎(P＜0.001)和脱发(P=0.02)等不良反应较5-FU基础化疗发病率更低,差异有统计学意义.结论 相比于5-FU基础化疗,S-1基础化疗在进展期胃癌一线治疗中均是有效且更安全的化疗方案.

Efficacy and safety of S-1 based regimens compared with 5-FU based regimens in the first-line therapy of advanced gastric cancer: A Meta-analysis

OBJECTIVE S-1 is widely used in the first-line therapy of advanced gastric cancer and its effect also becomes a major concern.The aim of this meta-analysis was to investigate the efficacy and toxicity of S-1 based regimens compared with 5-FU based therapy in the first-line therapy of advanced gastric cancer.METHODS Pubmed,Embase,the Cochrane Central Register of Controlled Trials,American Society of Clinical Oncology meeting abstracts,Chinese Biomedical Literature Database (CBM),Chinese Journal Full-text Database (CNKI),and Chinese Scientific Journal Fulltext Database (VIP) were searched for randomized clinical trials until Oct 2016 using different words,such as "gastric cancer,S-1,5-fluorouracil,randomized controlled trial".Data were extracted for overall survival (OS),progression freesurvival (PFS),objective response rate (ORR) and grade 3-4 adverse events.Data analysis was performed using Revman 5.3 and STATA12.0.RESULTS S-1 based therapy was not different with 5-FU based therapy (18 studies,n=3 581) in terms of OS [hazard ratio (HR)=0.92,95％ confidence interval (CI):0.84-1.01,P=0.07] and PFS (HR=0.90,95％CI:0.76-1.07,P=0.25),whereas ORR was higher [risk ratio (RR)=1.46,95％CI:1.22-1.74,P＜0.001].S-1 based therapy was associated with a lower rate of grade 3-4 neutropenia (P＜0.001),leucopenia (P＜0.001),thrombocytopenia (P=0.01),stomatitis (P＜0.001) and alopecia (P=0.02) compared with 5-FU based therapy,the differences were statistically significant.CONCLUSION Compared with 5-FU based regimens,S-1 based regimens are more effective and tolerable in the first-line therapy for advanced gastric cancer.