替吉奥与卡培他滨在老年晚期胃癌患者中的疗效与安全性的Meta分析

Meta-analysis on efficiency and safety of S-1 versus capecitabine for elderly advanced gastric cancer patients

目的运用Meta分析方法,评价老年晚期胃癌患者一线应用替吉奥(或联合奥沙利铂)与卡培他滨(或联合奥沙利铂)化疗的疗效与安全性。方法检索Cochrane library、pubmed、ovid(elsevier)、中国期刊全文数据库、维普数据库、万方资源数据和中国生物医学文献数据库系统,对纳入的随机对照试验(RCT),根据Cochrane Handbook 5.1进行文献质量评价,并运用RevMan 5.0软件进行统计学分析。主要结局指标为有效率、不良反应发生率,采用相对危险度(RR)为效应量,各效应量以95%置信区间(95%CI)表示。结果共纳入6项RCT,332例老年胃癌患者,其中2项RCT为联合奥沙利铂化疗组,4项RCT为单药治疗组。Meta分析结果显示,无论是否联合奥沙利铂化疗,应用替吉奥与卡培他滨治疗后疗效相当(RR=1.10,95%CI:0.84～1.45,P=0.49);亚组分析(单药组),纳入4项RCT,213例患者,结果显示单药组替吉奥与卡培他滨的有效率差异无显著性(RR=1.19,95%CI:0.81～1.74,P=0.92),但替吉奥组3度以上手足综合症(HFS)的发生率明显低于卡培他滨组(RR=0.11,95%CI:0.01～0.87,P=0.04)。结论无论是否联合奥沙利铂化疗,替吉奥在老年胃癌患者中在有效率方面与卡培他滨疗效相当,替吉奥单药组3度以上的HFS的发生率明显较低,替吉奥是老年晚期胃癌患者的较佳选择。但由于研究例数较少,该结论有待进一步加大样本量进行证实。

Objective To evaluate the effectiveness and safety of S-1（or with oxaliplatin） versus capecitabine（or with oxaliplatin） in elderly advanced gastric cancer by meta-analysis. Methods The Cochrane Library, Ovid, Pubmed, CNKI, VIP, WanFang, CBM, etc were retrieved by computer, and the quality assessment of qualified random control trials（RCTs） were evaluated according to Cochrane Handbook 5.1 and statistic analysis was carried out by RevMan 5.0 software. The outcomes included response rate and incidence of adverse reactions. Relative risk（RR） was used for the meta-analysis and was expressed with 95% confidence intervals（95% CI）. Results A total of six RCTs and 332 elderly patients with advanced gastric cancer were included in this review, of which four RCTs were treated with single drug regimen of S-1 or capecitabine and two RCTs were treated with oxaliplatin-based combined chemotherapy. Meta-analysis indicated that there were no statistical differences between S-1 and capecitabine regimens in the response rate whether combined with oxaliplatin or not（RR = 1.10, 95% CI： 0.84—1.45, P = 0.49）. Subgroup meta-analysis of single drug regimen indicated that there were no statistical differences between S-1 and capecitabine（RR = 1.19, 95% CI： 0.81—1.74, P = 0.92）. However, the incidence of grade 3/4 toxicities of Hand-Foot-syndrome was obviously decreased in S-1 regimen（RR = 0.11, 95% CI： 0.01—0.87, P = 0.04）. Conclusion S-1 is as effective as capecitabine in elderly advanced gastric cancer patients, whether combined with oxaliplatin or not. Moreover, the single drug S-1 which has a lower incidence of grade 3/4 toxicities of Hand-Foot-syndrome, can be the better choice for elderly advanced gastric cancer patients. The conclusion remains to be confirmed with more high quality RCTs.