替吉奥与氟尿嘧啶治疗中国晚期胃癌患者的Meta分析

Meta-analysis of S-1 versus fluorouracil chemotherapy in Chinese patients with advanced gastric cancer

目的比较替吉奥(S-1)与氟尿嘧啶(5-FU)在中国晚期胃癌患者中的有效性及安全性。方法检索中国知网、万方数据及PubMed,查找在中国晚期胃癌患者中应用S-1与5-FU的多中心随机对照试验(mcRCTs),采用RevMan 5.2软件进行Meta分析。结果纳入4个mcRCTs。Meta分析显示S-1可以显著提高客观缓解率[OR=1.90,95%CI(1.36~2.65),P<0.01]和疾病控制率[OR=2.08(1.43~3.03),P<0.01],但未显示出总生存优势[HR=0.76(0.39~1.50),P=0.82]。S-1组的白细胞减少[1~4级:OR=2.40(1.41~4.07),P<0.01;3~4级:OR=3.09(1.94~4.93),P<0.01]、中性粒细胞减少[1~4级:OR=2.23(1.60~3.10),P<0.01;3~4级:OR=2.90(1.40~6.02),P<0.01]、血小板减少[1~4级:OR=2.40(1.56~3.69),P<0.01]、贫血[3~4级:OR=1.78(1.11~2.87),P=0.02]及腹泻[3~4级:OR=2.51(1.13~5.58),P=0.02]的发生率均高于5-FU组,而其他的消化系统不良事件发生率相对低于5-FU组,但仅1~4级恶心的发生率显著低于5-FU组[OR=0.59(0.42~0.81),P<0.01]。结论对于中国晚期胃癌患者,S-1可以显著提高客观缓解率及疾病控制率,但增加血液系统不良事件及腹泻的发生率;而在生存时间方面虽不劣于5-FU。

Objective The aim of this study is to compare the efficacy and safety of S-1-based chemotherapy versus 5-fluorouracil-（5-FU-）based chemotherapy in Chinese patients with advanced gastric cancer（AGC）.Methods Multicenter randomized controlled trials（mcRCTs）,comparing S-1-based chemotherapy with 5-FU-based chemotherapy in Chinese patients with AGC,were searched in 3online databases CNKI,Wanfang Data and PubMed.Two reviewers independently screened studies according to the inclusion and exclusion criteria,assessed quality of the included studies and extracted the data.Meta-analysis was performed using RevMan 5.2.Results Four mcRCTs were included in the analysis.Meta-analysis showed that S-1could improve objective response rate[（OR=1.90,95%CI（1.36-2.65）,P〈0.01]and disease control rate[（OR=2.08,95%CI（1.43,3.03）,P〈0.01]compared with 5-FU,however,there was no significant difference in overall survival between the two groups[HR=0.76（0.39-1.50）,P=0.82].With regard to safety,S-1significantly increased the incidence of leukopenia[grade 1-4：OR=2.40（1.41,4.07）,P〈0.01;grade 3-4：OR=3.09（1.94,4.93）,P〈0.01],neutropenia[grade 1-4：OR=2.23（1.60-3.10）,P〈0.01;grade 3-4：OR=2.90（1.40-6.02）,P〈0.01],thrombocytopenia[grade 1-4：OR=2.40（1.56-3.69）,P〈0.01,anemia（grade 3-4：OR=1.78（1.11-2.87）,P=0.02]and diarrhea[grade 3-4：OR=2.51（1.13-5.58）,P=0.02];whereas,although the incidences of other gastrointestinal adverse events were relatively low in S-1group,only the difference of grade 1-4nausea was significant[OR=0.59（0.42-0.81）,P〈0.01].Conclusion For Chinese patients with AGC,S-1can significantly improve the objective response rate and disease control rate,whereas increase the incidence of hematological toxicities.