替吉奥与氟尿嘧啶治疗中国晚期胃癌患者的Meta分析

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.

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

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 3 online 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-1 could 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-1 significantly 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-1 group,only the difference of grade 1-4 nausea was significant[OR=0.59 (0.42-0.81),P＜0.01].Conclusion For Chinese patients with AGC,S-1 can significantly improve the objective response rate and disease control rate,whereas increase the incidence of hematological toxicities.