替吉奥一线治疗晚期胃癌的随机对照临床研究

Randomized controlled trial of S-1-based chemotherapy for the first-line treatment of advanced gastric carcinoma

目的比较替吉奥(S-1)、S-1联合顺铂(DDP)与氟尿嘧啶(5-FU)联合DDP一线治疗晚期胃癌的疗效和不良反应。方法选择2009-01～2010-06病理证实的23例晚期胃癌患者随机分为S-1单药组、S-1+DDP组与5-FU+DDP组。3周期后评价三组的有效率、不良反应、无进展生存时间(progression-free survival,PFS)和总生存时间(overall survival,OS)。结果所有患者中位OS为6.6月(95%CI 5.35-7.85月);中位PFS为3.0月(95%CI 2.37-3.63月)。S-1单药组、S-1+DDP组与5-FU+DDP组的OS分别为5.9,5.6和8.6月,三组间差异无统计学意义(P=0.84);三组PFS分别为3.4,2.4和3.0月,差异无统计学意义(P=0.74);三组有效率分别为42.9%,23.3%和0。S-1单药组和S-1+DDP组均无3-4级不良反应发生,5-FU+DDP组1例出现3级恶心呕吐。结论 S-1单药治疗晚期胃癌的近期疗效高,不良反应轻,可推荐一线治疗晚期胃癌。

Objective To assess the efficacy of S-1-based chemotherapy for advanced gastric carcinoma.Methods From January 2009 to June 2010,23 patients with newly pathologically diagnosed unresectable gastric carcinoma fulfilled the entry criteria and were randomly assigned into three groups：S-1 alone group,S-1 plus cisplatin group and fluorouracil plus cisplatin group.Clinical efficacy,adverse event and survival were the main end points.Results The median overall survival for the whole patients was 6.6 months（95% CI 5.35-7.85）,and the progression-free survival was 3.0 months（95% CI 2.37-3.63）.The median survival was 5.9 months in S-1 alone group,5.6 months in S-1 plus cispatin group,and 8.6 months in fluorouracil plus cisplatin group,but there was no significant difference among 3 groups（P=0.84）.The progression-free survival was 3.4,2.4 and 3.0 months in S-1 alone group,S-1 plus cisplatin group and fluorouracil plus cisplatin group,respectively,and the difference is not significant（P=0.74）.The response rate of patients was 42.9% for S-1 alone,33.3% for S-1 plus cisplatin,and 0 for fluorouracil plus cisplatin.There was no grade 3-4 adverse events in S-1 alone group or S-1 plus cisplatin group,but there was one case of grade 3 nausea and vomiting in fluorouracil plus cisplatin group.Conclusion S-1 used as a first-line drug for advanced gastric carcinoma can improve efficacy with less adverse events,and can be a first-line regimen for advanced gastric carcinoma.