Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC):Chinese subgroup analysis

目的 探讨CLASSIC研究即胃癌D2根治术后XELOX方案(卡培他滨和奥沙利铂联合应用)辅助化疗对中国胃癌患者的有效性和安全性.方法 CLASSIC研究是一项随机、开放、平行对照的亚太多中心Ⅲ期临床试验,本研究是CLASSIC研究的中国亚组分析.中国亚组于2006年6月至2009年6月期间共在中国大陆招募了100例胃癌D2根治术后患者,并以1:1的比例完全随机分配至XELOX组(术后口服卡培他滨联合静脉滴注奥沙利铂方案化疗)或对照组(单纯手术治疗),观察两组患者术后3年无疾病生存及总生存情况.结果 截至2012年11月22日,中国亚组分析结果显示,XELOX组和对照组3年无疾病生存率分别为78％和56％,XELOX治疗组的复发风险比对照组降低了59％(HR=0.41,95％CI:0.20～0.85,P=0.013)；3年总生存率分别为78％和66％,但差异并无统计学意义(HR=0.55,95％CI:0.26～1.16,P=0.110).结论 胃癌D2根治术后辅以XELOX方案化疗可明显改善中国胃癌患者的预后.To evaluate the efficacy and safety profile of XELOX (capecitabine/oxaliplatin) in patients with locally advanced gastric cancer who underwent curative D2 resection in China.This is a subgroup analysis of Chinese patients in the capecitabine and oxaliplatin adjuvant study in stomach cancer (CLASSIC study), which was a randomised, open-label, multicentre, parallel-group, phase III( study in the Asia-Pacific region. A total of 100 gastric cancer patients who received curative D2 gastrectomy were enrolled in this study and were randomly assigned to either XELOX group (oral capecitabine combined with intravenous oxaliplatin chemotherapy) or the control group (surgery alone). This study aims to compare the 3-year disease-free between the two groups.Subgroup analysis showed that 3-year DFS rate were 78% and 56% in XELOX and control group, respectively. The risk of relapse in XELOX group was reduced by 59% (HR=0.41, 95%CI:0.20-0.85, P=0.013), compared with the control group. The 3-year overall survival rate were 78% and 66% in XELOX and control group, with no statistically significant difference (HR=0.55, 95%CI:0.26-1.16, P=0.110).Adjuvant XELOX chemotherapy following D2 gastrectomy may improve the survival in patients with advanced gastric cancer in China.国家十二五科技支撑计划; 胃癌的转化医学及综合防治研究项目; 北京市科委首都市民健康项目PubMed中国科技核心期刊(ISTIC)中国科学引文数据库(CSCD)02133-1381