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

Abstract

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.