Comparison of SOX and CAPOX in patients with advanced gastric cancer after laparoscopic D2 gastrectomy: A randomized controlled trial

Abstract

Abstract Background: Optimal adjuvant chemotherapy after laparoscopic surgery in gastric cancer (GC) patients is still undefined. We aimed to evaluate the efficacy of S‐1 plus oxaliplatin (SOX) and capecitabine plus oxaliplatin (CAPOX) in patients with GC after laparoscopic gastrectomy. Methods: A non‐inferiority randomized controlled clinical trial was performed in China. Patients with advanced GC who underwent laparoscopic D2 gastrectomy were randomly assigned to receive SOX and CAPOX regimens. Results: In total, 191 patients were screened between May 2018 and June 2019, and 140 (73.3%) were included in the modified intent‐to‐treat analysis (mITT), of whom 69 and 71 were assigned to the SOX and CAPOX groups, respectively. The SOX group had similar 3‐year overall survival (OS) and disease‐free survival to the CAPOX group. Subgroup analysis revealed significantly better OS in the SOX group for male patients ([HR] = 0.395; 95% [CI], 0.153–1.019; p = 0.045), age >60 (HR = 0.219; 95% [CI], 0.064–0.753; p = 0.016), tumors in the gastric antrum (HR = 0.273; 95% [CI], 0.076–0.981; p = 0.047), and moderately differentiated tumors (HR = 0.338; 95% [CI], 0.110–1.041; p = 0.041). There were no significant differences observed in terms of adverse events and recurrence patterns between the two groups. Conclusion: Adjuvant SOX was non‐inferior to CAPOX treatments for patients with GC who underwent curative laparoscopic D2 gastrectomy. For male patients, aged >60 years, tumors in the gastric antrum, and moderately differentiated tumors, adjuvant SOX may achieve an improvement compared with CAPOX.