Adjuvant chemotherapy for chemotherapy-naive advanced gastric cancer patients with oxaliplatin plus tegafur versus oxaliplatin plus S-1

Background: Advanced gastric cancer (AGC) causes a huge economic burden to the society. This openlabel study was conducted to compare the efficacy and acceptability of oxaliplatin plus tegafur (OXT) vs. oxaliplatin plus S-1 (OXS) for chemotherapy-naive advanced gastric cancer patients. Material and methods: In this study, patients were randomly assigned to receive OXT or OXS. In a 3-week treatment cycle, the S-1 was given 80-120 mg/ day for 2 weeks, tegafur was given 1 g/day for the first five days and oxaliplatin was given 130 mg/m2 on day 1. The following indexes were assessed: progression-free survival (PFS), overall survival (OS), overall response rate (ORR), disease control rate (DRR) and adverse events. Results: Totally, 332 AGC patients were recruited to receive OXT (164 patients) or OXS (168 patients). The recruited patients had at least one metastatic site, and most of them were curatively unresectable. The median PFS for OXT and OXS were 6.1 and 5.5 months, respectively. The median PFS for OXT and OXS were 14.2 and 13.4 months, respectively. No significant difference was found in the PFS and OS. The OXT and OXS had comparable ORR (44.5% vs. 48.8%) and DRR (71.9% vs. 72.6%). The hyponatremia, diarrhea, nausea, vomiting, anorexia and constipation were more frequently observed in OXT than in OXS. Conclusions: These results showed that OXS was as effective as OXT for AGC patients with favorable safety profile; therefore, OXS could be a potential replacement method for OXT.