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Abstract
This randomized phase II study was performed to compare the efficacy and safety of oxaliplatin combined with S-1 (OXS regimen) with S-1 alone in the management of advanced gastric cancer (AGC). Ninety-four patients were 1:1 randomly assigned to S-1 on days 1–14 of a 3-week cycle or S-1 on days 1–14 plus oxaliplatin (130 mg/m2 i.v.) on day 1 of the 3-week cycle. S-1 was orally administered in a fixed quantity according to body surface area. The median survival time with OXS versus S-1 monotherapy was 14·0 versus 11·0 months (P = 0·03), progression-free survival was 6·5 versus 4·0 months (P = 0·02), and the 1-year survival rate was 63·8% versus 48·9%, respectively. The response rate was significantly higher for OXS than for S-1 monotherapy (51·1% vs. 27·7%, P = 0·03). OXS was well tolerated with no treatment-related death. In conclusion, the OXS regimen evidenced a relatively high efficacy and was well tolerated as a first-line therapy for AGC patients.