title: S-1 plus oxaliplatin vs. S-1 as first-line treatment in patients with previously untreated advanced gastric cancer: a randomized phase II study.
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/m(2) 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.
authors.forename: Yiming
authors.initials: Y
authors.lastname: Lu
authors.forename: Zanchao
authors.initials: Z
authors.lastname: Liu
authors.forename: Jun
authors.initials: J
authors.lastname: Zhang
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D016016:Proportional Hazards Models; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid
keywords: Advanced gastric cancer,; Oxaliplatin,; S-1,; Safety