Extended safety and efficacy data on S-1 plus cisplatin in patients with untreated, advanced gastric carcinoma in a multicenter phase II study

摘要: BACKGROUND. S-1 is a promising oral fluoropyrimidine. The authors obtained extended Phase II safety and efficacy data in multicenter setting for the S-1 plus cisplatin combination: experimental arm of global III First-Line Advanced Gastric Cancer Study (FLAGS) being compared with 5-fluorouracil/cisplatin. METHODS. Eligible patients had untreated, histologically confirmed advanced gastric cancer (AGC), Karnofsky performance status (KPS) ≥70%, adequate organ function, provided written consent. Patients received (25 mg/m2 twice daily on Days 1 through 21) (75 Day 1) every 28 days. overall response rate (CORR) also was designated by an external review. time to progression (TTP), median survival (MS), were assessed. RESULTS. All 72 assessed survival, 64 CORR. KPS 90%. number treatment cycles 4. CORR 55% (95% confidence interval [95% CI], 42–67%). duration >5 months. At 6 months, only estimated 38% progression. MS 10.4 months CI, 8.6–12.9 months). least serious adverse event occurred 44% patients. frequent grade 3 or 4 toxicities (using National Institute Common Toxicity Criteria), which >10% patients, included fatigue/asthenia (24%), emesis (17%), nausea (15%), diarrhea (13%), neutropenia (19%). Complicated (1.4%) rare. CONCLUSIONS. The current that combined highly desirable profile. against AGC, according review, encouraging. FLAGS expected complete its accrual 1050 December 2007. © 2006 American Society.