A Phase II Study of Epirubicin, Cisplatin and Uracil–Tegafur for Advanced Gastric Carcinoma

Background: Due to its greater convenience, a combination of uracil and tegafur (referred to as UFT) taken orally is an attractive alternative to continuous intravenous (i.v.) 5-fluorouracil (5-FU) infusion. This phase II study assessed the response rate and toxicity profile of the combination of epirubicin, cisplatin and UFT in patients with metastatic adenocarcinoma of the stomach. Methods: Epirubicin (50 mg/m2) and cisplatin (60 mg/m2) were administered i.v. to 35 patients with metastatic gastric carcinoma on day 1, and subsequently UFT (300 mg/m2/day) was admin-istered orally in divided doses for 21 days. The treatment was repeated every 3 weeks. The response rate, time to disease progression, survival and toxic effects were analyzed. Results: Thirty-two of the 35 enrolled patients were assessed subsequently for response. The median number of cycles was four. Thirteen patients (40.6%) showed partial responses, while none showed a complete response. The median time to progression of carcinoma was 20.4 weeks, and the median survival was 37 weeks. Grade 3 and 4 neutropenia was observed in 25 % of patients. Grade 3 nausea and vomiting was observed in 28 % of patients. No treatment-relateddeathwasobserved.All patients receiveddosesasplanned, except for onewho requireda 75%dose reductiondue tonephrotoxicity.Sixof132cyclesweredelayed>7daysafter four cycles. Conclusions: The combination of epirubicin, cisplatin and UFT showed anticancer activity against metastatic gastric adenocarcinoma, had a tolerable toxicity profile and showed excellent patient compliance. Key words: epirubicin – cisplatin – tegafur – gastric cance