[Combination chemotherapy with tegafur-uracil (UFT) and cisplatin (CDDP) for advanced gastric cancer. UFTP Study Group].

An early phase II study of tegafur-uracil (UFT) combined with cisplatin (CDDP) was conducted in patients with advanced gastric cancer. UFT was administered orally for 28 consecutive days at a dose of 400 mg/m2 and CDDP was injected intravenously for 3 day at a dose of 30 mg/m2 over 8 hours every 4 weeks. This treatment cycle was repeated every 4 weeks. Sixteen patients were enrolled in this study and 14 patients could be evaluated for clinical response and toxicity. Based on the results of extramural review, 6 of 14 patients achieved a partial response and the response rate was 42.9%. High grade toxicities (WHO grade 3 or 4), specifically anorexia, nausea and vomiting, diarrhea, and leukocytopenia, were seen in 5, 2, 3 and 2 patients, respectively. The overall median survival time was 347 days (11.4 months) for evaluated patients. Although these results are preliminary, this regimen does appear to be effective in terms of tumor response and survival. Larger patient numbers in a Phase II study and further studies to evaluate survival are awaited.