We conducted a phase II trial of oral administration of UFT and leucovorin in patients with advanced gastric adenocarcinoma. Sixteen patients entered on this study from September 1992 to November 1993. The treatment regiman consisted of oral administration of UFT (480 mg/m/day), and leucovorin (25 mg/ m(2)/day) for 21 consecutive days. The dosage of UFT was adjusted after each treatment and the treatment was repeated every 4 weeks. The total number of administered treatments in 16 patients was 55 and the median number was 4. Among 14 evaluable patients, 1 patient (7.2%) had a complete response and 3 patients (30%) achieved paritial response resulting in an overall response rate of 28.5%. The median duration of response was 15 weeks (4+- 48+). The median survival time for all 16 patients was 24 weeks (4+- 48+). Gastrointestinal toxicity was common and toxicity over grade 3 included diarrhea in 7 patients (43.8%), mucositis in 2 patients (12.5%) and anorexia, nausea and vomiting in 1 patient respectively. Grade 1 leukopenia was observed in 3 patients (18.8%). In conclusion, oral administration of UFT and leucovorin in patients with advanced gastric cancer who have poor general condition seems to be comparable to ther chemotherapy regi- mens in efficacy and toxicity.
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