UFT and leucovorin in first-line chemotherapy for patients with metastaticgastric cancer. An Early Clinical Studies Group (ECSG)/European Organization for Research Treatment of Cancer (EORTC) phase II trial

A phase II study was performed to evaluate 1-(2-tetrahydrofuryl)-5-fluorour acil and uracil (UFT) and leucovorin as first-line chemotherapy in European patients with advanced gastric cancer. From 38 patients, 25 were evaluable for response and 36 for toxicity. Patients received UFT at 300 mg/m(2)/day for 28 days, every 35 days and leucovorin at 90 mg/day on an identical sch edule. Overall response rate was 10.5% (95% confidence interval (CI): 3.7-2 2.5%) in intent-to-treat analysis and 16% (95% CI: 5.7-33%) in evaluable pa tients. Grade 3-4 common toxicity criteria (CTC) toxicities were diarrhoea (28%; 10/36), nausea (11%; 4/36), vomiting (8%; 3/36) and asthenia (11%; 4/ 36). 23 patients in 44% (42/96) of the courses had to skip days of treatmen t due to toxicity or to non-compliance. In conclusion, UFT + leucovorin has a definitive, but low, efficacy in advanced gastric cancer patients. Toxic ities were mainly gastrointestinal and treatment needs to be withheld if gr ade 2 diarrhoea occurs. (C) 2001 Elsevier Science Ltd. All rights reserved.