A phase II trial of oral UFT plus cisplatin (CDDP) in patients with non-small cell lung cancer (NSCLC)

Based on the results of our previous pilot study. we conducted a multi-institutional phase II study of combination chemotherapy consisting of oral UFT (Taiho Pharmaceutical Co. Ltd, Tokyo) plus cisplatin (CDDP) in patients with advanced non-small cell lung cancer (NSCLC). UFT capsule containing 100 mg tegafur and 224 mg uracil was orally administered in two divided doses on days 1 through 21 making the total tegafur dose 400 mg/m(2)/day (maximum 600 mg/body). CDDP was administered by drip infusion at a dose of 20 mg/m(2) on a 5-day schedule from day 8 to 12. Treatment was repeated every 4 weeks as long as the criteria for initiation of therapy were still met. Between April 1995 and March 1997. 51 patients were entered into the study. The mean age of all 50 eligible patients was 64 years (range: 40-78). There were 21 patients with clinical stage IIIB disease and 29 patients with IV disease. Thirty-two patients had adenocarcinoma, 14 had epidermoid carcinoma, and four had large cell carcinoma. Of the 47assessable patients, 18 achieved a partial response with an overall response rate of 38.3%, (95% confidence interval: 24.4- 52.2%). The median response duration was 113 days. The median survival time of the eligible patients was 12.8 months, and the 1-year suvival rate was 54%. Among the 51 patients enrolled, grade 3 or 4 leukopenia developed in one patient (2%). neutropenia in six patients (11.8%), thrombocytopenia in six patients (11.8%). and anemia in three patients (5. 9%). Non-hematological grade 3 or 4 toxicities included anorexia in 10 patients (19.6%), nausea in ten (19.6%). vomiting in two (3.9%). and diarrhea in two (3. 9%). Grade 3 abnormal laboratory data included bilirubinemia in four (7. 8%). GPT elevation in one (2.0%,), and hematuria in one (2.0%,). In conclusion, combination of CDDP plus oral UFT is efficacious, with low toxicity, in the treatment of advanced NSCLC. In particular, the low hematological toxicity may warrant application of this regimen to the treatment of elderly patients and in trials of concurrent chemoradiotherapy in patients with locally advanced NSCLC. (C) 2001 Elsevier Science Ireland Ltd. All rights reserved.