A phase II trial of oral tegafur and uracil plus cisplatin in patients with inoperable nonsmall cell lung cancer

Abstract

Background. The combination of uracil and tegafur in a 4:1 molar concentration (UFT) has a greater antitumor activity than 5‐fluorouracil (5‐FU) and tegafur. Because the combination of 5‐FU and cisplatin has been proven to have a synergistic antitumor effect in many experimental and clinical studies, a Phase II study was conducted using the combination of UFT and cisplatin in patients with inoperable nonsmall cell lung cancer. Methods. Thirty‐one patients with measurable disease were entered into the study; all were evaluable for toxicity and response. Their median age was 61 years (range, 36‐75 years). There were 13 patients with Stage III and 17 with Stage IV disease. Twenty‐two (71%) patients had received no prior treatment. UFT (400 mg/m2) was administered orally on days 1 through 21 and cisplatin (80 mg/m2) was injected intravenously on day 8. This treatment was repeated every 4 weeks. Results. The median number of treatment cycles was two (range, 1‐4 cycles). There were 11 partial responses (35%; 95% confidence interval, 19%‐52%). The median response time was 6 months (range, 3‐13 months). The median survival time was 11 months (range, 4‐27+ months) for Stage III and 8 months (range, 2‐22 months) for Stage IV. This chemotherapy regimen was well tolerated. The hematologic toxicities, such as leukopenia and thrombocytopenia of grades 3 and 4, occurred in only 2 of 31 (6%) patients. Nonhematologic toxicities of grades 3 or 4 were not observed. Conclusions. Oral UFT plus cisplatin administration demonstrated an activity comparable with that of other combinations based on cisplatin and an extremely low incidence of side effects. These observations suggest that this chemotherapy regimen is worthy of further investigation in a multi‐institutional trial to determine the antitumor effect and the quality of life of patients. Cancer 1995;75:2677–80. Copyright © 1995 American Cancer Society