UFT plus cisplatin combination chemotherapy in the treatment of patients with advanced nonsmall cell lung carcinoma - A multiinstitutional Phase II trial

BACKGROUND. Combination chemotherapy comprised of oral UFT (a combination o f tegafur and uracil) and cisplatin was shown to be an effective regimen fo r the treatment of advanced nonsmall cell lung carcinoma and to be associat ed with a conducted to confirm the earlier results. METHODS. Eligible patients had histologically or cytologically confirmed St age IIIB or IV nonsmall cell lung carcinoma and good performance status. Pa tients who had received prior treatment were excluded. All had measurable d isease. UFT (400 mg/m(2)) was administered orally on Days 1-14, and cisplat in (80 mg/m(2)) was injected intravenously on Day 8. Treatment was repeated every 3-4 weeks. RESULTS. Approximately 70% of the 108 eligible patients had systemic metast atic disease. All 108 patients were assessable for toxicity and survival, a nd 103 were assessable for response. Among these 103 patients there was 1 c omplete response and 29 partial responses, for an overall response rate of 29.1% (95% confidence limits [CL], 20.4-37.9%). The median survival time wa s 40 weeks and the 1-year survival rate Eyas 39% (95% CL, 30-49%). The medi an progression free survival time was 28 weeks. Eastern Cooperative Oncolog y Group Grade 3 leukopenia and thrombocytopenia were observed in only 1 pat ient (0.9%) and 3 patients (2.8%), respectively. Grade 3/4 nonhematologic t oxicities included elevated bilirubin (6.5%) and emesis (7.4%). One patient who had a past history of duodenal ulcer died of ulcer perforation 15 days after completing the first treatment cycle. CONCLUSIONS. Oral UFT plus cisplatin is a moderately active regimen with an extremely low rate of incidence of myelosuppression as an adverse event, a nd warrants comparison with other cisplatin-based regimens in a prospective randomized trial. (C) 2000 American Cancer Society.