Background

Combination chemotherapy comprised of oral UFT (a combination of tegafur and uracil) and cisplatin was shown to be an effective regimen for the treatment of advanced nonsmall cell lung carcinoma and to be associated with a low incidence rate of toxicity in a previous, single institution, Phase II trial on a small patient sample. Therefore, the current multiinstitutional Phase II trial was conducted to confirm the earlier results.

Methods

Eligible patients had histologically or cytologically confirmed Stage IIIB or IV nonsmall cell lung carcinoma and good performance status. Patients who had received prior treatment were excluded. All had measurable disease. UFT (400 mg/m(2)) was administered orally on Days 1-14, and cisplatin (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 metastatic disease. All 108 patients were assessable for toxicity and survival, and 103 were assessable for response. Among these 103 patients there was 1 complete 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 was 40 weeks and the 1-year survival rate was 39% (95% CL, 30-49%). The median progression free survival time was 28 weeks. Eastern Cooperative Oncology Group Grade 3 leukopenia and thrombocytopenia were observed in only 1 patient (0.9%) and 3 patients (2.8%), respectively. Grade 3/4 nonhematologic toxicities 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, and warrants comparison with other cisplatin-based regimens in a prospective randomized trial.