CISPLATIN AND UFT MODULATED WITH LEUCOVORIN FOR THE TREATMENT OF ADVANCED NON-SMALL-CELL LUNG-CANCER

We performed a phase II study to assess the efficacy and toxicity of t he cisplatin-UFT-leucovorin (LV) combination in patients with advanced non-small-cell lung cancer (NSCLC). Twenty-five patients with measura ble disease who had not received prior chemotherapy were entered into the trial, The therapeutic regimen consisted of cisplatin 90 mg/m(2) a nd i.v. LV 500 mg/m(2) on day 1, followed by oral UFT 390 mg/m(2)/day (in two doses) on days 1 through 14. Patients also received oral LV 15 mg/12 h on days 2 through 14. Seventeen patients required reduced dos es of UFT (200 mg/m(2)) due to toxicity. Courses were repeated every 2 8 days for a minimum of three per patient. Three of 25 patients (12%) achieved a partial response (95% CI: 2.6 to 32.2%), two with 390 mg/m( 2)/day and one with 200 mg/m(2)/day of UFT. The main side effects were hematological and gastrointestinal. In the courses including 390 mg/m (2)/day of UFT, grade 3-4 toxicity was leucopenia in 18% of the course s, nausea/vomiting in 27%, and diarrhea and epigastralgia in 13% each, Grade 3-4 toxicities for 200 mg/m(2)/day of UFT were leucopenia 2%, n ausea/vomiting 9% and diarrhea 7%. In conclusion, this regimen cannot be recommended for the treatment of advanced NSCLC due to its low resp onse rate and high toxicity.