PHASE-II TRIAL OF DOSE INTENSIFICATION WITH CISPLATIN AND CARBOPLATINPLUS VINDESINE IN PATIENTS WITH INOPERABLE NONSMALL CELL LUNG-CANCER

We conducted a phase II trial of a regimen that combined cisplatin (CD DP), carboplatin (CBDCA), and vindesine (VDS) in previously untreated patients with non-small cell lung cancer (NSCLC) to evaluate the effic acy and safety of the regimen. Thirty-five patients with inoperable NS CLC entered the study. Cisplatin (CDDP 80 mg/m(2)) was administered on day 1, and CBDCA 100 mg/m(2) and VDS 2 mg/m(2)) were administered on days 2, 3, and 8. We observed one complete response (CR) and 16 partia l responses (PR), with a total response rate of 49% [95% confidence in terval (CI) 31-66%]. The overall median survival was 58 weeks; the 1-y ear survival rate was 60%, and the 2-year survival rate was 23%. Major toxicities were hematologic; leukopenia of grades 3 and 4 occurred in 66% patients, and thrombocytopenia occurred in 23%. Therefore, the do se-intensified regimen of CDDP, CBDCA, and VDS was active in treating patients with inoperable NSCLC, with demonstration of a favorable medi an survival time.