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Phase II trial of dose intensification with cisplatin and carboplatin plus vindesine in patients with inoperable non-small cell lung cancer.

We conducted a phase II trial of a regimen that combined cisplatin (CDDP), carboplatin (CBDCA), and vindesine (VDS) in previously untreated patients with non-small cell lung cancer (NSCLC) to evaluate the efficacy and safety of the regimen. Thirty-five patients with inoperable NSCLC entered the study. Cisplatin (CDDP 80 mg/m2) was administered on day 1, and CBDCA 100 mg/m2 and VDS 2 mg/m2) were administered on days 2, 3, and 8. We observed one complete response (CR) and 16 partial responses (PR), with a total response rate of 49% [95% confidence interval (CI) 31-66%]. The overall median survival was 58 weeks; the 1-year 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 dose-intensified regimen of CDDP, CBDCA, and VDS was active in treating patients with inoperable NSCLC, with demonstration of a favorable median survival time.