Phase II study of cisplatin continuous infusion plus vindesine in the treatment of non-small-cell lung cancer.

We administered chemotherapy consisting of a combination of 5-day continuous intravenous infusion of cisplatin (25 mg/m2/day) plus vindesine (3 mg/m2, as a bolus, on days 1 and 8) to 30 patients with advanced non-small-cell lung cancer (NSCLC) and examined the effectiveness and safety of the treatment. Fifteen patients achieved a partial response, and the overall response rate was 50%, with a median response duration of 30.1 weeks (range 5-108.6 weeks) and a median survival of 39 weeks. Observed side effects were leukopenia (less than 3000/mm3) in 90% of patients (including less than 1000/mm3 in 23%), thrombocytopenia (less than 75000/mm3) in 30%, anemia (hemoglobin less than 9.5 g/dl) in 50%, vomiting in 43%, and alopecia in 77%. Elevated serum creatinine was not seen, and there were no treatment-related deaths. Toxicity was quite acceptable, but hematological toxicity was increased, and treatment was delayed for six patients because of leukopenia. We conclude that this regimen is generally well tolerated in patients with advanced NSCLC. Further studies in which the optimum therapeutic schedule can be made sufficiently safe to reduce leukopenia are needed.