A phase II trial of vinorelbine and cisplatin in previously untreated inoperable non-small-cell lung cancer

Weekly vinorelbine injection with cisplatin had been used in treatment of n on-small-cell lung cancer. We performed a phase II trial to evaluate the ef ficacy and toxicity of a new schedule of vinorelbine and cisplatin in patie nts with previously untreated, inoperable (stage IIIB or stage IV) non-smal l-cell lung cancer. From April 1996 to May 1997, 52 patients were enrolled for study, and 50 patients were eligible and evaluable for both response an d toxicity assessment. Therapy consisted of vinorelbine, 30 mg/m(2), intrav enously on days 1 and 5 of a 21-day cycle, and cisplatin 100 mg/m(2) (reduc ed to 80 mg/m(2) after the first seven patients) given on day 1. A total of 211 treatment courses were administered; the median number of cycles admin istered per patient was 4.5 (range: 1-6), the median dose intensity for vin orelbine was 16.9 mg/m(2)/week (84.4%), whereas that of cisplatin was 22.8 mg/m(2)/week (84.7%). Twenty-five patients responded to therapy for an over all response rate of 50%; one patient attained a complete response (2%). Th e main toxicities were vomiting, myelosuppression, and diarrhea, which incl uded World Health Organization grade 3 or 4 nausea/vomiting (58% patients), anemia (41% patients), neutropenia (12% patients), and diarrhea (14%). The median duration of responses was 9 months. The median time to disease prog ression was 6.8 months (range 0.4-18.1 months). Median survival was 13 mont hs, and 54% of patients were alive at 1 year. We conclude that this new sch edule of vinorelbine and cisplatin achieves a high response with acceptable toxicity profile in patients with advanced non-small-cell lung cancer.