Weekly gemcitabine and cisplatin in advanced non-small cell lung cancer: a phase II study

The combination of gemcitabine and cisplatin has proven effective in the treatment of advanced non-small-cell lung cancer (NSCLC). However, the optimal schedule for administration of the two drugs has not yet been determined. In this study we evaluated the activity and toxicity of a weekly gemcitabine and cisplatin schedule.Thirty-six untreated patients with stage IIIB IV NSCLC entered the study. Treatment consisted of gemcitabine 1000 mg/m2 i.v. and cisplatin 35 mg/m2 i.v., both given weekly on day 1,8, and 15, followed by one week of rest.Ninety-seven courses (273 weekly administrations) were delivered. The median dose-intensity was 612 mg/m2 per week for gemcitabine (82\%) and 21 mg/m2 per week for cisplatin (80\%). All 36 of the patients were evaluable for toxicity, and 30 for response. Partial remissions were observed in 12 patients, for an overall response rate of 40\% (95\% confidence interval (95\% CI): 22.5\%-57.5\%). Most of the partial remissions were seen in IIIB patients (54\% of the stage IIIB and 22\% of the stage IV patients responded). According to the intent-to-treat principle, the response rate was 33.3\% (12 of 36 patients). The median response duration was 9.9 months (range 4-23) and the median survival time 11.8 months (range 1-24). World Health Organization (WHO) grade 3-4 myelotoxicity was: thrombocytopenia in nine patients (25\%), neutropenia in six (16.6\%) and anemia in six (16.6\%); there was very little additional major toxicity.This regimen appears to be active and to have a favourable toxicity profile.