Gemcitabine plus vinorelbine in advanced non-small cell lung cancer: a phase II study of three different doses

摘要: Our aim was to study the activity and toxicity of gemcitabine plus vinorelbine (Gem Vin) combination identify optimal dose. Previously untreated patients aged < 70 years, with stage IV or IIIb (not candidates for radiotherapy) non-small cell lung cancer were eligible. Studied dose-levels Gem Vin, administered on days 1 8 every 3 weeks, (mg m–2): level I = 1000/25; II 1200/25; III 1000/30; 1200/30. A feasibility performed at each dose-level, followed by a single-stage phase study. Dose-level unfeasible because grade 4 neutropenia. Overall, out 126 enrolled in studies, there one complete 32 partial responses (response rate 26%: 95% CI 18–34%). Response rates 27.9%, 21.4% 29.3% levels I, III, respectively. The treatment well tolerated. Toxicity less frequent severe I. Overall median survival 33 weeks (95% 28–40). Descriptive quality life analysis showed that worse baseline global health status score tended drop earlier than those better score. Vin is feasible different doses. It sufficiently active compare effect (level I) vs cisplatin-based chemotherapy ongoing. © 2000 Cancer Research Campaign