A three-week schedule of gemcitabine–cisplatin in advanced non-small-cell lung cancer with two different cisplatin dose levels: A phase II randomized trial

摘要: Summary Background To explore a new schedule of gemcitabine–cisplatin (GP) combination therapy using two different cisplatin doses in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods From May to December 1997, 92 chemonaive entered the study 88 (28 locally 60 disseminated NSCLC) were evaluable for response toxicity (45 arm A 43 B). randomly assigned or B. Gemcitabine 1000 mg/m2 was given on days 1–8 plus 100 70 B day 2 every 21-day cycle. Results The overall rates arms 42% (95% confidence interval (CI): 27.8%–56.7%) 47% CI: 31.6%–61.5%), respectively. Median duration 9.7 months (range 1.8 30.9 months; 13.1 9.5 B, respectively), median survival 12 0.2 31.1 15.4 11.5 respectively). Major WHO grade 3–4 toxicities vs. included: thrombocytopenia (23% 17% courses), leukopenia (15% 4% anemia (7% 6% nausea-vomiting (20% 7% patients). Grade 1–2 nephrotoxicity occurred 20% one 4 episode A. Six discontinued treatment because toxicities, 5 1 Conclusions this trial indicate that both schedules are feasible active, milder lower dose.