A randomised phase II trial of two sequential schedules of docetaxel and cisplatin followed by gemcitabine in patients with advanced non-small-cell lung cancer

Purpose The aim of this study was to determine the activity and toxicity of two sequential chemotherapy regimens in the first-line treatment of advanced non-small-cell lung cancer (NSCLC). Methods Eighty-eight chemonaive patients with stage IIIB/IV NSCLC were randomised to receive either three cycles of 75 mg/m 2 cisplatin plus 75 mg/m 2 docetaxel, both administered on day 1 every 21 days, followed by three cycles of 1,200 mg/m 2 gemcitabine on days 1 and 8 every 3 weeks (arm A), or three cycles of 25 mg/m 2 cisplatin plus 25 mg/m 2 docetaxel on days 1, 8 and 15 every 28 days, followed by three cycles of 1,200 mg/m 2 gemcitabine on days 1 and 8 every 3 weeks (arm B). Results Of the evaluable patients, 61% in arm A ( n = 41) and 36% ( n = 44) in arm B completed treatment as per the protocol. The best tumour response rates were as follows (arm A and arm B): complete response: 2.4 and 2.3%; partial response: 39 and 20.4%; stable disease: 26.8 and 13.6%; and progressive disease: 31.8 and 45.4%. The median progression-free and overall survival were 3.9 and 12.3 months in arm A, respectively, 3.1 and 7.7 months in arm B. Grade 3–4 adverse events were more common in arm A. Grade 3–4 neutropenia was the main toxicity observed (56.1% in arm A and 11.4% in arm B). Conclusions Our data demonstrate the feasibility of a sequential approach of cisplatin plus docetaxel followed by single-agent gemcitabine. Weekly administration of platinum-docetaxel is associated with an improved safety profile but lower efficacy than the conventional three-weekly schedule (registration ID 2004-001044-72).