Gemcitabine plus vinorelbine in stage IIIB or IV non-small cell lung cancer (NSCLC): a multicentre phase II clinical trial

A phase II study in patients with stage IIIB/IV non-small cell lung cancer (NSCLC) was carried out to evaluate the clinical activity and toxicity of t he chemotherapeutic combination of gemcitabine + vinorelbine (GEM/VNR). For ty-five patients (40 male, 5 female) with a median age of 67 years (range 3 7-73) and a median ECOG performance status of 1 (range 0-2) were enrolled i nto the trial. Twenty patients had stage IIIB (two positive supraclavicular nodes and 20 cytologically positive pleural effusion), and 25 had stage IV NSCLC. GEM 1000 mg/m(2) diluted in 250 cc(3) of normal saline was administ ered iv on days 1, 8, and 15, while VNR was given 30 m/m on days 1 nd 8 eve ry 4 weeks. The median number of courses/patient was 4 (range 3-7). Accordi ng to an intent-to-treat analysis 2 (4%) patients had a complete response a nd 16 (36%; 95% CL 22-52%) had a partial response for an overall response r ate of 40% (95% CL 26-56%). Twelve (27%) patients had stable disease and 15 (33%) were considered as treatment failures. Median overall survival of th e whole series was 8 + months with 33% of patients alive at 1 year. Toxicit y was generally mild. WHO grade 3-4 neutropenia was recorded in 22% of case s, grade 1-3 liver toxicity in 6% of patients and neutropenia-unrelated fev er in 9%. This multicentre phase II study suggests that the GEM/VNR combina tion regimen is an active and well tolerated regimen in patients with stage IIIB/IV NSCLC. Larger studies comparing cisplatin-based regimens to new sc hedules without cisplatin are warranted. (C) 2001 Elsevier Science Ireland Ltd. All rights reserved.