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

Abstract 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 the chemotherapeutic combination of gemcitabine+vinorelbine (GEM/VNR). Forty-five patients (40 male, 5 female) with a median age of 67 years (range 37–73) and a median ECOG performance status of 1 (range 0–2) were enrolled into 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 administered iv on days 1, 8, and 15, while VNR was given 30 mg/m 2 on days 1 and 8 every 4 weeks. The…