Gemcitabine in locally advanced and metastatic non-small cell lung cancer:The Central European phase II study

The efficacy and toxicity profile of gemcitabine was evaluated in this phas e II study of chemonaive patients with locally advanced and metastatic non- small cell lung cancer (NSCLC). Eighty patients (62 males, 18 females) were entered into this study. The disease stage was IIIA in ten patients, IIIB in 32, and IV in 38 patients. The median age was 61 (range 41-78). Karnofsk y performance status was greater than or equal to 80 in 88% of patients. Al l patients were chemonaive, but five patients had received prior radiothera py and 34 patients had undergone prior surgery. Gemcitabine 1250 mg/m(2) wa s given as a 30-min intravenous infusion on days 1, 8, and 15 of a 28-day c ycle. Patients received up to nine cycles (median three cycles). Of 872 dos es 815 (93%) were administered without dose delay or modification. Of the 8 0 patients enrolled, 76 were evaluable for efficacy analysis, and 16 patien ts had a partial response for an overall response rate of 21.1%;1 (95% CI, 11.9-30.3%). A further 47 patients (61.8%) had stable disease. Partial resp onses were seen in eight of 41 stage III patients (19.5%) and in eight of 3 5 stage IV patients (22.9%). The median time to progressive disease was 4.6 months. Median survival for all 80 patients was 7.1 months. Haematological toxicity was mild with grade 3-4 neutropenia in 6.3% of patients, grade 3 thrombocytopenia in 3.8% of patients, and grade 3 anaemia in 2.5% of patien ts. Grade 3 non-laboratory toxicity was: somnolence (1.3% of patients), inf ection (1.3%), nausea and vomiting (6.4%) and dyspnoea (5.1%). This study c onfirms that single-agent gemcitabine is active in advanced NSCLC and its w ell-tolerated safety profile makes it particularly suited to outpatient use . (C) 1998 Elsevier Science Ireland Ltd. All rights reserved.