Phase II study of Gemcitabine and vindesine in patients with previously untreated non-resectable non-small-cell lung cancer

Because both vindesine and gemcitabine are active drugs in advanced non-sma ll-cell lung cancer (NSCLC), with different modes of action and only partly overlapping toxicity, a phase II study was performed. Gemcitabine 1000 mg m(-2) was given on days 1, 8 and 15 every 4 weeks, while vindesine 3 mg m(- 2) was administered weekly for 7 weeks, then every 2 weeks. A total of 42 p atients with nonresectable NSCLC were included. The median age of patients was 56 years; 57% were men, 52% had adenocarcinoma, 31% squamous cell carci noma and 17% had large-cell carcinoma. The performance status ranged from 0 to 2 with 83% in performance status 1. The majority (55%) had stage IV dis ease, while 40% had stage III B and 5% stage II[ A disease. WHO grade 3-4 l eucopenia occurred in five patients (12%) and 9% had grade 4 neutropenia. T hrombocytopenia grade 3-4 was observed in six patients (15%). There were no septic death or bleeding episodes. One patient had a transient WHO grade 4 increase in bilirubin, and four patients had a decrease in glomerular filt ration rate below the normal limit; one of these patients developed a non-r eversible renal insufficiency. Ten patients (24%) complained of dyspnoea of uncertain mechanism, possibly involving bronchoconstriction. There were on e complete and seven partial responses among 40 assessable patients (20%, 9 5% confidence limits 9-36%). Median response duration was 31 weeks (range 1 1-83 weeks) and median survival time 31 weeks (range 2-171 weeks). The curr ent combination of gemcitabine and vindesine does not appear to be promisin g for further examination because of the toxicity and somewhat disappointin g activity.