Activity of high-dose epirubicin combined with gemcitabine in advanced non-small-cell lung cancer: a multicenter phase I and II study

The aim of the study was to evaluate efficacy and tolerance of epirubicin a nd gemcitabine as first-line chemotherapy in patients with advanced non-sma ll-cell lung cancer. A phase I study was performed with the combination of escalating doses of epirubicin intravenously on day 1 and a fixed dose of g emcitabine on days 1 and 8 of a 21-day cycle. Eighteen patients were includ ed in the phase I part of the study before the maximum tolerated dose was f ound. Dose-limiting toxicity was febrile neutropenia. The phase II part of the study was continued with epirubicin 100 mg m(-2) on day 1 and gemcitabi ne 1125 mg m(-2) on days 1 and 8 of a 21-day cycle. Forty-three chemotherap y-naive patients were included. The median age of the patients was 60 years (range 26-75). Most patients (74%) were in stage IV. Granulocytopenia CTC grade 4 occurred in 32.5% and thrombocytopenia grade 4 in 11.6% of cycles. Febrile neutropenia occurred in six patients. Nonhaematological toxicity wa s mainly mucositis CTC grade 2 and 3 in 35% of patients. The tumour respons e rate was 49% (95% confidence interval (CI) 35-63%). The median survival t ime for the patients was 42 weeks (95% Cl 13-69). (C) 2000 Cancer Research campaign.