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Phase I/II study of gemcitabine and epirubicine in stage IIIB-IV non small cell lung cancer.

Platinum-based chemotherapy currently represents standard treatment for advanced non-small cell lung cancer (NSCLC). Gemcitabine is one of the most promising agents currently in use in advanced NSCLC. As a single-agent, epirubicin, showed tumour response rates ranging from 17% to 36% in NSCLC. The aim of the present study was to evaluate the combination of gemcitabine and epirubicin in a phase I-II study. Thirty chemotherapy-naive patients with stage III B-IV NSCLC received gemcitabine at a fixed dose of 1000 mg/m2 on days 1 and 8 every 3 weeks; epirubicin was administered every 21 days on day 1 at the initial dose of 80 mg/m2 which was subsequently escalated. Neutropenia was dose-limiting toxicity since it occurred in 3 out of five patients receiving epirubicin at the dose of 110 mg/m2. An objective response was observed in 14/30 patients, including 2 (7%) complete responses and 12 (40%) partial responses. Median duration of response was 12 months (range: 3 to 53 + months). Median overall survival was 16 months (range: 4 to 55 + months). The combination of gemcitabine and epirubicin is well tolerated. While the observed activity of this combinated treatment matches that of platinum-based regimens, the duration of response and survival have been sufficiently promising to initiate a phase II trial which is currently under way.