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/ m(2) 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.