A phase II trial testing gemcitabine as second-line chemotherapy for non small cell lung cancer

The purpose of the present trial was to determine the activity of gemeitabi ne as a second-line chemotherapy for non small cell lung cancer (NSCLC). To be eligible, patients had to have pathologically proven NSCLC that has fai led to respond to a first-line chemotherapy with a cisplatin-containing reg imen, a Karnofsky performance status greater than 50 and adequate renal. ha ematological and hepatic functions. After registration, patients were treat ed by gemcitabine given i.v. at a dose of 1 g/m(2) on days 1, 8, 15 every 4 weeks. Response was assessed after two courses of therapy. Eighty-two pati ents have been registered, five are ineligible and 65 are assessable for re sponse. Four partial responses were observed (6%). No change was documented in 18 cases (28%). Tolerance was good. A few grade III leucopenia and grad e III-IV thrombopenia were observed. We conclude that gemcitabine has a mod est activity as second-line chemotherapy for NSCLC. It has the advantage to be well tolerated and may thus be one drug to be proposed to the patients who have disease progression after a first-line chemotherapy and who ask fo r further treatment. (C) 2000 Elsevier Science Ireland Ltd. All rights rese rved.