ACTIVITY OF GEMCITABINE IN PATIENTS WITH NON-SMALL-CELL LUNG-CANCER -A MULTICENTER, EXTENDED PHASE-II STUDY

Gemcitabine is a novel nucleoside analogue with activity in solid tumo urs. This study assessed the objective response rate to gemcitabine gi ven weekly intravenously at a dose of 1250 mg/m(2) for 3 weeks followe d by 1 week of rest (one cycle) in chemonaive patients with inoperable non-small cell lung cancer (NSCLC). 161 patients with NSCLC were recr uited from 10 sites in nine countries. Most patients had stage IIIb (3 1.3%) or IV (64.6%) disease, and 93.8% had a performance status of 0 o r 1 according to the WHO scale. Of 151 evaluable patients, there were 3 complete responses and 30 partial responses lasting at least 4 weeks for an objective response rate of 21.8% (95% CI 15.5-29.3%). All resp onses were validated by an extramural Oncology Review Board. The mean duration of response was 8.8 months. The mean survival for all patient s (16.1% of patients still alive 26 months after last patient started treatment) was 11.5 months. Improvements were also observed in seconda ry efficacy parameters such as performance status, weight, analgesic r equirement, pain, and other disease-related symptoms including cough, dyspnoea, haemoptysis, anorexia, somnolence and hoarseness. Haematolog ical and non-haematological toxicity was mild given the biological act ivity of gemcitabine. This study confirms gemcitabine as one of the mo st active agents in NSCLC with the added benefit of a modest toxicity profile and ease of administration on an out-patient basis. Gemcitabin e is a suitable candidate for combination chemotherapy in patients wit h NSCLC.