A PHASE-II STUDY OF GEMCITABINE IN THE TR EATMENT OF NON-SMALL-CELL LUNG-CANCER

Gemcitabine is a novel pyrimidine nucleoside whose activity has been d emonstrated on solid tumors. We report here the results of a multicent re phase II trial of gemcitabine in chemonaive patients with inoperabl e non small cell lung cancer (NSCLC). Gemcitabine was given weekly at a dose of 1,250 mg/m(2) administered as a 30 min intravenous infusion, for 3 weeks followed by 1 week of rest (1 cycle). All the 161 patient s included were evaluable for toxicity and 151 of them were evaluable for efficacy. The majority of patients had a stage IIIb (31.1%) or sta ge IV (64.6%) disease; 10.6%, 83.2% and 62% of patients had a WHO perf ormance status (PS) 0, 1 and 2, respectively. Adenocarcinoma accounted for 52.2% of cases and squamous cell carcinoma for 43.5% of cases. Th ree complete responses and 30 partial responses gave an objective resp onse (OR) rate of 21.8% (95% confidence interval: 15.5-29.3%). All res ponses were validated by an independent Oncology Review Board. Median duration of response was 7.6 months. Median time to progression was 4. 6 months (3.3 months in non responders and 7.6 months in responders). Median survival was 7.3 months in non responders and 13.4 months in re sponders (P < 0.001), which gave an overall median survival of 8.9 mon ths (95% Cl: 0.1-21.9 months) in the entire study poptulation. An impr ovement of symptoms and personal state was also observed. Treatment wa s well tolerated. Neutropenia war the only dose-limiting toxicity. WHO grade 3 or 4 neutropenia occurred in 19.6% and 5.7% of patients, resp ectively. With a 21.8% OR rate, this multicentre study confirms the ac tivity of gemcitabine as a single agent in patients with inoperable NS CLC. Its good tolerance and original mode of action make gemcitabine a drug of choice in the therapeutic strategy of these tumors.