Burkes, RL

CortesFunes, H

Cottier, B

Gatzemeier, U

Gottfried, M

Groen, HJM

LeChevalier, T

Mattson, K

Ponzio, A

Rosso, R

Shepherd, F

Tonato, M

Voi, M

Weynants, P

Gemcitabine is a novel pyrimidine nucleoside whose activity has been demonstrated on solid tumors. We report here the results of a multicentre phase II trial of gemcitabine in chemonaive patients with inoperable 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 patients included were evaluable for toxicity and 151 of them were evaluable for efficacy. The majority of patients had a stage IIIb (31.1%) or stage IV (64.6%) disease; 10.6%, 83.2% and 62% of patients had a WHO performance status (PS) 0, 1 and 2, respectively. Adenocarcinoma accounted for 52.2% of cases and squamous cell carcinoma for 43.5% of cases. Three complete responses and 30 partial responses gave an objective response (OR) rate of 21.8% (95% confidence interval: 15.5-29.3%). All responses 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 responders (P &lt;0.001), which gave an overall median survival of 8.9 months (95% Cl: 0.1-21.9 months) in the entire study poptulation. An improvement of symptoms and personal state was also observed. Treatment was well tolerated. Neutropenia war the only dose-limiting toxicity. WHO grade 3 or 4 neutropenia occurred in 19.6% and 5.7% of patients, respectively. With a 21.8% OR rate, this multicentre study confirms the activity of gemcitabine as a single agent in patients with inoperable NSCLC. Its good tolerance and original mode of action make gemcitabine a drug of choice in the therapeutic strategy of these tumors.</p

Proceedings - University of Groningen

A phase II study of gemcitabine in the treatment of non small cell lung cancer

A phase II study of gemcitabine in the treatment of non small cell lung cancer

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Proceedings - University of Groningen