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

摘要: Gemcitabine is a novel pyrimidine nucleoside whose activity has been demonstrated on solid tumors. We report here the results of multicentre phase II trial gemcitabine in chemonaive patients with inoperable non small cell lung cancer (NSCLC). was given weekly at dose 1,250 mg/m(2) administered as 30 min intravenous infusion, for 3 weeks followed by 1 week rest (1 cycle). All 161 included were evaluable toxicity and 151 them efficacy. The majority had stage IIIb (31.1%) or IV (64.6%) disease; 10.6%, 83.2% 62% WHO performance status (PS) 0, 2, respectively. Adenocarcinoma accounted 52.2% cases squamous carcinoma 43.5% cases. Three complete responses partial gave an objective response (OR) rate 21.8% (95% confidence interval: 15.5-29.3%). validated independent Oncology Review Board. Median duration 7.6 months. time to progression 4.6 months (3.3 responders responders). survival 7.3 13.4 (P < 0.001), which overall median 8.9 Cl: 0.1-21.9 months) entire study poptulation. An improvement symptoms personal state also observed. Treatment well tolerated. Neutropenia war only dose-limiting toxicity. grade 4 neutropenia occurred 19.6% 5.7% patients, With OR rate, this confirms single agent NSCLC. Its good tolerance original mode action make drug choice therapeutic strategy these