Gemcitabine, ifosfamide, cisplatin (GIP) for the treatment of advanced non-small cell lung cancer: A phase II study of the Italian oncology group forclinical research (GOIRC)

The purpose of this study was to evaluate the activity and the toxicity of the combination of gemcitabine with ifosfamide and cisplatin (GIP) in chemo naive patients with advanced non small cell lung cancer (NSCLC). Eighty che monaive patients with Stage IIIB-IV NSCLC were treated with the combination of gemcitabine 1 g/m(2) on Days I and 8, ifosfamide 2 g/m(2) on Day I and cisplatin 80 mg/m(2) on Day 2, Cycles were administered on an outpatient ba sis every 3 weeks. Hematologic toxicity was the main side effect; Grade III -IV thrombocytopenia was observed in 54 (67%) patients and Grade Ill-IV leu copenia in 44 (55%) patients, with 4 episodes of febrile neutropenia and I toxic death. Thirteen patients received platelet transfusions and 38 were t ransfused with packed red cells. All patients were evaluable for response. The overall response rate was 54% (95% confidence interval 43 to 65%) with 1 complete response. In patients with Stage IIIB and IV disease, response r ates were 58% and 52%, respectively. Median time to progression was 40 week s (range 0-114) and median overall survival was 12 months (16.6 months for stage IIIB and 10.4 months for stage IV), Median and minimum follow-up were 19 and 12 months, respectively. The GIP combination shows a response rate and overall survival of clinical interest. Hematologic toxicity was the mai n toxic effect, especially in patients with tow performance status. This re gimen will be tested in a Phase ill randomized trial. (C) 2000 Wiley-Liss, Inc.