Phase II study with gemcitabine, ifosfamide and cisplatin in advanced non-small cell lung cancer

The aim of the present study was to determine the clinical activity and tox icity of a novel chemotherapy combination regimen of gemcitabine, ifosfamid e and cisplatin (GIP), administered every 3 weeks, in patients with inopera ble non-small cell lung cancer (NSCLC). From October 1998 to July 1999, Is previously untreated stages IIIb (4) and IV (14) patients were enrolled int o the study. Gemcitabine and ifosfamide (with mesna as uroprotection) was a dministered on days 1 and 6, at a dose of 1000 and 1500 mg/m(2), respective ly; and cisplatin was given on day 1 at a dose of 60 mg/m(2), every 3 weeks . All 18 patients were evaluable for response and toxicity profiles. One pa tient achieved a complete response, and 11 patients achieved a partial resp onse, with an overall response rate of 66.7% (95% CI, 45-89%). The main tox icity was hematological, a NCI grade 3-4 neutropenia in 16 patients (88.9%) during the treatment course. Febrile neutropenia occurred in three patient s (16.6%). Grade 3 anemia occurred in eight patients (44.4%) and grade 3-4 thrombocytopenia occurred in 11 patients (61.1%). Non-hematological toxicit y was mild and tolerable. No toxic death occurred. The median survival was 12.7 months and 1 year survival was 58.4%. The GIP combination chemotherapy produced a high response rate in advanced NSCLC; however, there was a rela tively high percentage of hematological toxicity that still could be tolera ted. A randomized trial comparing GIP to a two-drug combination of gemcitab ine and cisplatin is planned. (C) 2000 Elsevier Science Ireland Ltd. All ri ghts reserved.