Vinorelbine, ifosfamide and cisplatin as first-line treatment in patients with inoperable non-small cell lung cancer

To assess, in a multicenter setting, the effectiveness of a combination of vinorelbine, ifosfamide and cisplatin in the treatment of non-small cell lu ng cancer, 123 patients (males = 116) with a mean age of 60 years (range 27 -75) with stage IIIb/IV non-small cell lung cancer (NSCLC) and performance status less than or equal to 2 were treated with vinorelbine (VNR; 25 mg/m( 2)) on days I and 8; ifosfamide (IFO; 3 g/m(2)) on day 1; and cisplatin (CD DP; 80 mg/m(2)) on day 1, in repeated cycles of 21 days. Response rates, ov erall patient survival and toxicity profiles of the three-drug combination were assessed. The number of evaluable patients was 112, with a total of 44 1 cycles administered (mean = 3.6 cycles/patient). Dose intensities (mg/m(2 )/week; calculated in patients who concluded the proposed treatment and exp ressed as mean, median, and standard deviation) were: VNR 13.65, 13.32, 4.7 ; IFO 918.88, 868.97, 258.1; CDDP 23, 24.68, 6.98. Response rates were: com plete response = 3 (2.4%); partial response = 58 (47.2%%); stable disease = 20 (16.3%). The most frequent toxic events were nausea and vomiting (GI = 33%, G2 = 31%, G3 = 8%). Neutropenia was the dose limiting toxicity (G1 = 6 %, G2 = 11%, G3 = 10%, G4 = 7%). Alopecia G3 was a common undesirable effec t in all the patients. Time to progression was 296 days (95% confidence int erval 261-332) and the mean survival time was 338 days (95% Cl 301-374). We conclude that the described therapeutic schedule is effective with good su rvival rates and response ratios together with a good tolerance and an acce ptable toxicity level. (C) 2001 Elsevier Science Ireland Ltd. All rights re served.