IFOSFAMIDE AND VINORELBINE AS FIRST-LINE CHEMOTHERAPY FOR ADVANCED NONSMALL CELL LUNG-CARCINOMA

We evaluated the efficacy and toxicity of the novel combination of ifo sfamide (IFX) and vinorelbine (VNB) as first-line chemotherapy in pati ents with stage IIIB and IV nonsmall cell lung cancer (NSCLC). Between March 1993 and November 1993, 44 patients (17 stage IIIB: 27 stage IV ) received a regimen consisting of IFX, 2 g/m(2) in a I-h infusion, da ys 1-3, mesna, 400 mg/m(2) in an i.v. bolus at hours 0 and 4 and 800 m g orally at hour 8, days 1-3; and VNB, 35 mg/m(2) in a 20-min infusion , days 1 and 15. During the first course only, a half dose of VNB (17. 5 mg/m(2)) was administered on days 8 and 22. Courses were repeated ev ery 28 days. Forty patients were fully evaluable for response, and 44 were assessable for toxicity. Objective regression was recorded in 13 of 40 patients (33%). No patient achieved a complete response. Thirtee n patients presented a partial response (33%); 17(42%) had no change; and progressive disease was observed in 10(25%). The median duration o f response was 10 months, and the median time to treatment failure for the whole group was 4 months. Median survival was 1 1 months. The dos e-limiting toxic effect was myelosuppression. Leukopenia occurred in 2 5 patients (57%) and was grade 3 or 4 in 8 patients (18%). Twelve pati ents (27%) developed peripheral neurotoxicity, while five had mild IFX -induced CNS toxicity. Phlebitis was observed in 15 of 30 patients (50 %) who did not have central implantable venous systems. The IFX-VNB co mbination exhibited an activity against NSCLC that was among the highe st reported for non-cisplatin-containing regimens, with a toxicity pro file that was easily managed.