A phase II trial of navelbine, ifosfamide, and cisplatin (NIP) in patients with previously untreated advanced non-small cell lung cancer (NSCLC) / 대한내과학회지

ABSTRACT

BACKGROUND: We performed a phase II study to determine the activity and toxicity of Navelbine, Ifosfamide, and Cisplatin (NIP) combination in patients with stage IIIB-IV non-small cell lung cancer (NSCLC). METHODS: Thirty-two chemotherapy naive patients were enrolled from 2 centers between February 1997 and December 1997. The median age was 57 years (range, 29-71); stage IIIB/IV 6/26;male/female 23/9. The regimen consisted of navelbine (25 mg/m2 day 1 and 5), ifosfamide (3 g/m2 day 5 with uroprotective mesna), and cisplatin (80 mg/m2 day 5) every 3 weeks. RESULTS: Twenty-six were evaluable for response and 31 for toxicity. One patient was lost to follow up, one patient refused to continue, and 4 patients could not continue due to poor performance. Total of 120 cycles have been given, with median of 4 cycles per patient (range; 1-6). Sixteen patients achieved partial response (response rate on an intention-to-treat basis, 50%; 95% C.I32-68%). Neutropenia was the most common toxicity. Grade III-IV neutropenia was observed in 39% of courses; thrombocytopenia 4% of courses; anemia 14% of courses. Three patients developed febrile neutropenia; there was no treatment-related death. The median time to progression was 6.9 months and the median overall survival 8.0 months. The probability for 1-year survival was 25%. CONCLUSION: The NIP combination has promising activity and acceptable tolerance in advanced NSCLC patients. But modification of schedule is necessary to increase compliance or dose intensity of navelbine.