Korean J Med.
2001 May;60(5):472-478.
A phase II trial of navelbine, ifosfamide, and cisplatin (NIP) in patients with previously untreated advanced non-small cell lung cancer (NSCLC)
- Affiliations
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- 1Department of Medicine, Asan Medical Center, College of Medicine, University of Ulsan, Seoul.
- 2Department of Radiation Oncology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul.
- 3Department of Medicine, Kangnung Hospital, Kangnung, Korea.
Abstract
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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.I:32-68%). 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.