Phase II trial of irinotecan plus nedaplatin (INP) in treating patients with extensive stage small cell lung cancer.

Purpose: We conducted a phase II study of combination chemotherapy with irinotecan (CPT-11) and nedaplatin (NDP), (INP regimen), to determine the effects and toxicities in patients with extensive stage small cell lung cancer (SCLC). Methods: From March 2005 to December 2010, 60 patients with histologically or cytologically confirmed extensive SCLC were enrolled into this study. All received treatment CPT-11 at a dose of 60mg/m 2 on days 1 and 8, and NDP 20mg/m 2 on days1-5, every 3-4 weeks as a cycle. Patients were treated until tumor progression or unacceptable toxicity. Results: Main toxicities included: myelosuppression, nausea or vomiting, diarrhea, elevation of alanine aminotransferase,and bilirubin. No treatment related death occurred in this study. Thirteen patients had complete response, forty-two had partial response, three remained stable, and two had progressive disease. Median progression-free survival was 13 months (95% confidence interval: 9-17) and median overall survival was 22 months (95% confidence interval: 19-25). Conclusion: INP is an effective and well tolerated regimen for treatment of extensive staged SCLC.