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) andnedaplatin (NDP), (INP regimen), to determine the effects and toxicities in patients with extensive stage smallcell lung cancer (SCLC).
Methods: From March 2005 to December 2010, 60 patients with histologically orcytologically confirmed extensive SCLC were enrolled into this study. All received treatment CPT-11 at a doseof 60mg/m2 on days 1 and 8, and NDP 20mg/m2 on days1-5, every 3-4 weeks as a cycle. Patients were treateduntil tumor progression or unacceptable toxicity.
Results: Main toxicities included: myelosuppression, nausea orvomiting, diarrhea, elevation of alanine aminotransferase,and bilirubin. No treatment related death occurred inthis study. Thirteen patients had complete response, forty-two had partial response, three remained stable, andtwo 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 effectiveand well tolerated regimen for treatment of extensive staged SCLC.