A phase II study of irinotecan plus cisplatin for patients with advanced stage IIIB or IV NSCLC previously treated with nonplatinum‐based chemotherapy

Abstract
BACKGROUND. Irinotecan (I) and cisplatin (P) are active chemotherapy agents with clinical synergy in non–small‐cell lung cancer (NSCLC). We evaluated the efficacy of IP regimen as a salvage treatment of patients with NSCLC that progressed after nonplatinum‐containing regimen(s). METHODS. Eligibility required histologically confirmed NSCLC, bidimensionally measurable disease, ECOG PS 0‐2, and progressive disease after nonplatinum‐based chemotherapy. Treatment consisted of I (65 mg/m2) and P (30 mg/m2) i.v. on Days 1 and 8 of a 21‐day cycle, for a maximum of 6 cycles. An informed consent was obtained from all patients. RESULTS. Between August 2002 and May 2004, 32 patients with median age of 56 years (range, 42–74) were enrolled. Twenty‐four (75%) patients were men, and 28 (88%) had ECOG PS 0 or 1. Twenty‐five patients had adenocarcinoma and 6 had squamous‐cell carcinoma. All patients were evaluated for response and toxicity, and the response rate was 40.6%. After a median follow‐up of 18.5 months, the median survival time was found to be 9.3 months, with a 1‐year survival rate of 43.8%. Toxicities were moderate and manageable, with 47% G3 and 9% G4 neutropenia, 19% G3 diarrhea, and 22% G3 asthenia. There was no G4 nonhematologic toxicity. CONCLUSIONS. The irinotecan and cisplatin combination is an active and well‐tolerated regimen for the patients with advanced NSCLC that progressed after nonplatinum‐containing regimen(s). Cancer 2006. © 2006 American Cancer Society.

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