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Annals of Oncology Advance Access originally published online on January 19, 2006
Annals of Oncology 2006 17(4):663-667; doi:10.1093/annonc/mdj137
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© 2006 European Society for Medical Oncology

A randomized phase II trial of irinotecan plus carboplatin versus etoposide plus carboplatin treatment in patients with extended disease small-cell lung cancer

A. Schmittel1,*, L. Fischer von Weikersthal4, M. Sebastian5, P. Martus2, K. Schulze3, P. Hortig3, M. Reeb6, E. Thiel1 and U. Keilholz1

Department of 1 Hematology, Oncology and Transfusion Medicine; 2 Department of Biostatistics and Clinical Epedimiology and 3 Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin; 4 Department of Hematology and Oncology, St. Marien Hospital, Amberg; 5 Department of Pneumology, University of Mainz; 6 Department of Hematology and Oncology, Westpfalz-Clinic, Kaiserslautern, Germany

* Correspondence to: Alexander Schmittel M.D., Charité, Campus Benjamin-Franklin, Dept. of Hematology, Oncology and Transfusion Medicine, Hindenburgdamm 30, 12200 Berlin, Germany. Tel: +49-30-8445-3090; Fax: +49-30-8445-4468; E-mail: alexander.schmittel{at}charite.de

Background: Superiority of irinotecan/cisplatin over etoposide/cisplatin was suggested in small-cell lung cancer (SCLC). This trial investigated irinotecan/carboplatin (IP) versus etoposide/carboplatin (EP).

Patients and methods: The interim analysis at the phase II/phase III transition point of the multicenter trial is reported. Extensive disease SCLC patients were randomized to receive carboplatin AUC 5 mg • min/ml either in combination with 50 mg/m2 of irinotecan on days 1, 8 and 15 (IP) or with etoposide 140 mg/m2 days 1–3 (EP). The primary end point was response rate and the secondary end points were toxicity and progression-free survival.

Results: Seventy patients were randomized. Significant differences in grade 3 and 4 thrombopenia (17% IP versus 48% EP, P = 0.01) and neutropenia (26% IP versus 51% PE, P < 0.01) were found. Grade 3 and 4 diarrhea was more frequent with IP (18%) than with EP (6%) (P = 0.133). Response rates were 67% and 59% (P = 0.24) in the IP versus EP arm, respectively. Median progression-free survival (PFS) was 9 months (95% CI 7.1–10.9) in the IP arm and 6 months (95% CI 4.1–7.9) in the EP arm (P = 0.03).

Conclusions: IP is active, less toxic and appears to improve PFS. Based on the phase II results the trial has been extended to phase III to assess the impact on overall survival.

Key words: irinotecan, etoposide, carboplatin, SCLC, extensive disease, phase II


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