Annals of Oncology Advance Access published online on January 19, 2006
Annals of Oncology, doi:10.1093/annonc/mdj137
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1 Department of Hematology, Oncology and Transfusion Medicine, Charité, Campus Benjamin Franklin, Berlin, Germany
* To whom correspondence should be addressed. 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.
Received October 26, 2005
Revised November 30, 2005
Accepted December 14, 2005
original article
A randomized phase II trial of irinotecan plus carboplatin versus etoposide plus carboplatin treatment in patients with extended disease small cell lung cancer
A. Schmittel 1 *,
L. Fischer von Weikersthal 2,
M. Sebastian 3,
P. Martus 4,
K. Schulze 5,
P. Hortig 5,
M. Reeb 6,
E. Thiel 1,
and
U. Keilholz 1
2 Department of Hematology and Oncology, St. Marien Hospital, Amberg, Germany
3 Department of Pneumology, University of Mainz, Germany
4 Department of Biostatistics and Clinical Epedimiology, Charité, Campus Benjamin Franklin, Berlin, Germany
5 Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany
6 Department of Hematology and Oncology, Westpfalz-Clinic, Kaiserslautern, Germany
A. Schmittel, E-mail: alexander.schmittel{at}charite.de
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