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Annals of Oncology Advance Access published online on October 27, 2006
Annals of Oncology, doi:10.1093/annonc/mdl353
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© 2006 European Society for Medical Oncology
Received February 8, 2006
Revised August 21, 2006
Accepted August 23, 2006

original article

Randomised phase II study comparing topotecan/carboplatin administration for 5 versus 3 days in the treatment of extensive-stage small-cell lung cancer

U. Seifart 1 *, T. Fink 2, C. Schade-Brittinger 3, K. Hans 4, C. Mueller 5, G. Koschel 6, H. Schroeder 7, R. Lorenz 8, J. Dethling 9, and M. Wolf 10

1 Hamm-Kliniken, Bad Soden Salmünster, Germany
2 Klinikum Nuernberg-Nord, Nuernberg, Germany
3 Department of Medical Biometry and Informatics, University of Marburg and Giessen, Marburg, Germany
4 Department of Medical Biometry and Informatics, Johanniterkrankenanstalten Oberhausen, Oberhausen, Germany
5 Krankenhaus Luedenscheid, Leudenscheid, Germany
6 AK Hamburg-Harburg, Hamburg, Germany
7 St Johannes Hospital, Duisburg, Germany
8 Vogtlandklinikum, Plauen, Germany
9 GlaxoSmithKline, Munich, Germany
10 Department of Haematology and Oncology, Klinikum Kassel, Germany

* To whom correspondence should be addressed.
U. Seifart, E-mail: dr.seifart{at}hamm-kliniken.de


  Abstract

Background: Topotecan is an active drug in small-cell lung cancer (SCLC). In our previous study, a combination of topotecan with cisplatin was associated with a median overall survival of 7.6 or 8.7 months, depending on the duration of treatment. We have replaced cisplatin by carboplatin in this trial, with the objective of creating a more convenient schedule for our patients. Furthermore, we have also compared the standard 5-day schedule with an experimental 3-day schedule.

Patients and methods: A total of 100 patients with metastatic disease were included. Patients were randomly assigned to receive either topotecan 0.75 mg/m2, days 1-5, and carboplatin AUC 5, day 5 (arm A) or topotecan 1.25 mg/m2, days 1-3, and carboplatin AUC 5, day 3 (arm B). Six cycles were given at a 3-week interval.

Results: A total of 91 patients were assessable for response. The response during therapy was 86.9% in arm A and 80.0% in arm B. Median survival in arm A was 11.8 months and in arm B 11.6 months (P = 0.37).

Conclusions: The combination of topotecan and carboplatin is active in extensive-disease SCLC. Toxicity and median survival were comparable in both arms. Three days of treatment seems to be similar to the 5-day regimen.

Keywords: carboplatin; chemotherapy; extensive disease; small-cell lung cancer; topotecan.
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