Annals of Oncology Advance Access originally published online on October 27, 2006
Annals of Oncology 2007 18(1):104-109; doi:10.1093/annonc/mdl353
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© 2006 European Society for Medical Oncology
lung cancer |
Randomised phase II study comparing topotecan/carboplatin administration for 5 versus 3 days in the treatment of extensive-stage small-cell lung cancer
1 Hamm-Kliniken, Bad Soden Salmünster
2 Klinikum Nuernberg-Nord, Nuernberg
3 Department of Medical Biometry and Informatics, University of Marburg and Giessen, Marburg
4 Department of Medical Biometry and Informatics, Johanniterkrankenanstalten Oberhausen, Oberhausen
5 Krankenhaus Luedenscheid, Leudenscheid
6 AK Hamburg-Harburg, Hamburg
7 St Johannes Hospital, Duisburg
8 Vogtlandklinikum, Plauen
9 GlaxoSmithKline, Munich
10 Department of Haematology and Oncology, Klinikum Kassel, Germany
* Correspondence to: Dr U. Seifart, Hamm-Kliniken, Brüder Grimm-Strasse, 20 63628 Bad Soden Salmünster, Germany. Tel: +49-6056-72109; Fax: +49-6056-72150; E-mail: dr.seifart{at}hamm-kliniken.de
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.
Key words: carboplatin, chemotherapy, extensive disease, small-cell lung cancer, topotecan