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


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.
Seifart
U
U
Hamm-Kliniken, Bad Soden Salmünster. Electronic address: dr.seifart@hamm-kliniken.de.
Fink
T
T
Klinikum Nuernberg-Nord, Nuernberg.
Schade-Brittinger
C
C
Department of Medical Biometry and Informatics, University of Marburg and Giessen, Marburg.
Hans
K
K
Department of Medical Biometry and Informatics, Johanniterkrankenanstalten Oberhausen, Oberhausen.
Mueller
C
C
Krankenhaus Luedenscheid, Leudenscheid.
Koschel
G
G
AK Hamburg-Harburg, Hamburg.
Schroeder
H
H
St Johannes Hospital, Duisburg.
Lorenz
R
R
Vogtlandklinikum, Plauen.
Dethling
J
J
Glaxo Smith Kline, Munich.
Wolf
M
M
Department of Haematology and Oncology, Klinikum Kassel, Germany.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000556:secondary; D016543:Central Nervous System Neoplasms / Q000188:drug therapy / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D015996:Survival Rate; D013997:Time Factors; D019772:Topotecan / Q000008:administration & dosage; D016896:Treatment Outcome
D019772:Topotecan; D002945:Cisplatin