title: Randomised phase II study comparing topotecan/carboplatin administration for 5 versus 3 days in the treatment of extensive-stage small-cell lung cancer.
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.
  
  
  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.
authors.affiliation: Hamm-Kliniken, Bad Soden Salmünster. Electronic address: dr.seifart@hamm-kliniken.de.
authors.forename: U
authors.initials: U
authors.lastname: Seifart
authors.affiliation: Klinikum Nuernberg-Nord, Nuernberg.
authors.forename: T
authors.initials: T
authors.lastname: Fink
authors.affiliation: Department of Medical Biometry and Informatics, University of Marburg and Giessen, Marburg.
authors.forename: C
authors.initials: C
authors.lastname: Schade-Brittinger
authors.affiliation: Department of Medical Biometry and Informatics, Johanniterkrankenanstalten Oberhausen, Oberhausen.
authors.forename: K
authors.initials: K
authors.lastname: Hans
authors.affiliation: Krankenhaus Luedenscheid, Leudenscheid.
authors.forename: C
authors.initials: C
authors.lastname: Mueller
authors.affiliation: AK Hamburg-Harburg, Hamburg.
authors.forename: G
authors.initials: G
authors.lastname: Koschel
authors.affiliation: St Johannes Hospital, Duisburg.
authors.forename: H
authors.initials: H
authors.lastname: Schroeder
authors.affiliation: Vogtlandklinikum, Plauen.
authors.forename: R
authors.initials: R
authors.lastname: Lorenz
authors.affiliation: Glaxo Smith Kline, Munich.
authors.forename: J
authors.initials: J
authors.lastname: Dethling
authors.affiliation: Department of Haematology and Oncology, Klinikum Kassel, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Wolf
mesh_terms: 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
chemical_list: D019772:Topotecan; D002945:Cisplatin