title: Phase II study of a 3-day schedule with topotecan and cisplatin in patients with previously untreated small cell lung cancer and extensive disease.
abstract: BACKGROUND
  Treatment with a topoisomerase I inhibitor in combination with a platinum results in superior or equal survival compared with etoposide-based treatment in extensive disease small cell lung cancer (SCLC). Five-day topotecan is inconvenient and therefore shorter schedules of topotecan and cisplatin are needed. The aim of this phase II study was to establish the response rate and response duration in chemo-naive patients with SCLC receiving a 3-day topotecan and cisplatin schedule.
  
  
  METHODS
  Simons optimal two-stage design was used. Patients with previously untreated extensive disease SCLC, adequate organ functions and performance status less than 3 were eligible. Topotecan (2.0 mg/m, intravenously) was administered on days 1 to 3 with cisplatin (50 mg/m, intravenously) on day 3 every 3 weeks for a total of six cycles.
  
  
  RESULTS
  Forty-three patients received 219 cycles of chemotherapy. Median age was 59 (range 44-74), 79% had performance status 0 or 1. Thirty-one patients completed all six cycles. Grade 3/4 anemia, neutrocytopenia, and thrombocytopenia were recorded in 9.5%, 66.7%, and 21.4% of patients, respectively. Fourteen percent of patients experienced neutropenic fever. No episodes of fatal sepsis occurred. Non-hematologic toxicity was mild and manageable. Overall and complete response rates were 72.1% and 9.3%, respectively. The median overall survival and response duration were 10.3 months (95% confidence interval: 8.6-12.0) and 7.0 months (95% confidence interval: 6.3-7.7), respectively.
  
  
  CONCLUSIONS
  Three-day topotecan with cisplatin on day 3 is active and safe in extensive disease SCLC. An ongoing phase III randomized trial compares this combination to standard treatment.
authors.affiliation: Department of Oncology, the Finsen Centre, Rigshospitalet, Copenhagen, Denmark. msorensen@dadlnet.dk
authors.forename: Morten
authors.initials: M
authors.lastname: Sorensen
authors.forename: Ulrik
authors.initials: U
authors.lastname: Lassen
authors.forename: Peter Buhl
authors.initials: PB
authors.lastname: Jensen
authors.forename: Kell
authors.initials: K
authors.lastname: Østerlind
authors.forename: Nina
authors.initials: N
authors.lastname: Jeppesen
authors.forename: Britta Bjerregaard
authors.initials: BB
authors.lastname: Jensen
authors.forename: Anders
authors.initials: A
authors.lastname: Mellemgaard
authors.forename: Carsten
authors.initials: C
authors.lastname: Rytter
authors.forename: Seppo Wang
authors.initials: SW
authors.lastname: Langer
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000556:secondary; D015996:Survival Rate; D019772:Topotecan / Q000008:administration & dosage
chemical_list: D019772:Topotecan; D002945:Cisplatin