title: A phase II study of two topotecan regimens evaluated in recurrent platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer: a Gynecologic Oncology Group Study (GOG 146Q).
abstract: OBJECTIVE
  To evaluate the efficacy and safety of topotecan in patients with recurrent ovarian, primary peritoneal, and fallopian tube carcinomas.
  
  
  METHODS
  A randomized phase II analysis of platinum-sensitive patients with measurable disease was performed independently assessing intravenous topotecan 1.25 mg/m2 daily×5 every 21 days (regimen I) and topotecan 4.0 mg/m2/day on days 1, 8, and 15 of a 28-day cycle (regimen II). All patients were treated until disease progression, unmanageable toxicity, or patient refusal. Insufficient accrual related to regimen I resulted in a redesign of the study as a single arm phase II trial assessing only regimen II. More complete efficacy data is presented for regimen II as enrollment on regimen I was insufficient for some analyses.
  
  
  RESULTS
  A total of 81 patients were enrolled. One patient was ineligible. Fifteen patients received regimen I, while 65 patients were treated with regimen II. The response rate on regimen I (daily×5) was 27% (90% CI: 10-51%) and 12% (90% CI: 6-21%) on regimen II (weekly). The median PFS and OS were 4.8 and 27.8 months, respectively, for regimen II. Grade 3/4 neutropenia rate was 93% with daily×5 dosing and 28% for weekly treatment. Febrile neutropenia was very low in both groups.
  
  
  CONCLUSIONS
  The weekly regimen of topotecan appeared less active but resulted in less toxicity than the daily regimen in platinum-sensitive recurrent ovarian cancer patients.
authors.affiliation: Columbia University, New York Presbyterian Hospital, Department of OB/GYN, New York, NY 10032, USA. th2135@columbia.edu
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Herzog
authors.forename: Michael W
authors.initials: MW
authors.lastname: Sill
authors.forename: Joan L
authors.initials: JL
authors.lastname: Walker
authors.forename: David
authors.initials: D
authors.lastname: O'Malley
authors.forename: Mark
authors.initials: M
authors.lastname: Shahin
authors.forename: Koen
authors.initials: K
authors.lastname: DeGeest
authors.forename: Sheldon A
authors.initials: SA
authors.lastname: Weiner
authors.forename: David
authors.initials: D
authors.lastname: Mutch
authors.forename: Robert L
authors.initials: RL
authors.lastname: DeBernardo
authors.forename: Samuel S
authors.initials: SS
authors.lastname: Lentz
mesh_terms: D000328:Adult; D000368:Aged; D000077216:Carcinoma, Ovarian Epithelial; D004334:Drug Administration Schedule; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy / Q000401:mortality; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000401:mortality; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D059004:Topoisomerase I Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D019772:Topotecan / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D059004:Topoisomerase I Inhibitors; D019772:Topotecan