title: Topotecan versus paclitaxel for the treatment of recurrent epithelial ovarian cancer.
abstract: OBJECTIVE
  Topotecan and paclitaxel were evaluated in a randomized, multicenter study of patients with advanced epithelial ovarian carcinoma who had progressed during or after one platinum-based regimen.
  
  
  METHODS
  Patients received either topotecan (1.5 mg/m2) as a 30-minute infusion daily for 5 days every 21 days (n = 112) or paclitaxel (175 mg/m2) infused over 3 hours every 21 days (n = 114). Patients had bidimensionally measurable disease and were assessed for efficacy and toxicity.
  
  
  RESULTS
  Response rate was 23 of 112 (20.5%) in topotecan-treated patients and 15 of 114 (13.2%) in paclitaxel-treated patients (P = .138). Disease stabilization for at least 8 weeks was noted in 30% of patients with topotecan and 33% of patients with paclitaxel. Median durations of response to topotecan and paclitaxel were 32 and 20 weeks, respectively (P = .222) and median times to progression were 23 and 14 weeks, respectively (P = .002). Median survival was 61 weeks for topotecan and 43 weeks for paclitaxel (P = .515). Response rates for topotecan and paclitaxel were 13.3% versus 6.7% (P = .303) in resistant patients (not responded to prior platinum-based therapy or progressed within 6 months of an initial response) and 28.8% versus 20.0% (P = .213) in sensitive patients (progressed > 6 months after response). Neutropenia was significantly more frequent on the topotecan arm 79% versus paclitaxel arm 23% (P < .01). It was short-lasting and noncumulative in both arms. Nonhematologic toxicities were generally mild (grades 1 to 2) for both agents.
  
  
  CONCLUSIONS
  Topotecan has efficacy at least equivalent to paclitaxel manifested by the higher response rate and significantly longer time to progression.
authors.affiliation: The Netherlands Cancer Institute, Amsterdam. wtbh@nki.nl
authors.forename: W
authors.initials: W
authors.lastname: ten Bokkel Huinink
authors.forename: M
authors.initials: M
authors.lastname: Gore
authors.forename: J
authors.initials: J
authors.lastname: Carmichael
authors.forename: A
authors.initials: A
authors.lastname: Gordon
authors.forename: J
authors.initials: J
authors.lastname: Malfetano
authors.forename: I
authors.initials: I
authors.lastname: Hudson
authors.forename: C
authors.initials: C
authors.lastname: Broom
authors.forename: C
authors.initials: C
authors.lastname: Scarabelli
authors.forename: N
authors.initials: N
authors.lastname: Davidson
authors.forename: M
authors.initials: M
authors.lastname: Spanczynski
authors.forename: G
authors.initials: G
authors.lastname: Bolis
authors.forename: H
authors.initials: H
authors.lastname: Malmström
authors.forename: R
authors.initials: R
authors.lastname: Coleman
authors.forename: S C
authors.initials: SC
authors.lastname: Fields
authors.forename: J F
authors.initials: JF
authors.lastname: Heron
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D019772:Topotecan
chemical_list: D000970:Antineoplastic Agents; D019772:Topotecan; D017239:Paclitaxel; D002166:Camptothecin