title: Efficacy and toxicity of weekly topotecan in recurrent epithelial ovarian and primary peritoneal cancer.
abstract: OBJECTIVE
  We assessed the efficacy and toxicity of once-weekly topotecan (Hycamtin; GlaxoSmithKline) for relapsed or persistent epithelial ovarian cancer (EOC) and primary peritoneal carcinoma (PPC).
  
  
  METHODS
  Patients with recurrent or persistent EOC and PPC previously treated with > or = 1 course of platinum-based chemotherapy were treated with weekly topotecan 4.0 mg/m2 on days 1, 8, and 15 of a 28-day cycle in this prospective open-label, single-arm, phase II study.
  
  
  RESULTS
  The median age of the 63 study patients was 63 years (range, 36-88); patients had been previously exposed to a median of 1 course (range, 1-4) of chemotherapy. A median of 5 courses (range, 1-16) were administered. Median follow-up time was 13. 2 month s (range, 1.5-39.0). The overall response rate (RR) was 23.8%, of which 17.5% (11 patients) represented a complete response and 6.3% (4 patients) a partial response. Patients with platinum-sensitive disease had a RR of 20%, whereas patients with platinum-resistant disease had a RR of 28.6%. Median time to progression was 6.2 months (95% confidence interval: 4.43, 7.97), and median survival from initiation of topotecan therapy was 22.3 months (95% confidence interval: 14.56, 30.04). Hematologic toxicities included grade 3 anemia in 3 (4.8%) patients, grade 3 thrombocytopenia in 3 (4.8%) patients, and grades 3-4 neutropenia in 5 (7.9%) patients. Dose reductions, granulocyte colony-stimulating factor, and erythropoietin support were required by 10 (15.9%), 6 (9.5%), and 16 (25.4%) patients, respectively. The most frequent nonhematologic toxicities were grades 2-3 fatigue in 10 (15.9%) patients and grades 2-3 nausea/vomiting in 3 (4.7%) patients.
  
  
  CONCLUSIONS
  Weekly administration of topotecan 4.0 mg/m2 is active and well tolerated by patients with recurrent or persistent EOC and PPC.
authors.affiliation: Department of Oncology, Tel Aviv Sourasky Medical Center, 6 Weizmann Street, Tel Aviv, Israel 64239. safrat@bezeqint.net
authors.forename: Tamar
authors.initials: T
authors.lastname: Safra
authors.forename: Joseph
authors.initials: J
authors.lastname: Menczer
authors.forename: Rinat
authors.initials: R
authors.lastname: Bernstein
authors.forename: Shulem
authors.initials: S
authors.lastname: Shpigel
authors.forename: Moshe J
authors.initials: MJ
authors.lastname: Inbar
authors.forename: Dan
authors.initials: D
authors.lastname: Grisaru
authors.forename: Abraham
authors.initials: A
authors.lastname: Golan
authors.forename: Tally
authors.initials: T
authors.lastname: Levy
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004847:Epithelial Cells / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy*; D011446:Prospective Studies; D019772:Topotecan / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000970:Antineoplastic Agents; D019772:Topotecan