title: Oral topotecan as single-agent second-line chemotherapy in patients with advanced ovarian cancer.
abstract: OBJECTIVE
  To evaluate oral topotecan as single-agent, second-line therapy in patients with ovarian cancer previously treated with a platinum-based regimen.
  
  
  METHODS
  Patients (N = 116) received oral topotecan 2.3 mg/m2 daily for 5 days every 21 days. Eligibility criteria included histologic diagnosis of International Federation of Gynecology and Obstetrics stage III or IV epithelial ovarian cancer, bidimensionally measurable disease, prior platinum-containing chemotherapy, age > or = 18 years, performance status < or = 2, and life expectancy > or = 12 weeks.
  
  
  RESULTS
  Overall response rate was 21.6% (25 of 116 patients). Median duration of response was 25.0 weeks; median time to response was 8.4 weeks. Median time to progression was 14.1 weeks; median survival was 62.2 weeks. Grade 4 neutropenia was experienced by 50.4% of patients in 13.4% of courses administered. Grade 4 thrombocytopenia was experienced by 22.1% of patients in 5.1% of courses. Grade 3 or 4 anemia was experienced by 29.2% of patients in 8.5% of courses. Most frequent nonhematologic toxicities were predominantly (> 90%) grade 1 or 2 and included nausea, alopecia, diarrhea, and vomiting.
  
  
  CONCLUSIONS
  Second-line oral topotecan administered at 2.3 mg/m2 for 5 days every 21 days demonstrated activity in patients with progressive or recurrent ovarian cancer after first-line platinum-based chemotherapy. This activity was comparable to that seen in previous studies with intravenous topotecan. Grade 4 neutropenia was less frequent with oral topotecan than previously reported for intravenous topotecan. Oral topotecan is an active, tolerable, and convenient formulation of an established agent for the second-line treatment of advanced epithelial ovarian cancer and may also facilitate exploring prolonged treatment schedules.
authors.affiliation: Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC 27710-0001, USA. clark011@mc.duke.edu
authors.forename: D L
authors.initials: DL
authors.lastname: Clarke-Pearson
authors.forename: L
authors.initials: L
authors.lastname: Van Le
authors.forename: T
authors.initials: T
authors.lastname: Iveson
authors.forename: C W
authors.initials: CW
authors.lastname: Whitney
authors.forename: P
authors.initials: P
authors.lastname: Hanjani
authors.forename: G
authors.initials: G
authors.lastname: Kristensen
authors.forename: J H
authors.initials: JH
authors.lastname: Malfetano
authors.forename: R A
authors.initials: RA
authors.lastname: Beckman
authors.forename: G A
authors.initials: GA
authors.lastname: Ross
authors.forename: S R
authors.initials: SR
authors.lastname: Lane
authors.forename: M H
authors.initials: MH
authors.lastname: DeWitte
authors.forename: S Z
authors.initials: SZ
authors.lastname: Fields
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D019772:Topotecan / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D019772:Topotecan