title: Efficacy and safety of bevacizumab in recurrent sex cord-stromal ovarian tumors: results of a phase 2 trial of the Gynecologic Oncology Group.
abstract: BACKGROUND
  The Gynecologic Oncology Group conducted this phase 2 trial to estimate the antitumor activity of bevacizumab and to determine the nature and degree of toxicity in patients with recurrent sex cord-stromal tumors of the ovary.
  
  
  METHODS
  A prospective, multi-institutional cooperative group trial was performed in women with recurrent, measurable ovarian stromal tumors. Patients were allowed to have unlimited prior therapy, excluding bevacizumab. Bevacizumab 15 mg/kg was administered intravenously on day 1 of every 21-day cycle until patients developed disease progression or adverse effects that prohibited further treatment. The primary endpoint was the response rate (RR). Inhibin A and B levels were measured before each cycle, and the values were examined in relation to response and progression.
  
  
  RESULTS
  Thirty-six patients were enrolled, and all were eligible and evaluable. Patients received a median of 9 cycles of treatment (range, 2-37 cycles). Six patients (16.7%) had partial responses (90% confidence interval, 7.5%-30.3%), 28 patients (77.8%) had stable disease, and 2 patients (5.6%) had progressive disease. This met the criterion for declaring the regimen active. The median progression-free survival was 9.3 months, and the median overall survival was not reached in during reporting period. Two grade 4 toxicities occurred, including hypertension and proteinuria; and the most common grade 3 toxicities were hypertension (n = 5) and pain (n = 5). Inhibin A and B values were lower in patients who responded to treatment.
  
  
  CONCLUSIONS
  Bevacizumab has activity in the treatment of recurrent sex cord-stromal tumors of the ovary, and its toxicity is acceptable. Further investigation is warranted.
authors.affiliation: Department of Gynecologic Oncology and Reproductive Sciences, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Jubilee
authors.initials: J
authors.lastname: Brown
authors.forename: William E
authors.initials: WE
authors.lastname: Brady
authors.forename: Julian
authors.initials: J
authors.lastname: Schink
authors.forename: Linda
authors.initials: L
authors.lastname: Van Le
authors.forename: Mario
authors.initials: M
authors.lastname: Leitao
authors.forename: S Diane
authors.initials: SD
authors.lastname: Yamada
authors.forename: Koen
authors.initials: K
authors.lastname: de Geest
authors.forename: David M
authors.initials: DM
authors.lastname: Gershenson
mesh_terms: D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D005260:Female; D006801:Humans; D007265:Inhibins / Q000097:blood; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D011446:Prospective Studies; D018312:Sex Cord-Gonadal Stromal Tumors / Q000097:blood / Q000188:drug therapy* / Q000401:mortality
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; C422362:inhibin A; C422364:inhibin B; D000068258:Bevacizumab; D007265:Inhibins
keywords: Gynecologic Oncology Group; bevacizumab; stromal ovarian tumors; survival