title: Phase II trial of bevacizumab in recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study.
abstract: OBJECTIVE
  Bevacizumab, a recombinant humanized monoclonal antibody against vascular endothelial growth factor-A (VEGF-A), has clinical activity in multiple tumor types. We conducted a phase II trial to assess the activity and tolerability of single-agent bevacizumab in recurrent or persistent endometrial cancer (EMC).
  
  
  METHODS
  Eligible patients had persistent or recurrent EMC after receiving one to two prior cytotoxic regimens, measurable disease, and Gynecologic Oncology Group performance status of ≤ 2. Treatment consisted of bevacizumab 15 mg/kg intravenously every 3 weeks until disease progression or prohibitive toxicity. VEGF-A was assessed by immunohistochemistry in archival tumor and by enzyme-linked immunosorbent assay in pretreatment plasma. Primary end points were progression-free survival (PFS) at 6 months and overall response rate.
  
  
  RESULTS
  Fifty-six patients were enrolled. Fifty-two patients were eligible and evaluable. Median age was 62 years, and prior treatment consisted of one or two regimens in 33 (63.5%) and 19 (36.5%) patients, respectively. Twenty-nine patients (55.8%) received prior radiation. Adverse events were consistent with those expected with bevacizumab treatment. No GI perforations or fistulae were seen. Seven patients (13.5%) experienced clinical responses (one complete response and six partial responses; median response duration, 6.0 months), and 21 patients (40.4%) survived progression free for at least 6 months. Median PFS and overall survival times were 4.2 and 10.5 months, respectively. Suggested associations were observed between high VEGF-A and adjusted hazard of death or tumor response when evaluated in tumor/plasma or plasma, respectively.
  
  
  CONCLUSIONS
  Bevacizumab is well tolerated and active based on PFS at 6 months in recurrent or persistent EMC and warrants further investigation.
authors.affiliation: Gynecologic Medical Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY 10065, USA. aghajanc@mskcc.org
authors.forename: Carol
authors.initials: C
authors.lastname: Aghajanian
authors.forename: Michael W
authors.initials: MW
authors.lastname: Sill
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Darcy
authors.forename: Benjamin
authors.initials: B
authors.lastname: Greer
authors.forename: D Scott
authors.initials: DS
authors.lastname: McMeekin
authors.forename: Peter G
authors.initials: PG
authors.lastname: Rose
authors.forename: Jacob
authors.initials: J
authors.lastname: Rotmensch
authors.forename: Mack N
authors.initials: MN
authors.lastname: Barnes
authors.forename: Parviz
authors.initials: P
authors.lastname: Hanjani
authors.forename: Kimberly K
authors.initials: KK
authors.lastname: Leslie
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D018572:Disease-Free Survival; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D016879:Salvage Therapy / Q000379:methods; D042461:Vascular Endothelial Growth Factor A / Q000096:biosynthesis / Q000097:blood
chemical_list: D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D042461:Vascular Endothelial Growth Factor A; D000068258:Bevacizumab