title: The risk of gastrointestinal perforation and/or fistula in patients with recurrent ovarian cancer receiving bevacizumab compared to standard chemotherapy: a retrospective cohort study.
abstract: OBJECTIVE
  To determine the rate of gastrointestinal perforation and/or fistula in patients with recurrent ovarian cancer treated with and without bevacizumab.
  
  
  METHODS
  A retrospective chart review from January 2004 to August 2007 identified two cohorts of patients with recurrent ovarian cancer: 1) patients who were receiving bevacizumab either alone or in combination with standard chemotherapy; 2) patients who were receiving standard chemotherapy alone. Gastrointestinal toxicity (perforation and fistula) was assessed using NCI Common Toxicity Criteria. Relative risk and 95% confidence intervals were calculated. Chi square test and student's t test were used for statistical analysis.
  
  
  RESULTS
  Sixty-eight patients receiving bevacizumab for recurrent ovarian cancer were identified. 67% of these patients received chemotherapy in combination with bevacizumab. For comparison, 195 patients receiving standard chemotherapy alone for recurrent ovarian cancer were identified. A history of previous gastrointestinal resection (40% vs. 37%; p=0.79) and gastrointestinal obstruction (30% vs. 27%; p=0.74) was similar in both cohorts. Five patients (7.2%) developed a gastrointestinal perforation and/or fistula in the bevacizumab cohort compared to 13 patients (6.5%) in the chemotherapy alone cohort. The relative risk for developing a perforation and/or fistula is 1.09 (95% CI, 0.40 to 2.96).
  
  
  CONCLUSIONS
  Although a substantial number of patients with recurrent ovarian cancer experience gastrointestinal obstruction, the rate of gastrointestinal perforation and/or fistula is relatively low. Treatment with bevacizumab does not significantly increase gastrointestinal toxicity compared to standard salvage chemotherapy.
authors: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Alabama at Birmingham, Birmingham, Alabama 35249-7333, USA.
authors: Gregory P
authors: GP
authors: Sfakianos
authors: T Michael
authors: TM
authors: Numnum
authors: Caitlin B
authors: CB
authors: Halverson
authors: Deepa
authors: D
authors: Panjeti
authors: James E
authors: JE
authors: Kendrick
authors: J Michael
authors: JM
authors: Straughn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D000068258:Bevacizumab; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007412:Intestinal Fistula / Q000139:chemically induced*; D007416:Intestinal Perforation / Q000139:chemically induced*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D012189:Retrospective Studies; D016879:Salvage Therapy
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab