title: Influence of the American ODAC statement on Austrian bevacizumab prescribing practice for metastatic breast cancer.
abstract: BACKGROUND
  Results of trial E2100 led to the accelerated approval of bevacizumab as first-line therapy for patients with metastatic breast cancer (MBC) in the U.S. in February 2008. Based on results from subsequent trials, the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC) issued a statement proposing to withdraw the license for bevacizumab in July 2010, whereas bevacizumab approval for MBC was not withdrawn in Europe. In this nationwide survey, we investigated the influence of the discrepancy between the ODAC and European Medicines Agency (EMA) positions on the prescription practice of bevacizumab for MBC in Austria during the period January 2006 to June 2011.
  
  
  METHODS
  The absolute number of bevacizumab administrations for MBC patients per month in all Austrian hospitals within the mentioned time frame was retrieved from a comprehensive national database. Bevacizumab prescription numbers for other malignancies were retrieved in order to rule out that a change in bevacizumab prescribing practice might reflect general changes in Austrian health care policy.
  
  
  RESULTS
  A steady increase in bevacizumab use was seen from January 2006 to June 2010 (42 versus 1,357 administrations per month) for MBC. Thereafter, a significant decline in bevacizumab prescriptions for MBC became evident, with numbers dropping to 842 in March 2011 and 662 in June 2011. Bevacizumab prescriptions showed only minor variations in control cohorts.
  
  
  CONCLUSIONS
  The Austrian bevacizumab prescribing practice in MBC patients was significantly influenced by the ODAC statement issued in July 2010, whereas the EMA position was accepted to a lesser degree.
authors: Department of Medicine I, Medical University of Vienna General Hospital, Waehringer, Austria.
authors: Matthias
authors: M
authors: Preusser
authors: Gerhard
authors: G
authors: Fülöp
authors: Anna Sophie
authors: AS
authors: Berghoff
authors: Harald
authors: H
authors: Heinzl
authors: Guenther G
authors: GG
authors: Steger
authors: Richard
authors: R
authors: Greil
authors: Christoph C
authors: CC
authors: Zielinski
authors: Rupert
authors: R
authors: Bartsch
mesh_terms: D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D001317:Austria; D000068258:Bevacizumab; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017277:Drug Approval; D011307:Drug Prescriptions / Q000592:standards / Q000706:statistics & numerical data*; D005062:European Union; D005260:Female; D006801:Humans; D009362:Neoplasm Metastasis; D014481:United States
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab