title: Adverse events risk associated with bevacizumab addition to breast cancer chemotherapy: a meta-analysis.
abstract: BACKGROUND
  Bevacizumab is a monoclonal antibody against vascular endothelial growth factor with the ability to increase progression-free survival in metastatic breast cancer (MBC). A systematic review and meta-analysis was conducted to determine the risk of the most clinically relevant adverse outcomes associated with the use of bevacizumab in the treatment of breast cancer.
  
  
  METHODS
  We included phase III clinical trials that used bevacizumab alone or in combination with chemotherapy as for MBC or locally recurrent. Statistical analyses were conducted to calculate summary odds ratio (OR) of the eight most relevant adverse outcomes related with bevacizumab.
  
  
  RESULTS
  Five clinical trials were included in the meta-analysis. Summary odds ratios obtained showed a statistically significant bevacizumab-associated increased risk in four of the adverse outcomes studied: proteinuria (OR = 27.68), hypertension (OR = 12.76), left ventricular dysfunction (LVD) (OR = 2.25), and hemorrhagic events (OR = 4.07). No statistically significant differences were found for gastrointestinal (GI) perforation, vascular events, fatal events, or febrile neutropenia.
  
  
  CONCLUSIONS
  Bevacizumab did increase the risk of LVD and hemorrhagic events. The addition of bevacizumab to chemotherapy in patients with metastatic breast cancer was not associated with a significant increase in grade ≥ 3 arterial or venous thromboembolic events, GI perforation, or fatal events.
authors: Department of Medical Oncology, Vall d´Hebron University Hospital, Barcelona. Electronic address: jacortes@vhio.net.
authors: J
authors: J
authors: Cortes
authors: Department of Medical Oncology, Ramón y Cajal University Hospital, Madrid.
authors: V
authors: V
authors: Calvo
authors: Department of Medical Oncology, Hospital Universitario de Guadalajara, Guadalajara, Spain.
authors: N
authors: N
authors: Ramírez-Merino
authors: Department of Medical Oncology, Baylor-Charles A. Sammons Cancer Center, Texas Oncology, and US Oncology, Dallas.
authors: J
authors: J
authors: O'Shaughnessy
authors: Department of Medical Oncology, University of Pittsburgh Medical Center, Pittsburgh.
authors: A
authors: A
authors: Brufsky
authors: Department of Medical Oncology, Virginia Cancer Specialists, US Oncology, Fairfax, USA.
authors: N
authors: N
authors: Robert
authors: Department of Medical Oncology, Vall d´Hebron University Hospital, Barcelona.
authors: M
authors: M
authors: Vidal
authors: Department of Medical Oncology, Vall d´Hebron University Hospital, Barcelona.
authors: E
authors: E
authors: Muñoz
authors: Department of Medical Oncology, Vall d´Hebron University Hospital, Barcelona.
authors: J
authors: J
authors: Perez
authors: Department of Medical Oncology, Dubai Hospital, Dubai Health Authority, Dubai, United Arab Emirates.
authors: S
authors: S
authors: Dawood
authors: Department of Medical Oncology, Vall d´Hebron University Hospital, Barcelona.
authors: C
authors: C
authors: Saura
authors: Department of Medical Oncology, Vall d´Hebron University Hospital, Barcelona.
authors: S
authors: S
authors: Di Cosimo
authors: Department of Medical Oncology, MD Anderson Cancer Center, Madrid, Spain.
authors: A
authors: A
authors: González-Martín
authors: Department of Medical Oncology, Vall d´Hebron University Hospital, Barcelona.
authors: M
authors: M
authors: Bellet
authors: Department of Medical Oncology, University of Miami Leonard M. Miller School of Medicine, Miami, USA.
authors: O E
authors: OE
authors: Silva
authors: Department of Medical Oncology, Mount Vernon Cancer Centre, Middlesex, UK.
authors: D
authors: D
authors: Miles
authors: Department of Medical Oncology, Arnau de Vilanova Hospital, Lérida, Spain.
authors: A
authors: A
authors: Llombart
authors: Department of Medical Oncology, Massachusetts General Hospital, Boston, USA.
authors: J
authors: J
authors: Baselga
mesh_terms: D000465:Algorithms; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D000068258:Bevacizumab; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000453:epidemiology; D002277:Carcinoma / Q000188:drug therapy* / Q000453:epidemiology; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology; D005260:Female; D006801:Humans; D012307:Risk Factors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab