title: Safety of bevacizumab in metastatic breast cancer patients undergoing surgery.
abstract: BACKGROUND
  Evaluate the safety of surgery in relation to bevacizumab in the first-line treatment of metastatic breast cancer (mBC) in two international trials.
  
  
  METHODS
  The incidence, type and timing of post-surgical bleeding events and wound-healing complications were assessed in surgical patients in the AVastin And DOcetaxel (AVADO) (NCT00333775) and Avastin THErapy for advaNced breAst cancer (ATHENA) (NCT00448591) trials. Both study protocols followed recommendations to withhold bevacizumab for at least 6 weeks before elective surgery and to wait 28 days (or until the wound was fully healed) after major surgery before recommencing bevacizumab therapy.
  
  
  RESULTS
  In AVADO, 221 surgical procedures (55 major, 166 minor) were performed in 155 patients. In ATHENA, 1190 surgical procedures (435 major, 755 minor) were performed in 672 patients. One bevacizumab-treated AVADO patient (0.9%) who underwent surgery experienced a grade 3 bleeding event. In ATHENA, six patients (0.9%) who underwent surgery experienced grade 3 bleeding events and one patient (0.1%) experienced a grade 4 bleeding event. No grade 5 bleeding events in patients undergoing surgery were reported in either study. One grade 3 wound-healing complication was reported in each of the AVADO arms: placebo (n=46, 2.2%), bevacizumab 7.5mg/kg (n=57, 1.8%) and bevacizumab 15mg/kg (n=52, 1.9%). Incidence of grade 3-4 wound-healing complications in ATHENA was 2.2% and 1.3% in patients undergoing minor or major surgery, respectively.
  
  
  CONCLUSIONS
  Surgery can be performed on patients with mBC undergoing bevacizumab therapy with a low risk of severe bleeding or wound-healing complications post surgery, if current labelling recommendations are adhered to.
authors.affiliation: Department of Oncology, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain. jacortes@vhebron.net
authors.forename: Javier
authors.initials: J
authors.lastname: Cortés
authors.forename: Mireia
authors.initials: M
authors.lastname: Caralt
authors.forename: Suzette
authors.initials: S
authors.lastname: Delaloge
authors.forename: Hernan
authors.initials: H
authors.lastname: Cortes-Funes
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Pierga
authors.forename: Kathleen I
authors.initials: KI
authors.lastname: Pritchard
authors.forename: David T
authors.initials: DT
authors.lastname: Bollag
authors.forename: David W
authors.initials: DW
authors.lastname: Miles
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000068258:Bevacizumab; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology / Q000601:surgery*; D002277:Carcinoma / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology / Q000601:surgery*; D003131:Combined Modality Therapy; D015897:Comorbidity; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D013511:Minor Surgical Procedures / Q000706:statistics & numerical data; D020360:Neoadjuvant Therapy; D009362:Neoplasm Metastasis; D010919:Placebos; D019106:Postoperative Hemorrhage / Q000453:epidemiology; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D010919:Placebos; D043823:Taxoids; D000077143:Docetaxel; D000068258:Bevacizumab