title: Savene® (dexrazoxane) use in clinical practice.
abstract: BACKGROUND
  Anthracycline extravasation (ACEV) is a rare but potentially devastating event which can result in severe injuries including ulceration and necrosis, slow-healing lesions, serious joint damage and permanent disfigurement. It can delay further scheduled chemotherapy and affect cancer treatment outcome. Savene® (dexrazoxane) is the only approved antidote for ACEV in Europe (Totect® in the USA) and is administered by intravenous infusion. Its efficacy has been demonstrated in clinical trials with biopsy-verified ACEV with a 98% success rate (no need for surgical debridement) allowing for immediate continuation of chemotherapy in 71% of patients. Adverse events, mainly haematological toxicity, were rapidly reversible. The objective of the study was to assess, in clinical practice, the efficacy and safety profile of Savene® for ACEV in different Belgian hospitals.
  
  
  METHODS
  A survey of Savene® use was conducted in Belgium from 2007 to 2010 by using a questionnaire sent to 44 hospitals.
  
  
  RESULTS
  Data were obtained for 41 cancer patients, 68% (28/41) had ACEV from central venous catheters. Surgical debridement due to ACEV could be avoided in 26 out of 28 extravasations from a central venous access and in 95% (39/41) of the total population treated with Savene®. Planned chemotherapy was maintained in 73% (30/41) of patients. Eight adverse events were reported in four patients treated with Savene®, six events were assessed to be of common toxicity criteria grades 1-2 (nausea, leucopenia and arm pain) and two events (neutropenia and pancytopenia) were assessed to be grade 3.
  
  
  CONCLUSIONS
  These data are comparable with the data from previous clinical trials and confirm the efficacy and safety profile of Savene® in clinical practice for the treatment of anthracycline extravasation, including extravasations from central venous catheters.
authors.affiliation: Department of Medical Oncology, University Hospital of Brussels, 1090, Jette, Belgium. christel.fontaine@uzbrussel.be
authors.forename: Christel
authors.initials: C
authors.lastname: Fontaine
authors.forename: Luc
authors.initials: L
authors.lastname: Noens
authors.forename: Pascal
authors.initials: P
authors.lastname: Pierre
authors.forename: Jacques
authors.initials: J
authors.lastname: De Grève
mesh_terms: D018943:Anthracyclines / Q000009:adverse effects* / Q000627:therapeutic use; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D001530:Belgium; D002405:Catheterization, Central Venous; D002614:Chelating Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003625:Data Collection; D003646:Debridement / Q000379:methods; D005119:Extravasation of Diagnostic and Therapeutic Materials / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy; D011929:Razoxane / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic; D002614:Chelating Agents; D011929:Razoxane