Treatment of anthracycline extravasation with Savene (dexrazoxane): results from two prospective clinical multicentre studies
Research output: Contribution to journal › Journal article › Research › peer-review
BACKGROUND: The purpose of this study was to assess the efficacy and tolerability of i.v. dexrazoxane [Savene (EU), Totect (US)] as acute antidote in biopsy-verified anthracycline extravasation.
PATIENTS AND METHODS: Two prospective, open-label, single-arm, multicentre studies in patients with anthracycline extravasation were carried out. Patients with fluorescence-positive tissue biopsies were treated with a 3-day schedule of i.v. dexrazoxane (1000, 1000, and 500 mg/m(2)) starting no later than 6 h after the incident. Patients were assessed for efficacy (the possible need for surgical resection) and toxicity during the treatment period and regularly for the next 3 months.
RESULTS: In 53 of 54 (98.2%) patients assessable for efficacy, the treatment prevented surgery-requiring necrosis. One patient (1.8%) required surgical debridement. Thirty-eight patients (71%) were able to continue their scheduled chemotherapy without postponement. Twenty-two patients (41%) experienced hospitalisation due to the extravasation. Mild pain (10 patients; 19%) and mild sensory disturbances (nine patients; 17%) were the most frequent sequelae. Haematologic toxicity was common as expected from the fact that the extravasation occurred during a chemotherapy course. Other toxic effects were transient elevation of alanine aminotransferases, nausea, and local pain at the dexrazoxane injection site.
CONCLUSION: Dexrazoxane proved to be an effective and well-tolerated acute treatment with only one out of 54 assessable patients requiring surgical resection (1.8%).
Original language | English |
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Journal | Annals of oncology : official journal of the European Society for Medical Oncology |
Volume | 18 |
Issue number | 3 |
Pages (from-to) | 546-50 |
Number of pages | 5 |
ISSN | 0923-7534 |
DOIs | |
Publication status | Published - Mar 2007 |
- Adult, Aged, Aged, 80 and over, Anthracyclines/adverse effects, Antibiotics, Antineoplastic/adverse effects, DNA Topoisomerases, Type II/metabolism, Debridement, Enzyme Inhibitors/administration & dosage, Europe, Extravasation of Diagnostic and Therapeutic Materials/drug therapy, Female, Humans, Infusions, Intravenous, Length of Stay, Male, Middle Aged, Necrosis/prevention & control, Prospective Studies, Razoxane/administration & dosage, Topoisomerase II Inhibitors, Treatment Outcome
Research areas
ID: 247891733