TY - JOUR

T1 - Treatment of anthracycline extravasation with Savene (dexrazoxane)

T2 - results from two prospective clinical multicentre studies

AU - Mouridsen, H T

AU - Langer, S W

AU - Buter, J

AU - Eidtmann, H

AU - Rosti, G

AU - de Wit, M

AU - Knoblauch, P

AU - Rasmussen, A

AU - Dahlstrøm, K

AU - Jensen, P B

AU - Giaccone, G

PY - 2007/3

Y1 - 2007/3

N2 - 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%).

AB - 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%).

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Anthracyclines/adverse effects

KW - Antibiotics, Antineoplastic/adverse effects

KW - DNA Topoisomerases, Type II/metabolism

KW - Debridement

KW - Enzyme Inhibitors/administration & dosage

KW - Europe

KW - Extravasation of Diagnostic and Therapeutic Materials/drug therapy

KW - Female

KW - Humans

KW - Infusions, Intravenous

KW - Length of Stay

KW - Male

KW - Middle Aged

KW - Necrosis/prevention & control

KW - Prospective Studies

KW - Razoxane/administration & dosage

KW - Topoisomerase II Inhibitors

KW - Treatment Outcome

U2 - 10.1093/annonc/mdl413

DO - 10.1093/annonc/mdl413

M3 - Journal article

C2 - 17185744

VL - 18

SP - 546

EP - 550

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 3

ER -