Treatment of anthracycline extravasation with Savene (dexrazoxane): results from two prospective clinical multicentre studies.
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Treatment of anthracycline extravasation with Savene (dexrazoxane): results from two prospective clinical multicentre studies. / Mouridsen, H T; Langer, S W; Buter, J; Eidtmann, H; Rosti, G; De Wit, Maike; Knoblauch, P; Rasmussen, A; Dahlstrøm, K; Jensen, P B; Giaccone, G.
In: ANN ONCOL, Vol. 18, No. 3, 3, 2007, p. 546-550.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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T1 - Treatment of anthracycline extravasation with Savene (dexrazoxane): 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, Maike
AU - Knoblauch, P
AU - Rasmussen, A
AU - Dahlstrøm, K
AU - Jensen, P B
AU - Giaccone, G
PY - 2007
Y1 - 2007
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%).
M3 - SCORING: Zeitschriftenaufsatz
VL - 18
SP - 546
EP - 550
JO - ANN ONCOL
JF - ANN ONCOL
SN - 0923-7534
IS - 3
M1 - 3
ER -