Annals of Oncology Advance Access originally published online on December 21, 2006
Annals of Oncology 2007 18(3):546-550; doi:10.1093/annonc/mdl413
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© 2006 European Society for Medical Oncology
supportive care |
Treatment of anthracycline extravasation with Savene (dexrazoxane): results from two prospective clinical multicentre studies
1 Department of Oncology, Copenhagen University Hospital, Denmark
2 Department of Medical Oncology, Free University, Amsterdam, The Netherlands
3 Department of Obstetrics and Gynaecology, University Hospital Kiel, Kiel, Germany
4 Department of Oncology and Haematology, Ravenna Public Hospital, Ravenna, Italy
5 Department of Oncology and Haematology, University Hospital of Hamburg, Germany
6 TopoTarget A/S, Symbion Science Park, Fruebjergvej, Copenhagen
7 Department of Plastic Surgery, Copenhagen University Hospital, Herlev, Denmark
* Correspondence to: Mrs L. Handskemager, TopoTarget A/S, Fruebjergvej 3, DK-2100 Copenhagen, Denmark. Tel: +45 39179495; Fax: +45 39178322; E-mail: leh{at}topotarget.com
Background: The purpose of this study was to assess the efficacy and tolerability of i.v. dexrazoxane [SaveneTM (EU), TotectTM (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/m2) 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%).
Key words: anthracycline, antidote, dexrazoxane, extravasation, savene, totect
Received for publication September 22, 2006. Revision received October 6, 2006. Accepted for publication October 9, 2006.
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