Savene® (dexrazoxane) use in clinical practice

Abstract

Introduction: 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.

Patients and methods: A survey of Savene® use was conducted in Belgium from 2007 to 2010 by using a questionnaire sent to 44 hospitals.

Main 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.

Conclusion: 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.