Risk–Benefit of Dexrazoxane for Preventing Anthracycline-Related Cardiotoxicity: Re-Evaluating the European Labeling

Abstract

Dexrazoxane can prevent anthracycline-associated cardiotoxicity. However, in 2011, its use in children was contraindicated by the EMA over concerns of increased risk of infection, myelosuppression and second primary malignancies, and because its efficacy in children had not then been established. We review here the evidence published since 2011, which confirms that dexrazoxane is an effective cardioprotectant in children and adolescents, is not associated with an increased risk of second primary malignancies or excess early or late mortality and does not impair chemotherapy efficacy. Based on this evidence, the contraindication for children and adolescents requiring high doses of anthracyclines and at risk for cardiotoxicity was removed from the European labeling for dexrazoxane.

Update on pathophysiology and preventive strategies of anthracycline‐induced cardiotoxicity

“…In 2017, after reassessment of the data, the contraindication for children and adolescents at risk of cardiotoxicity was removed . The field of oncology has accepted the potential benefits of DRZ . Recently, Liesse et al generated predictions for treatment protocols with and without affiliated DRZ therapy.…”

Physiological levels of chromogranin A prevent doxorubicin‐induced cardiotoxicity without impairing its anticancer activity

“…However, despite various therapeutic interventions, the deterioration of the cardiac functions is often accompanied by high mortality rates (8). Dexrazoxane is the only U.S. Food and Drug Administration-approved cardioprotective agent for anthracycline-induced cardiotoxicity (10,11). However, only 26% of patients treated with dexrazoxane tolerate higher cumulative doses of Doxo (12).…”

Impact of chemotherapy cycles and intervals on outcomes of nonspinal Ewing sarcoma in adults: a real-world experience

“…Patients who receive high doses of anthracyclines are at risk for cardiotoxicity, dexrazoxane is often used as a cardioprotectant when prior doxorubicin reached a cumulative dose of 300 mg/m 2 [32]. But controversy exists if dexrazoxane reduces the antitumor effect of doxorubicin and increases the risk of second primary malignancies [33]. In the present study, we found that there were no differences of EFS and OS in patients with or without administration of dexrazoxane (log-rank test, P > 0.05), and there was no second primary malignancy occurred during the follow-up period.…”