Cardioprotection and Safety of Dexrazoxane in Patients Treated for Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Advanced-Stage Lymphoblastic Non-Hodgkin Lymphoma: A Report of the Children’s Oncology Group Randomized Trial Pediatric Oncology Group 9404
Barbara L. Asselin, (2016) JCO, (Link to Abstract)
Dexrazoxane was shown to have some cardioprotective effect if administered with anthracyclines. Some studies have reported a lower anti-tumour effect if administered with chemotherapies and a higher incidence of secondary malignancies. The purpose of this study was to determine the oncologic efficacy, cardioprotective effectiveness, and safety of dexrazoxane added to chemotherapy that included a cumulative doxorubicin dose of 360 mg/m2 to treat children and adolescents with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma.
537 patients were randomly assigned to either receive or not receive dexrazoxane. The 5-year event-free survival did not differ between groups. Of 11 second malignancies, eight occurred in patients who received dexrazoxane (P = .17). The mean left ventricular fractional shortening, wall thickness, and thickness-to-dimension ratio z scores measured 3 years after diagnosis were worse in the doxorubicin-alone group (n = 55 per group; P=0.01 for all comparisons). Mean fractional shortening z scores measured 3.5 to 6.4 years after diagnosis remained diminished and were lower in the 21 patients who received doxorubicin alone than in the 31 patients who received dexrazoxane (22.03
* 20.24; P value 0.001)
* There is improvement in echocardiographic markers of heart function in patients receiving dexrazoxane without evidence of a clearly increased risk of secondary malignancy or worsened efficacy of treatment. There was, however, a non-significant trend towards increased secondary malignancies. Therefore weighing risk and benefit of dexrazoxane remains important but difficult.