After extended follow-up, dexrazoxane treatment did not seem to compromise overall survival among pediatric patients with leukemia or lymphoma, according to a report from the Children’s Oncology Group and published online this week in the Journal of Clinical Oncology.
The three clinical trials conducted over a 5-year period were P9404 (T-cell acute lymphoblastic leukemia/lymphoma; n = 537), P9425 (intermediate/high-risk Hodgkin lymphoma; n = 216), and P9426 (low-risk Hodgkin lymphoma; n = 255).
The patients in each trial were randomly assigned to receive dexrazoxane and doxorubicin or doxorubicin alone. The dose ratio for dexrazoxane to doxorubicin was 10:1 where dexrazoxane was given as IV bolus prior to doxorubicin.
Out of 507 patients (1,008 total patients) treated with dexrazoxane, 67 died (132 total deaths) during a median follow-up of 12.6 years.
In general, there was no significant mortality difference based on dexrazoxane status where the mortality with and without dexrazoxane were12.8% and 12.2%, respectively (HR=1.03; 95% CI, 0.73-1.45).
Morality was mostly associated with the original cancer with 76.5% (HR=0.90; 95% CI, 0.61-1.32) of all deaths caused by the original cancer and 13.6% (HR=1.24; 95% CI, 0.49-3.15) of all deaths caused by second cancers.
The researchers found that dexrazoxane was not associated with deaths caused by acute myeloid leukemia/myelodysplasia or cardiovascular events.
Given concerns that dexrazoxane may reduce treatment efficacy, induce second cancers, and thus compromise overall survival among children, we examined long-term overall and cause-specific mortality and disease relapse rates from three randomized clinical trials.