Dexrazoxane Not Associated with Late Mortality in Pediatric Patients

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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.

Pediatric patients treated with ifosfamide-doxorubicin chemotherapy and radiotherapy experienced sat
Dexrazoxane treatment did not seem to compromise overall survival among pediatric patients with leukemia or lymphoma.
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.

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