Long-Term Follow-Up Suggests No Detrimental Survival Effect of Dexrazoxane in Pediatric Patients With Leukemia or Lymphoma
In an analysis of Children’s Oncology Group (COG) trials reported in the Journal of Clinical Oncology, Chow et al found that dexrazoxane use did not appear to be associated with poorer survival among pediatric patients with leukemia or lymphoma in long-term follow-up.
Study Details
The study involved data from 1,008 patients from 3 COG trials (P9404, P9425, and P9426) in which pediatric patients with leukemia or lymphoma were randomized to receive doxorubicin with (n = 507) or without dexrazoxane (n = 501). The dexrazoxane:doxorubicin dose ratio was 10:1, and the cumulative protocol-specified doxorubicin dose was 100 to 360 mg/m2. Dexrazoxane was given via intravenous bolus before each doxorubicin dose.
Outcomes
Over a median follow-up of 12.6 years (range = 0–15.5 years), 132 patients died, including 67 who had received dexrazoxane. The 10-year overall mortality rate was 12.8% in the dexrazoxane group vs 12.2% in the group not receiving dexrazoxane (overall mortality rate = 13.2% vs 13.0%; hazard ratio [HR] = 1.03, 95% confidence interval [CI] = 0.73–1.45). Original cancers caused 76.5% of all deaths, and second cancers caused 13.6%. Dexrazoxane use was not significantly associated with death from original cancers (9.5% vs 10.6%; HR = 0.90, 95% CI = 0.61–1.32) or death from second cancers (2.0 vs 1.6%; HR = 1.24, 95% CI = 0.49–3.15).
A total of 10 deaths were attributed to other treatment toxicities, with dexrazoxane use being associated with nonsignificantly increased risk (7 deaths, 1.4%, vs 3 deaths, 0.6%; HR = 2.31, 95% CI = 0.60–8.95). No patients died as a result of cardiovascular causes. Risk of relapse/progressive disease was also not significantly increased with dexrazoxane (15.6% vs 19.0%; HR = 0.81, 95% CI = 0.60–1.08).
The investigators concluded, “Among pediatric patients with leukemia or lymphoma, after extended follow-up, dexrazoxane use did not seem to compromise long-term survival.”
Eric J. Chow, MD, of Fred Hutchinson Cancer Research Center, is the corresponding author of the Journal of Clinical Oncology article.
The study was supported by the National Institutes of Health, St Baldrick’s Foundation, and the Leukemia and Lymphoma Society.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
