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Absence of Secondary Malignant Neoplasms in Children With High-Risk Acute Lymphoblastic Leukemia Treated With Dexrazoxane

Elly V. Barry, Lynda M. Vrooman, Suzanne E. Dahlberg, Donna S. Neuberg, Barbara L. Asselin, Uma H. Athale, Luis A. Clavell, Eric C. Larsen, Albert Moghrabi, Yvan Samson, Marshall A. Schorin, Harvey J. Cohen, Steven E. Lipshultz, Stephen E. Sallan, Lewis B. Silverman

From the Departments of Pediatric Oncology, Biostatistics and Computational Biology, Dana-Farber Cancer Institute; Division of Hematology/Oncology, Children's Hospital; Harvard Medical School, Boston, MA; Division of Pediatric Oncology, University of Rochester Medical Center, Rochester, NY; Division of Pediatric Hematology/Oncology, McMaster University, Hamilton, Ontario; Division of Hematology and Oncology, Hospital Sainte-Justine, University of Montreal; Centre Hospitalier Universitaire de Quebec, Quebec, Canada; Division of Pediatric Oncology, San Jorge Children's Hospital, San Juan, Puerto Rico; Department of Pediatric Hematology/Oncology, Maine Children's Cancer Program, Scarborough, ME; Section of Pediatric Hematology/Oncology, Inova Fairfax Hospital for Children, Falls Church, VA; Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA; and Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL

Corresponding author: Elly V. Barry, MD, Dana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115; e-mail: elly_barry{at}dfci.harvard.edu

Purpose: Dexrazoxane is a drug used to prevent anthracycline-induced cardiotoxicity. A recent report found an association between the use of dexrazoxane and the risk of developing secondary malignant neoplasms (SMNs) in children with Hodgkin's disease. We report the absence of an association of SMNs in children with acute lymphoblastic leukemia (ALL) treated on Dana-Farber Cancer Institute ALL Consortium Protocol 95-01.

Patients and Methods: Two hundred five children with high-risk (HR) ALL were randomly assigned to receive doxorubicin alone (n = 100) or doxorubicin with dexrazoxane (n = 105) during the induction and intensification phases of multiagent chemotherapy. We compared incidence of SMNs in these two groups.

Results: With a median follow-up of 6.2 years, no differences in the incidence of SMNs were noted between the group that received dexrazoxane and the group that did not (P = .66). One SMN (a melanoma located outside of the cranial radiation field) occurred in a patient who was randomly assigned to doxorubicin alone. No SMNs were observed in patients randomly assigned to receive dexrazoxane.

Conclusion: Dexrazoxane was not associated with an increased risk of SMNs in children treated for HR ALL. Given the potential importance of dexrazoxane as a cardioprotectant, we recommend that dexrazoxane continue to be used and studied in doxorubicin-containing pediatric regimens.

Supported in part by a grant from the National Institutes of Health (CA 68484).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.