title: Absence of secondary malignant neoplasms in children with high-risk acute lymphoblastic leukemia treated with dexrazoxane.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Departments of Pediatric Oncology, Dana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115, USA. elly_barry@dfci.harvard.edu
authors.forename: Elly V
authors.initials: EV
authors.lastname: Barry
authors.forename: Lynda M
authors.initials: LM
authors.lastname: Vrooman
authors.forename: Suzanne E
authors.initials: SE
authors.lastname: Dahlberg
authors.forename: Donna S
authors.initials: DS
authors.lastname: Neuberg
authors.forename: Barbara L
authors.initials: BL
authors.lastname: Asselin
authors.forename: Uma H
authors.initials: UH
authors.lastname: Athale
authors.forename: Luis A
authors.initials: LA
authors.lastname: Clavell
authors.forename: Eric C
authors.initials: EC
authors.lastname: Larsen
authors.forename: Albert
authors.initials: A
authors.lastname: Moghrabi
authors.forename: Yvan
authors.initials: Y
authors.lastname: Samson
authors.forename: Marshall A
authors.initials: MA
authors.lastname: Schorin
authors.forename: Harvey J
authors.initials: HJ
authors.lastname: Cohen
authors.forename: Steven E
authors.initials: SE
authors.lastname: Lipshultz
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Sallan
authors.forename: Lewis B
authors.initials: LB
authors.lastname: Silverman
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D016609:Neoplasms, Second Primary / Q000175:diagnosis*; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000473:pathology; D011929:Razoxane / Q000008:administration & dosage; D015996:Survival Rate
chemical_list: D011929:Razoxane; D004317:Doxorubicin