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Multicenter Study
. 2011 Jun;47(9):1373-9.
doi: 10.1016/j.ejca.2011.03.022. Epub 2011 Apr 20.

The low incidence of secondary acute myelogenous leukaemia in children and adolescents treated with dexrazoxane for acute lymphoblastic leukaemia: a report from the Dana-Farber Cancer Institute ALL Consortium

Lynda M Vrooman  1 , Donna S Neuberg, Kristen E Stevenson, Barbara L Asselin, Uma H Athale, Luis Clavell, Peter D Cole, Kara M Kelly, Eric C Larsen, Caroline Laverdière, Bruno Michon, Marshall Schorin, Cindy L Schwartz, Harvey J Cohen, Steven E Lipshultz, Lewis B Silverman, Stephen E Sallan
Affiliations
Multicenter Study

The low incidence of secondary acute myelogenous leukaemia in children and adolescents treated with dexrazoxane for acute lymphoblastic leukaemia: a report from the Dana-Farber Cancer Institute ALL Consortium

Lynda M Vrooman et al. Eur J Cancer. 2011 Jun.

Abstract

Background: Dexrazoxane reduces the risk of anthracycline-related cardiotoxicity. In a study of children with Hodgkin lymphoma, the addition of dexrazoxane may have been associated with a higher risk for developing second malignant neoplasms (SMNs) including acute myelogenous leukaemia (AML) and myelodysplastic syndrome (MDS). We determined the incidence of SMNs in children and adolescents with acute lymphoblastic leukaemia (ALL) who were treated with dexrazoxane.

Methods: Between 1996 and 2010, the Dana-Faber Cancer Institute ALL Consortium conducted three consecutive multicentre trials for children with newly diagnosed ALL. In the first (1996-2000), high risk patients were randomly assigned to receive doxorubicin (30mg/m(2)/dose, cumulative dose 300mg/m(2)) preceded by dexrazoxane (300mg/m(2)/dose, 10 doses), or the same dose of doxorubicin without dexrazoxane, during induction and intensification phases. In subsequent trials (2000-2005 and 2005-2010), all high risk and very high risk patients received doxorubicin preceded by dexrazoxane. Cases of SMNs were collected prospectively and were pooled for analysis. The frequency and 5-year cumulative incidence (CI) of SMNs were determined for patients who had received dexrazoxane.

Findings: Among 553 patients treated with dexrazoxane (1996-2000, N=101; 2000-2005, N=196; and 2005-2010, N=256), the number of SMNs observed by protocol was 0 (median follow-up 9.6years), 0 (median follow-up 5.2years), and 1 (median follow-up 2.1years). The only SMN was a case of AML, which developed in a patient with MLL-rearranged ALL 2.14years after initial diagnosis. The overall 5-year CI of SMNs for all 553 patients was 0.24±0.24%.

Interpretation: In a large population of children with high risk ALL who received dexrazoxane as a cardioprotectant drug, the occurrence of secondary AML was a rare event.

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Conflict of interest statement

Conflicts-of-interest disclosure: The authors declare no competing financial interests.

Figures

Figure 1
Figure 1
Selection process of 553 patients with high risk or very high risk acute lymphoblastic leukemia in an analysis of the incidence of second malignant neoplasms after treatment with dexrazoxane.
See this image and copyright information in PMC

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