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Blood, 1 February 2007, Vol. 109, No. 3, pp. 936-943. Prepublished online as a Blood First Edition Paper on September 28, 2006; DOI 10.1182/blood-2006-07-035915.
Submitted July 17, 2006
Pediatric Hematology and Oncology, University of Frankfurt, Frankfurt, Germany * Corresponding author; email: thomas_lehrnbecher{at}yahoo.com.
Children with acute myelogenous leukemia (AML) have a high risk of infectious complications which might be reduced by prophylactic granulocyte colony-stimulating factor (G-CSF). However, G-CSF could induce AML blast proliferation. The prospective randomized trial AML-BFM 98 investigated the impact of G-CSF on hematopoetic recovery and infectious complications (primary endpoints) and on outcome (secondary endpoint) in children (0-18 years) with de novo AML. Patients with >5% blasts in day 15 bone marrow or with FAB M3 were not included. Between 1998 and 2003, 161 children with AML were randomized to receive G-CSF after induction 1 and 2, whereas 156 patients were assigned to the control group. Time of neutropenia after induction 1 and 2 was significantly shorter in the G-CSF group (23 vs 18 and 16 vs 11 days, P=.02 and .001, respectively). G-CSF did not decrease the incidence of febrile neutropenia (72/36 vs 78/37), microbiologically-documented infections (27/25 vs 36/19) and infection-associated mortality (5 vs 2). Both groups had similar 5-year-EFS (59± 4% vs 58± 4%). Since G-CSF does not influence the risk of infectious complications or outcome in children undergoing therapy for AML, one can not advocate the routine use of G-CSF in this patient group.
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