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Published on: February 21, 2018
Prophylactic human granulocyte colony-stimulating factor after induction therapy in pediatric acute myeloid leukemia
Thomas Lehrnbecher1, Martin Zimmermann, Dirk Reinhardt
1Pediatric Hematology and Oncology, University of Frankfurt, Germany, and Children's Cancer Research Institute, St Anna Kinderspital, Vienna, Austria. thomas.lehrnbecher@kgu.de
Insights
Prophylactic granulocyte colony-stimulating factor (G-CSF) did not reduce infectious complications or improve outcomes in children with acute myelogenous leukemia (AML). Routine G-CSF use is not recommended for pediatric AML patients.
Area of Science:
- Pediatric Oncology
- Hematology
- Clinical Trials
Background:
- Children with acute myelogenous leukemia (AML) face high infectious risks.
- Granulocyte colony-stimulating factor (G-CSF) is explored to mitigate these risks.
- Concerns exist regarding G-CSF potentially stimulating AML blast proliferation.
Purpose of the Study:
- To evaluate the effect of G-CSF on hematopoietic recovery and infectious complications in pediatric AML.
- To assess the impact of G-CSF on the overall outcome for children with de novo AML.
- To determine if prophylactic G-CSF is beneficial in this patient population.
Main Methods:
- A prospective randomized trial (AML-BFM 98) involving children aged 0-18 years with de novo AML.
- Patients received G-CSF or were assigned to a control group following induction chemotherapy.
- Exclusion criteria included >5% blasts in day-15 bone marrow or FAB M3 classification.
Main Results:
- G-CSF significantly shortened neutropenia duration after induction chemotherapy (P=.02 and P=.001).
- No significant reduction was observed in febrile neutropenia, documented infections, or infection-associated mortality.
- Five-year event-free survival rates were comparable between the G-CSF and control groups (59% vs. 58%).
Conclusions:
- Prophylactic G-CSF does not appear to decrease infectious complications in pediatric AML.
- G-CSF administration did not positively influence the outcome for children treated for AML.
- Routine use of G-CSF in children undergoing therapy for AML is not supported by these findings.
Abstract:
Children with acute myelogenous leukemia (AML) have a high risk of infectious complications that 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 (aged 0-18 years) with de novo AML. Patients with more than 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 inductions 1 and 2, whereas 156 patients were assigned to the control group. Time of neutropenia after inductions 1 and 2 was significantly shorter in the G-CSF group (23 vs 18 days and 16 vs 11 days; P=.02 and=.001, respectively). G-CSF did not decrease the incidence of febrile neutropenia (72 and 36 patients vs 78 and 37 patients, respectively), microbiologically documented infections (27 and 25 patients vs 36 and 19 patients, respectively) and infection-associated mortality (5 vs 2 patients). Both groups had similar 5-year event-free survival (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 cannot advocate the routine use of G-CSF in this patient group.
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