Randomized trial of 2 dosages of prophylactic granulocyte–colony‐stimulating factor after induction chemotherapy in pediatric acute myeloid leukemia

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Abstract
BACKGROUND: Granulocyte–colony‐stimulating factor (G‐CSF) is effective in accelerating neutrophil recovery after intensive chemotherapy for acute myeloid leukemia (AML). However, the optimal G‐CSF dosage for patients with AML has not been determined. To the authors' knowledge, G‐CSF dosages have not been compared in a randomized AML study.METHODS: Patients who were enrolled on the St. Jude AML97 protocol and remained on study after window therapy were eligible to participate. The effect of the dosage of G‐CSF given after induction chemotherapy Courses 1 and 2 was analyzed in 46 patients who were assigned randomly in a double‐blinded manner to receive either 5 μg/kg daily or 10 μg/kg daily of G‐CSF. The number of days of G‐CSF treatment, neutropenia (an absolute neutrophil count 9/L), and hospitalization; the number of episodes of febrile neutropenia, grade 2 through 4 infection, and antimicrobial therapy; transfusion requirements; the cost of supportive care; and survival were compared between the 2 study arms.RESULTS: No statistically significant differences were observed between the 2 arms in any of the endpoints measured.CONCLUSIONS: The higher G‐CSF dosage (10 μg/kg daily) offered no greater benefit than the lower dosage (5 μg/kg daily) in patients who were receiving intensive chemotherapy for AML. Cancer 2011. © 2010 American Cancer Society.

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