Randomized Trial of 2 Dosages of Prophylactic Granulocyte Colony-Stimulating Factor After Induction Chemotherapy in Pediatric Acute Myeloid Leukemia

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 mu g/kg daily or 10 mu g/kg daily of G-CSF. The number of days of G-CSF treatment, neutropenia (an absolute neutrophil count <0.5 x 10(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 mu g/kg daily) offered no greater benefit than the lower dosage (5 mu g/kg daily) in patients who were receiving intensive chemotherapy for AML. Cancer 2011;117:1313-20. (C) 2070 American Cancer Society.