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Randomized trial of 2 dosages of prophylactic granulocyte–colony-stimulating factor after induction chemotherapy in pediatric acute myeloid leukemia
Article first published online: 8 NOV 2010
Copyright © 2010 American Cancer Society
Volume 117, Issue 6, pages 1313–1320, 15 March 2011
How to Cite
Inaba, H., Cao, X., Pounds, S., Pui, C.-H., Rubnitz, J. E., Ribeiro, R. C. and Razzouk, B. I. (2011), Randomized trial of 2 dosages of prophylactic granulocyte–colony-stimulating factor after induction chemotherapy in pediatric acute myeloid leukemia. Cancer, 117: 1313–1320. doi: 10.1002/cncr.25536
- Issue published online: 4 MAR 2011
- Article first published online: 8 NOV 2010
- Manuscript Accepted: 26 MAY 2010
- Manuscript Revised: 24 MAY 2010
- Manuscript Received: 9 APR 2010
- acute myeloid leukemia;
- granulocyte–colony-stimulating factor;
- randomized trial
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.
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 <0.5 × 109/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.
No statistically significant differences were observed between the 2 arms in any of the endpoints measured.
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.