Randomized comparison of antibiotics with and without granulocyte colony-stimulating factor in children with chemotherapy-induced febrile neutropenia: a report from the Children's Oncology Group.

PURPOSE: To determine if granulocyte colony-stimulating factor (G-CSF) with empirical antibiotics accelerates febrile neutropenia resolution compared with antibiotics without it.

PATIENTS AND METHODS: Eligible children were treated without prophylactic G-CSF and presented with fever (temperature >38.3 degrees C) and neutropenia afterward. Patients with acute myelogenous leukemia and myelodysplastic syndrome were excluded. Assignments were randomized between G-CSF (5 microg/kg/day) or none beginning within 24 hr of antibiotics. Subcutaneous administration was recommended, but intravenous G-CSF was allowed. Patients remained on study until absolute neutrophil count (ANC) >500/microl and > or =48 hr without fever.

RESULTS: One of 67 patients enrolled was ineligible, 59 had acute lymphoblastic leukemia (ALL). Thirty-four were assigned to antibiotics, 32 to G-CSF plus antibiotics. Adding G-CSF significantly reduced neutropenia and febrile neutropenia recovery times. Median days to febrile neutropenia resolution was nine earlier with G-CSF (4 vs. 13 days) (P < 0.0001). However, there was no difference in the resolution of fever between arms. Hospitalization median was shorter by 1 day with G-CSF (4 vs. 5 days) (P = 0.04). There was no difference in the duration of IV and oral antibiotic treatment, addition of antifungal therapy, and shock incidence. A trend for decreased incidence of late fever with G-CSF was noted (6.3 vs. 23.5%) (P = 0.08).

CONCLUSIONS: Adding G-CSF to empiric antibiotic coverage accelerates chemotherapy-induced febrile neutropenia resolution by 9 days in pediatric patients, mainly with ALL, which results in a small but significant difference in the median length of hospitalization.