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


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.
Ozkaynak
M Fevzi
MF
Section of Hematology/Oncology and Blood and Marrow Transplantation, Department of Pediatrics, New York Medical College, Valhalla, NY 10595, USA. mehmet_ozcaynak@nymc.edu
Krailo
Mark
M
Chen
Zhengjia
Z
Feusner
James
J
D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000139:chemically induced / Q000188:drug therapy*; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007902:Length of Stay; D008297:Male; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy; D009503:Neutropenia / Q000139:chemically induced / Q000188:drug therapy*; D018709:Statistics, Nonparametric; D013997:Time Factors
D000900:Anti-Bacterial Agents; D000970:Antineoplastic Agents; D016179:Granulocyte Colony-Stimulating Factor