GRANULOCYTE-COLONY-STIMULATING FACTOR IN ESTABLISHED FEBRILE NEUTROPENIA - A RANDOMIZED STUDY OF PEDIATRIC-PATIENTS

Purpose: Infection in neutropenic patients is potentially life-threate ning and carries important implications for hospital resource use, Pro phylactic administration of cytokines may reduce the severity of neutr openia, but involves the treatment of all patients for the possible be nefit of a minority. This study evaluates whether treatment with cytok ines in the setting of established febrile neutropenia will influence outcome and be potentially more cost-effective. Patients and Methods: In a double-blind study, pediatric patients with fever and severe neut ropenia were randomized to receive granulocyte colony-stimulating fact or ([G-CSF] filgrastim; 5 mu g/kg/d) or placebo, in addition to antibi otics. The study protocol required a resolution of fever and a neutrop hil count greater than or equal to 0.2 x 10(9)/L for hospital discharg e, Patients could be randomized for up to four independent febrile epi sodes. A total of 186 episodes of febrile neutropenia were investigate d. Results: patients randomized to G-CSF had a shorter hospital stay ( median, 5 v 7 days; P = .04) and fewer days of antibiotic use (median, 5 v 6 days; P = .02). G-CSF-treated patients also had more rapid neut rophil recovery and higher neutrophil levels at discharge, The 2-day r eduction in hospital stay reduced the median bed cost by 29% per patie nt admission (P = .04). Conclusion: Under the clinical guidelines of o ur institution, the use of G-CSF in the treatment of established febri le neutropenia produced a small but significant reduction in the time that children required antibiotics and hospital admission, with possib le cost savings. (C) 1997 by American Society of Clinicol Oncology.