Bl. Rapoport et al., Ceftriaxone plus once daily aminoglycoside with filgrastim for treatment of febrile neutropenia: Early hospital discharge vs. standard in-patient care, CHEMOTHERA, 45(6), 1999, pp. 466-476
Background: In febrile neutropenic patients, ceftriaxone plus an aminoglyco
side is effective for the treatment of infection, while filgrastim reduces
the extent and duration of neutropenia. Because the once daily dosing regim
en of this combination permits ambulatory treatment, there is a need to tes
t criteria for early hospital discharge. Methods: Hospitalized adult patien
ts with febrile neutropenia (following chemotherapy) considered to be poten
tially treatable on a follow-up out-patient basis were entered into this op
en-label, multinational study. Patients received a once daily combination o
f ceftriaxone for greater than or equal to 5 days, aminoglycoside for great
er than or equal to 2 days, and filgrastim until the absolute neutrophil co
unt was greater than or equal to 1.0 x 10(9)/l for 2 days. Those initially
responding to therapy (reduction of fever by greater than or equal to 1 deg
rees C within 72 h, and clinical improvement) were randomized into standard
in-patient or follow-up out-patient treatment groups, the latter patients
being discharged from hospital early, after meeting defined criteria. Resul
ts: 105 patients were enrolled, of whom 21 initial non-responders were not
randomized. Efficacy was evaluable in 80 patients. Success (resolution of f
ever and symptoms, maintained for 7 days after cessation of therapy, and er
adication of infecting pathogens) was similar among inpatients (40/42, 95%)
and out-patients (34/38, 89%). The duration of hospitalization was shorter
for out-patients than in-patients (median of 4 vs. 6 days, respectively).
No hospital readmissions were necessary in out-patients. All other efficacy
parameters assessed were comparable in both groups, as was tolerability/sa
fety. One potentially drug-related death was reported. Conclusions: Patient
s who satisfy prospectively defined criteria for early discharge can be tre
ated safely on an outpatient basis with a regimen of once daily ceftriaxone
plus an aminoglycoside with filgrastim. In addition to reducing healthcare
costs, it may im prove patients' quality of life. Copyright (C) 1999 S.Kar
ger AG, Basel.