Low-dose filgrastim significantly enhances neutrophil recovery following autologous peripheral-blood stem-cell transplantation in patients with lymphoproliferative disorders: evidence for clinical and economic benefit.
OBJECTIVE
To assess the clinical and economic benefit of low-dose (50 microg/m2) filgrastim after peripheral blood stem-cell transplantation (PBSCT) in a randomized, placebo-controlled double-blinded study.


METHODS
Thirty-eight patients with lymphoproliferative disorders were randomized to receive low-dose filgrastim (19 patients) or placebo (19 patients) beginning on the first day after stem-cell reinfusion and continuing until absolute neutrophil count (ANC) was greater than 0.5 x 10(9)/L. All patients received greater than 2.5 x 10(6) CD34+ cells/kg, which was mobilized with chemotherapy and filgrastim 300 microg from the fifth day. An economic analysis was performed based on the outcome in the two groups.


RESULTS
Neutrophil engraftment was significantly more rapid in patients who received filgrastim with a median number of days until ANC was greater that 0.5 x 10(9)/L of 10 (9 to 13) versus 14 (9 to 19; P < .0001). The time to reach an ANC greater than 1 x 109/L was 12 (9 to 14) versus 16 days (10 to 25; P < .0001). The total number of patients who required intravenous antibiotic therapy was lower in the filgrastim-treated group (68%) compared with the placebo group (89%); also, the median number of days with fever and the duration of antibiotic therapy were shorter, although these differences did not reach statistical significance. However, although only three of 19 (16%) patients who received filgrastim required amphotericin, 11 of 19 (58%) who received placebo did require it, and amphotericin usage was significantly less in the filgrastim group (P = .029). Finally, in-patient stay was significantly shortened in those who received filgrastim from 16 (13 to 23) to 13 days (11 to 18; P = .0003).


CONCLUSIONS
Low-dose filgrastim significantly reduces neutrophil engraftment time post-PBSCT and also reduces in-patient stay and costs, which makes it economically viable for patients who are undergoing high-dose chemotherapy.
McQuaker
I G
IG
Department of Haematology, University of Nottingham, United Kingdom.
Hunter
A E
AE
Pacey
S
S
Haynes
A P
AP
Iqbal
A
A
Russell
N H
NH
D000328:Adult; D000368:Aged; D000666:Amphotericin B / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use*; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D007902:Length of Stay; D008232:Lymphoproliferative Disorders / Q000191:economics* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000188:drug therapy* / Q000191:economics / Q000209:etiology; D009504:Neutrophils / Q000187:drug effects*; D011994:Recombinant Proteins; D014182:Transplantation, Autologous; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000666:Amphotericin B; D000069585:Filgrastim