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Optimizing dose and scheduling of filgrastim (granulocyte colony-
stimulating factor) for mobilization and collection of peripheral blood
progenitor cells in normal volunteers [see comments]
AP Grigg, AW Roberts, H Raunow, S Houghton, JE Layton, AW Boyd, KM McGrath and D Maher
Department of Clinical Hematology and Medical Oncology, Royal Melbourne
Hospital, Victoria, Australia.
To define an optimal regimen for mobilizing and collecting peripheral blood
progenitor cells (PBPC) for use in allogeneic transplantation, we evaluated
the kinetics of mobilization by filgrastim (recombinant met- human
granulocyte colony-stimulating factor [r-metHuG-CSF]) in normal volunteers.
Filgrastim was injected subcutaneously for up to 10 days at a dose of 3 (n
= 10), 5 (n = 5), or 10 micrograms/kg/d (n = 15). A subset of volunteers
from each dose cohort underwent a 7L leukapheresis on study day 6 (after 5
days of filgrastim). Granulocyte-macrophage colony-forming cell (GM-CFC)
numbers in the blood were maximal after 5 days of filgrastim; a broader
peak was evident for CD34+ cells between days 4 and 6. The 95% confidence
intervals (CI) for mean number of PBPC per milliliter of blood in the three
dose cohorts overlapped on each study day. However, on the peak day, CD34+
cells were significantly higher in the 10 micrograms/kg/d cohort than in a
pool of the 3 and 5 micrograms/kg/d cohorts. Mobilization was not
significantly influenced by volunteer age or sex. Leukapheresis products
obtained at the 10 micrograms/kg/d dose level contained a median GM-CFC
number of 93 x 10(4)/kg (range, 50 x 10(4)/kg to 172 x 10(4)/kg).
Collections from volunteers receiving lower doses of filgrastim contained a
median GM- CFC number of 36 x 10(4)/kg (range, 5 x 10(4)/kg to 204 x
10(4)/kg). The measurement of CD34+ cells per milliliter of blood on the
day of leukapheresis predicted the total yield of PBPC in the leukapheresis
product (r = .87, P < .0001). Assuming a minimum GM-CFC requirement of
50 x 10(4)/kg (based on our experience with autologous PBPC
transplantation), all seven leukapheresis products obtained at the 10
micrograms/kg/d dose level were potentially sufficient for allogeneic
transplantation purposes. We conclude that in normal donors, filgrastim 10
micrograms/kg/d for 5 days with a single leukapheresis on the following day
is a highly effective regimen for PBPC mobilization and collection. Further
studies are required to determine whether PBPC collected with this regimen
reliably produce rapid and sustained engraftment in allogeneic recipients.
Volume 86,
Issue 12,
pp. 4437-4445,
12/15/1995
Copyright © 1995 by The American Society of Hematology
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