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Blood, Vol. 96 No. 1 (July 1), 2000:
pp. 80-85
A randomized, double-blind trial of filgrastim (granulocyte
colony-stimulating factor) versus placebo following allogeneic blood
stem cell transplantation
Michael R. Bishop,
Stefano R. Tarantolo,
Robert B. Geller,
James C. Lynch,
Philip J. Bierman,
Z. Steven Pavletic,
Julie M. Vose,
Susan Kruse,
Suzanne P. Dix,
Mary E. Morris,
James
O. Armitage, and
Anne Kessinger
From the Department of Medicine, University of Nebraska Medical
Center, Omaha, NE; Blood and Marrow Transplant Program, Oncology and
Hematology Associates and Saint Lukes Hospital of Kansas City, Kansas
City, MO; and the Department of Preventive & Societal Medicine,
University of Nebraska Medical Center, Omaha, NE.
Blood stem cell transplantation (BSCT) results in rapid
hematopoietic recovery in both the allogeneic and autologous transplant settings. Because of the large numbers of progenitor cells in mobilized
blood, the administration of growth factors after transplantation may
not provide further acceleration of hematopoietic recovery. A
randomized, double-blind, placebo-controlled study was performed to
determine the effects of filgrastim (granulocyte colony-stimulating factor; G-CSF) administration on hematopoietic recovery after allogeneic BSCT. Fifty-four patients with hematologic malignancies undergoing a related, HLA-matched allogeneic BSCT were randomly assigned to receive daily filgrastim at 10 µg/kg or placebo
starting on the day of transplantation. A minimum of
3 × 106 CD34+ cells/kg in the allograft
was required for transplantation. All patients received a standard
preparative regimen and a standard regimen for the prevention of
graft-versus-host disease (GVHD). The median time to achieve an
absolute neutrophil count greater than
0.5 × 109/L was 11 days (range, 9-20 days)
for patients who received filgrastim compared with 15 days (range,
10-22 days) for patients who received placebo
(P = .0082). The median time to achieve a platelet
count greater than 20 × 109/L was 13 days (range, 8-35 days) for patients who received filgrastim compared with 15.5 days
(range, 8-42 days) for patients who received placebo
(P = .79). There were no significant differences for red blood cell transfusion independence, the incidence of acute GVHD, or 100-day mortality between the groups. The administration of filgrastim appears to be a safe and effective supportive-care measure following allogeneic BSCT.
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