1. A randomized, double-blind trial of filgrastim (granulocyte colony-stimulating factor) versus placebo following allogeneic blood stem cell transplantation.
- Author
-
Bishop MR, Tarantolo SR, Geller RB, Lynch JC, Bierman PJ, Pavletic ZS, Vose JM, Kruse S, Dix SP, Morris ME, Armitage JO, and Kessinger A
- Subjects
- Adolescent, Adult, Aged, Double-Blind Method, Female, Filgrastim, Graft vs Host Disease prevention & control, Hematopoiesis drug effects, Humans, Leukemia blood, Leukemia mortality, Leukocyte Count drug effects, Lymphoma, Non-Hodgkin blood, Lymphoma, Non-Hodgkin mortality, Male, Middle Aged, Multiple Myeloma blood, Multiple Myeloma mortality, Neutrophils, Placebos, Platelet Count drug effects, Recombinant Proteins, Survival Rate, Time Factors, Transplantation, Homologous, Treatment Outcome, Granulocyte Colony-Stimulating Factor therapeutic use, Hematopoietic Stem Cell Transplantation, Leukemia therapy, Lymphoma, Non-Hodgkin therapy, Multiple Myeloma therapy
- Abstract
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 microg/kg or placebo starting on the day of transplantation. A minimum of 3 x 10(6) 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 x 10(9)/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 x 10(9)/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.
- Published
- 2000