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Phase I/II study of recombinant human granulocyte-macrophage colony-
stimulating factor in aplastic anemia and myelodysplastic syndrome
JH Antin, BR Smith, W Holmes and DS Rosenthal
Department of Medicine, Brigham and Women's Hospital, Harvard Medical
School, Boston, MA 02115.
We performed a phase I/II study of the administration of recombinant human
granulocyte-macrophage colony-stimulating factor (GM-CSF) to patients with
aplastic anemia or myelodysplastic syndrome. Doses ranging from 15 to 480
micrograms/m2 were administered as a one-hour or four-hour intravenous
infusion daily for 7 days or as a 12-hour infusion for 14 days. Temporary
improvements were seen in granulocyte counts, monocyte counts, and
reticulocyte counts in six of eight patients with aplastic anemia and five
of seven patients with myelodysplastic syndromes. The patients with
myelodysplastic syndromes had larger increases in granulocyte, monocyte,
and reticulocyte counts than did those with aplastic anemia, and they also
had increases in the numbers of eosinophils (two of seven), immature
myeloid cells (two of seven), and myeloblasts (two of seven) that were not
observed in patients with aplastic anemia. There was no reduction in
erythrocyte transfusion requirements, and no effect was observed on
platelet counts. There was only minimal toxicity consisting of transient
low- back discomfort, anorexia, myalgias/arthralgias, and low-grade fever.
Our data suggest that GM-CSF is well tolerated and is more likely to result
in elevations of blood counts in patients with myelodysplasia than in
patients with aplastic anemia, but the role of GM-CSF therapy in these
disorders remains to be determined.
Volume 72,
Issue 2,
pp. 705-713,
08/01/1988
Copyright © 1988 by The American Society of Hematology
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