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Recombinant human granulocyte-macrophage colony-stimulating factor in
patients with myelodysplastic syndromes--a phase I/II trial
A Ganser, B Volkers, J Greher, OG Ottmann, F Walther, R Becher, L Bergmann, G Schulz and D Hoelzer
Department of Hematology, University of Frankfurt, FRG.
In a phase I/II study, 11 patients with myelodysplastic syndromes (MDS) and
severe transfusion-dependent cytopenia were treated with recombinant human
granulocyte-macrophage colony-stimulating factor (rhGM-CSF) to investigate
the effects of rhGM-CSF on normal hematopoiesis and leukemic cells. The
treatment schedule included dose escalation from 15 micrograms/m2 to 150
micrograms/m2 administered by continuous intravenous (IV) infusion for
seven to 14 days and was repeated after a two-week treatment-free interval.
The blood leukocyte counts increased dose dependently by 130% to 1,800% in
ten patients; a rise of monocytes and eosinophils occurred in seven and six
patients, respectively. No sustained increase in reticulocytes or platelets
was observed. Lymphocyte counts increased in all patients affecting both T-
helper and T-suppressor cells; however, the lymphocytes were not activated
as analyzed by the expression of the interleukin-2 receptor. In four of the
patients, all with greater than 14% blast cells in the bone marrow, the
percentage of bone marrow blast cells increased during treatment with
rhGM-CSF. Cytogenetic data indicated induction of both proliferation and
differentiation of the leukemic clones by rhGM-CSF. Toxic side effects were
minor with slight fever, phlebitis at the infusion site, and bone pain in
the minority of patients. In conclusion, rhGM-CSF effectively stimulates
hematopoiesis in vivo in patients with myelodysplastic syndromes. However,
as the leukemic cell population can be stimulated in patients with a higher
initial blast cell count, the combination of rhGM-CSF with other
differentiation- inducing or cytotoxic agents has to be considered.
Volume 73,
Issue 1,
pp. 31-37,
01/01/1989
Copyright © 1989 by The American Society of Hematology
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