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Sequential in vivo treatment with two recombinant human hematopoietic
growth factors (interleukin-3 and granulocyte-macrophage colony-
stimulating factor) as a new therapeutic modality to stimulate
hematopoiesis: results of a phase I study
A Ganser, A Lindemann, OG Ottmann, G Seipelt, U Hess, G Geissler, L Kanz, J Frisch, G Schulz and F Herrmann
Department of Hematology, University of Frankfurt, Germany.
In a phase I study, the sequentially administered combination of
recombinant human interleukin-3 (rhIL-3) and rhGM-CSF was compared with
treatment with rhIL-3 alone in 15 patients with advanced tumors but normal
hematopoiesis. Patients were initially treated with rhIL-3 for 15 days.
After a treatment-free interval, the patients received a second 5-day cycle
of rhIL-3 at an identical dosage, immediately followed by a 10-day course
of rhGM-CSF, to assess the toxicity and biologic effects of this sequential
rhIL-3/rhGM-CSF combination. rhIL-3 doses tested were 125, and 250
micrograms/m2, whereas rhGM-CSF was administered at a daily dosage of 250
micrograms/m2. Both cytokines were administered by subcutaneous (SC) bolus
injection. rhIL-3/rhGM-CSF treatment was more effective than rhIL-3 but
equally effective to each other in increasing peripheral leukocyte counts,
especially neutrophilic and eosinophilic granulocyte counts. In contrast,
both modes of cytokine therapy raised the platelet counts to the same
degree. rhIL-3/GM-CSF treatment was more effective than rhIL-3 in
increasing the number of circulating hematopoietic progenitor cells BFU- E
and CFU-GM. High-dose rhIL-3, but not low-dose rhIL-3, was as effective as
the rhIL-3/rhGM-CSF combinations in increasing the number of circulating
CFU-GEMM. The increase in absolute neutrophil counts correlated with the
increase in the number of circulating CFU-GM. Side effects, mainly fever,
headache, flushing, and sweating, were generally mild, but in two patients
the occurrence of chills, rigor, and dyspnea after initiation of GM-CSF
treatment necessitated dose reduction and discontinuation, respectively.
These results indicate that sequential treatment with rhIL-3 and rhGM-CSF
is as effective as single-factor treatment with rhIL-3 in stimulating
platelet counts, whereas the effect of combination therapy on neutrophil
counts and circulating progenitor cells is superior.
Volume 79,
Issue 10,
pp. 2583-2591,
05/15/1992
Copyright © 1992 by The American Society of Hematology
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