Journal of Clinical Oncology, Vol 7, 159-167, Copyright © 1989 by American Society of Clinical Oncology
Hematopoietic responses in patients with advanced malignancy treated with recombinant human granulocyte-macrophage colony-stimulating factor
F Herrmann, G Schulz, A Lindemann, W Meyenburg, W Oster, D Krumwieh and R Mertelsmann
Department of Hematology, University of Mainz, West Germany.
The in vivo effect of yeast-derived recombinant human granulocyte-
macrophage colony-stimulating factor (rh GM-CSF) was investigated in 30
patients with advanced malignancy in a phase Ib trial. Patients were
treated at four different dose levels (120 to 1,000 micrograms/m2/d) by
either daily intravenous (IV) bolus injection or 24-hour continuous
infusion. Administration of rh GM-CSF resulted in a broad spectrum of dose-
and schedule-dependent hematopoietic effects. Sustained infusion of rh
GM-CSF elicited a maximum 17-fold average peak increase of the total WBC
count with mainly neutrophils, eosinophils, and monocytes accounting for
this rise, and increases in bone marrow cellularity with a shift to
immature myeloid elements. Elevation of lymphocytes, platelets, and
reticulocytes was not induced. Within five days after discontinuation of
treatment the leukocytosis had disappeared. Adverse reactions encountered
with rh GM-CSF seen in 65% of the patients studied were never
life-threatening and always rapidly reversible. They included mild
myalgias, facial flushing, low-grade fever, headache, bone discomfort,
nausea, dyspnea, and transient decline of platelet counts. These results
suggest that rh GM-CSF can be safely administered at the doses and
schedules used and that it can induce in vivo some of the biological
effects reported in in vitro studies. Although no objective antitumour
responses have been seen, the ability of rh GM-CSF to increase number and
function of leukocytes in vivo may prevent neutropenia and infections when
GM-CSF is added to cytotoxic cancer therapy.
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