Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor in Patients With Advanced Malignancy: A Phase Ib Trial

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Abstract
We evaluated the toxic, hematopoietic and immunomodulatory effects of recombinant human granulocyte-macrophage colony-stimulating factoi (rHuGM-CSF). The rHuGM-CSF wa administered at doses up to 50 μg/kg by daily 2-hour intravenous infusions to 11 patients with advanced malignancy. It induced dose-related increases in cells of the myeloid series, but it had no significant effect on reticulocyte or platelet counts. Bone marrow cellularity increased with higher doses of rHuGM-CSF, but there was a dose-related decrease in the number of colony forming nits—granulocyte-monocyte—and colony-forming units—granulocyte-erythrocyte-monocyte-megakaryocyte-per 10 5 bone marrow cells. The rHuGM-CSF caused transient increased expression of CD11b and CD16 on granulocytes but increased expression of HLA-DR and decreased expression of the high-affinity Fc receptor on monocytes and no change in monocyte production of H 2 O 2 . Thus, rHuGM-CSF has potent effects on granulocyte, eosinophil, and monocyte numbers in the peripheral blood and bone marrow. In addition, it enhances the expression of monocyte and granulocyte activation-associated surface markers. [J Natl Cancer Inst 82:697–703,1990]

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