Effect of granulocyte-macrophage colony-stimulating factor on chemotherapy-induced granulocytopenia in patients with malignancies.

To investigate the effect of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) on cytotoxic chemotherapy-induced granulocytopenia, we performed an open nonrandomized clinical trial in 46 patients with malignancies receiving cytotoxic chemotherapy regimen. Twenty-six patients who received two cycles of the identical chemotherapy regimen and had granulocytopenia less than 1 x 10(9) cells/l after the first cycle of chemotherapy were eligible for this study. They received 60, 125 or 250 micrograms/m2/day of rhGM-CSF randomly. The nadirs of peripheral granulocytes demonstrated significantly much higher levels in all dosages studied than those of control cycles. The duration of granulocytopenia was shortened with rhGM-CSF support. Such granulocyte recovery appeared in parallel with increasing dosages of GM-CSF, thus, infections with febrile episodes were reduced. Toxicity of rhGM-CSF was generally well tolerated.