Effects of bacterially synthesized recombinant human granulocyte-macrophage colony-stimulating factor in patients with advanced malignancy

Abstract

Study Objective: To define the clinical and hematologic effects of subcutaneously administered bacterially synthesized recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF). Design: Single arm nonrandomized dose escalation study. Patients: Twenty-one patients with advanced malignancy who were not receiving concurrent myelosuppressive therapy. Interventions: Subcutaneous administration of rhGM-CSF by one-daily injection to groups of two to four patients at doses of 0.3 to 30 μg/kg body weight · d for 10 consecutive days. Some patients received a second 10-day period of daily rhGM-CSF treatment after a 10-day nontreatment interval followed by alternate-day treatment. Cl..