title: A phase II trial of concomitant interferon-alpha-2b and granulocyte-macrophage colony-stimulating factor in patients with advanced renal cell carcinoma.
abstract: This study was undertaken to test the hypothesis that the combination of granulocyte-macrophage colony-stimulating factor (GM-CSF) and interferon-alpha-2b (INF-alpha) would have a favorable clinical impact on patients with advanced renal cell carcinoma. Fifteen patients were treated with INF-alpha, 5 million U/m2 three times a week and GM-CSF 5 micrograms/kg, subcutaneously, daily. Patients received two consecutive 4-week cycles and then restaged. There were no complete responses, two of 15 partial responses (13%), and 13 of 15 had no response (87%). Biological effects (eosinophilia and leukocytosis) were characteristically observed. The therapy was well tolerated, and most side effects were attributable to INF-alpha. The study failed to show that the addition of GM-CSF to INF-alpha would increase the response rate in patients with metastatic renal cell carcinoma by enhancement of macrophage tumoricidal activity.
authors.affiliation: Department of Internal Medicine, University of California, Davis Medical Center, Sacramento, USA.
authors.forename: R T
authors.initials: RT
authors.lastname: O'Donnell
authors.forename: G
authors.initials: G
authors.lastname: Dea
authors.forename: F J
authors.initials: FJ
authors.lastname: Meyers
mesh_terms: D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000628:therapy*; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007167:Immunotherapy; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor