title: Recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) after chemotherapy in patients with non-Hodgkin's lymphoma; a placebo-controlled double blind phase III trial.
abstract: To assess the clinical and hematopoietic effects of rhGM-CSF, a placebo-controlled double blind multicenter phase III study was undertaken in patients with non-Hodgkin's lymphoma receiving cytotoxic chemotherapy. Sixty-two patients who had granulocytopenia (< 1 x 10(3)/microliters) after the first cycle of chemotherapy with cyclophosphamide, adriamycin, vincristine, and prednisolone were enrolled. After the second cycle of chemotherapy with the same regimen, patients randomly received either rhGM-CSF (125 micrograms/m2/day) or placebo for 14 days (rhGM-CSF; 31 patients and placebo; 31 patients). Administration of rhGM-CSF induced a significant increase in granulocytes mainly with neutrophils, eosinophils and monocytes, but elevation of lymphocytes, platelets, and reticulocytes was not induced. Median days of granulocytes less than 1 x 10(3)/microliters in patients receiving rhGM-CSF were significantly shorter than in patients receiving placebo (p = 0.001). Adverse reactions encountered with rhGM-CSF, and observed in 58% of the patients were never life-threatening and always rapidly reversible. They included fever, nausea and vomiting, diarrhea, skin eruption, and malaise. These results suggest that rhGM-CSF can be safely administered to prevent neutropenia after chemotherapy in patients with non-Hodgkin's lymphoma.
authors.affiliation: 3rd Department of Medicine, Yamaguchi University School of Medicine, Ube, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Kaku
authors.forename: M
authors.initials: M
authors.lastname: Takahashi
authors.forename: Y
authors.initials: Y
authors.lastname: Moriyama
authors.forename: T
authors.initials: T
authors.lastname: Nakahata
authors.forename: T
authors.initials: T
authors.lastname: Masaoka
authors.forename: Y
authors.initials: Y
authors.lastname: Yoshida
authors.forename: A
authors.initials: A
authors.lastname: Shibata
authors.forename: T
authors.initials: T
authors.lastname: Kaneko
authors.forename: S
authors.initials: S
authors.lastname: Miwa
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D004311:Double-Blind Method; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D011994:Recombinant Proteins / Q000627:therapeutic use; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D011994:Recombinant Proteins; D014750:Vincristine; D004317:Doxorubicin; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D003520:Cyclophosphamide; D011241:Prednisone