title: Recombinant granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer.
abstract: BACKGROUND
  The period of neutropenia after autologous bone marrow transplantation results in substantial morbidity and mortality. The results of previous phase I-II clinical trials suggest that recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) may accelerate neutrophil recovery and thereby reduce complications in patients after autologous bone marrow transplantation.
  
  
  METHODS
  We conducted a randomized, double-blind, placebo-controlled trial at three institutions. The study design and treatment schedules were identical, and the results were pooled for analysis. One hundred twenty-eight patients were enrolled. Sixty-five patients received rhGM-CSF in a two-hour intravenous infusion daily for 21 days, starting within four hours of the marrow infusion, and 63 patients received placebo.
  
  
  RESULTS
  No toxic effects specifically ascribed to rhGM-CSF were observed. The patients given rhGM-CSF had a recovery of the neutrophil count to 500 x 10(6) per liter 7 days earlier than the patients who received placebo (19 vs. 26 days, P less than 0.001), had fewer infections, required 3 fewer days of antibiotic administration (24 vs. 27 days, P = 0.009), and required 6 fewer days of initial hospitalization (median, 27 vs. 33 days; P = 0.01). There was no difference in the survival rate at day 100.
  
  
  CONCLUSIONS
  In patients undergoing autologous bone marrow transplantation for lymphoid neoplasia, rhGM-CSF significantly lessens morbidity. Further studies will be required to establish its optimal dosage and schedule of administration.
authors.affiliation: Fred Hutchinson Cancer Research Center, Seattle, WA.
authors.forename: J
authors.initials: J
authors.lastname: Nemunaitis
authors.forename: S N
authors.initials: SN
authors.lastname: Rabinowe
authors.forename: J W
authors.initials: JW
authors.lastname: Singer
authors.forename: P J
authors.initials: PJ
authors.lastname: Bierman
authors.forename: J M
authors.initials: JM
authors.lastname: Vose
authors.forename: A S
authors.initials: AS
authors.lastname: Freedman
authors.forename: N
authors.initials: N
authors.lastname: Onetto
authors.forename: S
authors.initials: S
authors.lastname: Gillis
authors.forename: D
authors.initials: D
authors.lastname: Oette
authors.forename: M
authors.initials: M
authors.lastname: Gold
mesh_terms: D000293:Adolescent; D000328:Adult; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D002648:Child; D004311:Double-Blind Method; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D017053:Infection Control; D007938:Leukemia / Q000601:surgery* / Q000628:therapy; D015470:Leukemia, Myeloid, Acute / Q000601:surgery; D007958:Leukocyte Count; D008223:Lymphoma / Q000601:surgery* / Q000628:therapy; D008228:Lymphoma, Non-Hodgkin / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000628:therapy; D011183:Postoperative Complications / Q000628:therapy; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000601:surgery; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D014182:Transplantation, Autologous
chemical_list: D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor