Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
1995-12-12
pubmed:abstractText
Preliminary studies in allogeneic BMT suggest that recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) is well tolerated. This is a prospective, multicenter, randomized, double-blind, placebo-controlled trial. Yeast-derived rhGM-CSF 250 micrograms/m2/day or placebo was administered by 4-hour i.v. infusion starting on the day of marrow infusion (day 0) to day 20. All patients received HLA-identical sibling marrow and cyclosporine and prednisone for GVHD prophylaxis. Fifty three patients received rhGM-CSF and 56 received placebo. Comparison of demographics revealed no differences. The time to achieve an absolute neutrophil count of > 0.5 x 10(9) cells/l was shortened in rhGM-CSF treated patients (day 13 vs. 17, P = 0.0001). The incidences of grade III-IV mucositis and infection were significantly reduced (P = 0.005, P = 0.001, respectively) and duration of hospitalization was modestly shortened by 1 day (P = 0.02) in rhGM-CSF treated patients. No differences in platelet recovery, erythrocyte recovery, incidence of veno-occlusive disease, GVHD severity, relapse or survival were observed. In conclusion, rhGM-CSF is well tolerated and reduces post-transplant morbidity in patients undergoing HLA-identical allogeneic BMT.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jun
pubmed:issn
0268-3369
pubmed:author
pubmed:issnType
Print
pubmed:volume
15
pubmed:owner
NLM
pubmed:authorsComplete
N
pubmed:pagination
949-54
pubmed:dateRevised
2004-11-17
pubmed:meshHeading
pubmed-meshheading:7581096-Adult, pubmed-meshheading:7581096-Bone Marrow Transplantation, pubmed-meshheading:7581096-Double-Blind Method, pubmed-meshheading:7581096-Female, pubmed-meshheading:7581096-Graft vs Host Disease, pubmed-meshheading:7581096-Granulocyte-Macrophage Colony-Stimulating Factor, pubmed-meshheading:7581096-HLA Antigens, pubmed-meshheading:7581096-Hematopoietic Cell Growth Factors, pubmed-meshheading:7581096-Hepatic Veno-Occlusive Disease, pubmed-meshheading:7581096-Humans, pubmed-meshheading:7581096-Infection, pubmed-meshheading:7581096-Leukemia, pubmed-meshheading:7581096-Leukocyte Count, pubmed-meshheading:7581096-Lymphoma, pubmed-meshheading:7581096-Male, pubmed-meshheading:7581096-Multiple Myeloma, pubmed-meshheading:7581096-Myelodysplastic Syndromes, pubmed-meshheading:7581096-Nuclear Family, pubmed-meshheading:7581096-Prospective Studies, pubmed-meshheading:7581096-Recombinant Proteins, pubmed-meshheading:7581096-Tissue Donors, pubmed-meshheading:7581096-Transplantation, Homologous, pubmed-meshheading:7581096-Treatment Outcome
pubmed:year
1995
pubmed:articleTitle
Phase III randomized, double-blind placebo-controlled trial of rhGM-CSF following allogeneic bone marrow transplantation.
pubmed:affiliation
Texas Oncology, PA/Sammons Baylor, Dallas 75204, USA.
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Multicenter Study, Clinical Trial, Phase III