Randomised vehicle-controlled dose-finding study of glycosylated recombinant human granulocyte colony-stimulating factor after bone marrow transplantation.
A multicentre, randomised vehicle-controlled single-blind dose ranging trial of intravenous recombinant granulocyte colony-stimulating factor (rhuG-CSF) administration after BMT has been performed in 121 patients with non-myeloid malignancies. All the doses of rhuG-CSF used (2-20 micrograms/kg/day) resulted in significant acceleration of neutrophil recovery, and a dose-response effect was apparent (p < 0.05). At the 20 micrograms/kg/day dose of rhuG-CSF the median time taken to achieve a neutrophil count of > 0.5 x 10(9)/1 was reduced from 19 to 13 days (p < 0.001) and the time to achieve a neutrophil count > 1.0 x 10(9)/1 on the first of 3 consecutive days, from 26 to 14 days (p < 0.001). There was a trend to less antibiotic use in the rhuG-CSF recipients and the median time in hospital was markedly reduced by 11-15 days (p < 0.01). There was no toxicity in this study attributable to rhuG-CSF.
Linch
D C
DC
University College Hospital, London, UK.
Scarffe
H
H
Proctor
S
S
Chopra
R
R
Taylor
P R
PR
Morgenstern
G
G
Cunningham
D
D
Burnett
A K
AK
Cawley
J C
JC
Franklin
I M
IM
D000293:Adolescent; D000328:Adult; D001803:Blood Transfusion; D016026:Bone Marrow Transplantation / Q000009:adverse effects*; D004334:Drug Administration Schedule; D005334:Fever / Q000209:etiology; D006031:Glycosylation; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006410:Hematopoiesis / Q000187:drug effects; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D007262:Infusions, Intravenous; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy; D009503:Neutropenia / Q000209:etiology / Q000628:therapy*; D014677:Pharmaceutical Vehicles; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018805:Sepsis / Q000209:etiology / Q000517:prevention & control; D016037:Single-Blind Method; D013280:Stomatitis / Q000453:epidemiology / Q000209:etiology
D007155:Immunologic Factors; D014677:Pharmaceutical Vehicles; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor