Glycosylated vs non-glycosylated granulocyte colony-stimulating factor (G-CSF)--results of a prospective randomised monocentre study.
The discovery of the haematopoietic growth factor granulocyte colony-stimulating factor (G-CSF) has reduced infection-related morbidity in cancer patients by alleviating post-chemotherapy neutropenia. Two formulations of recombinant human (rh) G-CSF, one glycosylated and one non-glycosylated, are available. The glycosylated form, lenograstim, possesses at least 25% greater bioactivity in vitro. Some comparative studies into the preparation's potential to mobilise haematopoietic stem cells suggest a similar advantage. In the light of the great clinical importance of G-CSF, we have performed the first prospective, randomised, crossover study on children with chemotherapy-induced neutropenia. G-CSF (250 microg/m(2)) was started 1 day after the chemotherapy block, and was administered until a WBC >1500/microl was achieved on 3 successive days. Thirty-three G-CSF cycles from 11 patients (16 lenograstim, 17 filgrastim) were studied. They were investigated for duration of very severe (WBC <500/microl, 9 vs 9.5 days, lenograstim vs filgrastim, median) and severe leukopenia (WBC <1000/microl, 11 vs 11 days), infections (CRP >5 mg/dl, 5 vs 5.5 days), infection-related hospital stay (11 vs 9 days) and antibiotic treatment (9 vs 9 days). Statistical evaluation by paired analysis could not detect any difference between treatment groups; the median difference for all end-points was zero. In summary, at least at 250 microg/m(2), in terms of their clinical effect on neutropenia, the two G-CSF preparations appear to have identical activity.
Bönig
H
H
Department of Paediatric Haematology and Oncology, Center of Child Health, Heinrich-Heine University Medical Center, Düsseldorf, Germany.
Silbermann
S
S
Weller
S
S
Kirschke
R
R
Körholz
D
D
Janssen
G
G
Göbel
U
U
Nürnberger
W
W
D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D001772:Blood Cell Count; D002097:C-Reactive Protein / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D005260:Female; D000069585:Filgrastim; D006031:Glycosylation; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000592:standards; D006801:Humans; D007239:Infections / Q000139:chemically induced; D000078224:Lenograstim; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D016555:Matched-Pair Analysis; D009503:Neutropenia / Q000139:chemically induced; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000592:standards; D013810:Therapeutic Equivalency
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim; D002097:C-Reactive Protein; D000069585:Filgrastim