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-stimul ating factor (G-CSF) has reduced infection-related morbidity in cancer pati ents by alleviating post-chemotherapy neutropenia. Two formulations of reco mbinant human (rh) G-CSF, one glycosylated and one non-glycosylated, are av ailable. The glycosylated form, lenograstim, possesses at least 25% greater bioactivity in vitro. Some comparative studies into the preparation's pote ntial 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 chemothera py-induced neutropenia. G-CSF (250 mg/m(2)) was started I day after the che motherapy block, and was administered until a WBC > 1500/mul was achieved o n 3 successive days. Thirty-three G-CSF cycles from 11 patients (16 lenogra stim, 17 filgrastim) were studied. They were investigated for duration of v ery severe (WBC < 500/mul, 9 vs 9.5 days, lenograstim vs filgrastim, median ) and severe leukopenia (WBC < 1000/mul, 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 analys is could not detect any difference between treatment groups; the median dif ference for all end-points was zero. In summary, at least at 250 mug/ml, in terms of their clinical effect on neutropenia, the two G-CSF preparations appear to have identical activity.