Abstract
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 μg/m2) was started 1 day after the chemotherapy block, and was administered until a WBC >1500/μl 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/μl, 9 vs 9.5 days, lenograstim vsfilgrastim, median) and severe leukopenia (WBC <1000/μl, 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 μg/m2, in terms of their clinical effect on neutropenia, the two G-CSF preparations appear to have identical activity. Bone Marrow Transplantation (2001) 28, 259–264.
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Acknowledgements
We acknowledge the advice of Dr Willers, Computer Center of the Heinrich-Heine University, on the statistic evaluation of the data, and the excellent collaboration of the nursing, laboratory, and medical staff of the Department of Paediatric Hamatology and Oncology and the Laboratory for Haematology and Experimental Stem Cell Transplantation. This study was supported by Rhône-Poulenc Rorer, distributors of lenograstim.
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Bönig, H., Silbermann, S., Weller, S. et al. Glycosylated vs non-glycosylated granulocyte colony-stimulating factor (G-CSF) – results of a prospective randomised monocentre study. Bone Marrow Transplant 28, 259–264 (2001). https://doi.org/10.1038/sj.bmt.1703136
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DOI: https://doi.org/10.1038/sj.bmt.1703136
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