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Mobilization of CD34+ cells by glycosylated and nonglycosylated G‐CSF in healthy volunteers — a comparative study
Author(s) -
Höglund M.,
Smedmyr B.,
Bengtsson M.,
Tötterman T. H.,
CourChabernaud V.,
Yver A.,
Simonsson B.
Publication year - 1997
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/j.1600-0609.1997.tb00972.x
Subject(s) - filgrastim , medicine , in vivo , microgram , granulocyte colony stimulating factor , cd34 , pharmacology , ex vivo , potency , adverse effect , gastroenterology , chemotherapy , in vitro , chemistry , stem cell , biology , biochemistry , genetics , microbiology and biotechnology
In vitro studies indicate that lenograstim (glycosylated G–CSF) is more potent than filgrastim (nonglycosylated G–CSF) on a weight for weight basis. However, such a difference has not yet been shown in vivo. The primary objective of this trial was to compare the efficacy of equivalent doses (μg) of lenograstim and filgrastim in mobilizing CD34+ cells. Thirty‐two healthy male volunteers, median age 27 yr (19–44 yr), were randomized to receive either lenograstim 10 μg/kg followed by filgrastim 10 μg/kg or vice versa with a washout period of a minimum 4 wk. Both drugs were administered as s.c. injections once daily for 5 d (d 1–5). CD34+ cells were mobilized with a similar kinetics, peaking at median d 6 (5–6) for both drugs. A significant difference in favour of lenograstim was shown for peak number of CD34+ cells/μl blood (104±38 vs. 82±35, mean±l SD, p <0.0001, paired t ‐test, n =30) and number of CFU‐GM/μl blood at d 6 (14.6±8.4 vs. 10.2±4.6, p <0.0001), respectively. There was no difference in the d 6 number of CD3+ cells. Both drugs were generally well tolerated and did not differ with respect to number of adverse events. In conclusion, lenograstim 10 μg/kg/d mobilizes PBPC more efficiently than the identical dose of filgrastim, indicating a difference in in vivo potency between the two G–CSFs.