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A randomized comparison of once versus twice daily recombinant human granulocyte colony‐stimulating factor (filgrastim) for stem cell mobilization in healthy donors for allogeneic transplantation
Author(s) -
Kröger Nicolaus,
Renges Helmut,
Krüger William,
Gutensohn Kai,
Löliger Cornelius,
Carrero Isabel,
Cortes Lourdes,
Zander Axel R.
Publication year - 2000
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/j.1365-2141.2000.02412.x
Subject(s) - filgrastim , granulocyte colony stimulating factor , apheresis , medicine , leukapheresis , transplantation , hematopoietic stem cell transplantation , progenitor cell , gastroenterology , granulocyte , cd34 , stem cell , immunology , surgery , chemotherapy , biology , platelet , genetics
To evaluate the schedule dependency of granulocyte colony‐stimulating factor (G‐CSF) (filgrastim) for stem cell mobilization, we conducted a randomized comparison in 50 healthy donors, with one subcutaneous daily injection of 10 µg/kg G‐CSF ( n = 25) compared with twice injections daily of 5 µg/kg G‐CSF ( n = 25). The two groups were well balanced for age, body weight and sex. G‐CSF application was performed on an out‐patient basis and leukapheresis was started in all donors on day 5. The most frequent side‐effects of G‐CSF were mild to moderate bone pain (88%), mild headache (72%), mild fatigue (48–60%) and nausea (8%) without differences between the two groups. The CD34 + cell count in the first apheresis was 5·4 × 10 6 /kg donor weight (range 2·8–13·3) in the 2 × 5 µg/kg group compared with 4·0 × 10 6 /kg (range 0·4–8·8) in the 1 × 10µg/kg group ( P = 0·007). The target of collecting > 3·0 × 10 6 CD34 + cells/kg donor weight with one apheresis procedure was achieved in 24/25 (96%) donors in the 2 × 5 µg/kg group and in 17/25 (68%) donors in the 1 × 10 µg/kg group. The target of collecting > 5·0 × 10 6 CD34 + cells/kg in the first apheresis was achieved in 64% in the 2 × 5µg/kg group, but in only 36% in the 1 × 10 µg/kg group. The progenitor cell assay for granulocyte–macrophage colony‐forming units (CFU‐GM) and erythroid burst‐forming units (BFU‐E) was higher in the 2 × 5 µg/kg group than in the 1 × 10 µg/kg group (7·0 vs. 3·5 × 10 5 /kg, P = 0·01; 6·6 vs. 5·0 × 10 5 /kg; P = 0·1). Administering G‐CSF (filgrastim) at a dosage of 5 µg/kg twice daily rather than 10 µg/kg once daily is recommended; this leads to a higher CD34 + cell yield and requires fewer apheresis procedures without increasing toxicity or cost.