Low doses of GM-CSF (molgramostim) and G-CSF (filgrastim) after cyclophosphamide (4 g/m2) enhance the peripheral blood progenitor cell harvest: results of two randomized studies including 120 patients.
The use of a combination of G-CSF and GM-CSF versus G-CSF alone, after cyclophosphamide (4 g/m2) was compared in two randomized phase III studies, including 120 patients. In study A, 60 patients received 5 x 2 microg/kg/day of G-CSF and GM-CSF compared to 5 mug/kg/day of G-CSF. In study B, 60 patients received 2.5 x 2 microg/kg/day G-CSF and GM-CSF compared to G-CSF alone (5 microg/kg/day). With the aim to collect at least 5 x 10(6)/kg CD34 cells in a maximum of three large volume leukapherises (LK), 123 LK were performed in study A, showing a significantly higher number of patients reaching 10 x 10(6)/kg CD34 cells (21/29 in G+GM-CSF arm vs 11/27 in G-CSF arm, P=0.00006). In study B, 109 LK were performed, with similar results (10/27 vs 15/26, P=0.003). In both the study, the total harvest of CD34 cells/kg was twofold higher in G-CSF plus GM-CSF group (18.3 x 10(6) in study A and 15.85 x 10(6) in study B) than in G-CSF group (9 x 10(6) in study A and 8.1 x 10(6) in study B), a significant difference only seen in multiple myeloma, with no significant difference in terms of mobilized myeloma cells between G-CSF and GM-CSF groups.
Quittet
P
P
Service Hématologie et Oncologie Médicale, Hopital Lapeyronie, Montpellier, France.
Ceballos
P
P
Lopez
E
E
Lu
Z Y
ZY
Latry
P
P
Becht
C
C
Legouffe
E
E
Fegueux
N
N
Exbrayat
C
C
Pouessel
D
D
Rouillé
V
V
Daures
J P
JP
Klein
B
B
Rossi
J F
JF
D000328:Adult; D000368:Aged; D018952:Antigens, CD34; D003520:Cyclophosphamide / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D007937:Leukapheresis / Q000379:methods* / Q000592:standards; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000473:pathology; D036102:Peripheral Blood Stem Cell Transplantation / Q000379:methods; D011994:Recombinant Proteins / Q000008:administration & dosage
D018952:Antigens, CD34; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D003520:Cyclophosphamide; C082430:molgramostim; D000069585:Filgrastim