Reduced dose of lenograstim is as efficacious as standard dose of filgrastim for peripheral blood stem cell mobilization and transplantation: a randomized study in patients undergoing autologous peripheral stem cell transplantation.
In vitro studies have demonstrated a 27% increased efficacy of lenograstim over filgrastim. However, equal doses of 10 microg/kg/day of filgrastim and lenograstim have been recommended for mobilization of CD34+ cells without associated chemotherapy. In this study, we investigated whether a 25% reduced dose of lenograstim at 7.5 microg/kg/day is equavalent to 10 microg/kg/day filgrastim for autologous peripheral blood stem cell (PBSC) mobilization and transplantation. A total of 40 consecutive patients were randomized to either filgrastim (n = 20) or lenograstim (n = 20). The two cohorts were similar in regard to disease, sex, body weight, body surface area, conditioning regimens, previous chemotherapy cycles and radiotherapy. Each growth factor was administered for 4 consecutive days. The first PBSC apheresis was done on the 5th day. In the posttransplant period, the same G-CSF was given at 5 microg/kg/day until leukocyte engraftment. Successful mobilization was achieved in 95% of patients. Successful mobilization with the first apheresis, was achieved in 10/20 (50%) patients in the filgrastim group versus 9/20 (46%) patients in the lenograstim group. No significant difference was seen in the median number of CD34+cells mobilized, as well as the median number of apheresis, median volume of apheresis, percentage of CD34+ cells, and CD34+ cell number. Leukocyte and platelet engraftments, the number of days requiring G-CSF and parenteral antibiotics, the number of transfusions were similar in both groups in the posttransplant period. Lenograstim 7.5 microg/kg/day is as efficious as filgrastim 10 microg/kg/day for autologous PBSC mobilization and transplantation.
GATA (Gulhane) Faculty of Medicine, Department of Medical Oncology and Bone Marrow Transplantation Unit, 06018 Etlik, Ankara, Turkey. sataergin@superonline.com
Selmin
S
Ataergin
Fikret
F
Arpaci
Mustafa
M
Turan
Luis
L
Solchaga
Turker
T
Cetin
Mustafa
M
Ozturk
Ahmet
A
Ozet
Seref
S
Komurcu
Bekir
B
Ozturk
D000293:Adolescent; D000328:Adult; D000368:Aged; D018952:Antigens, CD34; D001781:Blood Component Removal; D004305:Dose-Response Relationship, Drug; D005260:Female; D000069585:Filgrastim; D006085:Graft Survival; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods* / Q000592:standards; D006412:Hematopoietic Stem Cells / Q000166:cytology; D006801:Humans; D000078224:Lenograstim; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D036102:Peripheral Blood Stem Cell Transplantation / Q000379:methods; D011994:Recombinant Proteins / Q000008:administration & dosage; D014182:Transplantation, Autologous
D018952:Antigens, CD34; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim; D000069585:Filgrastim