Low-dose lenograstim to enhance engraftment after autologous stem cell transplantation: a prospective randomized evaluation of two different fixed doses.
BACKGROUND
G-CSF is used to enhance hematopoietic recovery after autologous stem cell transplantation (ASCT), but the optimal dose of G-CSF during engraftment has not been established. The medical cost of ASCT is a serious financial burden in developing countries, and G-CSF is the most costly drug used in this procedure. We evaluated whether a lower, vial-size fitted dose of lenograstim is clinically equivalent to a higher fixed dose.


METHODS
A prospective randomized study was performed on 33 patients (11 non-Hodgkin's lymphoma, 8 multiple myeloma, 14 breast cancer) undergoing ASCT. Patients were randomly administered 100 micro g or 250 micro g lenograstim daily starting on the next day of ASCT, with a minimum infusion of 3 x 10(6) CD34+ cells per kg.


RESULTS
For both lenograstim doses, median time to neutrophil engraftment was 9 days and median time to PLT engraftment was 11 days. Episodes of clinically documented infections were 10 per 379 patient-days in the 100 microg per day group and 10 per 320 patient-days in the 250 microg per day group. There were no between-group differences in requirements for transfusion of RBCs or PLTs. Duration of hospitalization was 16 days for the 100 microg per day group and 17 days for the 250 microg per day group. Daily lenograstim dose per patient's body weight and total amount of lenograstim used during ASCT were both significantly lower in the 100 microg per day group.


CONCLUSIONS
Administration of 100 microg per day of lenograstim showed comparable clinical efficacy to 250 microg per day lenograstim for immediate hematopoietic recovery after ASCT. Use of the lower dose was associated with lower overall lenograstim usage and lower cost.
Suh
Cheolwon
C
Department of Internal Medicine, ASAN Medical Center, University of Ulsan College of Medicine, Seoul, Korea. csuh@amc.seoul.kr
Kim
Hyo-Jung
HJ
Kim
Sang-Hee
SH
Kim
Shin
S
Lee
Soon-Jong
SJ
Lee
Yoon-Shin
YS
Kim
Eun-Kyoung
EK
Kim
Sung-Bae
SB
Lee
Jung-Sin
JS
Kim
Michael W
MW
Kim
Kihyun
K
Yoon
Sung-Soo
SS
D000293:Adolescent; D000328:Adult; D001772:Blood Cell Count; D001792:Blood Platelets; D001943:Breast Neoplasms / Q000150:complications / Q000628:therapy; D004305:Dose-Response Relationship, Drug; D005260:Female; D006085:Graft Survival / Q000187:drug effects*; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000191:economics; D019337:Hematologic Neoplasms / Q000150:complications / Q000628:therapy; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007239:Infections / Q000139:chemically induced; D007700:Kinetics; D007902:Length of Stay; D000078224:Lenograstim; D008297:Male; D008875:Middle Aged; D009504:Neutrophils; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000191:economics; D014182:Transplantation, Autologous; D016896:Treatment Outcome
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim