Prospective randomized comparative observation of single- versus split-dose lenograstim to enhance engraftment after autologous stem cell transplantation in patients with multiple myeloma or non-Hodgkin's lymphoma.
BACKGROUND
Granulocyte-colony-stimulating factor (G-CSF) is used to enhance hematopoietic recovery after autologous stem cell transplantation (ASCT). Recommendations for administration of G-CSF during the engraftment phase of ASCT have recently changed. This study sought to compare the early engraftment profile between groups receiving single-dose versus split-dose lenograstim to enhance engraftment after ASCT.


METHODS
A prospective, randomized study was performed with 40 patients (14 with non-Hodgkin's lymphoma, 26 with multiple myeloma) undergoing ASCT. Patients were randomly assigned to receive 5 microg per kg lenograstim once daily (single dose) or 2.5 microg per kg lenograstim twice daily (split dose) starting 1 day after transplantation (Day +1). A minimum of 3 x 10(6) per kg CD34+ cells per kg was required for the autograft.


RESULTS
The median time to neutrophil engraftment was 10 days for both groups. Platelet (PLT) engraftment was achieved in 11 days for the single-dose group and 14 days for the split-dose group. Episodes of clinically documented infection were low and similar in both groups (18 during 392 patient-days in the single-dose group and 22 during 556 patient-days in the split-dose group). There were no significant differences in requirements for red blood cell or PLT transfusion between the two groups. The duration of hospitalization after stem cell infusion was 18 days for the single-dose group and 22 days for the split-dose group.


CONCLUSIONS
Administration of split doses of lenograstim is not associated with superior clinical efficacy compared with conventional daily single-dose administration for immediate hematopoietic recovery after ASCT.
Jang
Geundoo
G
Department of Internal Medicine and Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Ko
Ock Bae
OB
Kim
Shin
S
Lee
Dae Ho
DH
Huh
Jooryung
J
Suh
Cheolwon
C
D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D000078224:Lenograstim; D008228:Lymphoma, Non-Hodgkin / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000628:therapy*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D014182:Transplantation, Autologous; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim