High-dose versus low-dose cyclophosphamide in combination with G-CSF for peripheral blood progenitor cell mobilization.
BACKGROUND
To compare the mobilizing effects and toxicities of two different doses of cyclophosphamide (CY) plus lenograstim (glycosylated G-CSF), we performed a prospective randomized study by enrolling patients suffering with either high-risk Non-Hodgkin's lymphoma (NHL) or breast cancer undergoing ablative chemotherapy.


METHODS
The NHL patients received 4 cycles of CHOP and the breast cancer patients received 2-3 cycles of FAC (FEC) adjuvant chemotherapy. Then, the patients were randomly allocated to receive CY 4 g/m2 (arm A) or 1.5 g/m2 (arm B) in combination with lenograstim. Large volume leukapheresis was carried out and it was continued daily until the target cell dose of 2 x 10(6) CD34+ cell/kg was reached.


RESULTS
Twenty-seven patients were enrolled in the study. The median number of leukaphereis sessions actually performed was 2.5 sessions in arm A and 3 sessions in arm B. The target cell dose was obtained with the median number of one leukapheresis session in both arms of the study (p=0.09). The collected number of CD34+ cells in the leukapheresis products was higher in arm A than arm B (22.4 vs. 9.9 x 10(6)/kg, respectively, p=0.05). Grade III or IV leukopenia was present in 14/15 patients (94%) in arm A and in 1/12 patients (8%) in arm B (p<0.0001). Grade Ill or IV thrombocytopenia was present in 8/15 patients (54%) in arm A, but this was not present in any patients of arm B (p=0.0004). Neutropenic fever occurred in 6/15 patients (40%) in arm A, and in 1/12 patients (8%) in arm B (p=0.09). The hematological recovery of the leukocytes and platelets after transplantation was not statistically different between the two doses.


CONCLUSIONS
Low-dose CY plus lenograstim is a safe and effective mobilizing regimen.
Ahn
Jin Seok
JS
Department of Internal Medicine, College of Medicine, Hallym University, Seoul, Korea .
Park
Seonyang
S
Im
Seock-Ah
SA
Yoon
Sung-Soo
SS
Lee
Jong-Seok
JS
Kim
Byoung Kook
BK
Bang
Soo-Mee
SM
Cho
Eun Kyung
EK
Lee
Jae Hoon
JH
Jung
Chul Won
CW
Kim
Hugh Chul
HC
Seong
Chu Myung
CM
Lee
Moon Hee
MH
Kim
Chul Soo
CS
Lee
Keun Seok
KS
Lee
Jung Ae
JA
Ahn
Myung-Ju
MJ
D000328:Adult; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000494:pharmacology; D004359:Drug Therapy, Combination; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000494:pharmacology; D019650:Hematopoietic Stem Cell Mobilization; D006801:Humans; D000078224:Lenograstim; D007937:Leukapheresis; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D019653:Myeloablative Agonists / Q000008:administration & dosage* / Q000494:pharmacology; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000494:pharmacology; D013234:Stem Cells / Q000187:drug effects*; D019172:Transplantation Conditioning
D019653:Myeloablative Agonists; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim; D003520:Cyclophosphamide