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

• Published in: American journal of hematology 2008-08, Vol.83 (8), p.644-648
• Main Authors: Ataergin, Selmin, Arpaci, Fikret, Turan, Mustafa, Solchaga, Luis, Cetin, Turker, Ozturk, Mustafa, Ozet, Ahmet, Komurcu, Seref, Ozturk, Bekir
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Antigens, CD34; Biological and medical sciences; Blood Component Removal; Dose-Response Relationship, Drug; Female; Filgrastim; Graft Survival; Granulocyte Colony-Stimulating Factor - administration & dosage; Hematologic and hematopoietic diseases; Hematopoietic Stem Cell Mobilization - methods; Hematopoietic Stem Cell Mobilization - standards; Hematopoietic Stem Cells - cytology; Humans; Leukocyte Count; Male; Medical sciences; Middle Aged; Peripheral Blood Stem Cell Transplantation - methods; Recombinant Proteins - administration & dosage; Transplantation, Autologous
• ISSN: 0361-8609; 1096-8652
• DOI: 10.1002/ajh.21206

In vitro studies have demonstrated a 27% increased efficacy of lenograstim over filgrastim. However, equal doses of 10 μg/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 μg/kg/day is equavalent to 10 μg/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 μg/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 μg/kg/day is as efficious as filgrastim 10 μg/kg/day for autologous PBSC mobilization and transplantation. Am. J. Hematol., 2008. © 2008 Wiley‐Liss, Inc.