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Efficacy of biosimilar granulocyte colony-stimulating factor versus originator granulocyte colony-stimulating factor in peripheral blood stem cell mobilization in de novo multiple myeloma patients.
- Source :
-
Cytotherapy [Cytotherapy] 2015 Oct; Vol. 17 (10), pp. 1485-93. Date of Electronic Publication: 2015 Jul 15. - Publication Year :
- 2015
-
Abstract
- Background Aims: Filgrastim and lenograstim are the standard granulocyte colony-stimulating factor (G-CSF) agents for peripheral blood stem cell mobilization (PBSC) in patients who undergo autologous stem cell transplantation.<br />Methods: To assess whether biosimilars are effective, we conducted a single-center, prospective study that included 40 consecutive de novo multiple myeloma patients who received cyclophosphamide 4 g/m(2) per day plus biosimilar filgrastim G-CSF to mobilize PBSC. These patients were compared with a group of 37 patients matched for age, diagnosis, previous chemotherapy and mobilization who had been treated with originator G-CSF. The mean number of CD34+ cells/μL in the peripheral blood was 199.6 ± 207.4 in the biosimilar and 192.8 ± 154.7 in the originator group (P = 0.87). The median number of CD34+ cells/kg recipient collected was 11.5 ± 5.8 and 12.3 ± 5.3 in the biosimilar and originator groups, respectively (P = 0.51). The mobilization failure rate was 2.5% and 2.7% in the biosimilar filgrastim and originator filgrastim cohorts (P = NS), respectively.<br />Results: Twenty-nine patients in the biosimilar group and 28 patients in the originator group underwent autologous transplantation. There were no statistically significant differences between the biosimilar and originator G-CSF cohorts in terms of hematopoietic recovery parameters and transplant-related toxicities.<br />Conclusions: The efficacy of biosimilar G-CSF appears to be equivalent to the reference G-CSF.<br /> (Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Aged
Antigens, CD34 metabolism
Female
Hematopoietic Stem Cells metabolism
Humans
Lenograstim
Male
Middle Aged
Prospective Studies
Recombinant Proteins pharmacology
Transplantation, Autologous
Biosimilar Pharmaceuticals pharmacology
Filgrastim pharmacology
Granulocyte Colony-Stimulating Factor pharmacology
Hematopoietic Stem Cell Mobilization methods
Hematopoietic Stem Cell Transplantation methods
Multiple Myeloma therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1477-2566
- Volume :
- 17
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Cytotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 26188967
- Full Text :
- https://doi.org/10.1016/j.jcyt.2015.05.010