Abstract
Introduction
Biosimilar versions of filgrastim [recombinant human granulocyte colony-stimulating factor (rhG-CSF)] are now widely available. To date, biosimilar rhG-CSF has demonstrated a comparable quality, safety and efficacy profile to the originator product (filgrastim [Neupogen®], Amgen Inc., CA, USA) in the prevention and management of neutropenia. Biosimilar rhG-CSFs have also been used to induce peripheral blood stem cell (PBSC) mobilization in patients undergoing autologous stem cell transplantation (AHSCT). The authors have examined the effectiveness of a biosimilar rhG-CSF (Zarzio®, Sandoz Biopharmaceuticals, Holzkirchen, Germany) in two retrospective studies across two medical centers in Hungary.
Methods
In Study 1, 70 patients with hematological malignancies scheduled to undergo AHSCT received chemotherapy followed by biosimilar rhG-CSF (2 × 5 μg) for facilitating neutrophil, leukocyte, and platelet engraftment. In study 2, 40 additional patients with lymphoid malignancies and planned AHSCT received chemotherapy followed by biosimilar rhG-CSF for PBSC mobilization. The effectiveness of treatment was assessed by the average yield of cluster of differentiation (CD) 34+ cells and the number of leukaphereses required.
Results
In Study 1 (patients undergoing AHSCT), the median age was 56 years and most patients were male (60%). The conditioning regimens were mainly high-dose melphalan (n = 41) and carmustine (BiCNU®, Bristol-Myers Squibb, NJ, USA), etoposide, cytarabine and melphalan BEAM (n = 21). Median times to absolute neutrophil and leukocyte engraftment were 9 (range 8–11 days) and 10 (8–12) days, respectively. Median time to platelet engraftment was 10.5 days (7–19 days). In Study 2, the patients’ median age was 54 years and the majority (57.5%) were female. The median time interval between day 1 of mobilizing chemotherapy and first leukapheresis was 12 (9–27) days. In the autologous PBSC grafts, the median number of CD34+ cells harvested was 5.2 × 106/kg (2.22–57.07 × 106/kg). The median yield of CD34+ cells per leukapheresis product was 2.47 × 106/kg. In total, 58 leukaphereses were performed in 40 successfully harvested patients.
Conclusions
In line with previous studies with originator rhG-CSF, the findings of this study indicate that biosimilar rhG-CSF following AHSCT is effective and generally well tolerated in the engraftment setting. In addition, biosimilar rhG-CSF is comparable to the originator rhG-CSF in terms of kinetics of PBSC mobilization and yield of CD34+ cells. In conclusion, the authors have demonstrated that the use of biosimilar rhG-CSF is effective and safe in autologous PBSC mobilization and engraftment after AHSCT.
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Acknowledgments
All named authors meet the ICMJE criteria for authorship for this manuscript. All authors had full access to all of the data in this study, take complete responsibility for the integrity of the data, the accuracy of the data analysis and take responsibility for the integrity of the work as a whole and have given final approval for the version to be published. Sponsorship for this study and article processing charges were funded by Sandoz Biopharmaceuticals (Sandoz International GmbH, Holzkirchen, Germany). Medical writing assistance in the preparation of this paper was provided by Dr. Sandra Cuscó of Spirit Medical Communications Ltd. (Manchester, UK) and was funded by Sandoz International GmbH.
Conflict of interest
P. Reményi, L. Gopcsa, I. Marton, M. Réti, G. Mikala, M. Pető, A. Barta, Á. Bátai, Z. Farkas, Z. Borbényi, Z. Csukly, I. Bodó, J. Fábián, Á. Király, L. Lengyel, K. Piukovics, É. Torbágyi, and T. Masszi declare no conflict of interest.
Compliance with ethics guidelines
Both studies were approved by the relevant ethics committee and were conducted in accordance with the Helsinki Declaration of 1975, as revised in 2000 and 2008. Informed written consent was obtained from all patients for being included in the study.
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Reményi, P., Gopcsa, L., Marton, I. et al. Peripheral Blood Stem Cell Mobilization and Engraftment after Autologous Stem Cell Transplantation with Biosimilar rhG-CSF. Adv Ther 31, 451–460 (2014). https://doi.org/10.1007/s12325-014-0114-z
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DOI: https://doi.org/10.1007/s12325-014-0114-z