Clinical Hematology International

In Press, Corrected Proof, Available Online: 14 October 2019

Use of Biosimilar Granulocyte Colony-Stimulating Factor for Mobilization in Autologous and Allogeneic Hematopoietic Stem Cell Transplantation

Authors
Dwight D. Eplin1, *, Anna D. Jackson1, Austin M. Smith1, Brent Salvig1, Wichai Chinratanalab1, 2, Bipin N. Savani1, 2
1 VA Tennessee Valley Healthcare System; Nashville, Tennessee
2 Vanderbilt University Medical Center; Nashville, Tennessee
*Corresponding author. Postal address: VA Tennessee Valley Healthcare System, 1310 24th Avenue South (119), Nashville, TN 37212. Tel.: +1-615-873-6386. Email: Dwight.Eplin@va.gov
Corresponding Author
Dwight D. Eplin
Received 23 August 2019, Accepted 4 October 2019, Available Online 14 October 2019.
DOI
https://doi.org/10.2991/chi.d.191008.001How to use a DOI?
Keywords
Hematopoietic stem cell transplantation, Biosimilar, Granulocyte colony-stimulating factor, Stem cell mobilization, Filgrastim, Tbo-filgrastim
Abstract

The biologic medication filgrastim is approved by the Food and Drug Administration (FDA) to mobilize hematopoietic progenitor cells (HPCs) for collection by leukapheresis for autologous hematopoietic stem cell transplant (HSCT). The FDA-approved biologic tbo-filgrastim is currently used off-label for this indication in both autologous and allogeneic HSCT at the Tennessee Valley Healthcare System. The purpose of this review is to compare the efficacy of filgrastim and tbo-filgrastim for this indication. The primary outcomes were the proportion of autologous patients and allogeneic donors with a CD34+ count ≥15 × 103 cells/uL on day 4 of filgrastim or tbo-filgrastim mobilization. The secondary outcome was the use of plerixafor in the autologous population. A total of 469 subjects were identified for inclusion; 367 underwent mobilization for autologous HSCT and 102 for allogeneic HSCT donation. The primary outcome was achieved in 47.5% of patients who received filgrastim compared to 50.2% who received tbo-filgrastim in the autologous population (p = 0.67). Among donors for allogeneic HSCT, there was no difference between those eligible for collection on day 4 of filgrastim or tbo-filgrastim administration (97.6% vs. 100%, p = 0.41). No significant difference was identified in the number of patients requiring plerixafor use in the autologous HSCT population. The use of the biosimilar tbo-filgrastim for mobilization in either autologous HSCT patients or allogeneic HSCT donors has comparable outcomes to that of the biotherapeutic reference product filgrastim at a reduced cost to the healthcare system.

Copyright
© 2019 International Academy for Clinical Hematology. Publishing services by Atlantis Press International B.V.
Open Access
This is an open access article distributed under the CC BY-NC 4.0 license (http://creativecommons.org/licenses/by-nc/4.0/).

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Journal
Clinical Hematology International
Publication Date
2019/10
ISSN (Online)
2590-0048
DOI
https://doi.org/10.2991/chi.d.191008.001How to use a DOI?
Copyright
© 2019 International Academy for Clinical Hematology. Publishing services by Atlantis Press International B.V.
Open Access
This is an open access article distributed under the CC BY-NC 4.0 license (http://creativecommons.org/licenses/by-nc/4.0/).

Cite this article

TY  - JOUR
AU  - Dwight D. Eplin
AU  - Anna D. Jackson
AU  - Austin M. Smith
AU  - Brent Salvig
AU  - Wichai Chinratanalab
AU  - Bipin N. Savani
PY  - 2019
DA  - 2019/10
TI  - Use of Biosimilar Granulocyte Colony-Stimulating Factor for Mobilization in Autologous and Allogeneic Hematopoietic Stem Cell Transplantation
JO  - Clinical Hematology International
SN  - 2590-0048
UR  - https://doi.org/10.2991/chi.d.191008.001
DO  - https://doi.org/10.2991/chi.d.191008.001
ID  - Eplin2019
ER  -