Comparison of biosimilar filgrastim and originator filgrastim for peripheral blood stem cell mobilization for allogeneic hematopoietic stem cell transplantation.

Autor: Shahzad M; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA.; H. Lee Moffitt Cancer Center, Tampa, Florida, USA.; Mikael Rayaan Foundation Global Health Consortium, Kansas City, USA., Amin MK; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA.; Mikael Rayaan Foundation Global Health Consortium, Kansas City, USA., Bellman P; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA., Al-Ramahi J; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA.; Mikael Rayaan Foundation Global Health Consortium, Kansas City, USA., Noor J; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA., Vyas A; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA., Mahmoudjafari Z; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA.; Mikael Rayaan Foundation Global Health Consortium, Kansas City, USA., McGuirk M; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA., DeJarnette S; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA.; Mikael Rayaan Foundation Global Health Consortium, Kansas City, USA., Ahmed N; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA.; Mikael Rayaan Foundation Global Health Consortium, Kansas City, USA., Abdallah AO; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA.; Mikael Rayaan Foundation Global Health Consortium, Kansas City, USA., Shune L; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA.; Mikael Rayaan Foundation Global Health Consortium, Kansas City, USA., Singh AK; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA.; Mikael Rayaan Foundation Global Health Consortium, Kansas City, USA., McGuirk JP; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA.; Mikael Rayaan Foundation Global Health Consortium, Kansas City, USA., Abhyankar S; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA.; Mikael Rayaan Foundation Global Health Consortium, Kansas City, USA., Mushtaq MU; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA.; Mikael Rayaan Foundation Global Health Consortium, Kansas City, USA.
Jazyk: angličtina
Zdroj: Transfusion [Transfusion] 2024 Aug; Vol. 64 (8), pp. 1402-1406. Date of Electronic Publication: 2024 Jun 07.
DOI: 10.1111/trf.17909
Abstrakt: Background: Nivestym, a biosimilar granulocyte colony-stimulating factor (G-CSF) to the originator filgrastim (Neupogen), is now being used for the mobilization of peripheral blood stem cells (PBSC) in allogeneic hematopoietic stem cell transplantation (allo-HSCT). We aim to compare the efficacy of Nivestym and Neupogen for PBSC mobilization in healthy allogeneic donors.
Methods: We conducted a retrospective single-center study including 541 adult allo-HSCT donors receiving Nivestym (January 2013-July 2020), or Neupogen (July 2020-June 2023) for donor PBSC mobilization. Bivariate analysis was conducted using SPSS version 28. Statistical significance was determined at a p-value <.05.
Results: Our study included 541 allo-HSCT donors who received Neupogen (n = 345, 64%) or Nivestym (n = 196, 36%) for PBSC mobilization. The median age was 47 years (range 17-76). The median donor weight was 86 kg (95% confidence interval [CI]: 87-91). Donors receiving Neupogen had similar pre-G-CSF white blood cell count, CD34 + percentages, and circulating CD34 + count compared with donors receiving Nivestym. The Neupogen group had similar median PBSC product total neutrophil count, CD34 + percentage, absolute CD34 + count, and infused CD34 + dose compared with the Nivestym group. For donors aged 35 years or younger, the median CD34 + dose was higher in donors who received Neupogen compared with Nivestym (6.9 vs. 6.3 million cells/kg, p = .044).
Conclusions: Nivestym demonstrated similar efficacy for PBSC mobilization compared with Neupogen among allo-HSCT donors. In donors aged 35 years or younger, a slightly lower PBSC product CD34 + count was noted with Nivestym compared with Neupogen.
(© 2024 AABB.)
Databáze: MEDLINE
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