Literature DB >> 27052362

Evaluation of the efficacy and safety of original filgrastim (Neupogen®), biosimilar filgrastim (Leucostim®) and Lenograstim (Granocyte®) in CD34(+) peripheral hematopoietic stem cell mobilization procedures for allogeneic hematopoietic stem cell transplant donors.

Serdar Sivgin1, Esen Karakus2, Muzaffer Keklik2, Gokmen Zararsiz3, Musa Solmaz4, Leylagul Kaynar2, Bulent Eser2, Mustafa Cetin2, Ali Unal2.   

Abstract

OBJECTIVES AND AIM: In this study, we aimed to compare the potency of different G-CSF agents including original filgrastim (Neupogen®), biosimilar filgrastim (Leucostim®) and Lenograstim (Granocyte®) on CD34(+) cell mobilization in patients that underwent allogeneic hematopoietic stem cell transplantation (alloHSCT). PATIENTS AND METHODS: The data of 243 donors for alloHSCT recipients diagnosed with mostly acute leukemia and myelodsyplastic syndromes (MDS) were analyzed, retrospectively. Data for stem cell mobilization have been recorded from patients' files. Donors who received Filgrastim (Neupogen®, Group I), biosimilar Filgrastim (Leucostim®, Group II) and Lenograstim (Granocyte®, Group III) were analyzed for total CD34(+) cell count at the end of mobilization procedures.
RESULTS: A total of 243 donors and patients for alloHSCT were analyzed retrospectively. The diagnosis of the patients were; acute myeloid leukemia (AML) (110 patients, 45.2%), acute lymphoid leukemia (ALL) (61 patients, 25.1%), aplastic anemia (AA) (38 patients, 15.6%), lymphomas (14 patients, 5.7%) and others (20 patients, 8.4%). The median number of total collected PB CD34(+) cells (×10(6)/kg) was 7.12 (min-max: 5.38-7.90) in the Neupogen® group, 7.27 (min-max: 6.79-7.55) in the Leucostim® group and 7.15 (min-max: 5.34-7.58) in the Granocyte® group. There was no statistically significant difference among groups in terms of total collected PB CD34(+) cells (p = 0.919). The median doses of G-CSF agents (µg/kg/day) in PBSC collection in Neupogen® group was; 11.00 (10.00-12.00) in Leucostim® group10.35 (min-max: 10.00-11.10) and in Granocyte® group11.00 (min-max: 10.00-11.00). There was no statistical significance among groups (p = 0.215).
CONCLUSION: Biosimilar filgrastim (Leucostim®) was found comparable to original Filgrastim (Neupogen®) and Lenograstim (Granocyte®) for PBSC mobilization in donors of the patients that underwent alloHSCT.
Copyright © 2016 Elsevier Ltd. All rights reserved.

Entities:  

Keywords:  Allogeneic hematopoietic stem cell transplantation; Biosimilars; G-CSF; Stem cell mobilization

Mesh:

Substances:

Year:  2016        PMID: 27052362     DOI: 10.1016/j.transci.2016.03.003

Source DB:  PubMed          Journal:  Transfus Apher Sci        ISSN: 1473-0502            Impact factor:   1.764


  3 in total

Review 1.  Worldwide Network for Blood and Marrow Transplantation (WBMT) perspective: the role of biosimilars in hematopoietic cell transplant: current opportunities and challenges in low- and lower-middle income countries.

Authors:  Ibrahim N Muhsen; Shahrukh K Hashmi; Dietger Niederwieser; Nicolaus Kroeger; Samir Agrawal; Marcelo C Pasquini; Yoshiko Atsuta; Karen K Ballen; Adriana Seber; Wael Saber; Mohamed A Kharfan-Dabaja; Walid Rasheed; Shinichiro Okamoto; Nandita Khera; William A Wood; Mickey B C Koh; Hildegard Greinix; Yoshihisa Kodera; Jeff Szer; Mary M Horowitz; Daniel Weisdorf; Mahmoud Aljurf
Journal:  Bone Marrow Transplant       Date:  2019-09-04       Impact factor: 5.483

2.  Improving Access to Cancer Treatments: The Role of Biosimilars.

Authors:  Rakesh Chopra; Gilberto Lopes
Journal:  J Glob Oncol       Date:  2017-04-14

3.  Innovator Filgrastim versus Generic Filgrastim in Hematopoietic Stem Cell Transplantation Mobilization.

Authors:  Sadik Husian; Preethi Jeyaraman; S K Gupta; Reeta Rai; Sangeeta Pathak; Nitin Dayal; Rahul Naithani
Journal:  South Asian J Cancer       Date:  2021-09-04
  3 in total

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