The comparison of effectiveness and safety between different biosimilars of G-CSF in the mobilization of peripheral blood stem cells (PBSCs) for autologous transplantation (autologous peripheral blood stem cell transplantation, auto-PBSCT)

J Clin Apher. 2020 Jan;35(1):4-8. doi: 10.1002/jca.21750. Epub 2019 Oct 30.

Abstract

Background: Autologous peripheral blood marrow stem cell transplantation (auto-PBSCT) preceded by high-dose chemotherapy is a well-known method of treatment for patients with hematological cancers. Performing the procedure entails obtaining from the patient their own stem cells from peripheral blood using G-CSF. Currently, various filgrastim biosimilars are widely used.

Aim of the study: The purpose of this study is to compare the efficacy and safety of three different biosimilars of filgrastim in PBSC mobilization in patients with hematological malignancies.

Materials and methods: This is a retrospective analysis of 282 patients (118 women and 164 men) who underwent stem cells mobilization for auto-PBSCT in the Department of Hematology in Wroclaw in 2012-2014. Three filgrastim biosimilars were used: Tevagrastim (95), Nivestim (92), and Zarzio (95). Ninety patients (32%) were diagnosed with multiple myeloma, 55 (19%) with Hodgkin's lymphoma, 90 (32%) with NHLs, 20 (7%) with acute myeloid leukemia, and 27 (10%) with another hematological cancer.

Results: The mean number of CD34+ cells collected during the first leukapheresis was 5.95 × 106 /kg for Tevagrastim, 7.08 × 106 /kg for Nivestim, and 6.8 × 106 /kg for Zarzio (P > .05). The necessary number of leukapheresis for patients receiving Zarzio, Nivestim, and Tevagrastim was 1.32, 1.37, and 1.66, respectively (P > .05). The percentage of effective mobilizations was 88.2% for Zarzio, 86.2% for Nivestim, and 84.9% for Tevagrastim. The side effects included bone pain and headache.

Conclusion: All tested biosimilars demonstrated similar effectiveness and safety profiles in patients with hematological tumors undergoing PBSC mobilization; therefore, they can be used interchangeably.

Keywords: auto-PBSCT; biosimilars of G-CSF; mobilization of PBSCs.

Publication types

  • Comparative Study

MeSH terms

  • Antigens, CD34 / metabolism
  • Biosimilar Pharmaceuticals / metabolism*
  • Female
  • Filgrastim / analogs & derivatives*
  • Filgrastim / therapeutic use
  • Granulocyte Colony-Stimulating Factor / metabolism*
  • Hodgkin Disease / drug therapy
  • Humans
  • Leukapheresis
  • Leukemia, Myeloid, Acute / drug therapy
  • Lymphoma, Non-Hodgkin / drug therapy
  • Male
  • Multiple Myeloma / drug therapy
  • Peripheral Blood Stem Cell Transplantation / methods*
  • Peripheral Blood Stem Cells / cytology
  • Retrospective Studies
  • Transplantation, Autologous / methods*

Substances

  • Antigens, CD34
  • Biosimilar Pharmaceuticals
  • Granulocyte Colony-Stimulating Factor
  • Filgrastim