PMID- 31663634
OWN - NLM
STAT- MEDLINE
DCOM- 20210708
LR  - 20210708
IS  - 1098-1101 (Electronic)
IS  - 0733-2459 (Linking)
VI  - 35
IP  - 1
DP  - 2020 Jan
TI  - 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).
PG  - 4-8
LID - 10.1002/jca.21750 [doi]
AB  - 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 x 10(6) /kg for Tevagrastim, 7.08 x 10(6) /kg for Nivestim, and 6.8 x 10(6) 
      /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.
CI  - (c) 2019 Wiley Periodicals, Inc.
FAU - Wicherska-Pawlowska, Katarzyna
AU  - Wicherska-Pawlowska K
AUID- ORCID: 0000-0001-6021-1123
AD  - Department of Hematology, Blood Cancer and Bone Marrow Transplantation, Wroclaw 
      University Hospital, Wroclaw, Lower Silesia, Poland.
AD  - Wroclaw Medical University, Wroclaw, Lower Silesia, Poland.
FAU - Rybka, Justyna
AU  - Rybka J
AD  - Department of Hematology, Blood Cancer and Bone Marrow Transplantation, Wroclaw 
      University Hospital, Wroclaw, Lower Silesia, Poland.
AD  - Wroclaw Medical University, Wroclaw, Lower Silesia, Poland.
FAU - Prajs, Iwona
AU  - Prajs I
AD  - Department of Hematology, Blood Cancer and Bone Marrow Transplantation, Wroclaw 
      University Hospital, Wroclaw, Lower Silesia, Poland.
FAU - Szmigiel, Katarzyna
AU  - Szmigiel K
AD  - Wroclaw Medical University, Wroclaw, Lower Silesia, Poland.
FAU - Tyc, Joanna
AU  - Tyc J
AD  - Wroclaw Medical University, Wroclaw, Lower Silesia, Poland.
FAU - Fraczak, Ewa
AU  - Fraczak E
AD  - Department of Hematology, Blood Cancer and Bone Marrow Transplantation, Wroclaw 
      University Hospital, Wroclaw, Lower Silesia, Poland.
FAU - Biedron, Monika
AU  - Biedron M
AD  - Department of Hematology, Blood Cancer and Bone Marrow Transplantation, Wroclaw 
      University Hospital, Wroclaw, Lower Silesia, Poland.
FAU - Kalicinska, Elzbieta
AU  - Kalicinska E
AD  - Department of Hematology, Blood Cancer and Bone Marrow Transplantation, Wroclaw 
      University Hospital, Wroclaw, Lower Silesia, Poland.
FAU - Szymczak, Donata
AU  - Szymczak D
AD  - Department of Hematology, Blood Cancer and Bone Marrow Transplantation, Wroclaw 
      University Hospital, Wroclaw, Lower Silesia, Poland.
FAU - Wrobel, Tomasz
AU  - Wrobel T
AD  - Department of Hematology, Blood Cancer and Bone Marrow Transplantation, Wroclaw 
      University Hospital, Wroclaw, Lower Silesia, Poland.
AD  - Wroclaw Medical University, Wroclaw, Lower Silesia, Poland.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20191030
PL  - United States
TA  - J Clin Apher
JT  - Journal of clinical apheresis
JID - 8216305
RN  - 0 (Antigens, CD34)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 143011-72-7 (Granulocyte Colony-Stimulating Factor)
RN  - PVI5M0M1GW (Filgrastim)
SB  - IM
MH  - Antigens, CD34/metabolism
MH  - Biosimilar Pharmaceuticals/*metabolism
MH  - Female
MH  - Filgrastim/*analogs & derivatives/therapeutic use
MH  - Granulocyte Colony-Stimulating Factor/*metabolism
MH  - Hodgkin Disease/drug therapy
MH  - Humans
MH  - Leukapheresis
MH  - Leukemia, Myeloid, Acute/drug therapy
MH  - Lymphoma, Non-Hodgkin/drug therapy
MH  - Male
MH  - Multiple Myeloma/drug therapy
MH  - Peripheral Blood Stem Cell Transplantation/*methods
MH  - Peripheral Blood Stem Cells/cytology
MH  - Retrospective Studies
MH  - Transplantation, Autologous/*methods
OTO - NOTNLM
OT  - auto-PBSCT
OT  - biosimilars of G-CSF
OT  - mobilization of PBSCs
EDAT- 2019/10/31 06:00
MHDA- 2021/07/09 06:00
CRDT- 2019/10/31 06:00
PHST- 2019/01/14 00:00 [received]
PHST- 2019/08/17 00:00 [revised]
PHST- 2019/09/07 00:00 [accepted]
PHST- 2019/10/31 06:00 [pubmed]
PHST- 2021/07/09 06:00 [medline]
PHST- 2019/10/31 06:00 [entrez]
AID - 10.1002/jca.21750 [doi]
PST - ppublish
SO  - J Clin Apher. 2020 Jan;35(1):4-8. doi: 10.1002/jca.21750. Epub 2019 Oct 30.