title: 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.
abstract: OBJECTIVE
  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).
  
  
  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).
  
  
  CONCLUSIONS
  Biosimilar filgrastim (Leucostim®) was found comparable to original Filgrastim (Neupogen®) and Lenograstim (Granocyte®) for PBSC mobilization in donors of the patients that underwent alloHSCT.
authors.affiliation: Department of Hematology, Erciyes Stem Cell Transplantation Hospital, Kayseri, Turkey. Electronic address: drssivgin@gmail.com.
authors.forename: Serdar
authors.initials: S
authors.lastname: Sivgin
authors.affiliation: Department of Hematology, Erciyes Stem Cell Transplantation Hospital, Kayseri, Turkey.
authors.forename: Esen
authors.initials: E
authors.lastname: Karakus
authors.affiliation: Department of Hematology, Erciyes Stem Cell Transplantation Hospital, Kayseri, Turkey.
authors.forename: Muzaffer
authors.initials: M
authors.lastname: Keklik
authors.affiliation: Department of Medical Statistics, Erciyes University, Kayseri, Turkey.
authors.forename: Gokmen
authors.initials: G
authors.lastname: Zararsiz
authors.affiliation: Apheresis Unit, Erciyes Stem Cell Transplantation Hospital, Department of Hematology, Faculty of Medicine, Erciyes University, Kayseri, Turkey.
authors.forename: Musa
authors.initials: M
authors.lastname: Solmaz
authors.affiliation: Department of Hematology, Erciyes Stem Cell Transplantation Hospital, Kayseri, Turkey.
authors.forename: Leylagul
authors.initials: L
authors.lastname: Kaynar
authors.affiliation: Department of Hematology, Erciyes Stem Cell Transplantation Hospital, Kayseri, Turkey.
authors.forename: Bulent
authors.initials: B
authors.lastname: Eser
authors.affiliation: Department of Hematology, Erciyes Stem Cell Transplantation Hospital, Kayseri, Turkey.
authors.forename: Mustafa
authors.initials: M
authors.lastname: Cetin
authors.affiliation: Department of Hematology, Erciyes Stem Cell Transplantation Hospital, Kayseri, Turkey.
authors.forename: Ali
authors.initials: A
authors.lastname: Unal
mesh_terms: D000328:Adult; D064591:Allografts; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D000069585:Filgrastim / Q000008:administration & dosage* / Q000009:adverse effects; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D019337:Hematologic Neoplasms / Q000628:therapy*; D019650:Hematopoietic Stem Cell Mobilization / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D000078224:Lenograstim; D008297:Male; D036102:Peripheral Blood Stem Cell Transplantation; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D061349:Unrelated Donors
chemical_list: D059451:Biosimilar Pharmaceuticals; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim; D000069585:Filgrastim
keywords: Allogeneic hematopoietic stem cell transplantation; Biosimilars; G-CSF; Stem cell mobilization