title: Peripheral blood stem cell mobilization and engraftment after autologous stem cell transplantation with biosimilar rhG-CSF.
abstract: BACKGROUND
  Biosimilar versions of filgrastim [recombinant human granulocyte colony-stimulating factor (rhG-CSF)] are now widely available. To date, biosimilar rhG-CSF has demonstrated a comparable quality, safety and efficacy profile to the originator product (filgrastim [Neupogen(®)], Amgen Inc., CA, USA) in the prevention and management of neutropenia. Biosimilar rhG-CSFs have also been used to induce peripheral blood stem cell (PBSC) mobilization in patients undergoing autologous stem cell transplantation (AHSCT). The authors have examined the effectiveness of a biosimilar rhG-CSF (Zarzio(®), Sandoz Biopharmaceuticals, Holzkirchen, Germany) in two retrospective studies across two medical centers in Hungary.
  
  
  METHODS
  In Study 1, 70 patients with hematological malignancies scheduled to undergo AHSCT received chemotherapy followed by biosimilar rhG-CSF (2 × 5 μg) for facilitating neutrophil, leukocyte, and platelet engraftment. In study 2, 40 additional patients with lymphoid malignancies and planned AHSCT received chemotherapy followed by biosimilar rhG-CSF for PBSC mobilization. The effectiveness of treatment was assessed by the average yield of cluster of differentiation (CD) 34+ cells and the number of leukaphereses required.
  
  
  RESULTS
  In Study 1 (patients undergoing AHSCT), the median age was 56 years and most patients were male (60%). The conditioning regimens were mainly high-dose melphalan (n = 41) and carmustine (BiCNU(®), Bristol-Myers Squibb, NJ, USA), etoposide, cytarabine and melphalan BEAM (n = 21). Median times to absolute neutrophil and leukocyte engraftment were 9 (range 8-11 days) and 10 (8-12) days, respectively. Median time to platelet engraftment was 10.5 days (7-19 days). In Study 2, the patients' median age was 54 years and the majority (57.5%) were female. The median time interval between day 1 of mobilizing chemotherapy and first leukapheresis was 12 (9-27) days. In the autologous PBSC grafts, the median number of CD34+ cells harvested was 5.2 × 10(6)/kg (2.22-57.07 × 10(6)/kg). The median yield of CD34+ cells per leukapheresis product was 2.47 × 10(6)/kg. In total, 58 leukaphereses were performed in 40 successfully harvested patients.
  
  
  CONCLUSIONS
  In line with previous studies with originator rhG-CSF, the findings of this study indicate that biosimilar rhG-CSF following AHSCT is effective and generally well tolerated in the engraftment setting. In addition, biosimilar rhG-CSF is comparable to the originator rhG-CSF in terms of kinetics of PBSC mobilization and yield of CD34+ cells. In conclusion, the authors have demonstrated that the use of biosimilar rhG-CSF is effective and safe in autologous PBSC mobilization and engraftment after AHSCT.
authors.affiliation: Department of Hematology and Stem Cell Transplantation, St. Istvan and St. Laszlo Hospital of Budapest, Budapest, Hungary, premenyi@laszlokorhaz.hu.
authors.forename: Péter
authors.initials: P
authors.lastname: Reményi
authors.forename: László
authors.initials: L
authors.lastname: Gopcsa
authors.forename: Imelda
authors.initials: I
authors.lastname: Marton
authors.forename: Marienn
authors.initials: M
authors.lastname: Réti
authors.forename: Gábor
authors.initials: G
authors.lastname: Mikala
authors.forename: Mónika
authors.initials: M
authors.lastname: Pető
authors.forename: Anikó
authors.initials: A
authors.lastname: Barta
authors.forename: Arpád
authors.initials: A
authors.lastname: Bátai
authors.forename: Zita
authors.initials: Z
authors.lastname: Farkas
authors.forename: Zita
authors.initials: Z
authors.lastname: Borbényi
authors.forename: Zoltán
authors.initials: Z
authors.lastname: Csukly
authors.forename: Imre
authors.initials: I
authors.lastname: Bodó
authors.forename: János
authors.initials: J
authors.lastname: Fábián
authors.forename: Agnes
authors.initials: A
authors.lastname: Király
authors.forename: Lilla
authors.initials: L
authors.lastname: Lengyel
authors.forename: Klára
authors.initials: K
authors.lastname: Piukovics
authors.forename: Eva
authors.initials: E
authors.lastname: Torbágyi
authors.forename: Tamás
authors.initials: T
authors.lastname: Masszi
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage; D005260:Female; D000069585:Filgrastim / Q000008:administration & dosage*; D006401:Hematologic Agents / Q000008:administration & dosage; D019337:Hematologic Neoplasms / Q000628:therapy*; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods*; D006801:Humans; D006814:Hungary; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control; D036102:Peripheral Blood Stem Cell Transplantation / Q000379:methods*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals; D006401:Hematologic Agents; D000069585:Filgrastim