title: Comparison of biosimilar filgrastim with originator filgrastim for peripheral blood stem cell mobilization and engraftment in patients with multiple myeloma undergoing autologous stem cell transplantation.
abstract: BACKGROUND
  Nivestim is a biosimilar approved for the same indications as Neupogen including the mobilization of autologous peripheral blood stem cells (PBSCs). The clinical efficacy and safety of Nivestim for this use have not been formally assessed in clinical trials.
  
  
  METHODS
  In our retrospective single-center study we compared variables of PBSC mobilization and engraftment of 60 patients mobilized with Nivestim to that of 38 patients mobilized with Neupogen.
  
  
  RESULTS
  We found no difference between Nivestim and Neupogen in peripheral blood CD34+ at first leukapheresis (47 × 10(6) cells/L vs. 60 × 10(6) cells/L, p = 0.48) nor the total CD34+ collected (5.37 × 10(6)/kg vs. 4.59 × 10(6) /kg, p = 0.22). However, a difference in the median number of leukapheresis procedures (one vs. two, p = 0.0007) was observed. Eighty-one patients (51 Nivestim and 30 Neupogen mobilized) went on to transplantation. Median time to neutrophil engraftment (15 days vs. 13.5 days, p = 0.09) and platelet (PLT) engraftment (20 days vs. 18 days, p = 0.01) was longer in the Nivestim group. The significant delay in PLT engraftment did not, however, translate to increased PLT transfusions (two vs. three, p = 0.2) or impact significantly on hospitalization time for admissions within 30 days posttransplant (20 days vs. 18 days, p =  .17).
  
  
  CONCLUSIONS
  Nivestim is as effective as Neupogen for PBSC mobilization; however, its use was associated with a delay in PLT recovery. A prospective study should be conducted to confirm our findings.
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Tina
authors.initials: T
authors.lastname: Pham
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Sushrut
authors.initials: S
authors.lastname: Patil
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Shaun
authors.initials: S
authors.lastname: Fleming
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Sharon
authors.initials: S
authors.lastname: Avery
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Patricia
authors.initials: P
authors.lastname: Walker
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Wei
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Curtis
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Georgia
authors.initials: G
authors.lastname: Stuart
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Daniela
authors.initials: D
authors.lastname: Klarica
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Maureen
authors.initials: M
authors.lastname: O'Brien
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Karen
authors.initials: K
authors.lastname: Morris
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Tongted
authors.initials: T
authors.lastname: Das
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Geraldine
authors.initials: G
authors.lastname: Bollard
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Muirhead
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: John
authors.initials: J
authors.lastname: Coutsouvelis
authors.affiliation: Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Victoria, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Spencer
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D000069585:Filgrastim / Q000627:therapeutic use*; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000628:therapy*; D012189:Retrospective Studies; D014182:Transplantation, Autologous / Q000379:methods
chemical_list: D000069585:Filgrastim