title: Biosimilar granulocyte-colony-stimulating factor for mobilization of autologous peripheral blood stem cells in pediatric hematology-oncology patients.
abstract: BACKGROUND
  Recently biosimilars of granulocyte-colony-stimulating factor (G-CSF) became available for prophylaxis and treatment of postchemotherapy neutropenia and for mobilization of peripheral blood CD34+ cells for either autologous or allogeneic hematopoietic stem cell transplant. Most of the data on the mobilization efficacy and safety of biosimilar G-CSF are from adult patients, whereas no data are available in pediatric patients.
  
  
  METHODS
  This was a retrospective study on cases treated at three Italian pediatric transplant centers, from January 2011 to October 2013. Data were collected on all children undergoing first peripheral blood stem cell (PBSC) mobilization after stimulation with biosimilar G-CSF and chemotherapy. The results were compared with a historical control group.
  
  
  RESULTS
  Twenty-nine children underwent mobilization with biosimilar G-CSF. Peak peripheral blood CD34+ cell count of 20 × 10(6) /L was achieved in 90% of patients, with a median value of 71 × 10(6) /L. Eighty-three percent reached the desired target (CD34+/kg) dose. The median number of collected CD34+ cells was 10 × 10(6) /kg (range, 4.8 × 10(6) -68.8 × 10(6) /kg). No difference was observed in comparison with historical control group mobilized with originator filgrastim. Moreover, no major and/or unexpected side effects were reported.
  
  
  CONCLUSIONS
  Biosimilar G-CSF resulted as effective and safe as originator filgrastim molecule in mobilizing PBSCs in children, with the advantage of a reduced cost.
authors: Pediatric Hematology Oncology, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.
authors: Simone
authors: S
authors: Cesaro
authors: Gloria
authors: G
authors: Tridello
authors: Arcangelo
authors: A
authors: Prete
authors: Sandro
authors: S
authors: Dallorso
authors: Elisa
authors: E
authors: Cannata
authors: Erika
authors: E
authors: Massaccesi
authors: Marco
authors: M
authors: Risso
authors: Massimiliano
authors: M
authors: De Bortoli
authors: Désirée
authors: D
authors: Caselli
mesh_terms: D000293:Adolescent; D064591:Allografts; D018952:Antigens, CD34; D064592:Autografts; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods*; D006412:Hematopoietic Stem Cells; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009369:Neoplasms / Q000628:therapy*; D036102:Peripheral Blood Stem Cell Transplantation; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012189:Retrospective Studies
chemical_list: D018952:Antigens, CD34; D059451:Biosimilar Pharmaceuticals; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim