First experience of autologous peripheral blood stem cell mobilization with biosimilar granulocyte colony-stimulating factor

Adv Ther. 2011 Apr;28(4):304-10. doi: 10.1007/s12325-011-0009-1. Epub 2011 Mar 10.

Abstract

Introduction: Mobilization techniques for autologous peripheral blood stem cell (PBSC) collection include chemotherapy followed by hematopoietic growth factors, such as granulocyte colony-stimulating factor (G-CSF). Biosimilar versions of G-CSF are now available in Europe.

Methods: In this study, 40 patients with a hematological malignancy scheduled to receive biosimilar G-CSF (Zarzio(®) Sandoz Biopharmaceuticals, Paris, France) following first-cycle chemotherapy for treatment and autologous PBSC mobilization were prospectively included at a single center. These patients were compared with a historical control group who had been treated with G-CSF (Neupogen(®) Paris, France) at the same center according to the same clinical protocol. PBSC harvesting was considered successful if at least 3×10(6) CD34+ cells/kg were collected. If three consecutive CD34+ tests were below 10/μL then PBSC harvesting was not performed.

Results: Patient characteristics were similar in both groups with no significant differences in age, diagnosis, previous chemotherapy, or chemotherapy mobilization regimen. No significant differences were observed between groups in median CD34+ cells mobilized and collected, or the number of G-CSF injections and leukaphereses required to obtain the minimal CD34+ cell count. Proportion of failures was also similar in both groups.

Conclusion: Zarziois(®) comparable to Neupogen(®) for PBSC mobilization and collection after chemotherapy and so may provide a more cost-effective strategy.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / pharmacokinetics
  • Antineoplastic Combined Chemotherapy Protocols
  • Female
  • Filgrastim
  • Granulocyte Colony-Stimulating Factor* / administration & dosage
  • Granulocyte Colony-Stimulating Factor* / adverse effects
  • Granulocyte Colony-Stimulating Factor* / pharmacokinetics
  • Hematologic Neoplasms / therapy
  • Hematopoietic Stem Cell Mobilization / methods*
  • Hematopoietic Stem Cell Mobilization / standards
  • Humans
  • Injections, Subcutaneous
  • Leukapheresis / standards
  • Male
  • Middle Aged
  • Peripheral Blood Stem Cell Transplantation / methods*
  • Recombinant Proteins
  • Research Design
  • Transplantation, Autologous / methods
  • Treatment Outcome

Substances

  • Antineoplastic Agents
  • Recombinant Proteins
  • Granulocyte Colony-Stimulating Factor
  • Filgrastim