Advances in Therapy

, Volume 28, Issue 4, pp 304–310

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

  • François Lefrère
  • Anne-Colette Brignier
  • Caroline Elie
  • Jean-Antoine Ribeil
  • Michael Bernimoulin
  • Charbel Aoun
  • Liliane Dal Cortivo
  • Richard Delarue
  • Olivier Hermine
  • Marina Cavazzana-Calvo
Original Research

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 3×106 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.

Keywords

autologous transplantation biosimilars G-CSF hematological malignancies leukapheresis stem cell mobilization Zarzio 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Child JA, Morgan GJ, Davies FE, et al. Medical Research Council Adult Leukaemia Working Party. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med. 2003;348:1875–1883.PubMedCrossRefGoogle Scholar
  2. 2.
    Pettengell R, Radford JA, Morgenstern GR, et al. Survival benefit from high-dose therapy with autologous blood progenitor-cell transplantation in poor-prognosis non-Hodgkin’s lymphoma. J Clin Oncol. 1996;14:586–592.PubMedGoogle Scholar
  3. 3.
    Lefrere F, Makke J, Fermand J, et al. Blood stem cell collection using chemotherapy with or without systematic G-CSF: experience in 52 patients with multiple myeloma. Bone Marrow Transplant. 1999;24:463–466.PubMedCrossRefGoogle Scholar
  4. 4.
    Crawford J, Ozer H, Stoller R, et al. Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med. 1991;325:164–170.PubMedCrossRefGoogle Scholar
  5. 5.
    Smith TJ, Khatcheressian J, Lyman GH, et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidencebased clinical practice guideline. J Clin Oncol. 2006;24:3187–3205.PubMedCrossRefGoogle Scholar
  6. 6.
    Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411–419.PubMedCrossRefGoogle Scholar
  7. 7.
    del Giglio A, Eniu A, Ganea-Motan D, Topuzov E, Lubenau H. XM02 is superior to placebo and equivalent to Neupogen in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy. BMC Cancer. 2008;8:332.PubMedCrossRefGoogle Scholar
  8. 8.
    Engert A, Griskevicius L, Zyuzgin Y, Lubenau H, del Giglio A. XM02, the first granulocyte colonystimulating factor biosimilar, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with non-Hodgkin lymphoma receiving chemotherapy. Leuk Lymphoma. 2009;50:374–379.PubMedCrossRefGoogle Scholar
  9. 9.
    Engert A, del Giglio A, Bias P, Lubenau H, Gatzemeier U, Heigener D. Incidence of febrile neutropenia and myelotoxicity of chemotherapy: a meta-analysis of biosimilar G-CSF studies in breast cancer, lung cancer, and non-Hodgkin’s lymphoma. Onkologie. 2009;32:599–604.PubMedCrossRefGoogle Scholar
  10. 10.
    Gatzemeier U, Ciuleanu T, Dediu M, Ganea-Motan E, Lubenau H, Del Giglio A. XM02, the first biosimilar G-CSF, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with small cell or non-small cell lung cancer receiving platinumbased chemotherapy. J Thorac Oncol. 2009;4:736–740.PubMedCrossRefGoogle Scholar
  11. 11.
    Gascon P, Fuhr U, Sörgel F, et al. Development of a new G-CSF product based on biosimilarity assessment. Ann Oncol. 2010;21:1419–1429.PubMedCrossRefGoogle Scholar
  12. 12.
    Lubenau H, Sveikata A, Gumbrevicius G, et al. Bioequivalence of two recombinant granulocyte colony-stimulating factor products after subcutaneous injection in healthy volunteers. Int J Clin Pharmacol Ther. 2009;47:275–282.PubMedGoogle Scholar
  13. 13.
    Lubenau H, Bias P, Maly AK, Siegler KE, Mehltretter K. Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen: single-blind, randomized, crossover trial. BioDrugs. 2009;23:43–51.PubMedCrossRefGoogle Scholar
  14. 14.
    Waller CF, Bronchud M, Mair S, Challand R. Pharmacokinetic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial. Ann Hematol. 2010;89:927–933.PubMedCrossRefGoogle Scholar
  15. 15.
    Sörgel F, Lerch H, Lauber T. Physicochemical and biologic comparability of a biosimilar granulocyte colony-stimulating factor with its reference product. BioDrugs. 2010;24:347–357.PubMedCrossRefGoogle Scholar
  16. 16.
    Skrlin A, Radic I, Vuletic M, et al. Comparison of the physicochemical properties of a biosimilar filgrastim with those of reference filgrastim. Biologicals. 2010;38:557–566.PubMedCrossRefGoogle Scholar
  17. 17.
    R Development Core Team. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria, 2010. Available at: http://www.r-project.org. Accessed March 4, 2011.
  18. 18.
    Rajkumar SV. Multiple myeloma: 2011 update on diagnosis, risk-stratification, and management. Am J Hematol. 2011;86:57–65.PubMedCrossRefGoogle Scholar
  19. 19.
    Niitsu N. Current treatment strategy of diffuse large B-cell lymphomas. Int J Hematol. 2010;92:231–237.PubMedCrossRefGoogle Scholar
  20. 20.
    Lefrère F, Zohar S, Ghez D, et al. The VAD chemotherapy regimen plus a G-CSF dose of 10 microg/kg is as effective and less toxic than highdose cyclophosphamide plus a G-CSF dose of 5 microg/kg for progenitor cell mobilization: results from a monocentric study of 82 patients. Bone Marrow Transplant. 2006;37:725–729.PubMedCrossRefGoogle Scholar
  21. 21.
    Lefrère F, Bernard M, Audat F, et al. Comparison of lenograstim vs filgrastim administration following chemotherapy for peripheral blood stem cell collection: a retrospective study of 126 patients. Leuk Lymphoma. 1999;35:501–505.PubMedCrossRefGoogle Scholar
  22. 22.
    Perry AR, Watts MJ, Peniket AJ, Goldstone AH, Linch DC. Progenitor cell yields are frequently poor in patients with histologically indolent lymphomas especially when mobilized within 6 months of previous chemotherapy. Bone Marrow Transplant. 1998;21:1201–1205.PubMedCrossRefGoogle Scholar
  23. 23.
    Bensinger W, Appelbaum F, Rowley S et al. Factors that influence collection and engraftment of autologous peripheral-blood stem cells. J Clin Oncol. 1995;13:2547–2555.PubMedGoogle Scholar
  24. 24.
    Engelhardt M, Bertz H, Afting M, Waller CF, Finke J. High-versus standard-dose filgrastim (rhG-CSF) for mobilization of peripheral-blood progenitor cells from allogeneic donors and CD34(+) immunoselection. J Clin Oncol. 1999;17:2160–2172.PubMedGoogle Scholar
  25. 25.
    Vidal. Tarex 2011. Vidal, Issy Les Moulineaux, France, 2011. Available at: http://www.vidal.fr/lesproduits-professionnels/tarex. Accessed March 4, 2011.

Copyright information

© Springer Healthcare 2011

Authors and Affiliations

  • François Lefrère
    • 1
    • 2
  • Anne-Colette Brignier
    • 2
  • Caroline Elie
    • 3
  • Jean-Antoine Ribeil
    • 2
  • Michael Bernimoulin
    • 2
  • Charbel Aoun
    • 2
  • Liliane Dal Cortivo
    • 2
  • Richard Delarue
    • 4
  • Olivier Hermine
    • 4
  • Marina Cavazzana-Calvo
    • 2
  1. 1.Service de BiothérapieGroupe Hospitalier Necker-Enfants MaladesParis Cedex 15France
  2. 2.Service de Biothérapie, H≪tal NeckerAPHPParisFrance
  3. 3.Service de Biostatique, Hôpital Necker, APHPUniversité Paris DescartesParisFrance
  4. 4.Service d’Hématologie Adultes, H≪tal NeckerAPHPParisFrance

Personalised recommendations