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Experience (1 year) of G-CSF biosimilars in PBSCT for lymphoma and myeloma patients

Bone Marrow Transplantation volume 47, pages 874–876 (2012)Cite this article

The costs of medical care are always increasing. To limit them, several pharmaceutical laboratories have developed substitutes of effective, but costly, products. They have produced biosimilars of G-CSF-like filgrastim—Neupogen from Amgen pharmaceutical (Thousand Oaks, CA, USA). The methods of synthesis are quite different from the synthesis of the original product because they utilise bacterial support to yield new bioproducts with lower costs, but that induces modifications of the molecules like glycosylation and phosphorylation.1, 2 But, final products already seem to be as effective as the classical version of G-CSF. Despite the limited number of prospective studies in the field of haematology, these biosimilars were awarded the same authorisations of use as those of the original product. There are few data available on the use of biosimilars of filgrastim in PBSCT.3, 4 Because of the potentially decreased costs, biosimilars of G-CSF have become available in our hospital. Over the course of a year, we have used these products for patients with lymphoma and myeloma who underwent PBSCT. We initiated a retrospective study comparing the efficacy on BM recovery with the use of biosimilars of G-CSF vs a historical cohort of patients.5

We identified 88 consecutive patients who underwent PBSCT in our centre: 50 patients were treated with classical G-CSF (25 with lymphoma and 25 with myeloma) and 38 patients (25 with lymphoma and 13 with myeloma) received biosimilars of G-CSF. Patient characteristics are summarised in Table 1. Patients with lymphoma received a BEAM conditioning regimen, and myeloma patients were treated with a melphalan (140 or 200 mg/m2) conditioning regimen. The injection of G-CSF began at day 5 after PBSCT injection. We evaluated eight clinical parameters: the number of G-CSF injections, the number of days of hospitalisation, the number of units of red blood cell or platelet transfusions, the days on which body temperature exceeded 38 °C, the days of parenteral nutrition, the weight loss and the hospitalisation costs. We also studied four biological parameters: the number of CD34+ cells injected, the days on which leucocyte counts were less than 1 × 109 cells/L, the days on which Hb was less than 90 g/L or platelet counts were less than 50 × 109/L. No differencies appeared in the global characteristics of the two groups of patients (Table 1). Furthermore, the numbers of CD34+ cells injected were identical in each subgroup. Despite the apparent superiority of classical G-CSF stimulation, we did not observe statistically significant differences for the 12 parameters studied between the two groups of patients with lymphoma and myeloma. Only one patient from the biosimilar group died from transplantation-related mortality. These data are summarised in Table 2.

Table 1 Demographic and baseline characteristics of patients
Full size table
Table 2 Biological and clinical parameters studied for patients with lymphoma or myeloma who underwent PBSCT with biosimilars or classical G-CSF
Full size table

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References

  1. Kuhlmann M, Covic A . The protein science of biosimilars. Nephrol Dial Transplant 2006; 21: v4–v8.

    Article  CAS  Google Scholar 

  2. Mellstedt H, Niederwieser D, Ludwig H . The challenge of biosimilars. Ann Oncol 2008; 19: 411–419.

    Article  CAS  Google Scholar 

  3. Niederwieser D, Schmitz S . Biosimilar agents in oncology/haematology: from approval to practice. Eur J Haematol 2011; 86: 277–288.

    Article  CAS  Google Scholar 

  4. Ferro HH, Juni M, Bello R, Vidal A, Diez RA, Pavlovsky S . Utilization study of filgrastim (neutromax) during autologous haematopoietic precursor transplantation for myeloma and lymphoma patients. Transfus Apher Sci 2009; 41: 87–93.

    Article  Google Scholar 

  5. Ianotto JC, Tempescul A, Delepine P, Guillerm G, Hardy E, Eveillard JR et al. Delayed G-CSF stimulation after PBSCT does not seem to modify the biological parameters of bone marrow recovery. Am J Hematol 2011; 86: 351–352.

    Article  CAS  Google Scholar 

  6. McQuaker IG, Hunter AE, Pacey S, Haynes AP, Iqbal A, Russell NH . Low-dose filgrastim significantly enhances neutrophil recovery following autologous peripheral-blood stem-cell transplantation in patients with lymphoproliferative disorders: evidence for clinical and economic benefit. J Clin Oncol 1997; 15: 451–457.

    Article  CAS  Google Scholar 

  7. Valteau-Couanet D, Faucher C, Aupérin A, Michon J, Milpied N, Boiron JM et al. Cost effectiveness of day 5 G-CSF (lenograstim) administration after PBSC transplantation: results of a SFGM-TC randomised trial. Bone Marrow Transplant 2005; 36: 547–552.

    Article  CAS  Google Scholar 

  8. Pagliuca A, Carrington PA, Pettengell R, Tule S, Keidan J . Haemato-oncology task force of the British committee for standards in haematology. Guidelines on the use of colony-stimulating factors in haematological malignancies. Br J Haematol 2003; 123: 22–33.

    Article  Google Scholar 

  9. Smith TJ, Khatcheressian J, Lyman GH, Ozer H, Armitage JO, Balducci L et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol 2006; 24: 3187–3205.

    Article  CAS  Google Scholar 

  10. Apperley J, Carreras E, Gluckman E, Masszi T (eds). Haematopoietic stem cell transplantation. The EBMT handbook 2008 revised version. EBMT, Paris, France, pp 171–173.

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Authors and Affiliations

  1. Department of Clinical Haematology, Institute of Oncology and Hematology, Hopital Morvan, CHRU Brest, France

    J-C Ianotto, A Tempescul, R Le Calloch, J-R Eveillard, C Berthou & G Guillerm

  2. Department of haematology, First Affiliated Hospital of Chongqing Medical University, Chongqing, China

    X Yan

  3. Etablissement Français du Sang Bretagne, Site de Brest, France

    P Delepine & E Hardy

  4. Pharmacie Oncologique, Hopital Morvan, CHRU Brest, France

    N Mugnier

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  1. J-C Ianotto
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  2. A Tempescul
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Correspondence to J-C Ianotto.

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Ianotto, JC., Tempescul, A., Yan, X. et al. Experience (1 year) of G-CSF biosimilars in PBSCT for lymphoma and myeloma patients. Bone Marrow Transplant 47, 874–876 (2012). https://doi.org/10.1038/bmt.2011.189

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