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G-CSF in healthy donors. Safe or harmful?


Authors: D. Lysák 1;  J. Navrátilová 2
Authors‘ workplace: Hematologicko-onkologické oddělení FN Plzeň , 2Český národní registr dárců dřeně 1
Published in: Transfuze Hematol. dnes,13, 2007, No. 3, p. 149-153.
Category: Comprehensive Reports, Original Papers, Case Reports

Overview

Granulocyte-colony stimulating factor (filgrastim, G-CSF) represents a standard mobilizing cytokine, which is being used to prepare allogeneic donors before hematopoietic progenitor cells collection with apheresis for more than a decade. While its short-term effects are sufficiently known, long-term influence on donor’s health is less discovered as well as whole mechanism of mobilization. Although any negative impact of short-term filgrastim application has not been displayed in healthy individual yet, the discussion about possible association with increased risk of malignant disease, especially leukemia, is still in progress. Maximal donors’ health protection is a main rule in allogeneic hematopoietic progenitor cells collections. Both medical and ethical questions of donation require to keep the issue of the long-term effects of G-CSF application in mind during the daily work with allogeneic donors. It is appropriate to reduce filgrastim dosage to necessary minimum, to provide donor with information about up to date knowledge regarding filgrastim long-term effects and extend the follow-up period after the donation too.

Key words:
filgrastim, healthy donors, peripheral blood stem cells, leukemogenesis


Sources

1. Bennett Ch, Evens AM, Andritsos LA, et al. Haematological malignancies developing in previously healthy individuals who received haematopoietic growth factors: report from the Research on Adverse Drug Events and Reports (RADAR). Br J Haematol 2006; 135: 642–650.

2. Hershman D, Neugut AI, Jacobson JS, et al. Acute Myeloid leukemia or Myelodysplastic Syndrome Following Use of Granulocyte Colony-Stimulating Factors during Brest Cancer Adjuvant Chemotherapy. J Natl Cancer Inst 2007; 99: 196–205.

3. Cavallaro AM, Lilleby K, Majolino I, et al. Three to six year follow-up of normal donors who received recombinant human granulocyte colony-stimulating factor. Bone Marrow Transplant 2000; 25: 85–89.

4. Tassi C, Tazzari PL, Bonifazi F, et al. Short- and long-term haematological surveillance of healthy donors of allogeneic peripheral haematopoietic progenitors mobilized with G-CSF: a single institution prospective study. Bone Marrow Transplant 2005; 736: 289–294.

5. LeBlanc R, Roy J, Demers C, et al. A prospective study of G-CSF effects on hemostasis in allogeneic blood stem cell donors. Bone Marrow Transplant 1999; 23: 991–996.

6. Nuamah NM, Goker H, Kilic YA, et al. Spontaneous splenic rupture in a healthy allogeneic donor of peripheral-blood stem cell following the administration of granulocyte colony-stimulating factor (g-csf). A case report and review of the literature. Haematologica 2006; 91: 9–11.

7. Anderlini P, Chan FA, Champlin RE, et al. Long-term follow-up of normal peripheral blood progenitor cell donors treated with filgrastim: no evidence of increased risk of leukemia development. Bone Marrow Transplant 2002; 30: 661-663.

8. Makita K, Ohta K, Mugitani A, et al. Acute myelogenous leukemia in a donor after granulocyte colony-stimulating factor-primed peripheral blood stem cell harvest. Bone Marrow Transplant 2004; 33: 661–665.

9. Rauscher GH, Sandler DP, Poole C, et al. Family History of Cancer and Incidence of Acute Leukemia in Adults. Am J Epid 2002; 156: 517–526.

10. Segel GB, Lichtman MA. Familial (inherited) leukemia, lymphoma, and myeloma: an overview. Blood Cells, Molecules, and Diseases 2004; 32: 246–261.

11. Confer D, Miller JP. Long-term safety of filgrastim (rhG-CSF) administration. Br J Haematol 2006; 137: 77–78.

12. Tigue CC, Trifilio SM, Tallman MS, et al. Long-term safety of filgrastim (rhG-CSF) administration: response to Confer & Miller and Bache & Zander. Br J Haematol 2006; 137: 79–80.

13. Grupp SA, Frangoul H, Wall D, et al. Use of G-CSF in matched sibling donor pediatric allogeneic transplantation: a consensus statement from the Children’s Oncology Group (COG) transplant discipline committee and Pediatric Blood and Marrow transplant Consortium (PBMTC) executive committee. Pediatr Blood Cancer 2006; 46:414–421.

14. Hasenclever D, Sextro M. Safety of AlloPBPCT donors: biometrical considerations on monitoring long term risks. Bone Marrow Transplant 1996; 17: S28–S30.

15. Rosenberg PS, Alter BP, Bolyard AA, et al. The incidence of leukemia and mortality from sepsis in patients with severe congenital neutropenia receiving long-term G-CSF therapy. Blood 2006; 107: 4628–4635.

16. Pulsipher MA, Nagler A, Iannone R, Nelson RM. Weighing the risk of G-CSF administration, leukapheresis, and standard marrow harvest: ethical and safety considerations for normal pediatric hematopoietic cell donors. Pediatr Blood Cancer 2006; 46: 422–433.

17. Heil G, Hoelzer D, Sanz MA, et al. A randomized, double-blind, placebo-controlled, phase III study of filgrastim in remission induction and consolidation therapy for Adults with de novo acute myeloid leukemia. Blood 1997; 90: 4710–4718.

18. Casadevall N, Durieux P, Dubois S, et al. Health, economic, and quality-of-life effects of erythropoietin and granulocyte colony-stimulating factor for the treatment of myelodysplastic syndromes: a randomized, controlled trial. Blood 2004; 104: 321–327.

19. Greenberg P, Taylor K, Larson R, et al. Phase III randomized multicenter trial of G-CSF vs. observation for myelodysplastic syndromes (MDS). Blood 1993; suppl 1, 82: 196a.

20. Usuki K, Urabe A, Masaoka T, et al. Efficacy of granulocyte colony-stimulating factor in the treatment of acute myelogenous leukaemia: a multicentre randomized study. Br J Haematol 2002; 116: 103–112.

21. Nagler A, Korenstein-Ilan A, Amiel A, et al. Granulocyte colony-stimulating factor generates epigenetic and genetic alterations on lymphocytes of normal volunteer donors of stem cells. Experimental Hematology 2004; 32: 122–130.

22. Shapira MY, Kaspler P, Samuel S, et al. Granulocyte Colony Stimulating Factor Does Not Induce Long-Term DNA Instability in Healthy Peripheral Blood Stem Cell Donors. Am J Hematol 2003; 73: 33–36.

23. Kaplinsky C, Trakhtenbrot L, Hardan I, et al. Tetraploid myeloid cells in donors of peripheral blood stem cells treated with rhG-CSF. Bone Marrow Transplant 2003; 32: 31–34.

24. Weaver CH, Birch R, Greco FA, et al. Mobilization and harvesting of peripheral stem cells: randomized evaluations of different doses of filgrastim. Br J Haematol 1998; 100: 338–347.

25. Engelhardt M, Bertz H, Afting M, et al. 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.

26. Kröger N, Renges H, Sonnenberg S, et al. Stem ell mobilization with 16 μg/kg vs. 10 μg/kg of G-CSF for allogeneic transplantation in healthy donors. Bone Marrow Transplant 2002; 29: 727–730.

27. Russell N, Gratwohl A, Schmitz N. The place of blood stem cells in allogeneic transplantation. Br J Haematol 1996; 93: 747–753.

28. Stroncek DF, Clay ME, Petzoldt ML, et al. Treatment of normal individuals with granulocyte-colony-stimulating factor: donor experiences and the effects on peripheral blood CD34+ cell counts and on the collection of peripheral blood stem cells. Transfusion 1996; 36: 601–610.

29. Martínez C, Urbano-Ispizua A, Marín P, et al. Efficacy and toxicity of a high dose G-CSF schedule for peripheral blood progenitor cell mobilization in healthy donors. Bone Marrow Transplant 1999; 24: 1273–1278.

30. Haas M, Kerst JM, Schoot E, et al. Granulocyte colony-stimulating factor administration to healthy volunteers: analysis of the immediate activating effects on circulating neutrophils. Blood 1994; 84: 3885–3894.

31. Stute N, Santana VM, Rodman JH, et al. Pharmacokinetics of subcutaneous recombinant human granulocyte colony– stimulating factor in children. Blood 1992; 79: 2849–2854.

32. Watts MJ, Addison I, Ings SJ et, al. Optimal timing for collection of PBSC after glycosylated G-CSF administration. Bone Marrow Transplant 1998; 21: 365–368.

33. Faulkner LB, Tucci F, Tamburini A, et al. G-CSF serum pharmacokinetics during peripheral blood progenitor cell mobilization: neutrophil count-adjusted dosage might potentially improve mobilization and be more cost-effective. Bone Marrow Transplant 1998; 21: 1091–1095.

34. Kröger N, Renges H, Krüger W, et al. A randomized comparison of once versus twice daily recombinant human granulocyte colony-stimulating factor (filgrastim) for stem cell mobilization in healthy donors for allogeneic transplantation. Br J Haematol 2000; 111: 761–765.

35. Arbona C, Prosper F, Benet I, et al. Comparison between once a day vs. twice a day G-CSF for mobilization of peripheral blood progenitor cells in normal donors for allogeneic PBSC transplantation. Bone Marrow Transplant 1998; 22: 39–45.

Labels
Haematology Internal medicine Clinical oncology

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Transfusion and Haematology Today

Issue 3

2007 Issue 3

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