Skip to main content

Long-Term Safety of Filgrastim in Chronic Neutropenias

  • Chapter
Hematopoietic Growth Factors in Oncology

Part of the book series: Cancer Drug Discovery and Development ((CDD&D))

  • 166 Accesses

Abstract

Twenty years after the detection of human granulocyte colony-stimulating factor (G-SCF) (1) and 10 years since commercial launch of the recombinant human form, filgrastim, millions of patients have been treated to decrease the incidence of infection, as manifested by neutropenia (2). Filgrastim has utility in patients with nonmyeloid malignancies who are receiving myelosuppressive anticancer drugs. These drugs are associated with a significant incidence of severe febrile neutropenia (FN) in the settings of bone marrow transplantation (BMT), severe chronic neutropenia (SCN), and mobilization of peripheral blood progenitor cells (PBPCs). In addition to adverse events reported in these licensed indications, postmarket reports in nonlicensed clinical settings, i.e., human immunodeficiency virus (HIV) infection, myelodysplastic syndromes (MDS), and noncytotoxic drug-induced neutropenia, have been published (3).

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 89.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 119.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 169.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Weite K, Platzer E, Lu L, et al. Purification and biochemical characterization of human pluripotent hematopoietic colony-stimulating factor. Proc Natl Acad Sci USA 1985; 82: 1526–1530.

    Article  Google Scholar 

  2. Weite K, Gabrilove J, Bronchud MH, Platzer E, Morstyn G. Filgrastim (r-metHuG-CSF): the first 10 years. Blood 1996; 88: 1907–1929.

    Google Scholar 

  3. Patterson KL, Masuda SY, Brown SL. Safety profile of filgrastim (r-metHuG-CSF). In: Morstyn G, Dexter TM, Foote MA, ed., Filgrastim (r-metHuG-CSF) in Clinical Practice, 2nd ed. Totowa, NJ: Humana. 1998: 583–602.

    Google Scholar 

  4. stRice L, Nichol JL, McMillan R, Roskos LK, Bacile-M. Cyclic immune thrombocytopenia responsive to thrombopoietic growth factor therapy. Am J Hematol 2001; 68: 210–214.

    Article  Google Scholar 

  5. Reuss-Borst MA, Muller CA, Waller HD. The possible role of G-CSF in the pathogenesis of Sweet’s syndrome. Leuk Lymphoma 1994; 15: 261–264.

    Article  PubMed  CAS  Google Scholar 

  6. Bleomycin at www.dhs.sa.gov/cancare. Accessed 12 May 2003.

    Google Scholar 

  7. Adach K, Suzuki M, Sugimoto T, et al. Granulocyte colony-stimulating factor exacerbates the acute lung injury and pulmonary fibrosis induced by intratracheal administration of bleomycin in rats. Exp Toxicol Pathol 2002; 53: 501–510.

    Article  PubMed  Google Scholar 

  8. Hay J, Shahzeidi S, Laurent G. Mechanisms of bleomycin-induced lung damage. Arch Toxicol 191; 65: 81–94.

    Google Scholar 

  9. Takamizawa A, Koyama S, Sato E, et al. Bleomycin stimulates lung fibroblasts to release neutrophil and monocyte chemotactic activity. J Immunol 1999; 162: 6200–6208.

    PubMed  CAS  Google Scholar 

  10. Saxman SB, Nichols CR, Einhorn LH. Pulmonary toxicity in patients with advanced-stage germ cell tumors receiving bleomycin with and without granulocyte colony stimulating factor. Chest 1997; 111: 657–660.

    Article  PubMed  CAS  Google Scholar 

  11. Lei KI, Leung WT, Johnson PJ. Serious pulmonary complications in patients receiving recombinant granulocyte colony-stimulating factor during BACOP chemotherapy for aggressive non-Hodgkin’s lymphoma. Br J Cancer 1994; 70: 1009–10013.

    Article  PubMed  CAS  Google Scholar 

  12. Sargramostim. http:/csi.micromedex.com. Accessed 12 May 2003.

    Google Scholar 

  13. Stanworth SJ, Bhavnani N, Chatopadhya C, Miller H, Swinson DR. Treatment of Felty’s syndrome with the haemopoietic growth factor granulocyte colony-stimulating factor (G-CSF). Q J Med 1998; 91: 49–56.

    Article  CAS  Google Scholar 

  14. Lehrnbecher T, Welte K. Haematopoietic growth factors in children with neutropenia. Br J Haematol 2002; 116: 28–56.

    Article  PubMed  CAS  Google Scholar 

  15. Medlock ES, Kaplan DL, Cecchini M. Ulich TR, delCastillo J, Andresen J. Granulocyte colony-stimulating factor crosses the placenta and stimulates fetal rat granulopoiesis. Blood 1993; 81: 91–92.

    Google Scholar 

  16. Novales JS, Salva AM, Modanlou HD, et al. Maternal administration of granulocyte-stimulating factor improves neonatal rat survival after a lethal group B streptococcal infection. Blood 1993; 15: 81: 923–927.

    Google Scholar 

  17. Calhoun DA, Donnelly WH, Du Y, Dame JB, Li Y, Christensen RD. Distribution of granulocyte colony-stimulating factor (G-CSF) and G-CSF-receptor mRNA and protein in the human fetus. Pediatr Res 1999; 46: 333–338.

    Article  PubMed  CAS  Google Scholar 

  18. Kostmann R. Infantile genetic agranulocytosis. Acta Pediatr Scand 1956; 45: 1–78.

    Article  CAS  Google Scholar 

  19. Horwitz M, Benson KF, Person RE, et al. Mutations in ELA2, encoding neutrophil elastase, define a 21-day biological clock in cyclic haematopoesis. Nature Genet 1999; 23: 433–436.

    Article  PubMed  CAS  Google Scholar 

  20. Dale DC, Person RE, Bolyard AA, et al. Mutations in the gene encoding neutrophil elastase in congenital and cyclic neutropenia. Blood 2000; 96: 2317–2322.

    PubMed  CAS  Google Scholar 

  21. Germeshausen M, Schulze H, Ballmaier M, et al. Mutations in the gene encoding neutrophil elastase (ELA2) are not sufficient to cause the phenotype of congenital neutropenia. Br J Haematol 2001; 115: 1–4.

    Article  Google Scholar 

  22. Dong F, Russel KB, Tidow N, et al. Mutations in the gene for the granulocyte-colony stimulating factor receptor in patients with acute myeloid leukemia preceded by severe congenital neutropenia. N Engl JMed 1995; 333: 487–493.

    Article  CAS  Google Scholar 

  23. Tidow N, Pilz C, Teichmann B, et al. Clinical relevance of point mutations in the cytoplasmatic domain of the granulocyte-colony stimulating factor gene in patients with severe congenital neutropenia. Blood 1997; 88: 2369–2375.

    Google Scholar 

  24. Tschan CA, Pilz C, Zeidler C, et al. Time course of increasing numbers of mutations in the granulocyte colony-stimulating factor receptor gene in a patient with congenital neutropenia who developed leukemia. Blood 2001; 97: 1882–1884.

    Article  PubMed  CAS  Google Scholar 

  25. Bernard T, Gale R, Evans J, et al. Mutations of the granulocyte-colony stimulating factor receptor in patients with severe congenital neutropenia are not required for transformation to acute myeloid leukaemia and may be a bystander phenomenon. Br J Haematol 1998; 101: 141–149.

    Article  PubMed  CAS  Google Scholar 

  26. Welte K, Boxer L. Severe chronic neutropenia: pathophysiology and therapy. Semin Hematol 1997; 34: 267–278.

    PubMed  CAS  Google Scholar 

  27. Bux J, Behrens G, Jaeger G, et al. Diagnosis and clinical course of autoimmune neutropenia in infancy: analysis of 240 cases. Blood 1998; 91: 181–186.

    PubMed  CAS  Google Scholar 

  28. Bonilla M, Dale D, Zeidler C, et al. Long-term safety of treatment with recombinant human granulocyte colony-stimulating factor (r-metHuG-CSF) in patients with severe congential neutropenias. Br J Hematol 1994; 88: 723–730.

    Article  CAS  Google Scholar 

  29. Bonilla M, Gillio A, Ruggeiro M, et al. Effects of recombinant human granulocyte colony-stimulating factor on neutropenia in patients with congenital agranulocytosis. N Engl J Med 1989; 320: 1574–1580.

    Article  PubMed  CAS  Google Scholar 

  30. Welte K, Zeidler C, Reiter A, et al. Differential effects of granulocyte-macrophage colony-stimulating factor and granulocyte colony-stimulating factor in children with severe congenital neutropenia. Blood 1990; 75: 1056–1063.

    PubMed  CAS  Google Scholar 

  31. Zeidler C, Welte K, Barak Y, et al. Stem cell transplantation in patients with severe congenital neutropenia without evidence of leukemia transformation. Blood 2000; 95: 1195–1198.

    PubMed  CAS  Google Scholar 

  32. Rappeport J, Parkman R, Newburger P, et al. Correction of infantile granulocytosis (Kostmann syndrome) by allogeneic bone marrow transplantation. Am J Med 1980; 68: 605–609.

    Article  PubMed  CAS  Google Scholar 

  33. Rosen R, Kang S. Congenital agranulocytosis terminating in acute myelomonocytic leukemia. J Pediatr 1979; 94: 406–408.

    Article  PubMed  CAS  Google Scholar 

  34. Gilman P, Jackson D, Guild H. Congenital agranulocytosis: prolonged survival and terminal acute leukemia. Blood 1970; 36: 576–585.

    PubMed  CAS  Google Scholar 

  35. Freedman MH, Alter BP. Risk of myelodysplastic syndrome and acute myeloid leukemia in congenital neutropenias. Semin Hematol 2002; 39: 128–133.

    Article  PubMed  CAS  Google Scholar 

  36. Yakisan E, Schirg E, Zeidler C, et al. High incidence of significant bone loss in patients with severe congenital neutropenia (Kostmann’s syndrome). J Pediatr 1997; 131: 592–597.

    Article  PubMed  CAS  Google Scholar 

  37. Leale M. Recurrent furunculosis in an infant showing an unusual blood picture. JAMA 1910; 54: 1854–1855.

    Article  Google Scholar 

  38. Dale D, Bonilla M, Davis M, et al. A randomized controlled phase III trial of recombinant human granulocyte colony-stimulating factor (G-CSF) for treatment of severe chronic neutropenia. Blood 1993; 81: 2496–2502.

    PubMed  CAS  Google Scholar 

  39. Dale DC, Bolyard AA, Aprikyan A. Cyclic neutropenia. Semin Hematol 2002; 39: 89–94.

    Article  PubMed  CAS  Google Scholar 

  40. Milkovitch G, Moleski RJ, Reitan JF, et al. Comparative safety of filgrastim versus sargramostim in patients receiving myelosuppressive chemotherapy. Pharmacotherapy 2000, 20: 1432–1440.

    Article  Google Scholar 

Download references

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2004 Humana Press Inc., Totowa, NJ

About this chapter

Cite this chapter

Welte, K. (2004). Long-Term Safety of Filgrastim in Chronic Neutropenias. In: Morstyn, G., Foote, M., Lieschke, G.J. (eds) Hematopoietic Growth Factors in Oncology. Cancer Drug Discovery and Development. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-59259-747-5_20

Download citation

  • DOI: https://doi.org/10.1007/978-1-59259-747-5_20

  • Publisher Name: Humana Press, Totowa, NJ

  • Print ISBN: 978-1-4684-9847-9

  • Online ISBN: 978-1-59259-747-5

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics