Reassessments of ESAs for cancer treatment in the US and Europe.

Charles L. Bennett, June M. McKoy, Michael Henke, Samuel M. Silver, Iain C. MacDougall, Gunnar Birgegård, Stefano Luminari, Nicole Casadevall, Huub Schellekens, Oliver Sartor, Stephen Y. Lai, James O. Armitage

Research output: Contribution to journalArticle

Abstract

Anemia is a widely prevalent complication among cancer patients. At the time of diagnosis, 30% to 40% of patients with non-Hodgkin lymphoma or Hodgkin lymphoma and up to 70% of patients with multiple myeloma are anemic; rates are higher among persons with myelodysplastic syndromes. Among patients with solid cancers or lymphomas, up to half develop anemia following chemotherapy. For almost 2 decades, erythropoiesis-stimulating agents (ESAs) were the primary treatment for cancer-related anemia. However, reassessments of benefits and risks of ESAs for cancer-associated anemia have occurred internationally. We reviewed guidelines and notifications from regulatory agencies and manufacturers, reimbursement policies, and utilization for ESAs in the cancer and chronic kidney disease settings within the United States, Europe, and Canada. In 2008 the US Food and Drug Administration (FDA) restricted ESAs from cancer patients seeking cure. Reimbursement is limited to hemoglobin levels < 10 g/dL. In the United States, ESA usage increased 340% between 2001 and 2006, and decreased 60% since 2007. The European Medicines Agency (EMEA) recommended that ESA benefits do not outweigh risks. In Europe between 2001 and 2006, ESA use increased 51%; since 2006, use decreased by 10%. In 2009, Canadian manufacturers recommended usage based on patient preferences. In Canada in 2007, approximately 20% of anemic cancer patients received ESAs, a 20% increase since 2004. In contrast to Europe, where ESA use has increased over time, reassessments of ESA-associated safety concerns in the United States have resulted in marked decrements in ESA use among cancer patients.

Original languageEnglish (US)
Pages (from-to)260-268
Number of pages9
JournalOncology (Williston Park, N.Y.)
Volume24
Issue number3
StatePublished - Mar 2010
Externally publishedYes

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Hematinics
Neoplasms
Anemia
Therapeutics
Canada
Second Primary Neoplasms
Patient Preference
Kidney Neoplasms
Myelodysplastic Syndromes
United States Food and Drug Administration
Multiple Myeloma
Hodgkin Disease
Chronic Renal Insufficiency
Non-Hodgkin's Lymphoma
Lymphoma
Hemoglobins

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Bennett, C. L., McKoy, J. M., Henke, M., Silver, S. M., MacDougall, I. C., Birgegård, G., ... Armitage, J. O. (2010). Reassessments of ESAs for cancer treatment in the US and Europe. Oncology (Williston Park, N.Y.), 24(3), 260-268.

Reassessments of ESAs for cancer treatment in the US and Europe. / Bennett, Charles L.; McKoy, June M.; Henke, Michael; Silver, Samuel M.; MacDougall, Iain C.; Birgegård, Gunnar; Luminari, Stefano; Casadevall, Nicole; Schellekens, Huub; Sartor, Oliver; Lai, Stephen Y.; Armitage, James O.

In: Oncology (Williston Park, N.Y.), Vol. 24, No. 3, 03.2010, p. 260-268.

Research output: Contribution to journalArticle

Bennett, CL, McKoy, JM, Henke, M, Silver, SM, MacDougall, IC, Birgegård, G, Luminari, S, Casadevall, N, Schellekens, H, Sartor, O, Lai, SY & Armitage, JO 2010, 'Reassessments of ESAs for cancer treatment in the US and Europe.', Oncology (Williston Park, N.Y.), vol. 24, no. 3, pp. 260-268.
Bennett CL, McKoy JM, Henke M, Silver SM, MacDougall IC, Birgegård G et al. Reassessments of ESAs for cancer treatment in the US and Europe. Oncology (Williston Park, N.Y.). 2010 Mar;24(3):260-268.
Bennett, Charles L. ; McKoy, June M. ; Henke, Michael ; Silver, Samuel M. ; MacDougall, Iain C. ; Birgegård, Gunnar ; Luminari, Stefano ; Casadevall, Nicole ; Schellekens, Huub ; Sartor, Oliver ; Lai, Stephen Y. ; Armitage, James O. / Reassessments of ESAs for cancer treatment in the US and Europe. In: Oncology (Williston Park, N.Y.). 2010 ; Vol. 24, No. 3. pp. 260-268.
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