Impact of safety concerns and regulatory changes on the usage of erythropoiesis-stimulating agents and RBC transfusions

Oncologist. 2010;15(12):1359-69. doi: 10.1634/theoncologist.2010-0293. Epub 2010 Dec 15.

Abstract

Purpose: Safety concerns raised in the recent oncology trials with erythropoiesis-stimulating agents (ESAs) have led to regulatory restrictions on their use. We wished to determine the impact of these changes on the use of ESAs and RBC transfusions.

Methods: In a retrospective observational study of patients treated at a comprehensive cancer center in 2006-2008, data on all ESA doses dispensed, RBCs transfused, and hemoglobin levels on the days of transfusions and ESA initiations were analyzed.

Results: Compared with 2006, the total patients treated was 14% higher (28,339 versus 24,806) in 2007 and 22% higher (30,254) in 2008. Patients receiving ESAs decreased by 26% and 61%, and ESA units dispensed decreased by 29% (from 30,206 units to 21,409 units) and 80% (6,102 units) in 2007 and 2008, respectively. However, RBC transfusions increased by only 2% (from 38,218 units to 38,948 units) in 2007 and by 8% (41,438) in 2008. The mean hemoglobin on the day of transfusion was the same for each year (8.4 g/dl); however, an increasing proportion of patients initiated ESAs at lower hemoglobin (< 10 g/dl) levels. After adjusting for demographics and diagnostic variables for 3 years (n = 83,399), a multivariate logistic regression showed a significant decline in ESA use (p < .0001) without an increase in RBC transfusions.

Conclusions: Recent ESA safety concerns and regulatory restrictions have significantly decreased ESA use. The lack of a significant impact on transfusions may be related to a lower hemoglobin threshold used to initiate ESAs or treatment of patients less likely to respond.

MeSH terms

  • Drug Utilization / legislation & jurisprudence*
  • Erythrocyte Transfusion*
  • Female
  • Hematinics / therapeutic use*
  • Hemoglobins / metabolism*
  • Humans
  • Male
  • Middle Aged
  • Neoplasms / drug therapy*
  • Neoplasms / pathology
  • Retrospective Studies
  • Safety
  • Survival Rate
  • Treatment Outcome

Substances

  • Hematinics
  • Hemoglobins