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Are restrictions on ESA use justified?
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Erythropoiesis-stimulating agents are clearly an effective therapy when the drugs are used in an appropriate manner. It is not surprising that when a hemoglobin level is raised too much, it could lead to thromboembolic events.
Harry S. Jacob, MD
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Every increase in red blood cells increases the risk for clotting, not only because of changes in viscosity but also because the red cells potentiate platelet activation and aggregation.
It’s rational to want to increase a hemoglobin level to a level associated with improved quality of life, which for many patients is 12 g/dL. The only evidence of potential thromboembolic events was seen when hemoglobin levels were pushed past this.
Physicians should be able to make judgment calls regarding the risk vs. benefit in any given patient. The CMS restrictions are a response to increased risk of thromboembolic events in approximately 15% of patients.
This increased risk in a small percentage of patients should not mean that we are going to deny the other 85% of patients the benefits that these agents offer, one of which is improved quality of life.
Physicians can balance the risks and benefits in their individual patients and make reasonable judgments based on patient histories. The CMS restrictions require that all patients with Medicare be treated the same way and limit hemoglobin level to a level that is not indicative of better quality of life.
Harry S. Jacob, MD, HemOnc Today’s Chief Medical Editor is Professor of Medicine at the University of Minnesota.
Charles Bennett, MD, PhD
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The FDA has stated that this drug is to be used to replace transfusions, which are prescribed based on a combination of clinical conditions and hemoglobin levels.
There is no specific hemoglobin level that warrants transfusion in all patients, which is why the patient’s clinical profile is necessary. The same is true for erythropoietin use.
Our decision to use these drugs is based on guidelines set by ASCO and the NCCN. It is important to understand that neither guideline invokes a quality-of-life benefit for the use of ESAs. The factors that we use to determine whether or not to administer erythropoietin should not be inclusive of quality of life.
Previous meta-analyses and other nonrandomized studies have clearly identified that the quality-of-life data are not enough to be support a quality-of-life benefit.
There are more questions than answers with ESAs. We need to have appropriately designed clinical trials to determine any quality-of-life benefit, and we also need trials with a single disease and a single regimen to see if ESAs pose risks for tumor progression and death when used on-label. One aspect of these trials is to test the use of prophylactic measures for thromboembolic events. These clinical studies need to be interspaced with basic science studies to identify correlates of erythropoietin toxicity.
Charles Bennett, MD, PhD, is the AC Buehler Professor of Geriatrics and Economics at the Jesse Brown VA and Robert H. Lurie Comprehensive Cancer Center of Northwestern University Feinberg School of Medicine.