COLUMBIA, SC — Erythropoiesis-stimulating agents were indicated for use in patients with cancer who receive noncurative myelosuppressive chemotherapy, with the intention of mitigating symptoms and side effects to decrease the need for red blood cell transfusions. More recently, safety concerns have been raised.
The Food and Drug Administration’s Oncology Drug Advisory Committee addressed ESA use in meetings between 2004 and 2008, while. FDA safety-focused regulatory actions occurred in 2007 and 2008. In 2007, black box warnings advised of early death and venous thromboembolism risks with ESAs in oncology.
In 2010, a Risk Evaluation Strategies (REMS) program was initiated, requiring cancer patient consent that they understand that mortality and VTE risks are increased with ESA.
A report in PLoS One looked at what effect those warnings about ESA utilization had on VA cancer patients with chemotherapy-induced anemia. University of South Carolina-led researchers employed data were from the VA database from 2003 to 2012. Rates of use of epoetin and darbepoetin were defined as primary outcomes.1
Results indicated that ESA use fell by 95% and 90% from 2005, for epoetin and darbepoetin, from 22% and 11%, respectively, to 1% and 1%, respectively, among cancer patients with chemotherapy-induced anemia.
Following REMS initiation in 2010, researchers report that mean hematocrit levels at ESA initiation decreased from 30% to 21%. They noted that black box warnings preceded decreased ESA use among VA cancer patients with chemotherapy-induced anemia, and that REMS was followed by reduced hematocrit levels at ESA initiation.
“Our findings contrast with privately- insured and Medicaid insured cancer patient data on chemotherapy-induced anemia where ESA use decreased to 3% to 7% by 2010-2012,” the authors added.
Yet, that wasn’t the end of the story, researchers pointed out, explaining, “By 2012, the era of ESA administration to VA to cancer patients had ended but the warnings remain relevant and significant. In 2019, oncology/hematology national guidelines (ASCO/ASH) recommend that cancer patients with chemotherapy-induced anemia should receive ESAs or red blood cell transfusions after risk-benefit evaluation.”
- Hoque S, Chen BJ, Schoen MW, et al. End of an era of administering erythropoiesis stimulating agents among Veterans Administration cancer patients with chemotherapy-induced anemia. PLoS One. 2020;15(6):e0234541. Published 2020 Jun 25. doi:10.1371/journal.pone.0234541