Updated ASCO and ASH Guidelines on Managing Anemia Support Safety, Efficacy of Biosimilar ESAs

The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) first published their guidelines on erythropoiesis-stimulating agents (ESAs) in cancer care in 2002, with updates in 2007 and 2010, and the new update is the first to address biosimilar epoetin alfa.
 
The Center for Biosimilars Staff
April 16, 2019
The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) have issued an updated practice guideline on the use of erythropoiesis-stimulating agents (ESAs) in cancer care in which they state that the available literature suggests that biosimilars of epoetin alfa have similar efficacy and safety to reference agents and that both biosimilars and their references may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent.

ASCO and ASH first published their guidelines on ESAs in cancer care in 2002, with updates in 2007 and 2010, and the new update is the first to address biosimilar epoetin alfa.

In producing the 2019 guideline update, ASCO and ASH reviewed randomized controlled trials and meta-analyses on ESAs used in treating patients with cancer or chronic kidney disease, as well as cohort studies in patients with cancer, focusing on literature published between 2010 and 2018. An expert panel was convened to assess the evidence and revise previous recommendations.

With respect to biosimilars, hemoglobin response and immunogenicity were outcomes of interest in addition to the primary outcomes of mortality, frequency of red blood cell transfusion, thromboembolic risk, and progression-free survival.

The new guideline includes the moderate recommendation, on the basis of intermediate-quality evidence, that epoetin beta and alfa, darbepoetin, and biosimilar epoetin alfa are all equivalent with respect to their safety and efficacy.

“Based on limited evidence, it seems that compared with the originator, biosimilars of epoetin alfa are safe and effective,” write the authors. They add that biosimilar ESAs have been used in Europe for more than a decade without major concerns having arisen.

“Ultimately, the choice of a particular agent will depend on cost, availability, convenience, and personal considerations or preference,” they write.

Reference
Bohlius J, Bohlke K, Castelli R, et al. Management of cancer-associated anemia with erythropoiesis-stimulating agents: ASCO/ASH clinical practice guideline update. Blood Advances. 2019;3:1197-1210. doi: 10.1182/bloodadvances.2018030387.

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