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Guideline Updates

ASCO, ASH Guideline Supports Safety, Efficacy of Biosimilar for Managing Anemia

April 22, 2019

The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) released an updated practice guideline that suggests biosimilars of epoetin alfa—an erythropoiesis-stimulating agent (ESA)—may be offered to patients with chemotherapy-associated anemia whose cancer treatment in not meant to be curative.

In 2002, ASCO and ASH published their first guideline on ESAs in cancer care. Updates to the guideline came in 2007 and 2010. The latest 2019 update is the first to address biosimilars of epoetin alfa.

An expert panel reviewed meta-analyses and randomized controlled trials in patients with cancer or chronic kidney disease from January 2010 through May 2018, as well as cohort studies in patients with cancer due to limited randomized controlled trial evidence in the cancer setting. A total of 15 meta-analyses of randomized controlled trials and two randomized controlled trials were identified to guide the updated treatment recommendations.

The expert panel found that with respect to biosimilars, hemoglobin response and immunogenicity were outcomes of interest, along with the primary outcomes of mortality, frequency of red blood cell transfusion, thromboembolic risk, and progression-free survival.

The biosimilar literature review suggested that biosimilars of epoetin alfa have similar efficacy and safety to reference products, though evidence in cancer remains limited. The guideline recommends ESAs—including biosimilars—may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative and whose hemoglobin has declined to less than 10 g/dL. Red blood cell transfusion is also an option in this population, the guideline states.

ESAs should not be offered to most patients with nonchemotherapy-associated anemia, with the exception of selected patients with myelodysplastic syndromes, the panel recommends.

Additionally, the panel noted that during ESA treatment, hemoglobin may be increased to the lowest concentration needed to avoid transfusions. Iron replacement may be used to improve hemoglobin response and reduce red blood cell transfusions for patients receiving ESAs with or without iron deficiency.

“Ultimately, the choice of a particular agent will depend on cost, availability, convenience, and personal considerations or preference,” authors of the guideline wrote.—Zachary Bessette

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