The use of erythropoiesis-stimulating agents (ESAs) including biosimilars can be administered to patients with non-curative cancer and chemotherapy-associated anemia, according to a study published in Journal of Clinical Oncology.
While administering ESAs to manage anemia raises hemoglobin (HgB) levels and decreases the need for RBC transfusions, they also augment the risk of thromboembolic events. The risk of ESAs prompted the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) to issue a joint evidence-based clinical practice guideline for ESA use in cancer patients with anemia in 2002 – followed by subsequent updates in 2007 and 2010. Due to the emergence of additional information pertaining to the safety and efficacy of ESAs, and the expansion of treatment options with the approval of a biosimilar of epoetin alfa, a guideline update is warranted.
In this study, researchers sought to update the ASCO and ASH guidelines for oncology patients using ESAs. They canvassed PubMed and the Cochrane Library for Randomized Controlled Trials (RCTs) and meta-analyses of RCTs performed on cancer patients. To qualify, the trials had to be published between January 31, 2010 and May 14, 2018, must have assessed the efficacy and safety of ESAs in treating cancer, as well included a minimum of 50 patients per arm. With respect to the question of biosimilars, the same databases were searched for RCTs and meta-analyses of RCTs conducted on patients with cancer or chronic kidney disease (CKD) or cancer cohort studies. Frequency of RBC transfusion, thromboembolic risk, and progression-free survival were the primary outcomes for all questions, while the outcomes of interest for biosimilars were HgB response and immunogenicity. The study’s secondary outcomes were quality of life, fatigue, and overall survival. The primary literature review comprised 15 meta-analyses of RCTs accompanied by two RCTs.
The results of the literate review suggest that adding iron to treatment with an ESA may improve blood stem cell response while reducing the odds of having to undergo RBC transfusion. Regarding biosimilars, the review results indicate that biosimilars of epoetin alfa exhibit comparable safety and efficacy to reference originator products. However, the study notes that “(biosimilar) evidence in cancer remains limited.”