Aapro Matti, Gascón Pere, Patel Kashyap, Rodgers George M, Fung Selwyn, Arantes Luiz H, Wish Jay
Genolier Cancer Centre, Clinique de Genolier, Genolier, Switzerland.
Division of Medical Oncology, Hospital Clinic, University of Barcelona, Barcelona, Spain.
Front Pharmacol. 2019 Jan 9;9:1498. doi: 10.3389/fphar.2018.01498. eCollection 2018.
Anemia is common in patients with cancer or with chronic kidney disease (CKD). Although the introduction of erythropoiesis-stimulating agents (ESAs) has transformed the management of anemia, their use has been complicated by a number of factors including frequent guideline updates, safety concerns and, in the United States, a Risk Evaluation and Mitigation Strategy (REMS) program, which aimed to ensure that the benefits of ESAs outweigh the risks. Many previous concerns around ESA use in cancer and CKD have been addressed by the reassuring results of post-approval studies, and biosimilar ESAs have been used in Europe for many years, with safety and efficacy profiles similar to originator products. This review describes the evolution of the use of ESAs from approval to the present day, discussing results from clinical studies of ESAs in cancer and CKD, and the influence of these findings on product labeling and guideline updates. We also discuss the impact of the introduction of ESA biosimilars in Europe, bringing cost savings and increased access to patients.
贫血在癌症患者或慢性肾脏病（CKD）患者中很常见。尽管促红细胞生成素（ESAs）的引入改变了贫血的治疗方式，但其使用因多种因素而变得复杂，包括频繁的指南更新、安全问题，以及在美国实施的风险评估与缓解策略（REMS）计划，该计划旨在确保ESAs的益处大于风险。先前许多关于ESAs在癌症和CKD中使用的担忧已通过批准后研究的令人安心的结果得到解决，生物类似物ESAs在欧洲已使用多年，其安全性和有效性与原研产品相似。本综述描述了ESAs从获批至今的使用演变，讨论了ESAs在癌症和CKD中的临床研究结果，以及这些发现对产品标签和指南更新的影响。我们还讨论了欧洲引入ESA生物类似物的影响，带来了成本节约并增加了患者的可及性。
