Respiratory Oncology Unit (Pulmonology) and Leuven Lung Cancer Group University Hospital Gasthuisberg, Catholic University, Leuven, Belgium.
Ther Clin Risk Manag. 2006 Jun;2(2):175-86. doi: 10.2147/tcrm.2006.2.2.175.
Anemia is frequent in cancer patients with chemotherapy, and has an important negative effect on health-related quality of life (QoL). Darbepoetin alfa belongs to a new class of erythropoietic proteins with a unique molecular structure and interesting properties compared with classic recombinant human erythropoietin. Darbepoetin alfa is effective for chemotherapy-induced anemia when administered once weekly at a dose of 2.25 mug/kg, as shown in two large phase III placebo-controlled trials in patients with solid tumors and hematological malignancies. Furthermore, it was safe and well tolerated. More recently attention has been focused on optimizing Darbepoetin alfa therapy. Front-loaded dosing was explored to accelerate the hemoglobin (Hb) response and effect on QoL, but this idea could not be confirmed in a large phase III study. Based on the prolonged half-life of Darbepoetin alfa, administration every 3 weeks was appealing. In a large phase III trial, noninferiority of administration of 500 mug every 3 weeks compared with the weekly dosing could be confirmed, both in terms of reduction of red blood cell transfusion, Hb parameters, and QoL. This schedule is very convenient for patients and caregivers as it allows synchronization of erythropoietic therapy and common chemotherapy schedules. Questions for future study are the optimal iron supplementation strategy and the effect of Darbepoetin alfa on outcome. This article reviews the clinical development of Darbepoetin alfa with emphasis on recent data.
贫血在接受化疗的癌症患者中很常见，对健康相关生活质量（QoL）有重要的负面影响。达贝泊汀 α 属于一种新型红细胞生成素蛋白，与经典的重组人红细胞生成素相比，具有独特的分子结构和有趣的特性。达贝泊汀 α 在每周一次、剂量为 2.25μg/kg 时，对化疗引起的贫血有效，这在两项大型 III 期安慰剂对照试验中得到了证实，这些试验的患者包括实体瘤和血液恶性肿瘤患者。此外，它的安全性和耐受性良好。最近，人们更加关注优化达贝泊汀 α 的治疗方案。研究人员探索了负荷剂量给药方案，以加快血红蛋白（Hb）反应和对 QoL 的影响，但在一项大型 III 期研究中，这一想法并未得到证实。基于达贝泊汀 α 的延长半衰期，每 3 周给药的方案具有吸引力。在一项大型 III 期试验中，每 3 周给予 500μg 与每周剂量方案相比，可以确认其非劣效性，在减少红细胞输注、Hb 参数和 QoL 方面都是如此。这种方案对患者和护理人员非常方便，因为它可以使红细胞生成素治疗与常见化疗方案同步进行。未来研究的问题是最佳的铁补充策略和达贝泊汀 α 对结局的影响。本文回顾了达贝泊汀 α 的临床开发情况，重点介绍了最近的数据。
