Cejalvo María J, Ribas Paz, de la Rubia Javier
a Hematology Service , University Hospital Doctor Peset , Valencia , Spain.
b Medical Department, Division of Hematology , Universidad Católica de Valencia "San Vicente Mártir" , Valencia , Spain.
Expert Opin Drug Saf. 2017 Jun;16(6):753-760. doi: 10.1080/14740338.2017.1328053. Epub 2017 May 22.
The overall survival of patients with multiple myeloma (MM) has changed dramatically in the last decade. MM remains an incurable plasma cell disorder but immunotherapy with monoclonal antibodies (MoAbs) has emerged as a promising treatment. Areas covered: Fully published, clinical trials including patients with relapsed or refractory MM were reviewed. Safety data of daratumumab (DARA) single-agent or in combination regimens have been addressed. Additionally, infusion-related reactions, data on special populations, and DARA-interference with laboratory testing, including assessment of MM response in patients have also been addressed. Expert opinion: Daratumumab both as single agent and in combination regimens has shown a favorable safety profile without significant increase in toxicities. Extensive clinical development of DARA is currently ongoing and given the efficacy that has been seen with this drug in clinical trials, DARA is likely to change the landscape of myeloma treatment.
在过去十年中,多发性骨髓瘤(MM)患者的总生存期发生了巨大变化。MM仍然是一种无法治愈的浆细胞疾病,但单克隆抗体(MoAbs)免疫疗法已成为一种有前景的治疗方法。涵盖领域:对已完全发表的包括复发或难治性MM患者的临床试验进行了综述。讨论了达雷妥尤单抗(DARA)单药或联合方案的安全性数据。此外,还讨论了输注相关反应、特殊人群数据以及DARA对实验室检测的干扰,包括对患者MM反应的评估。专家意见:达雷妥尤单抗单药及联合方案均显示出良好的安全性,毒性无显著增加。目前DARA正在进行广泛的临床开发,鉴于该药物在临床试验中已观察到的疗效,DARA可能会改变骨髓瘤治疗的格局。