达雷妥尤单抗单药治疗复发或难治性多发性骨髓瘤的真实世界中大量预处理患者的疗效。
Efficacy of daratumumab monotherapy in real-world heavily pretreated patients with relapsed or refractory multiple myeloma.
机构信息
Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland.
Department of Hematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.
出版信息
Adv Med Sci. 2019 Sep;64(2):349-355. doi: 10.1016/j.advms.2019.05.001. Epub 2019 May 21.
PURPOSE
Daratumumab is a promising new agent for relapsed/refractory multiple myeloma (RRMM). However, there are limited data on its clinical activity and tolerability in the real-world patients. The purpose of this study is to determine the efficacy and toxicity profile of daratumumab monotherapy in the real-life setting.
PATIENTS AND METHODS
Thirty RRMM patients treated with daratumumab who had previously received at least three treatment lines including a proteasome inhibitor and an immunomodulatory drug or had been double refractory (DRMM) were included to the Polish Myeloma Group observational study.
RESULTS
The objective response rate to daratumumab was 42.8%. Median progression-free survival (PFS) and overall survival reached 9.5 and 13.8 months, respectively. Importantly, patients with DR-MM had a significantly shorter PFS than other patients (median PFS of 4.1 vs. 12.1 months). Daratumumab was generally well tolerated, however two patients had their therapy interrupted due to adverse events.
CONCLUSION
Daratumumab monotherapy has significant activity and good tolerance in heavily pretreated RRMM patients.
目的
达雷妥尤单抗是一种有前途的复发性/难治性多发性骨髓瘤（RRMM）新药。然而，在真实世界的患者中，其临床疗效和耐受性的数据有限。本研究旨在确定达雷妥尤单抗单药治疗在真实环境中的疗效和毒性特征。
患者和方法
30 名接受过达雷妥尤单抗治疗的 RRMM 患者，这些患者此前至少接受过三线治疗，包括蛋白酶体抑制剂和免疫调节剂，或为双重难治（DRMM）患者，被纳入波兰骨髓瘤组观察性研究。
结果
达雷妥尤单抗的客观缓解率为 42.8%。中位无进展生存期（PFS）和总生存期分别达到 9.5 和 13.8 个月。重要的是，DR-MM 患者的 PFS 明显短于其他患者（中位 PFS 为 4.1 与 12.1 个月）。达雷妥尤单抗总体耐受性良好，但有两名患者因不良反应中断治疗。
结论
达雷妥尤单抗单药治疗在接受过多线治疗的 RRMM 患者中具有显著的疗效和良好的耐受性。
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