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基于达雷妥尤单抗方案治疗多发性骨髓瘤患者的静脉血栓栓塞症:3 期临床试验分析。

Venous thromboembolism in patients with multiple myeloma receiving daratumumab-based regimens: a analysis of phase 3 clinical trials.

机构信息

Department of Internal Medicine, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA.

出版信息

Leuk Lymphoma. 2021 Sep;62(9):2219-2226. doi: 10.1080/10428194.2021.1910687. Epub 2021 Apr 9.

Abstract

It is unknown if daratumumab could affect venous thromboembolism (VTE) risks in patients with multiple myeloma (MM). In this study, individual participant data from three trials comparing daratumumab (DARA) and non-DARA regimens, the CASTOR, PULLOX and MAIA trial, were pooled into two groups. A total of 896 and 899 patients received DARA and non-DARA regimens, respectively. After a median follow-up of 13.9 and 13.5 months, there was no significant difference in VTE incidence between the two groups (hazard ratio 0.80, 95% confidence interval 0.57-1.13,  = 0.17). The two groups shared similar VTE risk factors. The SAVED score and IMPEDE-VTE score are two validated VTE risk-stratification tools in MM. In the DARA group, the SAVED score had better performance than the IMPEDE-VTE score in identifying high risk patients.

摘要

尚不清楚达雷妥尤单抗是否会影响多发性骨髓瘤(MM)患者的静脉血栓栓塞(VTE)风险。在这项研究中,将 CASTOR、PULLOX 和 MAIA 试验中比较达雷妥尤单抗(DARA)和非 DARA 方案的三个试验的个体参与者数据汇总为两组。共有 896 名和 899 名患者分别接受了 DARA 和非 DARA 方案治疗。中位随访 13.9 和 13.5 个月后,两组的 VTE 发生率无显著差异(风险比 0.80,95%置信区间 0.57-1.13,P=0.17)。两组具有相似的 VTE 危险因素。SAVED 评分和 IMPEDE-VTE 评分是 MM 中两种经过验证的 VTE 风险分层工具。在 DARA 组中,SAVED 评分在识别高危患者方面优于 IMPEDE-VTE 评分。

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