特克司他单抗对复发性或难治性 AL 淀粉样变性患者的安全性和有效性

IF 2.3 3区 医学 Q2 HEMATOLOGY
Margaret Stalker, Alfred Garfall, Adam Cohen, Dan T Vogl, Mia Djulbegovic, Sandra Susanibar-Adaniya, Edward Stadtmauer, Oxana Megherea, Adam J Waxman
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引用次数: 0

摘要

简介在MajesTEC-1研究中,特克司他单抗已对多发性骨髓瘤患者产生了深度反应。然而,特克司他单抗在AL淀粉样变性患者中的安全性和有效性尚不清楚:我们对宾夕法尼亚大学2022年12月至2024年2月期间接受替卡单抗治疗的活检证实复发/难治性AL淀粉样变性患者进行了回顾性分析。数据截止日期为2/29/24。不良事件(AE)从电子病历中提取。根据共识指南对患者进行血液学和器官反应评估:本病例系列共纳入八名患者:中位年龄 63 岁(59-67 岁不等),75% 为女性,88% 为白人。所有八名患者都至少获得了很好的部分反应(VGPR),游离轻链(FLC)恢复正常,其中六名患者(75%)的FLC水平检测不到。在完成免疫固定的六名患者中,所有六名患者(100%)都获得了血液学完全应答(hCR)。血液学 VGPR 和 hCR 的中位时间分别为 13 天(12-18 天)和 88 天(32-150 天)。随访时间的中位数为 8.5 个月(1-14 个月)。在五名心脏受累的患者中,四名(80%)获得了心脏反应。在7名肾脏受累的患者中,2名患者在使用替卡司他单抗前已经获得了肾脏反应,其余5名患者中,3名(60%)获得了肾脏反应。六名患者(75%)出现了低度细胞因子释放综合征(CRS)。没有患者出现 ICANS。分别有25%的患者出现中性粒细胞减少和AKI:结论:在这一系列患者中,替卡单抗显示出卓越的反应深度和良好的耐受性。特克司他单抗有望治疗复发的AL淀粉样变性患者。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and Efficacy of Teclistamab in Patients With Relapsed or Refractory AL Amyloidosis.

Introduction: Teclistamab has demonstrated deep responses in patients with multiple myeloma in the MajesTEC-1 study. However, the safety and efficacy of teclistamab in patients with AL amyloidosis are unknown.

Methods: We retrospectively analyzed patients with biopsy-proven relapsed/refractory AL amyloidosis who were treated with teclistamab from December 2022 to February 2024 at the University of Pennsylvania. The data cutoff was 2/29/24. Adverse events (AE) were extracted from the electronic medical record. Patients were assessed for hematologic and organ response per consensus guidelines.

Results: Eight patients were included in this case series: median age 63 (range 59-67), 75% female, 88% White. All eight patients achieved at least very good partial response (VGPR) and had normalization of free light chains (FLC), and six (75%) patients achieved undetectable FLC levels. Of the six patients with immunofixation completed, all six (100%) achieved hematologic complete response (hCR). The median time to hematologic VGPR and hCR was 13 days (range 12-18 days) and 88 days (range 32-150 days), respectively. The median duration of follow-up was 8.5 months (range 1-14 months). Of the five patients with cardiac involvement, four (80%) achieved a cardiac response. Of the seven patients with renal involvement, two patients already achieved renal response prior to teclistamab, and of the remaining five, three (60%) achieved renal response. Six patients (75%) developed low-grade cytokine release syndrome (CRS). No patients developed ICANS. Neutropenia and AKI both occurred in 25% of patients, respectively.

Conclusions: In this series of patients, teclistamab showed outstanding depth of response and was well-tolerated. Teclistamab shows promise in treating patients with relapsed AL amyloidosis.

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来源期刊
CiteScore
5.50
自引率
0.00%
发文量
168
审稿时长
4-8 weeks
期刊介绍: European Journal of Haematology is an international journal for communication of basic and clinical research in haematology. The journal welcomes manuscripts on molecular, cellular and clinical research on diseases of the blood, vascular and lymphatic tissue, and on basic molecular and cellular research related to normal development and function of the blood, vascular and lymphatic tissue. The journal also welcomes reviews on clinical haematology and basic research, case reports, and clinical pictures.
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