Suppr超能文献

替西他单抗在复发或难治性AL淀粉样变性患者中的安全性和有效性

Safety and Efficacy of Teclistamab in Patients With Relapsed or Refractory AL Amyloidosis.

作者信息

Stalker Margaret, Garfall Alfred, Cohen Adam, Vogl Dan T, Djulbegovic Mia, Susanibar-Adaniya Sandra, Stadtmauer Edward, Megherea Oxana, Waxman Adam J

机构信息

Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Division of Hematology and Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

出版信息

Eur J Haematol. 2025 Mar;114(3):443-447. doi: 10.1111/ejh.14348. Epub 2024 Nov 17.

Abstract

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.

摘要

引言

在MajesTEC-1研究中,替雷利珠单抗已在多发性骨髓瘤患者中显示出深度缓解。然而,替雷利珠单抗在AL淀粉样变性患者中的安全性和有效性尚不清楚。

方法

我们回顾性分析了2022年12月至2024年2月在宾夕法尼亚大学接受替雷利珠单抗治疗的经活检证实为复发/难治性AL淀粉样变性患者。数据截止日期为2024年2月29日。不良事件(AE)从电子病历中提取。根据共识指南对患者的血液学和器官反应进行评估。

结果

本病例系列纳入了8名患者:中位年龄63岁(范围59-67岁),75%为女性,88%为白人。所有8名患者均至少达到非常好的部分缓解(VGPR),游离轻链(FLC)正常化,6名(75%)患者的FLC水平检测不到。在完成免疫固定的6名患者中,所有6名(100%)均达到血液学完全缓解(hCR)。达到血液学VGPR和hCR的中位时间分别为13天(范围12-18天)和88天(范围32-150天)。中位随访时间为8.5个月(范围1-14个月)。在5名有心脏受累的患者中,4名(80%)实现了心脏反应。在7名有肾脏受累的患者中,2名患者在接受替雷利珠单抗治疗前已实现肾脏反应,其余5名患者中,3名(60%)实现了肾脏反应。6名患者(75%)发生了低级别细胞因子释放综合征(CRS)。没有患者发生免疫效应细胞相关神经毒性综合征(ICANS)。中性粒细胞减少症和急性肾损伤的发生率均为25%。

结论

在这一系列患者中,替雷利珠单抗显示出出色的缓解深度且耐受性良好。替雷利珠单抗在治疗复发的AL淀粉样变性患者方面显示出前景。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da96/11798760/5d2af14bef87/EJH-114-443-g001.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验