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重度预处理复发/难治性多发性骨髓瘤患者接受 ciltacabtagene autoleucel 后的血细胞减少和感染

英文原题:Cytopenias and infections following ciltacabtagene autoleucel in heavily pretreated relapsed or refractory multiple myeloma.

查看英文原题

Cytopenias and infections following ciltacabtagene autoleucel in heavily pretreated relapsed or refractory multiple myeloma.

PubMed 2025/07/10(内容时间) Haematologica Q1 · IF 8.2(JCR 2025)

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中文摘要

西达基奥仑赛(cilta-cel)于2022年2月获美国食品药品监督管理局批准,用于治疗接受过四线治疗后的复发/难治性多发性骨髓瘤。在CARTITUDE-1试验中,≥3级血细胞减少和感染较为常见。

在此,我们旨在描述标准治疗背景下cilta-cel输注后血细胞减少和感染的特征。这项多中心回顾性研究纳入105例接受cilta-cel治疗的患者;91例随访至第90天,49例随访至第180天。第30天时52%的患者存在≥3级血细胞减少,第90天时为24%。根据较新的免疫效应细胞相关血液毒性(ICAHT)中性粒细胞减少严重程度分级,11例患者(10%)在最初30天内发生≥3级早期ICAHT,而仅3例(3.3%)在第30天后发生≥3级晚期ICAHT。单因素分析显示,采集时任何级别的血小板减少均与第30天和第90天的≥3级血细胞减少相关。65%的患者接受了粒细胞集落刺激因子,38%接受了输血支持,10%接受了血小板生成素激动剂,52%接受了静脉注射免疫球蛋白,9.5%的患者接受了CD34+干细胞补充。49%的患者发生感染,其中32%为严重感染。最初30天内的早期感染中细菌性(42%)和病毒性(42%)各占一半。第31-100天及第100天后的晚期感染大多为病毒性(分别为59%和60%),各时间段中仅32%和12%为≥3级。单因素分析显示,淋巴细胞清除时较差的东部肿瘤协作组体能状态、较高的细胞因子释放综合征最高分级、迟发性神经毒性、类固醇和阿那白滞素的使用,以及第90天较低的IgA水平与严重感染相关。

展开英文摘要原文

Ciltacabtagene autoleucel (cilta-cel) was approved by the Food and Drug Administration in February 2022 for the treatment of relapsed/refractory multiple myeloma after four lines of therapy. On the CARTITUDE-1 trial, grade ≥3 cytopenias and infections were common.

Herein, we sought to characterize cytopenias and infections after cilta-cel infusion in the standardof- care setting. This multicenter, retrospective study included 105 patients who received cilta-cel; 91 reached day 90 and 49 reached day 180 of follow-up. Grade ≥3 cytopenia was present among 52% of patients on day 30, and 24% of patients on day 90. Based on the newer immune effector cell-associated hematotoxicity (ICAHT) grading for neutropenia severity, 11 patients (10%) experienced grade ≥3 early ICAHT in the first 30 days, while only three (3. 3%) experienced grade ≥3 late ICAHT after day 30. On univariate analysis, any grade thrombocytopenia at apheresis was associated with grade ≥3 cytopenia at both days 30 and 90.

Granulocyte colony-stimulating factor was administered to 65%, transfusion support to 38%, thrombopoietin agonists to 10%, intravenous immunoglobulins to 52%, and CD34+ stem cell boosts to 9. 5% of patients. Infections occurred in 49% of patients and were severe in 32%. Earlier infections in the first 30 days were equally bacterial (42%) and viral (42%).

Later infections between days 31-100 and after day 100 were mostly viral (59% and 60%, respectively), with only 32% and 12% being grade ≥3 in each time period. On univariate analysis, worse Eastern Cooperative Oncology Group performance status at lymphodepletion, higher maximum grade of cytokine-release syndrome, delayed neurotoxicity, steroid and anakinra use, and lower IgA levels at day 90 were associated with severe infections.

论文信息

作者
Dima D、Logue JM、Waqar SHB、Peres LC、Colin-Leitzinger CM、De Avila G、Smith EC、Skelson L
第一作者单位
University of Washington, Fred Hutch Cancer Center, Seattle, WA.United States
通讯作者单位
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL. Doris.Hansen@moffitt.org.United States
文献类型
多中心研究 · 美国 NIH 资助研究
期刊
Haematologica2026 Jan 1
原文标识
PubMed 40637727 · DOI 10.3324/haematol.2025.287783