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复发/难治性多发性骨髓瘤标准治疗 idecabtagene vicleucel 后的早期血细胞减少与感染

英文原题:Early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma.

查看英文原题

Early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma.

PubMed 2022/12/27(内容时间) Blood Adv Q1 · IF 7.7(JCR 2025)

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中文摘要

Idecabtagene vicleucel(ide-cel)于2021年3月获美国FDA批准,用于既往接受4线治疗后复发/难治性多发性骨髓瘤患者。KarMMa试验中,3级血细胞减少和感染较常见。

本研究旨在描述标准治疗(SOC)情境下ide-cel治疗后100天内的血细胞减少和感染。该多中心回顾性研究纳入52名接受SOC ide-cel的患者,其中47人完成第90天随访,数据随访截至第100天。第30天和第90天分别有65%和40%的患者存在3级血细胞减少。88%的患者接受粒细胞集落刺激因子(G-CSF),63%接受浓缩红细胞输注,42%接受血小板输注,21%接受血小板生成素(TPO)激动剂,13%接受静脉注射免疫球蛋白,8%接受CD34阳性干细胞加强输注。第100天时,仍有19%和13%的患者继续使用TPO激动剂和G-CSF。感染发生率为54%,其中23%为3级。治疗后前30天较早发生的感染通常为细菌感染(68%),且较严重(50%);第31~100天发生的后期感染中,50%为细菌感染、42%为病毒感染,仅13%为3级。单变量分析显示,CAR-T 前骨髓骨髓瘤负荷高(≥50%)、淋巴清除前外周血存在浆细胞,以及淋巴清除前3级贫血,均与第30和90天3级血细胞减少相关。末次桥接治疗至淋巴清除的间隔更长,是感染的唯一显著危险因素。

展开英文摘要原文

Idecabtagene vicleucel (ide-cel) was FDA-approved in March 2021 for the treatment of relapsed/refractory multiple myeloma after 4 lines of therapy. On the KarMMa trial, grade 3 cytopenias and infections were common.

We sought to characterize cytopenias and infections within 100 days after ide-cel in the standard-of-care (SOC) setting. This multi-center retrospective study included 52 patients who received SOC ide-cel; 47 reached day-90 follow-up. Data were censored at day 100. Grade 3 cytopenia was present among 65% of patients at day 30 and 40% of patients at day 90. Granulocyte colony stimulating factor (G-CSF) was administered to 88%, packed red blood cell transfusions to 63%, platelet transfusions to 42%, thrombopoietin (TPO) agonists to 21%, intravenous immunoglobulin to 13%, and CD34+ stem cell boosts to 8%.

At day 100, 19% and 13% of patients had ongoing use of TPO agonists and G-CSF, respectively. Infections occurred in 54% of patients and were grade 3 in 23%. Earlier infections in the first 30 days were typically bacterial (68%) and severe (50%). Later infections between days 31 and 100 were 50% bacterial and 42% viral; only 13% were grade 3.

On univariate analysis, high pre-CAR-T marrow myeloma burden ( 50%), circulating plasma cells at pre-lymphodepletion (LD), and grade 3 anemia at pre-LD were associated with grade 3 cytopenia at both days 30 and 90. Longer time from last bridging treatment to LD was the only significant risk factor for infection.

论文信息

作者
Logue JM、Peres LC、Hashmi H、Colin-Leitzinger CM、Shrewsbury AM、Hosoya H、Gonzalez RM、Copponex C
单位
Department of Blood and Marrow Transplant and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.United States
文献类型
多中心研究 · 美国 NIH 资助研究 · 非美国政府资助研究
期刊
Blood advances2022 Dec 27
原文标识
PubMed 35939783 · DOI 10.1182/bloodadvances.2022008320