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慢性肾脏病与急性肾损伤对淋巴瘤患者 CAR-T 细胞治疗安全性与结局的影响

英文原题:Impact of Chronic Kidney Disease and Acute Kidney Injury on Safety and Outcomes of CAR T-Cell Therapy in Lymphoma Patients.

PubMed 2022/07/18(内容时间) Clin Lymphoma Myeloma Leuk Q1 · IF 4.1(JCR 2025)

研究概要

CAR-T后发生CKD或AKI对术后OS和PFS无影响。

研究思路结论见上方概要

CAR-T 细胞疗法是复发/难治性侵袭性B细胞非霍奇金淋巴瘤的标准治疗。关于CAR-T治疗前存在的慢性肾脏病(CKD)以及CAR-T治疗后发生的急性肾损伤(AKI)的影响,现有数据有限,我们试图在我们的患者中对此进行评估。

在这项单中心回顾性分析中,CKD队列定义为在CAR-T治疗前评估时依据KDIGO分期,eGFR <60 mL/min/1.73 m2(3期及以上)。其余患者构成无CKD组。AKI依据CTCAEv.4定义,数据提取至CAR-T治疗后第100天。主要结局为既往存在的CKD对无进展生存期(PFS)、总生存期(OS)和不良事件的影响。此外,我们还分析了AKI对PFS和OS的影响。

共识别出32例患者,其中7例存在既往CKD。在伴或不伴CKD的患者中,中位PFS分别为8.8个月和2.9个月(p值0.78)。中位OS分别为10个月和7个月(p值0.64)。CAR-T后共有9例患者(29%)发生AKI,包括7例基线无CKD的患者。未发生AKI和发生AKI的患者中位PFS分别为3.6个月和2.8个月(p值0.84)。中位OS按相同顺序分别为10个月和3.9个月(p值0.2)。单因素分析中,基线肌酐(p值0.018)和ICANS 2级及以上(p值0.016)与发生AKI风险增加相关。

展开英文摘要原文

INTRODUCTION: Chimeric antigen receptor T-cell (CAR-T) therapy is standard-of-care in relapse/refractory aggressive B-cell non-Hodgkin lymphoma. There are limited data regarding the impact of pre-existing chronic kidney disease (CKD) and acute kidney injury (AKI) post CAR-T and we sought to evaluate these in our patients. METHOD: In this single center retrospective analysis CKD cohort was defined KDIGO staging with eGFR of <60 mL/min/1.73 m2 (Stage ...3) at the time of pre-CAR-T assessment. Remaining patients constituted the no CKD group. AKI was defined by CTCAEv.4 and data were abstracted through Day 100 post-CAR-T therapy. The primary outcome was impact of pre-existing CKD on progression-free survival (PFS), overall survival (OS) and adverse events. Additionally, we also analyzed the impact of AKI on PFS and OS. RESULTS: Thirty-two patients were identified with 7 having pre-existing CKD. Among the patients with or without CKD, the median PFS was 8.8 and 2.9 months respectively (pvalue 0.78). The median OS was 10 and 7 months respectively (p-value 0.64). AKI developed in a total of 9 patients (29%) post CAR-T, including 7 patients without CKD at baseline. The median PFS was 3.6 and 2.8 months for patients not developing AKI and developing AKI (p-value 0.84). Median OS in similar order was 10 and 3.9 months respectively (p-value 0.2). On univariate analysis, creatinine at baseline (p-value 0.018) and ICANS grade 2+ (p-value 0.016) were associated with an increased risk of developing AKI. CONCLUSIONS: CKD or AKI after CAR-T showed no impact on post procedure OS and PFS.

论文信息

作者
Ahmed G、Bhasin-Chhabra B、Szabo A、Shah NN、Longo W、Dhakal B、Chhabra S、D'Souza A
第一作者单位
BMT and Cellular Therapy Program, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI.United States
通讯作者单位
BMT and Cellular Therapy Program, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI. Electronic address: mhamadani@mcw.edu.United States
期刊
Clinical lymphoma, myeloma & leukemia2022 Nov
原文标识
PubMed 35934632 · DOI 10.1016/j.clml.2022.07.007