慢性肾脏病和急性肾损伤对淋巴瘤患者 CAR T 细胞治疗的安全性和结局的影响。

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

机构信息

BMT and Cellular Therapy Program, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI.

Division of Nephrology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI.

出版信息

Clin Lymphoma Myeloma Leuk. 2022 Nov;22(11):863-868. doi: 10.1016/j.clml.2022.07.007. Epub 2022 Jul 18.

DOI:10.1016/j.clml.2022.07.007

PMID:35934632

Abstract

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.

摘要

简介

嵌合抗原受体 T 细胞（CAR-T）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方法。关于 CAR-T 后预先存在的慢性肾脏病（CKD）和急性肾损伤（AKI）的影响的数据有限，我们试图在我们的患者中评估这些。

方法

在这项单中心回顾性分析中，CKD 队列根据 KDIGO 分期定义，在 CAR-T 前评估时 eGFR<60mL/min/1.73m2（阶段...3）。其余患者构成无 CKD 组。AKI 由 CTCAEv.4 定义，并通过 CAR-T 治疗后第 100 天的数据进行分析。主要结局是预先存在的 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。

结果

确定了 32 名患者，其中 7 名患有预先存在的 CKD。在有或没有 CKD 的患者中，中位 PFS 分别为 8.8 和 2.9 个月（p 值为 0.78）。中位 OS 分别为 10 和 7 个月（p 值为 0.64）。CAR-T 后共发生 AKI 9 例（29%），其中基线时无 CKD 7 例。未发生 AKI 和发生 AKI 的患者的中位 PFS 分别为 3.6 和 2.8 个月（p 值为 0.84）。中位 OS 也相似，分别为 10 和 3.9 个月（p 值为 0.2）。单因素分析显示，基线时的肌酐（p 值为 0.018）和 ICANS 等级 2+（p 值为 0.016）与 AKI 发生风险增加相关。