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弥漫性大 B 细胞淋巴瘤患者接受 CD19 导向嵌合抗原受体 T 细胞治疗后的真实世界治疗模式。

Real-World Treatment Patterns After CD19-Directed CAR T Cell Therapy Among Patients with Diffuse Large B Cell Lymphoma.

机构信息

Regeneron Pharmaceuticals, Inc, 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.

Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.

出版信息

Adv Ther. 2022 Jun;39(6):2630-2640. doi: 10.1007/s12325-022-02087-4. Epub 2022 Apr 9.

DOI:10.1007/s12325-022-02087-4
PMID:35397110
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9123047/
Abstract

INTRODUCTION

CD19-directed chimeric antigen receptor T cells (CAR T) are approved for treatment of adults with relapsed/refractory diffuse large B cell lymphoma (DLBCL) following at least two lines of therapy.

METHODS

This study describes real-world treatment patterns after CAR T in adults with DLBCL. It includes adults diagnosed with DLBCL in IBM MarketScan Commercial and Medicare Supplemental healthcare claims databases administered CAR T between 2017 and 2019 (index event) and at least 6 months of continuous health plan enrollment pre-index. Kaplan-Meier methods were used to estimate risk and time to first subsequent treatment after CAR T, as a proxy for CAR T failure.

RESULTS

Among 129 patients meeting study criteria, most (123; 95.4%) were hospitalized during CAR T therapy. Median length of stay was 17 (25th-75th percentile, 13-22) days. Estimated 6-month risk of subsequent treatment was 36.2% (95% confidence interval [CI] 27.1-45.8%). During median follow-up of 195 (25th-75th percentile, 102-362) days, median time to the first line of therapy after CAR T, accounting for censoring, was 378 days (95% CI 226, not reached). Among 48 patients who received another therapy after CAR T, 58.3% received immunotherapy, 50.0% radiation therapy, 25.0% chemotherapy, 25.0% targeted therapy, and 12.5% hematopoietic stem cell transplant.

CONCLUSIONS

Among real-world patients with DLBCL treated with CAR T, the risk of not achieving a durable response is considerable; additional, effective options for DLBCL salvage treatment are needed.

摘要

简介

嵌合抗原受体 T 细胞(CAR T)针对至少接受过两种治疗方案后复发/难治性弥漫性大 B 细胞淋巴瘤(DLBCL)的成人患者已被批准使用。

方法

本研究描述了接受 CAR T 治疗的成人 DLBCL 患者的真实世界治疗模式。它包括在 2017 年至 2019 年期间(索引事件)在 IBM MarketScan 商业和 Medicare 补充医疗保健索赔数据库中接受 CAR T 治疗的、被诊断为 DLBCL 的成年人,以及至少 6 个月的索引前连续健康计划参保。采用 Kaplan-Meier 方法估计 CAR T 后首次后续治疗的风险和时间,作为 CAR T 失败的替代指标。

结果

在符合研究标准的 129 名患者中,大多数(123 名;95.4%)在接受 CAR T 治疗期间住院。中位住院时间为 17 天(25 百分位至 75 百分位,13-22)。估计 6 个月时后续治疗的风险为 36.2%(95%置信区间[CI]27.1-45.8%)。在 CAR T 后中位随访 195 天(25 百分位至 75 百分位,102-362)期间,考虑到删失,CAR T 后首次治疗的中位时间为 378 天(95%CI226,未达到)。在 48 名接受 CAR T 后接受另一种治疗的患者中,58.3%接受了免疫治疗,50.0%接受了放射治疗,25.0%接受了化疗,25.0%接受了靶向治疗,12.5%接受了造血干细胞移植。

结论

在接受 CAR T 治疗的真实世界 DLBCL 患者中,无法实现持久缓解的风险相当大;需要针对 DLBCL 挽救治疗的其他有效选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac44/9123047/8fd07f494dbf/12325_2022_2087_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac44/9123047/8fd07f494dbf/12325_2022_2087_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac44/9123047/8fd07f494dbf/12325_2022_2087_Fig1_HTML.jpg

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Am J Hematol. 2021 Oct 1;96(10):E386-E389. doi: 10.1002/ajh.26293. Epub 2021 Jul 29.