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嵌合抗原受体 T 细胞治疗试验与普通人群中淋巴瘤患者的差异。

Differences in lymphoma patients between chimeric antigen receptor T-cell therapy trials and the general population.

机构信息

Southern California Evidence-Based Practice Center, RAND Corporation, 1776 Main St, Santa Monica, CA, 90401-3208, USA.

Center for the Study of Healthcare Innovation, Implementation and Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.

出版信息

Clin Exp Med. 2022 Feb;22(1):151-155. doi: 10.1007/s10238-021-00724-w. Epub 2021 May 17.

Abstract

Chimeric antigen receptor (CAR)-T cell therapies appear to be promising treatments for non-Hodgkin's and B-cell lymphoma. However, several CAR-T therapies approved by the US Food and Drug Administration have only been tested for efficacy in relatively few single-arm clinical trials with small sample sizes. We sought to examine the differences between patients in these trials and the general population of patients with non-Hodgkin's and B-cell lymphoma. Five hundred and twenty-two patients from 15 CAR-T trials found in a systematic review and 417,492 patients from the Surveillance, Epidemiology, and End Results (SEER) Program database were compared. CAR-T study participants appeared to be younger (46.7% under 70 years old vs. 42.2%), more male (68.0% vs. 55.7%), and followed for a shorter period of time compared to patients in the SEER population (mean [M] 45.6 months, 95% confidence interval [CI] 17.7 to 63.3 months follow-up vs. M 57.1 months, 95% CI 57.0 to 57.3 months survival). CAR-T study participants may differ significantly from the general population of patients with non-Hodgkin's and B-cell lymphoma. Effectiveness of CAR-T therapies in the general population of lymphoma patients may differ from effectiveness demonstrated in trials. Newly created CAR-T patient registries are essential to establishing population-level effectiveness of the therapies.

摘要

嵌合抗原受体 (CAR)-T 细胞疗法似乎是治疗非霍奇金淋巴瘤和 B 细胞淋巴瘤的有前途的方法。然而,美国食品和药物管理局批准的几种 CAR-T 疗法仅在少数样本量较小的单臂临床试验中测试了疗效。我们试图研究这些试验中的患者与非霍奇金淋巴瘤和 B 细胞淋巴瘤的一般人群之间的差异。从系统评价中发现的 15 项 CAR-T 试验中,有 522 名患者和监测、流行病学和最终结果 (SEER) 计划数据库中的 417,492 名患者进行了比较。与 SEER 人群中的患者相比,CAR-T 研究参与者似乎更年轻(46.7%年龄在 70 岁以下,而 42.2%年龄在 70 岁以下),男性更多(68.0%,而 55.7%),随访时间更短(平均 [M]45.6 个月,95%置信区间 [CI]17.7 至 63.3 个月随访,而 M57.1 个月,95%CI57.0 至 57.3 个月生存)。CAR-T 研究参与者与非霍奇金淋巴瘤和 B 细胞淋巴瘤的一般人群可能有很大的不同。CAR-T 疗法在淋巴瘤患者一般人群中的有效性可能与临床试验中证明的有效性不同。新创建的 CAR-T 患者登记册对于确定这些疗法的人群水平有效性至关重要。

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