CAR-T(CAR-T)细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Differences in lymphoma patients between chimeric antigen receptor T-cell therapy trials and the general population.
Differences in lymphoma patients between chimeric antigen receptor T-cell therapy trials and the general population.
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嵌合抗原受体(CAR)T 细胞疗法有望治疗非霍奇金淋巴瘤及 B 细胞淋巴瘤。然而,美国食品药品监督管理局批准的几种 CAR-T 疗法,其疗效仅在样本量较小的少数单臂临床试验中得到评估。
本研究比较这些试验患者与非霍奇金淋巴瘤和 B 细胞淋巴瘤总体患者群体的差异。研究者比较了系统综述纳入的 15 项 CAR-T 试验中 522 例患者,以及监测、流行病学和最终结果(SEER)项目数据库的 417,492 例患者。与 SEER 人群相比,CAR-T 试验参与者似乎年龄更轻(70 岁以下占 46.7% 对 42.2%)、男性比例更高(68.0% 对 55.7%),随访时间也更短(平均 [M] 45.6 个月,95% 置信区间 [CI] 随访 17.7–63.3 个月;SEER 人群平均生存期 57.1 个月,95% CI 57.0–57.3)。CAR-T 试验参与者可能与非霍奇金淋巴瘤和 B 细胞淋巴瘤总体患者存在显著差异,因此 CAR-T 在总体淋巴瘤患者中的疗效可能不同于试验所显示的疗效。新建 CAR-T 患者登记系统对于确定其人群层面的实际疗效至关重要。
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.
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