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.
CAR-T(CAR-T)细胞在血液系统恶性肿瘤中的应用推动了这种免疫治疗形式的显著进展。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:A Prospective Population-Based Study of Chimeric Antigen Receptor T-Cell Therapy for Patients with Diffuse Large B-Cell Lymphoma.
A Prospective Population-Based Study of Chimeric Antigen Receptor T-Cell Therapy for Patients with Diffuse Large B-Cell Lymphoma.
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背景:CAR-T 细胞疗法已成为弥漫性大B细胞淋巴瘤(DLBCL)的新标准治疗,但缺少纳入常规医疗卫生资源利用(HRU)的研究。因此,我们利用加拿大安大略省链接行政数据库开展人群研究。纳入两线全身治疗失败的DLBCL患者。采用Cox比例风险模型评估协变量与总生存期(OS)的关联,并通过逻辑回归、二项回归和Poisson回归分析协变量与毒性及HRU的关系。我们识别出308例接受CAR-T 治疗的患者,其中255例实际接受输注(平均年龄59岁;女性占39%)。自CAR-T 输注日起,中位OS为25.0个月(95% CI,21.6–28.1个月)。155例患者具有细胞因子释放综合征和免疫效应细胞相关神经毒性综合征数据,分别有135例(87.1%)和42例(27.1%)发生相应毒性。接受CAR-T 细胞治疗者中,172例(67%)住院,中位住院时间5天(四分位距0–20天);243例(95%)曾就诊急诊但未住院。本前瞻性人群研究显示,真实世界CAR-T 疗效和安全性与关键性试验相近,并表明常规临床照护中该疗法是DLBCL患者有效且相对安全的治疗选择。
Chimeric antigen receptor (CAR) T-cell therapy is a new standard of care for patients with diffuse large B-cell lymphoma (DLBCL); however, studies including healthcare resource utilization (HRU) during routine care are lacking. Accordingly, a population-based study was conducted using linked administrative databases from Ontario, Canada.
Patients with DLBCL that failed 2 lines of systemic therapy were included. Cox proportional hazard models estimated associations between covariates and overall survival (OS). Logistic, binomial and Poisson regression explored associations between covariates with toxicity and HRU.
We identified 308 patients enrolled to receive CAR T-cell therapy of which 255 patients received CAR T-cells (mean age 59 years; 39% female). From the date of CAR T-cell infusion, the median OS was 25. 0 months (95% CI, 21. 6-28. 1 months).
Cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome data were available for 155 patients and were reported in 135 (87. 1%) and 42 (27. 1%) patients, respectively. Of those that received CAR-T cells, 172 patients (67%) were hospitalized with a median length of stay of 5 days (IQR, 0-20) and 243 (95%) had an emergency department visit without hospitalization.
Our prospective population-based study demonstrates comparable efficacy and safety of CAR T-cell therapy in the real-world to the pivotal trials and highlights this as an efficacious and relatively safe treatment option for patients with DLBCL in routine clinical care.
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