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:6-month Progression-Free Survival (PFS6) as a prognostic factor in large B-cell lymphoma patients undergoing chimeric antigen receptor T-cell therapy: A real-world multicenter study.
6-month Progression-Free Survival (PFS6) as a prognostic factor in large B-cell lymphoma patients undergoing chimeric antigen receptor T-cell therapy: A real-world multicenter study.
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CAR-T 细胞疗法显著改善了复发/难治性大B细胞淋巴瘤(R/R LBCL)的总生存期(OS)。然而,R/R LBCL患者接受CAR-T 细胞治疗后的结局相关因素尚未完全阐明。且支持使用早期终点评估疗效和长期生存的证据有限。6个月无进展生存期(PFS6)定义为CAR-T 细胞输注后6个月内存活且无复发或进展。
我们旨在通过分析2家医院71例接受CAR-T 治疗的R/R LBCL患者数据,评估按PFS6分层的OS。后续OS定义为从PFS6时点或6个月内进展时点至死亡。其中,58%达到PFS6。与未达到PFS6的患者相比,1年OS分别为91.3% vs. 40.2%,2年OS分别为91.3% vs. 32.1%。达到PFS6的患者结局优异,而较早进展的患者生存较差。PFS失败的关键预测因素包括年龄较大(> 60)(P = 0.040,OR:3.40,95%CI:1.06 10.93)、输注前血红蛋白水平较低(P = 0.019,OR:0.27,95%CI:0.09 0.81)和IFN-水平较高(P = 0.022,OR:2.00,95% CI:1.66 4.08)。这一发现有助于风险分层,并支持将PFS6作为临床试验的替代终点。
Chimeric antigen receptor T-cell (CAR-T) therapy has significantly improved overall survival (OS) in relapsed or refractory large B-cell lymphomas (R/R LBCL).
However, factors associated with outcomes of CAR-T cell therapy in patients with R/R LBCL have not been fully elucidated. And limited evidence supports the use of early endpoints to evaluate the efficacy and long-term survival. Progression-free survival (PFS) at 6 months (PFS6) was defined as being alive and free of relapse or progression within 6 months of CAR-T cell infusion.
We aimed to assessed OS stratified by PFS6 by analyzing data from 71 R/R LBCL patients treated with CAR-T therapy across 2 hospitals. Subsequent OS was defined from the time of PFS6 or progression within 6 months to death. Among them, 58% reached PFS6. Compared with patients failed to achieve PFS6, 1-year OS was 91. 3% vs. 40. 2% and 2-year OS was 91. 3% vs. 32. 1%, respectively.
Patients achieving PFS6 had excellent outcome, whereas patients exhibiting earlier progression had a poor survival. Key predictors of PFS failure included older age (> 60) (P = 0. 040, OR:3. 40, 95%CI:1. 06 10. 93), lower pretransfusion hemoglobin level (P = 0. 019 OR:0. 27, 95%CI:0. 09 0. 81), and higher IFN- level (P = 0. 022, OR:2. 00, 95% CI:1. 66 4. 08). This insight could aid in risk stratification and support the use of PFS6 as a surrogate endpoint in clinical trials.
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