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
CAR-T 细胞时代复发/难治性弥漫大 B 细胞淋巴瘤中无进展生存期与总生存期强相关
英文原题：Progression-free survival is strongly associated with overall survival in relapsed/refractory diffuse large B-cell lymphoma in the CAR T-cell era.
查看英文原题
Progression-free survival is strongly associated with overall survival in relapsed/refractory diffuse large B-cell lymphoma in the CAR T-cell era.
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研究概要
这些发现提供证据表明，在当代 R/R DLBCL 治疗格局中，PFS 仍是 OS 有效且强有力的替代终点。这支持继续将 PFS 作为 R/R DLBCL 新疗法监管研究的主要终点，并为关于侵袭性淋巴瘤药物批准、保险覆盖和报销决策的卫生政策讨论提供了重要信息。
研究思路结论见上方概要
背景
在弥漫性大B细胞淋巴瘤（DLBCL）的临床试验中，无进展生存期（PFS）已被用作经过验证的替代终点，以帮助加速药物开发和监管审批。嵌合抗原受体（CAR）T细胞疗法的出现彻底改变了治疗格局，可能延长进展后生存期并削弱PFS与总生存期（OS）之间的相关性。本研究评估在CAR-T 细胞时代，PFS作为复发/难治性（R/R）DLBCL中OS替代终点的效用。
方法
对2015年之后启动的针对R/R DLBCL的3期随机临床试验进行了系统综述。采用加权线性回归分析评估PFS与OS之间的相关性。
结果
六项试验，共1577名患者，符合纳入标准。加权线性回归显示决定系数（R²）为0.88（p = 0.0054），表明自CAR-T 细胞疗法引入以来，在R/R DLBCL试验中PFS与OS之间存在强关联。
展开英文摘要原文
MATERIALS AND METHODS
A systematic review of Phase 3 randomized clinical trials for R/R DLBCL initiated after 2015 was conducted. A weighted linear regression analysis was performed to assess the correlation between PFS and OS.
RESULTS
Six trials, comprising 1577 patients, met the inclusion criteria. Weighted linear regression demonstrated a coefficient of determination (R ) of 0.88 (p = 0.0054), indicating a strong association between PFS and OS in R/R DLBCL trials conducted since the introduction of CAR T-cell therapy. DISCUSSION: These findings provide evidence that PFS remains a valid and strong surrogate endpoint for OS in the contemporary R/R DLBCL treatment landscape. This supports the continued use of PFS as a primary endpoint in regulatory studies for new therapies for R/R DLBCL and provides important information for health policy discussions on drug approval, insurance coverage, and reimbursement decisions for aggressive lymphomas.
论文信息
- 作者
- Gorzewski AM、Steuer RZ、Trivedi C、Mandi K、Raker CA、Milrod CJ、Pelcovits AR
- 单位
- Brown University, 593 Eddy Street, Providence, RI 02903, USA. Electronic address: alexander_gorzewski@brown.edu.United States
- 文献类型
- 系统综述
- 期刊
- Journal of cancer policy2026 Mar
- 原文标识
- PubMed 41429401 · DOI 10.1016/j.jcpo.2025.100699