无进展生存率与CAR T细胞时代复发/耐药扩散大B细胞淋巴瘤的整体生存率密切相关
Alexander M Gorzewski1, Rebecca Z Steuer1, Charmi Trivedi1
1Brown University, 593 Eddy Street, Providence, RI 02903, USA.
Journal of cancer policy
|December 22, 2025
概括
在扩散性大B细胞淋巴瘤 (DLBCL) 试验中,即便使用CAR T细胞疗法,无进展生存率 (PFS) 仍然是整体生存率 (OS) 的强有力的替代品. 这证实了PFS在药物开发中用于复发/耐药DLBCL的有效性.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 扩散性大B细胞淋巴瘤 (DLBCL) 治疗已经被CAR T细胞疗法彻底改变.
- 在DLBCL临床试验中,无进展生存 (PFS) 是总生存 (OS) 的验证替代品.
- CAR T细胞治疗对PFS-OS相关性的影响需要评估.
研究的目的:
- 评估PFS作为复发性/耐火性 (R/R) DLBCL中OS的替代终点的实用性.
- 在CAR T细胞治疗时代评估PFS-OS相关性.
主要方法:
- 2015年之后开始的R/R DLBCL第三期随机临床试验的系统审查.
- 权重线性回归分析以评估PFS-OS相关性.
主要成果:
- 六项与1577名患者的试验符合纳入标准.
- 权重线性回归显示了PFS和OS之间的强烈关联 (R2 = 0.88,p=0.0054).
结论:
- 在R/R DLBCL中,PFS仍然是OS的有效和强大的替代终点.
- 支持在新的R/R DLBCL疗法的监管研究中继续使用PFS.
- 为卫生政策提供关于药物批准和对侵袭性淋巴瘤的补偿的信息.
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