二线复发性或耐火性大B细胞淋巴瘤的利索卡巴基因maraleucel:来自PILOT研究的患者报告的结果
Leo I Gordon1, Fei Fei Liu2, Julia Braverman2
1Northwestern University, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, Chicago, IL. l-gordon@northwestern.edu.
Haematologica
|August 30, 2023
概括
化学抗原受体 (CAR) T细胞治疗 lisocabtagene maraleucel (liso-cel) 改善了复发或耐药的大B细胞淋巴瘤患者的健康相关生活质量. 这些发现支持 liso-cel作为首选的二线治疗选择.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
背景情况:
- 复发性或耐药性大B细胞淋巴瘤 (R/R LBCL) 提出了重大治疗挑战,特别是对于那些不符合血液造血干细胞移植 (HSCT) 资格的患者.
- 化学抗原受体 (CAR) T细胞疗法已成为R / R LBCL的有前途的治疗方式.
- 利索卡巴丁基马拉莱塞尔 (liso-cel) 是一种自主CD19导向的4-1BBCART细胞疗法.
研究的目的:
- 评估二线利索卡巴丁基马拉莱塞尔 (liso-cel) 对R/RLBCL患者与健康相关的生活质量 (HRQOL) 的影响.
- 用验证的患者报告的结果仪器来评估HRQOL变化.
- 为了确定利索细胞治疗是否能在这个患者群体中维持或改善HRQOL.
主要方法:
- 该分析是在单臂,开放标签,多中心,II期PILOT研究 (NCT03483103) 中进行的.
- 患者接受了利索-细胞作为二线治疗.
- 在预先指定的时间点使用EORTC QLQ-C30,FACT-LymS和EQ-5D-5L仪器评估HRQOL.
主要成果:
- 在大多数治疗后访问中,在EORTC QLQ-C30疲劳和FACT-LymS中观察到临床上有意义的改善.
- 与基线相比,在EORTC QLQ-C30疲劳,疼痛,食欲丧失,FACT-LymS和EQ VAS测试中,在545日内发现了显著的改善.
- 患者内部分析显示,大多数患者在关键时间点 (90天,180天,270天和365天) 维持或改善HRQOL.
结论:
- 用 lisocabtagene maraleucel (liso-cel) 进行的二线治疗表明,在不用于HSCT的R/R LBCL患者中,持续或改善了与健康有关的生活质量.
- 这些HRQOL发现补充了疗效和安全性数据,支持 liso-cel作为首选的二线选择.
- 该研究强调了在R/R LBCL治疗决策中考虑HRQOL的重要性.
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