Department of Health Services, University of Washington, Seattle, WA.
Fred Hutchinson Cancer Research Center, Seattle, WA.
Blood Adv. 2021 Apr 27;5(8):2245-2255. doi: 10.1182/bloodadvances.2020003503.
CD19-directed chimeric antigen receptor (CAR) T-cell therapy has shown efficacy as a third-line or later treatment in patients with relapsed/refractory large B-cell lymphoma (LBCL). Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, we evaluated the impact of CAR T-cell treatment with lisocabtagene maraleucel (liso-cel) on health-related quality of life (HRQoL) and symptoms in patients with relapsed/refractory LBCL in the ongoing, open-label, nonrandomized TRANSCEND NHL 001 trial. Clinically meaningful improvement was observed in EORTC QLQ-C30 scores for global health status/QoL, based on a minimally important difference of 10 points at 2 to 18 months after liso-cel infusion. There were no clinically meaningful changes in physical functioning and pain, whereas clinically meaningful improvements were observed in fatigue at 2, 12, and 18 months. The proportion of patients with clinically meaningful improvement in global health status/QoL was generally higher for treatment responders than for nonresponders. A trend toward decreased mean EQ-5D-5L index scores was observed at 1 month after liso-cel infusion, followed by subsequent increases through 18 months. Mean EQ-5D-5L visual analog scale scores increased from 2 through 18 months. In summary, patients with relapsed/refractory LBCL treated with liso-cel had early, sustained, and clinically meaningful improvements in HRQoL and symptoms that correlated with antitumor activity. This study was registered at www.clinicaltrials.gov as #NCT02631044.
CD19 导向嵌合抗原受体 (CAR) T 细胞疗法已显示出作为三线或更后的治疗在复发/难治性大 B 细胞淋巴瘤 (LBCL) 患者中的疗效。使用欧洲癌症研究与治疗组织生活质量问卷 (EORTC QLQ-C30) 和欧洲五维健康量表 (EQ-5D-5L) 问卷，我们评估了在正在进行的、开放标签、非随机的 TRANSCEND NHL 001 试验中，利妥昔单抗卡马鲁单抗 (liso-cel) 治疗对复发/难治性 LBCL 患者健康相关生活质量 (HRQoL) 和症状的影响。在 liso-cel 输注后 2 至 18 个月，根据 10 分的最小临床重要差异，EORTC QLQ-C30 评分在全球健康状况/生活质量方面观察到有临床意义的改善。身体功能和疼痛方面没有临床意义的变化，而疲劳方面则观察到有临床意义的改善，在 2、12 和 18 个月时。在治疗反应者中，全球健康状况/生活质量有临床意义改善的患者比例通常高于无反应者。在 liso-cel 输注后 1 个月观察到平均 EQ-5D-5L 指数评分呈下降趋势，随后在 18 个月内持续增加。平均 EQ-5D-5L 视觉模拟评分从 2 个月增加到 18 个月。总之，接受 liso-cel 治疗的复发/难治性 LBCL 患者的 HRQoL 和症状有早期、持续和有临床意义的改善，与抗肿瘤活性相关。本研究在 www.clinicaltrials.gov 上注册为 #NCT02631044。
