Chimeric antigen receptor (CAR) T-cell therapy has transformed the care of patients with relapsed/refractory B-cell-derived hematologic malignancies. To date, six CAR T-cell therapies, targeting either CD19 or B-cell maturation antigen, have received regulatory approval. Along with the promising survival benefit, CAR T-cell therapy is associated with potentially life-threatening adverse events, including cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. While clinical trials evaluating CAR T-cell therapy consistently report the incidence of these adverse events, most trials do not collect health-related quality of life (HRQoL) data. As such, the impact of the CAR T-cell therapy process and related adverse events on the physical and psychological well-being of patients remains uncertain. HRQoL and other patient-reported outcome (PRO) assessments in patients with relapsed or refractory hematologic malignancies are of utmost importance, as individuals may have unmet needs and a high demand for tolerable therapy if a cure is not obtained. In addition, it is important to standardize methods of data collection to better assess the impact of CAR T-cell therapy on quality of life, optimize patients' care and costs, and enable comparisons between different studies. We conducted a literature search up to June 2023 to identify the HRQoL tools used in clinical trials and in real-world studies investigating CAR T-cell therapy in patients with lymphomas or leukemias. In the present comprehensive review, we summarize the most commonly used CAR T-cell specific and non-specific HRQoL tools and discuss how the use of HRQoL and other PRO tools may be optimized.

中文翻译：

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嵌合抗原受体 T 细胞疗法治疗血液恶性肿瘤患者的健康相关生活质量：回顾和当前进展。


嵌合抗原受体 (CAR) T 细胞疗法改变了复发/难治性 B 细胞源性血液恶性肿瘤患者的护理。迄今为止，六种针对 CD19 或 B 细胞成熟抗原的 CAR T 细胞疗法已获得监管部门批准。除了有希望的生存益处外，CAR T 细胞疗法还可能导致危及生命的不良事件，包括细胞因子释放综合征和免疫效应细胞相关的神经毒性综合征。虽然评估 CAR T 细胞疗法的临床试验一致报告了这些不良事件的发生率，但大多数试验并未收集与健康相关的生活质量 (HRQoL) 数据。因此，CAR T细胞治疗过程和相关不良事件对患者身心健康的影响仍不确定。复发或难治性血液恶性肿瘤患者的 HRQoL 和其他患者报告结果 (PRO) 评估至关重要，因为如果未治愈，个体可能会有未满足的需求和对可耐受治疗的高需求。此外，标准化数据收集方法也很重要，以便更好地评估 CAR T 细胞疗法对生活质量的影响，优化患者护理和成本，并能够在不同研究之间进行比较。我们进行了截至 2023 年 6 月的文献检索，以确定临床试验和研究淋巴瘤或白血病患者 CAR T 细胞疗法的现实研究中使用的 HRQoL 工具。在本次综合综述中，我们总结了最常用的 CAR T 细胞特异性和非特异性 HRQoL 工具，并讨论了如何优化 HRQoL 和其他 PRO 工具的使用。