Cheng Rebecca, Scippa Kayla, Locke Frederick L, Snider Julia Thornton, Jim Heather
ZS Associates, Thousand Oaks, CA, USA.
ZS Associates, Princeton, NJ, USA.
Oncol Ther. 2022 Jun;10(1):123-141. doi: 10.1007/s40487-021-00174-0. Epub 2021 Nov 15.
Chimeric antigen receptor T-cell (CAR T) therapy offers a potentially curative option for patients with relapsed and refractory hematologic malignancies, including diffuse large B-cell lymphoma (DLBCL). Patient-reported experiences with CAR T therapy are limited and have not been well characterized. The purpose of this qualitative study was to explore patient descriptions of key domains of health-related quality of life (HRQoL) in DLBCL patients treated with CAR T therapy.
A targeted literature review was initially conducted to inform the development of the interview guide comprising predetermined open-ended questions. Two focus groups were conducted with a total of 18 patients with DLBCL identified from patient advisory boards. Focus group sessions were recorded and transcribed verbatim. MAXQDA 18.2.0 qualitative data analysis software was utilized to facilitate a constant-comparative coding process to identify key concepts.
Eight domain impairments (social functioning, emotional functioning, fatigue, physical functioning, cognitive functioning, role functioning, sleep, and pain/discomfort) were identified from the qualitative analysis and endorsed by DLBCL patients treated with CAR T. Compared with before CAR T therapy, patients reported increased impairment in every domain during or immediately after CAR T therapy. This impairment improved for each domain 6 months after CAR T therapy except for pain/discomfort. Compared with before CAR T therapy, improvement in impairment for each domain was observed 6 months after CAR T therapy except for fatigue, sleep, and pain/discomfort.
This study provides meaningful information regarding the impact of CAR T therapy on HRQoL in patients with DLBCL throughout their treatment journey. Health care professionals and investigators can utilize these data in examining existing patient-reported outcome (PRO) measures that are used in DLBCL clinical trials and to better understand the needs of DLBCL survivors.
嵌合抗原受体T细胞（CAR T）疗法为复发难治性血液系统恶性肿瘤患者提供了一种潜在的治愈选择，包括弥漫性大B细胞淋巴瘤（DLBCL）。患者报告的CAR T疗法体验有限，且尚未得到充分描述。这项定性研究的目的是探索接受CAR T疗法的DLBCL患者对健康相关生活质量（HRQoL）关键领域的描述。
最初进行了有针对性的文献综述，以指导访谈指南的制定，该指南包括预先确定的开放式问题。对从患者咨询委员会中确定的总共18名DLBCL患者进行了两个焦点小组访谈。焦点小组会议进行了录音，并逐字转录。使用MAXQDA 18.2.0定性数据分析软件促进持续比较编码过程，以识别关键概念。
通过定性分析确定了八个领域的损害（社会功能、情绪功能、疲劳、身体功能、认知功能、角色功能、睡眠和疼痛/不适），并得到接受CAR T治疗的DLBCL患者的认可。与CAR T治疗前相比，患者报告在CAR T治疗期间或治疗后立即每个领域的损害都有所增加。除疼痛/不适外，CAR T治疗6个月后每个领域的这种损害都有所改善。与CAR T治疗前相比，CAR T治疗6个月后除疲劳、睡眠和疼痛/不适外，每个领域的损害都有所改善。
本研究提供了关于CAR T疗法在整个治疗过程中对DLBCL患者HRQoL影响的有意义信息。医疗保健专业人员和研究人员可以利用这些数据来检查DLBCL临床试验中使用的现有患者报告结局（PRO）指标，并更好地了解DLBCL幸存者的需求。
