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代表性不足人群中嵌合抗原受体 T 细胞临床试验的可及性:儿科和青年急性淋巴细胞白血病患者的多中心队列研究。

Access to Chimeric Antigen Receptor T Cell Clinical Trials in Underrepresented Populations: A Multicenter Cohort Study of Pediatric and Young Adult Acute Lymphobastic Leukemia Patients.

机构信息

Division of Hematology and Oncology, University of Washington, Seattle Children's Hospital, Seattle, Washington; Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, Washington.

Division of Pediatric Allergy, Immunology, and Blood & Marrow Transplantation, UCSF Benioff Children's Hospitals, San Francisco, California.

出版信息

Transplant Cell Ther. 2023 Jun;29(6):356.e1-356.e7. doi: 10.1016/j.jtct.2023.03.022. Epub 2023 Mar 24.

Abstract

Chimeric antigen receptor T cell (CAR-T) therapy is a promising approach to improve survival for children and adults with relapsed/refractory (r/r) B cell acute lymphoblastic leukemia (B-ALL), but these clinical trials might not be equally accessible to patients of low socioeconomic status (SES) or to patients from racial or ethnic minority groups. We sought to describe the sociodemographic characteristics of pediatric and adolescent and young adult (AYA) patients enrolled in CAR-T clinical trials and to compare these characteristics to those of other patients with r/r B-ALL. We conducted a multicenter retrospective cohort study at 5 pediatric consortium sites to compare the sociodemographic characteristics of patients treated and enrolled in CAR-T trials at their home institution, other patients with r/r B-ALL treated at these sites, and patients referred from an external hospital for CAR-T trials. The patients were age 0 to 27 years with r/r B-ALL treated at 1 of the consortium sites between 2012 and 2018. Clinical and demographic data were collected from the electronic health record. We calculated distance from home to treating institution and assigned SES scores based on census tract. Among the 337 patients treated for r/r B-ALL, 112 were referred from an external hospital to a consortium site and enrolled in a CAR-T trial and 225 were treated primarily at a consortium site, with 34% enrolled in a CAR-T trial. Patients treated primarily at a consortium site had similar characteristics regardless of trial enrollment. Lower proportions of Hispanic patients (37% versus 56%; P = .03), patients whose preferred language was Spanish (8% versus 22%; P = .006), and publicly insured patients (38% versus 65%; P = .001) were referred from an external hospital than were treated primarily at a consortium site and enrolled in a CAR-T trial. Patients who are Hispanic, Spanish-speaking, or publicly insured are underrepresented in referrals from external hospitals to CAR-T centers. External provider implicit bias also may influence referral of these patients. Establishing partnerships between CAR-T centers and external hospital sites may improve provider familiarity, patient referral, and patient access to CAR-T clinical trials.

摘要

嵌合抗原受体 T 细胞 (CAR-T) 疗法是提高复发/难治性 (r/r) B 细胞急性淋巴细胞白血病 (B-ALL) 儿童和成人生存率的一种有前途的方法,但这些临床试验可能对社会经济地位 (SES) 较低的患者或来自少数族裔的患者并不平等。我们旨在描述参与 CAR-T 临床试验的儿科和青少年及年轻成人 (AYA) 患者的社会人口统计学特征,并将这些特征与其他 r/r B-ALL 患者进行比较。我们在 5 个儿科联盟站点进行了一项多中心回顾性队列研究,以比较在家机构接受治疗和入组 CAR-T 试验的患者、在这些站点接受治疗的其他 r/r B-ALL 患者以及从外部医院转诊接受 CAR-T 试验的患者的社会人口统计学特征。患者年龄在 0 至 27 岁之间,2012 年至 2018 年在联盟站点之一接受 r/r B-ALL 治疗。从电子健康记录中收集临床和人口统计学数据。我们根据普查区计算离家到治疗机构的距离,并根据普查区分配 SES 分数。在 337 名接受 r/r B-ALL 治疗的患者中,有 112 名从外部医院转诊至联盟站点并入组 CAR-T 试验,225 名主要在联盟站点接受治疗,其中 34%入组 CAR-T 试验。无论是否入组试验,主要在联盟站点接受治疗的患者具有相似的特征。从外部医院转诊的患者中,西班牙裔患者比例较低 (37%比 56%;P=.03)、首选语言为西班牙语的患者比例较低 (8%比 22%;P=.006)、公共保险患者比例较低 (38%比 65%;P=.001),而主要在联盟站点接受治疗并入组 CAR-T 试验的患者比例较高。西班牙语裔、讲西班牙语或有公共保险的患者在从外部医院转诊到 CAR-T 中心的患者中代表性不足。外部提供者的隐性偏见也可能影响这些患者的转诊。在 CAR-T 中心和外部医院之间建立伙伴关系可能会提高提供者的熟悉程度、患者转诊和患者获得 CAR-T 临床试验的机会。

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