嵌合抗原受体 T 细胞疗法并发症的管理:欧洲血液和骨髓移植协会的报告。
Management of complications of chimeric antigen receptor T-cell therapy: a report by the European Society of Blood and Marrow Transplantation.
发表日期:2024 May 30
作者:
Olaf Penack, Christophe Peczynski, William Boreland, Daniel Wolff, Ivan Moiseev, Hélène Schoemans, Christian Koenecke, Charlotte Graham, Zinaida Peric
来源:
HAEMATOLOGICA
摘要:
CAR-T 细胞在临床上标准用于治疗复发性或难治性血液恶性肿瘤,例如非霍奇金淋巴瘤、多发性骨髓瘤和急性淋巴细胞白血病。由于 CAR-T 细胞治疗领域的快速发展以及缺乏普遍接受的治疗指南,我们假设欧洲中心之间在短期和长期并发症的预防、诊断和管理方面存在显着差异。为了了解 EBMT 中心当前 CAR-T 细胞管理情况并确定未来临床研究的医疗需求和具体领域,EBMT 移植并发症工作组对 227 个 EBMT CAR-T 细胞中心进行了调查。我们收到了来自 106 个中心 (47%) 的完整答复,解决了产品选择、CAR-T 细胞物流、细胞因子释放综合征和免疫效应细胞相关神经毒性综合征的管理以及后期管理(包括长期血细胞减少症)等领域的问题。我们确定了并发症管理的常见模式,但也发现了各中心临床管理在重要方面的显着差异。我们的结果表明,以下领域对治疗协调和未来临床研究有很高的医疗需求:类固醇难治性和非常严重的 CRS/神经毒性的治疗、血细胞减少症的治疗、早期出院和门诊管理以及免疫球蛋白替代。
CAR-T cells are in standard clinical use to treat relapsed or refractory hematologic malignancies, such as non-Hodgkin's lymphoma, multiple myeloma and acute lymphoblastic leukemia. Owing to the rapidly progressing field of CAR-T cell therapy and the lack of generally accepted treatment guidelines, we hypothesized significant differences between European centers in prevention, diagnosis and management of short- and long-term complications. To capture the current CAR-T cell management among EBMT centers and to determine the medical need and specific areas for future clinical research the EBMT Transplant Complications Working Party performed a survey among 227 EBMT CAR-T cell centers. We received complete servey answers from 106 centers (47%) addressing questions in the areas of product selection, CAR-T cell logistics, management of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome as well as management in later phases including prolonged cytopenias. We identified common patterns in complication management, but also significant variety in clinical management of the centers in important aspects. Our results demonstrate a high medical need for treatment harmonization and future clinical research in the following areas: treatment of steroid-refractory and very severe CRS/neurotoxicity, treatment of cytopenia, early discharge and outpatient management, as well as immunoglobulin substitution.