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Brexucabtagene Autoleucel:治疗套细胞淋巴瘤的新型 CAR-T 细胞疗法

英文原题:Brexucabtagene Autoleucel: A Novel Chimeric Antigen Receptor T-cell Therapy for the Treatment of Mantle Cell Lymphoma.

查看英文原题

Brexucabtagene Autoleucel: A Novel Chimeric Antigen Receptor T-cell Therapy for the Treatment of Mantle Cell Lymphoma.

PubMed 2021/08/02(内容时间) Ann Pharmacother Q3 · IF 2.5(JCR 2025)

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研究概要

Brexu-cel 已成为套细胞淋巴瘤(MCL)一种可行的治疗选择。

中文摘要

识别并评估现有关于brexucabtagene autoleucel(brexu-cel)治疗复发/难治性(r/r)套细胞淋巴瘤(MCL)的安全性、疗效和实际应用考量的文献。资料来源:以“brexucabtagene autoleucel”与“mantle cell lymphoma”或“KTE-X19”为检索词,在PubMed(建库至2021年5月1日)、EMBASE(建库至2021年5月1日)及ClinicalTrials.gov进行英文文献检索。研究筛选和数据提取:考虑纳入所有评估brexu-cel用于MCL的研究。数据综合:关键性ZUMA-2试验中,brexu-cel的客观缓解率和完全缓解率分别为85%和59%。高危亚组中结果一致。值得关注的治疗相关不良反应包括3级血细胞减少(94%)、免疫效应细胞相关神经毒性综合征(31%)和细胞因子释放综合征(15%)。brexu-cel的毒性特征与其他新型嵌合抗原受体(CAR)T细胞产品相似,未发现新的安全性信号。与患者照护及临床实践的相关性:目前尚无直接比较brexu-cel与其他获批后续治疗方案在r/r MCL中疗效的临床试验。一项规模相对较小的II期试验显示,brexu-cel在既往接受多线治疗、可行替代方案很少的患者中取得了显著缓解率。brexu-cel的长期安全性和疗效结局尚不明确。预防、识别和管理CAR-T 细胞特有毒性,需要训练有素的多学科团队提供专业照护。

brexu-cel已成为MCL的一种可行治疗选择。仍需更多研究确定其最佳治疗顺序及其在这种高度异质、病理生物学特征独特且不可治愈的恶性肿瘤治疗中的定位。

展开英文摘要原文

To identify and assess the current literature surrounding the safety, efficacy, and practical considerations of brexucabtagene autoleucel (brexu-cel) for the treatment of relapsed or refractory (r/r) mantle cell lymphoma (MCL). DATA SOURCES: An English-based literature search was conducted using the terms " brexucabtagene autoleucel " AND " mantle cell lymphoma " OR " KTE-X19 "in PubMed (inception through May 1, 2021), EMBASE (inception through May 1, 2021), and ClinicalTrials.gov. STUDY SELECTION AND DATA EXTRACTION: All studies evaluating the use of brexu-cel in MCL were considered for inclusion. DATA SYNTHESIS: In the pivotal ZUMA-2 trial, brexu-cel demonstrated objective response and complete response rates of 85% and 59%, respectively. These results were consistent among high-risk subgroups. Noteworthy treatment-related adverse effects included grade 3 cytopenias (94%), immune effector cell-associated neurotoxicity syndrome (31%), and cytokine release syndrome (15%). Brexu-cel elicited a toxicity profile similar to that of other novel chimeric antigen receptor (CAR) T-cell products, with no new safety signals. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: There are currently no head-to-head clinical trials evaluating brexu-cel against other approved subsequent-line options in r/r MCL. In a relatively small phase II trial, brexu-cel demonstrated impressive response rates in heavily pretreated patients, with few viable alternatives. Long-term safety and efficacy outcomes with brexu-cel are unknown. The prevention, identification, and management of unique CAR T-cell toxicities requires expert care from a well-trained interdisciplinary team.

Brexu-cel has emerged as a viable treatment option in MCL. Additional studies are required to determine the optimal sequencing and place in therapy for brexu-cel in this highly heterogeneous, pathobiologically distinct, and incurable malignancy.

论文信息

作者
Anderson MK、Torosyan A、Halford Z
第一作者单位
The Children's Hospital at Saint Francis, Tulsa, OK, USA.United States
通讯作者单位
Union University College of Pharmacy, Jackson, TN, USA.United States
文献类型
综述
期刊
The Annals of pharmacotherapy2022 May
原文标识
PubMed 34340597 · DOI 10.1177/10600280211026338