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探索新获批的利妥昔单抗在套细胞淋巴瘤治疗中的风险与益处。

Navigating the risks and benefits of newly approved Lisocabtagene Maraleucel in mantle cell lymphoma treatment.

作者信息

Khan Ayesha, Khan Maryam, Rana Muhammad Owais, Haque Md Ariful

机构信息

Dow University of Health Sciences, Karachi, Pakistan.

Department of Public Health, Atish Dipankar University of Science and Technology, Dhaka, Bangladesh.

出版信息

Ann Med Surg (Lond). 2025 Apr 25;87(6):3073-3075. doi: 10.1097/MS9.0000000000003325. eCollection 2025 Jun.

DOI:10.1097/MS9.0000000000003325
PMID:40486643
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12140671/
Abstract

Mantle cell lymphoma (MCL) is a rare disorder that comprises 5-10% of non-Hodgkin's lymphoma, with an increasing incidence of about 1-2 cases per 100 000 people. It is characterized by cyclin D1 mutation. The intricate genomic landscape and cells' proliferation history contribute to its clinical heterogeneity. Multiple treatments often result in relapse and resistance owing to various mutations. To overcome the need for therapies in patients with relapsed/refractory (R/R) МСL, amidst increasing resistance to other treatment options, the Food and Drug Administration (FDA) approved Lisocabtagene Maraleucel (Lіѕо-Сеl) on 30 May 2024. In the clinical trial, Lisocabtagene Maraleucel showcased a high response rate and a manageable safety profile. However, severe adverse events were also observed, highlighting the need for risk and mitigation analysis before administration. Additionally, long-term studies evaluating its comparative efficacy and safety against existing therapies are needed, and more defined guidelines for managing high-risk patients are required.

摘要

套细胞淋巴瘤(MCL)是一种罕见疾病,占非霍奇金淋巴瘤的5%-10%,发病率呈上升趋势,约为每10万人中有1-2例。其特征为细胞周期蛋白D1突变。复杂的基因组格局和细胞增殖史导致了其临床异质性。由于各种突变,多种治疗方法常常导致复发和耐药。为了满足复发/难治性(R/R)MCL患者的治疗需求,在对其他治疗选择的耐药性不断增加的情况下,美国食品药品监督管理局(FDA)于2024年5月30日批准了利索卡妥基因马罗芦卡(Liso-Cel)。在临床试验中,利索卡妥基因马罗芦卡显示出高缓解率和可控的安全性。然而,也观察到了严重不良事件,这凸显了给药前进行风险和缓解分析的必要性。此外,需要进行长期研究以评估其与现有疗法相比的疗效和安全性,并且需要更明确的高危患者管理指南。

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本文引用的文献

1
Lisocabtagene Maraleucel in Relapsed/Refractory Mantle Cell Lymphoma: Primary Analysis of the Mantle Cell Lymphoma Cohort From TRANSCEND NHL 001, a Phase I Multicenter Seamless Design Study.利妥昔单抗注射用冻干粉在复发/难治性套细胞淋巴瘤中的应用:TRANSCEND NHL 001 研究中套细胞淋巴瘤队列的初步分析,这是一项 I 期多中心无缝设计研究。
J Clin Oncol. 2024 Apr 1;42(10):1146-1157. doi: 10.1200/JCO.23.02214. Epub 2023 Dec 10.
2
The shifting therapeutic paradigm for relapsed/refractory mantle cell lymphoma.复发/难治性套细胞淋巴瘤治疗模式的转变。
Leuk Res. 2023 Nov;134:107385. doi: 10.1016/j.leukres.2023.107385. Epub 2023 Sep 1.
3
Pirtobrutinib in Covalent Bruton Tyrosine Kinase Inhibitor Pretreated Mantle-Cell Lymphoma.泊鲁替尼治疗共价布鲁顿酪氨酸激酶抑制剂预处理的套细胞淋巴瘤。
J Clin Oncol. 2023 Aug 20;41(24):3988-3997. doi: 10.1200/JCO.23.00562. Epub 2023 May 16.
4
Genetic mutations and features of mantle cell lymphoma: a systematic review and meta-analysis.套细胞淋巴瘤的基因突变和特征:系统评价和荟萃分析。
Blood Adv. 2020 Jul 14;4(13):2927-2938. doi: 10.1182/bloodadvances.2019001350.
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KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma.KTE-X19 嵌合抗原受体 T 细胞疗法治疗复发或难治性套细胞淋巴瘤。
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Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.新诊断及复发的套细胞淋巴瘤:ESMO诊断、治疗及随访临床实践指南
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Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.新诊断及复发的套细胞淋巴瘤:ESMO 诊断、治疗及随访临床实践指南
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