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新获批的 Lisocabtagene Maraleucel 在套细胞淋巴瘤治疗中的风险与获益评估

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

查看英文原题

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

PubMed 2025/04/25(内容时间) Ann Med Surg (Lond) Q2 · IF 1.6(JCR 2025)

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中文摘要

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%,发病率约为每10万人1-2例,且呈上升趋势。其特征是cyclin D1突变。复杂的基因组景观和细胞增殖历史导致其临床异质性。由于多种突变,多种治疗常导致复发和耐药。为满足复发/难治性(R/R)MCL患者的治疗需求,在其他治疗选择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Lisocabtagene Maraleucel(Liso-Cel)。在临床试验中,Lisocabtagene Maraleucel显示出高缓解率和可控的安全性特征。然而,也观察到了严重不良事件,凸显了在给药前进行风险和缓解分析的必要性。此外,需要评估其与现有疗法相比疗效和安全性的长期研究,并且需要更明确的指南来管理高风险患者。

展开英文摘要原文

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.

论文信息

作者
Khan A、Khan M、Rana MO、Haque MA
第一作者单位
Dow University of Health Sciences, Karachi, Pakistan.Pakistan
通讯作者单位
Department of Public Health, Atish Dipankar University of Science and Technology, Dhaka, Bangladesh.Bangladesh
文献类型
社论
期刊
Annals of medicine and surgery (2012)2025 Jun
原文标识
PubMed 40486643 · DOI 10.1097/MS9.0000000000003325