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替本他富在转移性葡萄膜黑色素瘤中的疗效与耐受性:一项真实世界回顾性多中心研究

Efficacy and Tolerability of Tebentafusp in Metastatic Uveal Melanoma: A Real-life Retrospective Multicentre Study.

作者信息

Vitek Lucille, Goronflot Thomas, Dutriaux Caroline, Deleuze Antoine, Le Corre Yannick, Duval-Modeste Anne-Bénédicte, Fresnard Cécile, Jeudy Géraldine, Lamoureux Anouck, Gaudy-Marqueste Caroline, Legoupil Delphine, Baroudjian Barouyr, L'Orphelin Jean-Matthieu, Peuvrel Lucie, Khammari Amir, Mortier Laurent, Quereux Gaëlle

机构信息

Department of Dermatology, CHU de Nantes, Nantes, France.

Nantes University, Pôle Hospitalo-Universitaire 11: Santé Publique, Clinique des Données, INSERM, CIC 1413, CHU Nantes, Nantes, France.

出版信息

Acta Derm Venereol. 2024 Dec 12;104:adv41297. doi: 10.2340/actadv.v104.41297.

DOI:10.2340/actadv.v104.41297
PMID:39670438
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11681141/
Abstract

Metastatic uveal melanoma is a rare disease with a poor prognosis. Usual treatments have not proven effective. Tebentafusp, a bispecific protein targeting melanoma cells and T lymphocytes, is the first approved treatment with a proven survival benefit in a randomized clinical. Our purpose was to evaluate tebentafusp's real-life efficacy and tolerability for metastatic uveal melanoma. This retrospective study included patients from 14 French centres. Twenty-three patients were included. One-year survival was 66%; median progression-free survival was 5.7 months. Objective response rate was 23% and best overall response was complete remission for 4% of patients; partial remission for 18%, stable disease for 41%, and progressive disease for 36%. The most frequent adverse events were fever, chills, pruritus, and rash; 30% experienced severe adverse events. No death or treatment discontinuation was linked to adverse events. These data showed better overall survival with tebentafusp than that reported in historical cohorts.

摘要

转移性葡萄膜黑色素瘤是一种罕见疾病,预后较差。常规治疗方法尚未证实有效。替贝福单抗是一种靶向黑色素瘤细胞和T淋巴细胞的双特异性蛋白,是首个在随机临床试验中被证实具有生存获益的获批治疗药物。我们的目的是评估替贝福单抗对转移性葡萄膜黑色素瘤的实际疗效和耐受性。这项回顾性研究纳入了来自法国14个中心的患者。共纳入23例患者。1年生存率为66%;无进展生存期的中位数为5.7个月。客观缓解率为23%,最佳总体缓解情况为4%的患者完全缓解;18%的患者部分缓解,41%的患者病情稳定,36%的患者病情进展。最常见的不良事件为发热、寒战、瘙痒和皮疹;30%的患者发生严重不良事件。未出现与不良事件相关的死亡或治疗中断情况。这些数据表明,与历史队列报告相比,替贝福单抗治疗的总生存期更好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70e5/11681141/c1772979f527/ActaDV-104-41297-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70e5/11681141/ef04851e4034/ActaDV-104-41297-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70e5/11681141/f2d6b52c8532/ActaDV-104-41297-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70e5/11681141/c1772979f527/ActaDV-104-41297-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70e5/11681141/ef04851e4034/ActaDV-104-41297-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70e5/11681141/f2d6b52c8532/ActaDV-104-41297-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70e5/11681141/c1772979f527/ActaDV-104-41297-g003.jpg

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本文引用的文献

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N Engl J Med. 2023 Dec 14;389(24):2256-2266. doi: 10.1056/NEJMoa2304753. Epub 2023 Oct 21.
2
Tebentafusp in Patients with Metastatic Uveal Melanoma: A Real-Life Retrospective Multicenter Study.替本他阜治疗转移性葡萄膜黑色素瘤患者:一项真实世界回顾性多中心研究
Cancers (Basel). 2023 Jun 30;15(13):3430. doi: 10.3390/cancers15133430.
3
Is tebentafusp superior to combined immune checkpoint blockade and other systemic treatments in metastatic uveal melanoma? A comparative efficacy analysis with population adjustment.
在转移性葡萄膜黑色素瘤中,替贝福单抗是否优于联合免疫检查点阻断及其他全身治疗?一项进行了人群校正的疗效对比分析。
Cancer Treat Rev. 2023 Apr;115:102543. doi: 10.1016/j.ctrv.2023.102543. Epub 2023 Mar 13.
4
Advances in the clinical management of uveal melanoma.葡萄膜黑色素瘤的临床治疗进展。
Nat Rev Clin Oncol. 2023 Feb;20(2):99-115. doi: 10.1038/s41571-022-00714-1. Epub 2023 Jan 4.
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Clinical and molecular response to tebentafusp in previously treated patients with metastatic uveal melanoma: a phase 2 trial.特泊替尼治疗既往治疗转移性葡萄膜黑色素瘤患者的临床和分子应答:一项 2 期试验。
Nat Med. 2022 Nov;28(11):2364-2373. doi: 10.1038/s41591-022-02015-7. Epub 2022 Oct 13.
6
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J Clin Oncol. 2022 Jun 10;40(17):1939-1948. doi: 10.1200/JCO.21.01805. Epub 2022 Mar 7.
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