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特普替尼治疗转移性葡萄膜黑色素瘤患者的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of tebentafusp in patients with metastatic uveal melanoma: A systematic review and meta-analysis.

机构信息

Department of Dermatology, Xiangya Hospital, Central South University, Changsha, China.

National Engineering Research Center of Personalized Diagnostic and Therapeutic Technology, Changsha, China.

出版信息

Hum Vaccin Immunother. 2024 Dec 31;20(1):2374647. doi: 10.1080/21645515.2024.2374647. Epub 2024 Jul 14.

Abstract

Patients with metastatic uveal melanoma (mUM) have a poor prognosis, and few appropriate medications are available. Tebentafusp is approved by the Food and Drug Administration for mUM recently. However, the real efficacy and safety of tebentafusp are still unclear. We searched PubMed, Embase, and Cochrane Library from inception to March 20, 2024. The research was reported based on the preferred reporting items for systematic reviews and meta-analysis guidelines. We used random effects models to aggregate data on the response rates and adverse events of tebentafusp therapy. Six studies met the inclusion criteria with a total sample of 589 participants. The pooled objective response rate was 0.08 (95% CI: 0.05-0.12), and pooled disease control rate was 0.51 (95% CI: 0.44-0.57). The overall incidence was 0.99 (95% CI: 0.95-1.00) for any grade adverse events, 0.50 (95% CI: 0.41-0.59) for grade 3-4 adverse events, and 0.01 (95% CI: 0-0.03) for discontinuation due to adverse events. Tebentafusp exhibits promising treatment outcomes for mUM patients. Although accompanied with a common occurrence of adverse events, which can typically be managed and controlled. Future research is necessary for substantiating these findings and refining guidelines for management of mUM.

摘要

转移性葡萄膜黑色素瘤(mUM)患者预后较差,且可供选择的合适药物有限。Tebentafusp 最近被美国食品和药物管理局批准用于 mUM。然而,tebentafusp 的真实疗效和安全性仍不清楚。我们检索了 PubMed、Embase 和 Cochrane Library,检索时间截至 2024 年 3 月 20 日。研究报告基于系统评价和荟萃分析的首选报告项目。我们使用随机效应模型汇总了关于 tebentafusp 治疗反应率和不良事件的数据。符合纳入标准的研究有 6 项,共纳入 589 名参与者。汇总的客观缓解率为 0.08(95%CI:0.05-0.12),疾病控制率为 0.51(95%CI:0.44-0.57)。任何级别不良事件的总发生率为 0.99(95%CI:0.95-1.00),3-4 级不良事件的发生率为 0.50(95%CI:0.41-0.59),因不良事件停药的发生率为 0.01(95%CI:0-0.03)。Tebentafusp 对 mUM 患者具有有前景的治疗效果。虽然伴有不良事件的常见发生,但通常可以管理和控制。需要进一步研究来证实这些发现,并完善 mUM 管理的指南。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f179/11249029/416c10b7cbcf/KHVI_A_2374647_F0001_OC.jpg

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