贝尔祖替芬治疗肾细胞癌：平衡监管批准与社会和患者影响。

IF 12.8 Q1 MEDICINE, RESEARCH & EXPERIMENTAL Med Pub Date : 2025-01-10 DOI:10.1016/j.medj.2024.11.016

Jad Chahoud, Pavlos Msaouel

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引用次数: 0

摘要

LITESPARK-005评估了贝尔祖替芬与依维莫司在晚期肾细胞癌（RCC）中的疗效，1显示出显著的无进展生存改善，但未能达到总生存期（OS）的共同主要终点。尽管FDA批准了该试验，但由于缺乏OS改善，缺乏生物标志物研究，高财务毒性以及在美国以外的可及性有限，该试验突出了RCC药物开发的关键障碍。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Belzutifan for renal cell carcinoma: Balancing regulatory approval with societal and patient impact.

LITESPARK-005 evaluated belzutifan against everolimus in advanced renal cell carcinoma (RCC),¹ demonstrating significant progression-free survival improvement but failing to meet the overall survival (OS) co-primary endpoint. Despite FDA approval, the trial highlights key obstacles in drug development in RCC, given the absence of OS improvement, lack of biomarker studies, high financial toxicity, and limited accessibility outside the United States.

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来源期刊

Med MEDICINE, RESEARCH & EXPERIMENTAL-

CiteScore

17.70

自引率

0.60%

发文量

102

期刊介绍： Med is a flagship medical journal published monthly by Cell Press, the global publisher of trusted and authoritative science journals including Cell, Cancer Cell, and Cell Reports Medicine. Our mission is to advance clinical research and practice by providing a communication forum for the publication of clinical trial results, innovative observations from longitudinal cohorts, and pioneering discoveries about disease mechanisms. The journal also encourages thought-leadership discussions among biomedical researchers, physicians, and other health scientists and stakeholders. Our goal is to improve health worldwide sustainably and ethically. Med publishes rigorously vetted original research and cutting-edge review and perspective articles on critical health issues globally and regionally. Our research section covers clinical case reports, first-in-human studies, large-scale clinical trials, population-based studies, as well as translational research work with the potential to change the course of medical research and improve clinical practice.