Enzalutamide in patients with high-risk biochemically recurrent prostate cancer according to the European Association of Urology definition: a post hoc analysis of EMBARK

IF 5.8 2区医学 Q1 ONCOLOGY Prostate Cancer and Prostatic Diseases Pub Date : 2025-03-26 DOI:10.1038/s41391-025-00959-8

Ugo De Giorgi, Stephen J. Freedland, Antti Rannikko, Miguel Ramirez-Backhaus, Arnauld Villers, Jamal Tarazi, Yiyun Tang, Gabriel P. Haas, Matt Rosales, Neal D. Shore

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Abstract

High-risk biochemical recurrence (BCR) definition varies across clinical studies/practice guidelines. We evaluated metastasis-free survival (MFS) by blinded, independent, central review and safety in EMBARK (NCT02319837) patients defined as high-risk BCR per European Association of Urology (EAU) criteria. Patients post-radical prostatectomy (prostatic-specific antigen doubling time ≤9 months) or post-radiation therapy with a Gleason score > 7, were considered EAU high-risk. MFS improved with enzalutamide + leuprolide (HR 0.37, 95% CI 0.25‒0.57) and enzalutamide monotherapy (HR 0.57, 95% CI 0.39‒0.83) versus leuprolide alone. MFS and safety for enzalutamide ± leuprolide versus leuprolide alone were similar in EMBARK patients with EAU-consistent or protocol-defined high-risk BCR. Clinical trial registration number: NCT02319837.

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恩杂鲁胺在高危生化复发前列腺癌患者中的应用，根据欧洲泌尿外科协会的定义：一项对EMBARK的事后分析。

高危生化复发（BCR）的定义因临床研究/实践指南而异。我们通过盲法、独立、中心评价和安全性评估了根据欧洲泌尿外科协会（EAU）标准定义为高风险BCR的EMBARK （NCT02319837）患者的无转移生存（MFS）。根治性前列腺切除术后（前列腺特异性抗原倍增时间≤9个月）或放疗后Gleason评分为bb70的患者为EAU高危患者。与单独使用leuprolide相比，enzalutamide + leuprolide （HR 0.37, 95% CI 0.25-0.57）和enzalutamide单药治疗（HR 0.57, 95% CI 0.39-0.83）可改善MFS。在与eau一致或方案定义的高风险BCR的EMBARK患者中，恩杂鲁胺±leuprolide与单独使用leuprolide的MFS和安全性相似。临床试验注册号：NCT02319837。

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来源期刊

Prostate Cancer and Prostatic Diseases 医学-泌尿学与肾脏学

CiteScore

10.00

自引率

6.20%

发文量

142

审稿时长

6-12 weeks

期刊介绍： Prostate Cancer and Prostatic Diseases covers all aspects of prostatic diseases, in particular prostate cancer, the subject of intensive basic and clinical research world-wide. The journal also reports on exciting new developments being made in diagnosis, surgery, radiotherapy, drug discovery and medical management. Prostate Cancer and Prostatic Diseases is of interest to surgeons, oncologists and clinicians treating patients and to those involved in research into diseases of the prostate. The journal covers the three main areas - prostate cancer, male LUTS and prostatitis. Prostate Cancer and Prostatic Diseases publishes original research articles, reviews, topical comment and critical appraisals of scientific meetings and the latest books. The journal also contains a calendar of forthcoming scientific meetings. The Editors and a distinguished Editorial Board ensure that submitted articles receive fast and efficient attention and are refereed to the highest possible scientific standard. A fast track system is available for topical articles of particular significance.