Correlation of PSA and survival in metastatic hormone-sensitive prostate cancer treated with rezvilutamide plus ADT in the CHART trial.

IF 12.8 Q1 MEDICINE, RESEARCH & EXPERIMENTAL Med Pub Date : 2024-10-14 DOI:10.1016/j.medj.2024.09.009

Xiaojie Bian, Weijie Gu, Xuepei Zhang, Liping Xie, Shaogang Wang, Benkang Shi, Ting Sun, Shaozhong Wei, Zhiliang Weng, Shujie Xia, Bangmin Han, Zhuoqun Xu, Jinchun Xing, Dahong Zhang, Danfeng Xu, Chuanjun Du, Chaohong He, Qilin Wang, Xinfeng Yang, Jianpo Lian, Wenliang Wang, Dingwei Ye

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Abstract

Background: This exploratory analysis of the CHART trial (ClinicalTrials.gov: NCT03520478) investigated prostate-specific antigen (PSA) kinetics and the correlation between PSA and survival outcomes in high-volume, metastatic, hormone-sensitive prostate cancer (mHSPC).

Methods: A total of 654 patients were randomized 1:1 to receive either rezvilutamide plus androgen deprivation therapy (ADT; n = 326) or bicalutamide plus ADT (n = 328). PSA kinetics were evaluated, and the correlation between survival and the achievement of undetectable PSA (≤0.2 ng/mL) or ≥90% PSA reduction (PSA90) was assessed.

Findings: The rezvilutamide group exhibited higher proportions of ≥50% PSA reduction (PSA50; 98.2% vs. 87.5%), PSA90 (88.7% vs. 63.1%), and undetectable PSA (38.3% vs. 17.7%) responses compared to the bicalutamide group by 3 months. The rezvilutamide group demonstrated superior efficacy in delaying PSA progression compared to the bicalutamide group (hazard ratio [HR] 0.21, 95% confidence interval 0.16-0.27). The achievement of undetectable PSA and PSA90 by 6 months in the rezvilutamide group was associated with prolonged overall survival (undetectable PSA, HR = 0.34; PSA90, HR = 0.22), radiographic progression-free survival (HR = 0.36, HR = 0.26), time to PSA progression (HR = 0.25, HR = 0.17), and time to castration resistance (HR = 0.34, HR = 0.23) compared to those who did not achieve these PSA milestones. Stratification by baseline PSA level revealed consistent survival improvements with rezvilutamide plus ADT across quartiles.

Conclusions: PSA kinetics is a valuable prognostic factor in mHSPC treated with rezvilutamide plus ADT, and the achievement of undetectable PSA and PSA90 is associated with improved survival. These findings highlight the importance of monitoring PSA kinetics in the management of mHSPC.

Funding: This study was funded by Jiangsu Hengrui Pharmaceuticals Co., Ltd.

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在 CHART 试验中，转移性激素敏感性前列腺癌患者接受雷珠鲁胺加 ADT 治疗后，PSA 与存活率之间存在相关性。

背景：这项对CHART试验（ClinicalTrials.gov：NCT03520478）的探索性分析调查了前列腺特异性抗原（PSA）动力学以及PSA与高体积、转移性、激素敏感性前列腺癌（mHSPC）生存结果之间的相关性：共有654名患者按1:1随机分配接受雷珠鲁胺加雄激素剥夺疗法（ADT；n = 326）或比卡鲁胺加ADT（n = 328）治疗。对PSA动力学进行了评估，并评估了存活率与PSA检测不到（≤0.2 ng/mL）或PSA降低≥90%（PSA90）之间的相关性：与比卡鲁胺组相比，雷珠鲁胺组在3个月后PSA降低≥50%（PSA50；98.2%对87.5%）、PSA90（88.7%对63.1%）和检测不到PSA（38.3%对17.7%）的比例更高。与比卡鲁胺组相比，雷珠鲁胺组在延缓PSA进展方面的疗效更优（危险比[HR]为0.21，95%置信区间为0.16-0.27）。瑞兹维鲁胺组在6个月前达到检测不到的PSA和PSA90与总生存期延长（检测不到的PSA，HR = 0.34；PSA90，HR = 0.22）、无放射进展生存期延长（HR = 0.36，HR = 0.26）、PSA 进展时间（HR = 0.25，HR = 0.17）和阉割抵抗时间（HR = 0.34，HR = 0.23）。根据基线PSA水平进行的分层显示，雷珠鲁胺加ADT治疗在不同的四分位数上都能改善生存率：PSA动力学是接受雷珠鲁胺加ADT治疗的mHSPC的一个重要预后因素，达到检测不到的PSA和PSA90与生存率的提高有关。这些发现强调了监测PSA动力学在mHSPC治疗中的重要性：本研究由江苏恒瑞医药股份有限公司资助。

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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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.