在CHART试验中，使用瑞维鲁胺联合雄激素剥夺治疗（ADT）的转移性激素敏感性前列腺癌患者中前列腺特异性抗原（PSA）与生存的相关性
Correlation of PSA and survival in metastatic hormone-sensitive prostate cancer treated with rezvilutamide plus ADT in the CHART trial.
作者信息
Bian Xiaojie, Gu Weijie, Zhang Xuepei, Xie Liping, Wang Shaogang, Shi Benkang, Sun Ting, Wei Shaozhong, Weng Zhiliang, Xia Shujie, Han Bangmin, Xu Zhuoqun, Xing Jinchun, Zhang Dahong, Xu Danfeng, Du Chuanjun, He Chaohong, Wang Qilin, Yang Xinfeng, Lian Jianpo, Wang Wenliang, Ye Dingwei
机构信息
Department of Urology, Fudan University Shanghai Cancer Center, Fudan University, Shanghai, China; Cancer Institute, Shanghai Urological Cancer Institute, Fudan University Shanghai Cancer Center, Fudan University, Shanghai, China.
Department of Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
出版信息
Med. 2025 Feb 14;6(2):100520. doi: 10.1016/j.medj.2024.09.009. Epub 2024 Oct 16.
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.
背景
这项对CHART试验（ClinicalTrials.gov：NCT03520478）的探索性分析研究了高负荷、转移性、激素敏感性前列腺癌（mHSPC）中前列腺特异性抗原（PSA）动力学以及PSA与生存结果之间的相关性。
方法
总共654例患者按1:1随机分组，分别接受瑞维鲁胺联合雄激素剥夺治疗（ADT；n = 326）或比卡鲁胺联合ADT（n = 328）。评估PSA动力学，并评估生存与达到不可检测的PSA（≤0.2 ng/mL）或PSA降低≥90%（PSA90）之间的相关性。
结果
与比卡鲁胺组相比，到3个月时，瑞维鲁胺组≥50% PSA降低（PSA50；98.2%对87.5%）、PSA90（88.7%对63.1%）和不可检测PSA（38.3%对17.7%）反应的比例更高。与比卡鲁胺组相比，瑞维鲁胺组在延迟PSA进展方面显示出更优的疗效（风险比[HR] 0.21，95%置信区间0.16 - 0.27）。瑞维鲁胺组在6个月时达到不可检测的PSA和PSA90与总生存期延长相关（不可检测的PSA，HR = 0.34；PSA90，HR = 0.22），与影像学无进展生存期（HR = 0.36，HR = 0.26）、至PSA进展时间（HR = 0.25，HR = 0.17）以及至去势抵抗时间（HR = 0.34，HR = 0.23）延长相关，与未达到这些PSA里程碑的患者相比。按基线PSA水平分层显示，瑞维鲁胺联合ADT在各四分位数中均持续改善生存。
结论
PSA动力学是以瑞维鲁胺联合ADT治疗的mHSPC中的一个有价值的预后因素，达到不可检测的PSA和PSA90与生存改善相关。这些发现突出了在mHSPC管理中监测PSA动力学的重要性。
资助
本研究由江苏恒瑞医药股份有限公司资助。
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