Patient-reported outcomes of rezvilutamide versus bicalutamide in combination with androgen deprivation therapy in high-volume metastatic hormone-sensitive prostate cancer patients (CHART): a randomized, phase 3 study  

作　　者：Hongkai Wang Shusuan Jiang Hong Luo Fangjian Zhou Dalin He Lulin Ma Hongqian Guo Chaozhao Liang Tie Chong Jun Jiang Zhiwen Chen Yong Wang Qing Zou Ye Tian Jun Xiao Jian Huang Jinchao Chen Qiang Dong Xiaoping Zhang Hanzhong Li Xinfeng Yang Jianpo Lian Wenliang Wang Dingwei Ye 

机构地区：[1]Department of Urology,Fudan University Shanghai Cancer Center,Fudan University,Shanghai,China [2]Cancer Institute,Shanghai Urological Cancer Institute,Fudan University Shanghai Cancer Center,Fudan University,Shanghai,China [3]Urology Surgery,Hunan Cancer Hospital,Changsha,China [4]Department of Urology,Chongqing University Cancer Hospital,Chongqing,China [5]Urology Surgery,Sun Yat-sen University Cancer Center,Guangzhou,China [6]Urology Surgery,The First Affiliated Hospital of Xi’an Jiaotong University,Xi’an,China [7]Urology Surgery,Peking University Third Hospital,Beijing,China [8]Department of Urology,Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School,Nanjing,China [9]Department of Urology,The First Affiliated Hospital of Anhui Medical University,Hefei,China [10]Urology Surgery,The Second Affiliated Hospital of Xi’an Jiaotong University,Xi’an,China [11]Department of Urology,Army Medical Center of PLA,Chongqing,China [12]Department of Urology,The First Affiliated Hospital of the Army Medical University,Chongqing,China [13]Department of Urology,The Second Hospital of Tianjin Medical University,Tianjin,China [14]Department of Urology,Jiangsu Cancer Hospital,The Affiliated Cancer Hospital of Nanjing Medical University,Jiangsu Institute of Cancer Research,Nanjing,China [15]Urology Surgery,Beijing Friendship Hospital Affiliated to Capital Medical University,Beijing,China [16]Division of Life Sciences and Medicine,Department of Urology,The First Affiliated Hospital of USTC,University of Science and Technology of China,Hefei,China [17]Urology Surgery,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou,China [18]Department of Urology,Zhejiang Cancer Hospital,Hangzhou,China [19]Department of Urology,West China Hospital of Sichuan University,Chengdu,China [20]Urology Surgery,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,China [21]Urology Surgery,Peking Union Medical College Hospital,Beijing,China [22]Department of Biomet

出　　处：《Signal Transduction and Targeted Therapy》2025年第1期360-368,共9页信号转导与靶向治疗(英文)

摘　　要：The randomized phase 3 CHART trial(NCT03520478)revealed that rezvilutamide(REZ)plus androgen deprivation therapy(ADT)in high-volume,metastatic,hormone-sensitive prostate cancer(mHSPC)significantly enhanced radiographic progression-free and overall survival than bicalutamide(BIC)-ADT.Accordingly,we examined patient-reported outcomes(PROs)results,which were exploratory endpoints in the CHART trial.The patients were randomly allocated to receive REZ-ADT or BIC-ADT in a 1:1 ratio.The PROs were evaluated with the Brief Pain Inventory-Short Form(BPI-SF)and the Functional Assessment of Cancer Therapy-Prostate(FACT-P)questionnaires.Both study groups displayed comparable baseline pain scores and functional status.Patients administered REZ-ADT had an extended time to progression of worst pain intensity in comparison to those treated with BIC-ADT(25th percentile,9.2[95%CI 7.4-16.6]vs.6.4 months[95%CI 5.5-8.3];HR 0.75[95%CI 0.57-0.97];p=0.026).Similarly,patients received REZ-ADT exhibited a delayed time to progression of pain interference in comparison to those receiving BIC-ADT(25th percentile,20.2[95%CI 12.9-31.3]vs.10.2 months[95%CI 7.4-11.1];HR 0.70[95%CI 0.52-0.93];p=0.015).Additionally,the REZ-ADT group demonstrated a prolonged delay in the deterioration of the total score on the FACT-P questionnaire(25th percentile,12.8[95%CI 7.4-20.3]vs.6.0 months[95%CI 4.6-9.2];HR 0.66[95%CI 0.50-0.86];p=0.002),as well as most of the FACT-P subscale scores,in comparison to the BIC-ADT group.In conclusion,REZ-ADT is superior to BIC-ADT regarding the pain alleviation and enhancement of functional scales for high-volume mHSPC.

关 键 词：patients cancer RANDOMIZED 

分 类 号：R73[医药卫生—肿瘤]