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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

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收录情况： ◇ SCIE ◇ 统计源期刊 ◇ CSCD-C ◇ 卓越：领军期刊

作者：
Wang Hongkai[1,2] * ; Jiang Shusuan[3] ; Luo Hong[4] ; Zhou Fangjian[5] ; He Dalin[6] ; Ma Lulin[7] ; Guo Hongqian[8] ; Liang Chaozhao[9] ; Chong Tie[10] ; Jiang Jun[11] ; Chen Zhiwen[12] ; Wang Yong[13] ; Zou Qing[14] ; Tian Ye[15] ; Xiao Jun[16] ; Huang Jian[17] ; Chen Jinchao[18] ; Dong Qiang[19] ; Zhang Xiaoping[20] ; Li Hanzhong[21] ; Yang Xinfeng[22] ; Lian Jianpo[23] ; Wang Wenliang[23] ; Ye Dingwei[1,2] ;
机构： [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 Biometrics, Jiangsu Hengrui Pharmaceuticals Co. Ltd., Shanghai, China [23]Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co. Ltd., Shanghai, China
出处：
DOI： 10.1038/s41392-024-02064-z
ISSN：

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.© 2024. The Author(s).

基金：
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
语种：
外文
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出版当年[2024]版：
无
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 生化与分子生物学 1 区 细胞生物学
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出版当年[2024]版：
无
最新[2023]版：
Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY Q1 CELL BIOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2023版]

第一作者：
第一作者机构： [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
通讯作者：
通讯机构： [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
推荐引用方式(GB/T 7714)：
Wang Hongkai,Jiang Shusuan,Luo Hong,et al.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[J].Signal Transduction And Targeted Therapy.2024,9(1):351.doi:10.1038/s41392-024-02064-z.
APA：
Wang Hongkai,Jiang Shusuan,Luo Hong,Zhou Fangjian,He Dalin...&Ye Dingwei.(2024).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.Signal Transduction And Targeted Therapy,9,(1)
MLA：
Wang Hongkai,et al."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".Signal Transduction And Targeted Therapy 9..1(2024):351

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