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

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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
Signal Transduction and Targeted Therapy ( IF 40.8 ) Pub Date : 2024-12-18 , DOI: 10.1038/s41392-024-02064-z
Hongkai Wang _{1,

2} , Shusuan Jiang ₃ , Hong Luo ₄ , Fangjian Zhou ₅ , Dalin He ₆ , Lulin Ma ₇ , Hongqian Guo ₈ , Chaozhao Liang ₉ , Tie Chong ₁₀ , Jun Jiang ₁₁ , Zhiwen Chen ₁₂ , Yong Wang ₁₃ , Qing Zou ₁₄ , Ye Tian ₁₅ , Jun Xiao ₁₆ , Jian Huang ₁₇ , Jinchao Chen ₁₈ , Qiang Dong ₁₉ , Xiaoping Zhang ₂₀ , Hanzhong Li ₂₁ , Xinfeng Yang ₂₂ , Jianpo Lian ₂₃ , Wenliang Wang ₂₃ , Dingwei Ye _{1,

2}

Affiliation

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.
Urology Surgery, Hunan Cancer Hospital, Changsha, China.
Department of Urology, Chongqing University Cancer Hospital, Chongqing, China.
Urology Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.
Urology Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Urology Surgery, Peking University Third Hospital, Beijing, China.
Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Department of Urology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Urology Surgery, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Department of Urology, Army Medical Center of PLA, Chongqing, China.
Department of Urology, The First Affiliated Hospital of the Army Medical University, Chongqing, China.
Department of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.
Department of Urology, Jiangsu Cancer Hospital, The Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Institute of Cancer Research, Nanjing, China.
Urology Surgery, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing, China.
Division of Life Sciences and Medicine, Department of Urology, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China.
Urology Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Department of Urology, Zhejiang Cancer Hospital, Hangzhou, China.
Department of Urology, West China Hospital of Sichuan University, Chengdu, China.
Urology Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Urology Surgery, Peking Union Medical College Hospital, Beijing, China.
Department of Biometrics, Jiangsu Hengrui Pharmaceuticals Co. Ltd., Shanghai, China.
Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co. Ltd., Shanghai, China.

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.

中文翻译：

rezvilutamide 与比卡鲁胺联合雄激素剥夺治疗在高容量转移性激素敏感性前列腺癌患者中的患者报告结果（CHART）：一项随机 3 期研究

随机 3 期 CHART 试验（NCT03520478）显示，与比卡鲁胺（BIC）-ADT 相比，rezvilutamide （REZ）联合雄激素剥夺疗法（ADT）在高容量、转移性、激素敏感性前列腺癌（mHSPC）中显著提高了影像学无进展生存期和总生存期。因此，我们检查了患者报告结局（PROs）结果，这些结果是 CHART 试验中的探索性终点。患者以 1：1 的比例随机分配接受 REZ-ADT 或 BIC-ADT。使用简明疼痛量表-简表（BPI-SF）和癌症治疗功能评估-前列腺（FACT-P）问卷评估 PRO。两个研究组都显示出相似的基线疼痛评分和功能状态。与接受 BIC-ADT 治疗的患者相比，接受 REZ-ADT 的患者疼痛强度进展的时间更长（第 25 个百分位数，9.2 [95% CI 7.4-16.6] 对 6.4 个月 [95% CI 5.5-8.3];HR 0.75 [95% CI 0.57–0.97];p = 0.026）。同样，与接受 BIC-ADT 的患者相比，接受 REZ-ADT 的患者表现出疼痛干扰进展的延迟时间（第 25 个百分位数，20.2 [95% CI 12.9-31.3] vs. 10.2 个月 [95% CI 7.4-11.1];HR 0.70 [95% CI 0.52–0.93];p = 0.015）。此外，REZ-ADT 组在 FACT-P 问卷中表现出总分恶化的延迟时间延长（第 25 个百分位数，12.8 [95% CI 7.4-20.3] 对比 6.0 个月 [95% CI 4.6-9.2];HR 0.66 [95% CI 0.50–0.86];p = 0.002），以及与 BIC-ADT 组相比，大多数 FACT-P 子量表分数。总之，REZ-ADT 在减轻高容量 mHSPC 的疼痛和增强功能量表方面优于 BIC-ADT。

更新日期：2024-12-18

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