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.

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。