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Abstract：
UNASSIGNED: The current treatment strategy for metastatic Hormone-Sensitive Prostate Cancer (mHSPC) is the combination of Androgen Receptor Signaling Inhibitors (ARSIs) medicines with androgen deprivation therapy (ADT). However, there is a lack of real-world data comparing the efficacy of different ARSI pharmaceuticals. Therefore, the objective of this study was to compare the effectiveness and safety of bicalutamide, abiraterone, enzalutamide, and apalutamide in combination with ADT for patients with mHSPC.
UNASSIGNED: We retrospectively analyzed 82 patients diagnosed with mHSPC, including 18 patients treated with abiraterone acetate with prednisone, 21 patients with enzalutamide, 20 patients with apalutamide, and 23 patients with bicalutamide. We evaluated PSA progression-free survival (PSA-PFS), imaging progression-free survival (r PFS), castration resistance progression-free survival (CRPC-PFS), and overall survival (OS) using Kaplan-Meier survival analyses. Additionally, we explored relevant factors affecting prognosis through univariate and multivariate Cox risk-proportionality models. PSA response rates at 3, 6, and 12 months, nadir PSA levels (nPSA), and time to nadir (TTN) in different medication subgroups after treatment were documented, and we used one-way ANOVA to determine the effect of these measures on patient prognosis.
UNASSIGNED: In comparison with bicalutamide, both enzalutamide and apalutamide have shown significant advantages in delaying disease progression among mHSPC patients. Specifically, enzalutamide has been found to significantly prolong PSA-PFS (HR 2.244; 95% CI 1.366-3.685, p=0.001), rPFS (HR 2.539; 95% CI 1.181-5.461; p= 0.007), CRPC-PFS (HR 2.131; 95% CI 1.295-3.506; p= 0.003), and OS (HR 2.06; 95% CI 1.183-3.585; P=0.005). Similarly, apalutamide has significantly extended PSA-PFS (HR 5.071; 95% CI 1.711-15.032; P= 0.003) and CRPC-PFS (HR 6.724; 95% CI 1.976-22.878; P=0.002) among patients. On the other hand, the use of abiraterone in combination with ADT did not demonstrate a significant advantage in delaying diseases progression when compared with the other three agents in mHSPC patients. There were no significant differences in overall adverse event rates among the four pharmaceuticals in terms of safety. Additionally, the observation of PSA kinetics revealed that enzalutamide, apalutamide, and abiraterone acetate had a significant advantage in achieving deep PSA response (PSA ≤ 0.2 ng/ml) compared with bicalutamide (p=0.007 at 12 months). Enzalutamide and apalutamide exhibited preeminence efficacy, with no substantial difference observed between the two medications.
UNASSIGNED: Abiraterone, enzalutamide, and apalutamide were found to significantly reduce and stabilize PSA levels in mHSPC patients more quickly and thoroughly than bicalutamide. Furthermore, enzalutamide and apalutamide were found to significantly prolong survival and delay disease progression in mHSPC patients compared with bicalutamide. It should be noted that abiraterone did not demonstrate a significant advantage in delaying disease compared with enzalutamide and apalutamide. After conducting drug toxicity analyses, it was determined that there were no significant differences among the four drugs.
UNASSIGNED: We retrospectively analyzed 82 patients diagnosed with mHSPC, including 18 patients treated with abiraterone acetate with prednisone, 21 patients with enzalutamide, 20 patients with apalutamide, and 23 patients with bicalutamide. We evaluated PSA progression-free survival (PSA-PFS), imaging progression-free survival (r PFS), castration resistance progression-free survival (CRPC-PFS), and overall survival (OS) using Kaplan-Meier survival analyses. Additionally, we explored relevant factors affecting prognosis through univariate and multivariate Cox risk-proportionality models. PSA response rates at 3, 6, and 12 months, nadir PSA levels (nPSA), and time to nadir (TTN) in different medication subgroups after treatment were documented, and we used one-way ANOVA to determine the effect of these measures on patient prognosis.
UNASSIGNED: In comparison with bicalutamide, both enzalutamide and apalutamide have shown significant advantages in delaying disease progression among mHSPC patients. Specifically, enzalutamide has been found to significantly prolong PSA-PFS (HR 2.244; 95% CI 1.366-3.685, p=0.001), rPFS (HR 2.539; 95% CI 1.181-5.461; p= 0.007), CRPC-PFS (HR 2.131; 95% CI 1.295-3.506; p= 0.003), and OS (HR 2.06; 95% CI 1.183-3.585; P=0.005). Similarly, apalutamide has significantly extended PSA-PFS (HR 5.071; 95% CI 1.711-15.032; P= 0.003) and CRPC-PFS (HR 6.724; 95% CI 1.976-22.878; P=0.002) among patients. On the other hand, the use of abiraterone in combination with ADT did not demonstrate a significant advantage in delaying diseases progression when compared with the other three agents in mHSPC patients. There were no significant differences in overall adverse event rates among the four pharmaceuticals in terms of safety. Additionally, the observation of PSA kinetics revealed that enzalutamide, apalutamide, and abiraterone acetate had a significant advantage in achieving deep PSA response (PSA ≤ 0.2 ng/ml) compared with bicalutamide (p=0.007 at 12 months). Enzalutamide and apalutamide exhibited preeminence efficacy, with no substantial difference observed between the two medications.
UNASSIGNED: Abiraterone, enzalutamide, and apalutamide were found to significantly reduce and stabilize PSA levels in mHSPC patients more quickly and thoroughly than bicalutamide. Furthermore, enzalutamide and apalutamide were found to significantly prolong survival and delay disease progression in mHSPC patients compared with bicalutamide. It should be noted that abiraterone did not demonstrate a significant advantage in delaying disease compared with enzalutamide and apalutamide. After conducting drug toxicity analyses, it was determined that there were no significant differences among the four drugs.
摘要：
目前针对转移性激素敏感性前列腺癌(mHSPC)的治疗策略是雄激素受体信号抑制剂(ARSI)药物与雄激素剥夺疗法(ADT)的组合。然而,缺乏比较不同ARSI药物疗效的真实数据。因此,这项研究的目的是比较比卡鲁胺的有效性和安全性，阿比特龙,恩扎鲁他胺,阿帕鲁胺联合ADT治疗mHSPC患者。
■我们回顾性分析了82例诊断为mHSPC的患者，包括18例醋酸阿比特龙和泼尼松治疗，21例恩杂鲁胺患者，阿帕鲁胺20例，和23例比卡鲁胺患者。我们评估了PSA无进展生存期（PSA-PFS），影像学无进展生存期（rPFS），去势抵抗无进展生存期（CRPC-PFS），和总生存期（OS）使用Kaplan-Meier生存分析。此外,我们通过单变量和多变量Cox风险比例模型探讨了影响预后的相关因素.3、6和12个月时的PSA反应率，最低PSA水平（nPSA），记录治疗后不同药物亚组的最低点时间（TTN），我们使用单因素方差分析来确定这些指标对患者预后的影响.
■与比卡鲁胺相比，在mHSPC患者中,恩杂鲁胺和阿帕鲁胺在延缓疾病进展方面均显示出显著优势.具体来说,恩杂鲁胺可显著延长PSA-PFS(HR2.244;95%CI1.366-3.685,p=0.001),rPFS（HR2.539；95%CI1.181-5.461；p=0.007），CRPC-PFS（HR2.131；95%CI1.295-3.506；p=0.003），和OS（HR2.06；95%CI1.183-3.585；P=0.005）。同样，阿帕鲁胺显著延长患者PSA-PFS(HR5.071;95%CI1.711-15.032;P=0.003)和CRPC-PFS(HR6.724;95%CI1.976-22.878;P=0.002)。另一方面,在mHSPC患者中,与其他3种药物相比,阿比曲酮联合ADT在延缓疾病进展方面没有显著优势.就安全性而言，四种药物之间的总体不良事件发生率没有显着差异。此外,对PSA动力学的观察表明，恩杂鲁胺，阿帕鲁胺,与比卡鲁胺相比,醋酸阿比特龙在实现深PSA反应(PSA≤0.2ng/ml)方面具有显著优势(12个月时p=0.007).恩扎鲁胺和阿帕鲁胺表现出卓越的疗效，两种药物之间没有实质性差异。
■阿比特龙，恩扎鲁他胺,发现阿帕鲁胺比比卡鲁胺更快，更彻底地降低和稳定mHSPC患者的PSA水平。此外，与比卡鲁胺相比，恩杂鲁胺和阿帕鲁胺可显着延长mHSPC患者的生存期并延迟疾病进展。应当指出，与恩杂鲁胺和阿帕鲁胺相比，阿比曲酮在延缓疾病方面没有显着优势。在进行药物毒性分析后，确定四种药物之间没有显着差异。
■我们回顾性分析了82例诊断为mHSPC的患者，包括18例醋酸阿比特龙和泼尼松治疗，21例恩杂鲁胺患者，阿帕鲁胺20例，和23例比卡鲁胺患者。我们评估了PSA无进展生存期（PSA-PFS），影像学无进展生存期（rPFS），去势抵抗无进展生存期（CRPC-PFS），和总生存期（OS）使用Kaplan-Meier生存分析。此外,我们通过单变量和多变量Cox风险比例模型探讨了影响预后的相关因素.3、6和12个月时的PSA反应率，最低PSA水平（nPSA），记录治疗后不同药物亚组的最低点时间（TTN），我们使用单因素方差分析来确定这些指标对患者预后的影响.
■与比卡鲁胺相比，在mHSPC患者中,恩杂鲁胺和阿帕鲁胺在延缓疾病进展方面均显示出显著优势.具体来说,恩杂鲁胺可显著延长PSA-PFS(HR2.244;95%CI1.366-3.685,p=0.001),rPFS（HR2.539；95%CI1.181-5.461；p=0.007），CRPC-PFS（HR2.131；95%CI1.295-3.506；p=0.003），和OS（HR2.06；95%CI1.183-3.585；P=0.005）。同样，阿帕鲁胺显著延长患者PSA-PFS(HR5.071;95%CI1.711-15.032;P=0.003)和CRPC-PFS(HR6.724;95%CI1.976-22.878;P=0.002)。另一方面,在mHSPC患者中,与其他3种药物相比,阿比曲酮联合ADT在延缓疾病进展方面没有显著优势.就安全性而言，四种药物之间的总体不良事件发生率没有显着差异。此外,对PSA动力学的观察表明，恩杂鲁胺，阿帕鲁胺,与比卡鲁胺相比,醋酸阿比特龙在实现深PSA反应(PSA≤0.2ng/ml)方面具有显著优势(12个月时p=0.007).恩扎鲁胺和阿帕鲁胺表现出卓越的疗效，两种药物之间没有实质性差异。
■阿比特龙，恩扎鲁他胺,发现阿帕鲁胺比比卡鲁胺更快，更彻底地降低和稳定mHSPC患者的PSA水平。此外，与比卡鲁胺相比，恩杂鲁胺和阿帕鲁胺可显着延长mHSPC患者的生存期并延迟疾病进展。应当指出，与恩杂鲁胺和阿帕鲁胺相比，阿比曲酮在延缓疾病方面没有显着优势。在进行药物毒性分析后，确定四种药物之间没有显着差异。
