■新型雄激素受体抑制剂(ARIs;达鲁鲁胺,恩扎鲁他胺,和阿帕鲁胺)是非转移性去势抵抗性前列腺癌(nmCRPC)的标准治疗方法。然而,有稀疏的数据比较他们的临床使用和耐受性.
■为了比较达鲁柳胺的临床使用和结果,恩扎鲁他胺,和阿帕鲁胺在nmCRPC患者中的应用。
■这项回顾性队列研究回顾了来自美国泌尿外科实践的PrecisionPoint专业网络的电子病历。符合条件的患者在2019年8月1日至2022年3月31日期间接受了nmCRPC且未接受新的激素治疗,并开始了新的ARI治疗。数据从2019年2月1日至2022年12月31日进行了分析。
■患者服用达洛鲁胺,恩扎鲁他胺,或阿帕鲁胺作为他们的第一部小说ARInmCRPC。
■主要结果是2个终点的综合结果,停止治疗并进展为转移性CRPC(mCRPC),以先发生者为准。还分别评估了两个终点。
■纳入所有870名符合资格标准的患者(362名接受达洛鲁胺[41.6%];382名接受恩杂鲁胺[43.9%];126名接受阿帕鲁胺[14.5%]);平均(SD)年龄为78.8(8.7)岁。在187名患者中,自我报告的种族是黑人或非裔美国人(21.5%),白色在585(67.2%),98年其他或未知(11.3%)。达洛鲁胺队列中出现复合终点事件的患者比例较低(恩杂鲁胺134[37.0%]vs201[52.6%],阿帕鲁胺66[52.4%]),停药(达鲁他胺110[30.4%],恩扎鲁他胺156[40.8%],阿帕鲁他胺58[46.0%]),在研究期间进展为mCRPC(达洛鲁胺为64[17.7%],恩杂鲁胺为108[28.3%],阿帕鲁胺为35[27.8%])。在调整基线协变量后,与恩杂鲁胺相比,接受达洛鲁胺的患者发生复合终点事件的风险较低(降低风险,33.8%;危险比[HR],0.66[95%CI,0.53-0.84])和阿帕鲁胺(降低风险,35.1%;HR,0.65[95%CI,0.48-0.88])。同样,与恩扎鲁他胺相比,接受达鲁他胺的患者停药风险较低(降低风险,27.4%;HR,0.73[95%CI,0.56-0.94])和阿帕鲁胺(降低风险,39.1%;HR,0.61[95%CI,0.44-0.85]),与恩杂鲁胺相比,进展为mCRPC的风险较低(风险降低,40.6%;HR,0.59[95%CI,0.43-0.82])和阿帕鲁胺(降低风险,35.3%;HR,0.65[95%CI,0.42-0.99])。恩杂鲁胺和阿帕鲁胺治疗在不同结局之间没有差异。
■在这项接受新型ARIs治疗的nmCRPC患者的大型队列研究中,结果表明,与恩扎鲁他胺和阿帕鲁他胺相比,达鲁他胺的耐受性更好,这可能与临床有效性优势有关。在没有头对头临床试验的情况下,需要比较临床研究来指导治疗决策。
UNASSIGNED: Novel androgen receptor inhibitors (ARIs; darolutamide, enzalutamide, and apalutamide) are standard-of-care treatments for nonmetastatic castration-resistant prostate cancer (nmCRPC). However, there are sparse data comparing their clinical use and tolerability.
UNASSIGNED: To compare clinical use and outcomes for darolutamide, enzalutamide, and apalutamide in patients with nmCRPC.
UNASSIGNED: This retrospective cohort study reviewed electronic medical records from the Precision Point Specialty network of US urology practices. Eligible patients had nmCRPC and no prior novel hormonal therapy and initiated novel ARI treatment between August 1, 2019, and March 31, 2022. Data were analyzed from February 1, 2019, to December 31, 2022.
UNASSIGNED: Patients were prescribed darolutamide, enzalutamide, or apalutamide as their first novel ARI for nmCRPC.
UNASSIGNED: The main outcome was a composite of 2 end points, treatment discontinuation and progression to metastatic CRPC (mCRPC), whichever occurred first. Both end points were also assessed separately.
UNASSIGNED: All 870 patients meeting eligibility criteria were included (362 receiving darolutamide [41.6%]; 382, enzalutamide [43.9%]; 126, apalutamide [14.5%]); mean (SD) age was 78.8 (8.7) years. Self-reported race was Black or African American in 187 patients (21.5%), White in 585 (67.2%), and other or unknown in 98 (11.3%). The darolutamide cohort had lower proportions of patients with a composite end point event (134 [37.0%] vs 201 [52.6%] for enzalutamide and 66 [52.4%] for apalutamide), discontinuation (110 [30.4%] for darolutamide vs 156 [40.8%] for enzalutamide and 58 [46.0%] for apalutamide), and progression to mCRPC (64 [17.7%] for darolutamide vs 108 [28.3%] for enzalutamide and 35 [27.8%] for apalutamide) during the study period. After adjusting for baseline covariates, patients receiving darolutamide had a lower risk of a composite end point event compared with enzalutamide (risk reduction, 33.8%; hazard ratio [HR], 0.66 [95% CI, 0.53-0.84]) and apalutamide (risk reduction, 35.1%; HR, 0.65 [95% CI, 0.48-0.88]). Similarly, patients receiving darolutamide had a lower risk of discontinuation compared with enzalutamide (risk reduction, 27.4%; HR, 0.73 [95% CI, 0.56-0.94]) and apalutamide (risk reduction, 39.1%; HR, 0.61 [95% CI, 0.44-0.85]) and a lower risk of progression to mCRPC compared with enzalutamide (risk reduction, 40.6%; HR, 0.59 [95% CI, 0.43-0.82]) and apalutamide (risk reduction, 35.3%; HR, 0.65 [95% CI, 0.42-0.99]). There was no difference between enzalutamide and apalutamide treatment across outcomes.
UNASSIGNED: In this large cohort study of patients with nmCRPC treated with novel ARIs, results suggest better tolerability for darolutamide compared with enzalutamide and apalutamide, which may be associated with a clinical effectiveness advantage. Comparative clinical studies are needed to guide treatment decisions in the absence of head-to-head clinical trials.