Enzalutamide (ENZ) and abiraterone plus prednisolone (ABI) can improve the survival of patients with castration-resistant prostate cancer (CRPC). However, the agent that is more effective against nonmetastatic CRPC remains unclear. To evaluate the agent that can be used as the first-line treatment for CRPC, an investigator-initiated, multicenter, randomized controlled trial (ENABLE Study for PCa) including both metastatic and nonmetastatic CRPC was conducted in Japan. The prostate-specific antigen (PSA) response rate, overall survival, some essential survival endpoints, and safety of patients with nonmetastatic CRPC were also analyzed. In this subanalysis, 15 and 26 patients in the ENZ and ABI arms, respectively, presented with nonmetastatic CRPC. There was no significant difference in terms of the PSA response rate between the ENZ and ABI arms (80% and 64%, respectively;p= 0.3048). The overall survival did not significantly differ between the two arms (HR: 0.68; 95% CI: 0.22–2.14,p= 0.5260). No significant differences were observed in terms of radiographic progression-free survival and cancer-specific survival between the ENZ and ABI arms (HR: 0.81; 95% CI: 0.35–1.84;p= 0.6056 and HR: 0.72; 95% CI: 0.19–2.73;p= 0.6443, respectively). Only four and six patients in the ENZ and ABI arms, respectively, had ≥grade 3 adverse events. ABI and ENZ had similar efficacy and safety profiles in patients with nonmetastatic CRPC.
恩杂鲁胺（ENZ）与阿比特龙联合泼尼松龙（ABI）可改善去势抵抗性前列腺癌（CRPC）患者的生存。然而，对于非转移性CRPC，何种药物更具疗效仍不明确。为评估可作为CRPC一线治疗的药物，日本开展了一项由研究者发起的多中心随机对照试验（ENABLE前列腺癌研究），同时纳入了转移性与非转移性CRPC患者。本研究亦针对非转移性CRPC患者的前列腺特异性抗原（PSA）应答率、总生存期、若干关键生存终点及安全性进行了分析。在此亚组分析中，ENZ组与ABI组分别有15例和26例非转移性CRPC患者。两组间PSA应答率无显著差异（分别为80%和64%；p=0.3048）。总生存期在两组间亦无显著差异（风险比：0.68；95%置信区间：0.22–2.14，p=0.5260）。ENZ组与ABI组在影像学无进展生存期和癌症特异性生存期方面均未观察到显著差异（风险比分别为0.81；95%置信区间：0.35–1.84；p=0.6056，以及0.72；95%置信区间：0.19–2.73；p=0.6443）。ENZ组与ABI组分别仅有4例和6例患者出现≥3级不良事件。在非转移性CRPC患者中，ABI与ENZ具有相似的疗效与安全性特征。
肿瘤(癌症)患者之家