BACKGROUND Before the androgen target therapy era, flutamide was widely used for castration-resistant prostate cancer in Japan. Enzalutamide is currently the recommended treatment; however, the efficacy and safety of enzalutamide and flutamide after combined androgen blockade therapy with bicalutamide, has not been compared. METHODS Patients with castration-resistant prostate cancer who received combined androgen blockade therapy with bicalutamide were randomly assigned to receive either enzalutamide or flutamide. The primary endpoint for efficacy was the 3-month prostate-specific antigen response rate. This trial is registered with ClinicalTrials.gov (NCT02346578) and the University hospital Medical Information Network (UMIN000016301). RESULTS Overall, 103 patients were enrolled. The 3- (80.8% vs. 35.3%; p < 0.001) and 6-month (73.1% vs. 31.4%; p < 0.001) prostate-specific antigen response rates were higher in the enzalutamide than in the flutamide group. The 3-month disease progression rates (radiographic or prostate-specific antigen progression) were 6.4% and 38.8% in the enzalutamide and flutamide groups, respectively [hazard ratio (HR): 0.16; 95% confidence interval (CI): 0.05-0.47; p < 0.001]; the 6-month rates were 11.4% and 51.1%, respectively (HR 0.22; 95% CI 0.09-0.50; p < 0.001). Enzalutamide provided superior prostate-specific antigen progression-free survival compared with flutamide (HR 0.29; 95% CI 0.15-0.54; p < 0.001). Median time to prostate-specific antigen progression-free survival was not reached and was 6.6 months in the enzalutamide and flutamide groups, respectively. CONCLUSIONS As an alternative anti-androgen therapy in patients with castration-resistant prostate cancer who fail bicalutamide-combined androgen blockade therapy, enzalutamide provides superior clinical outcomes compared with flutamide. Enzalutamide should be preferred over flutamide in these patients.

中文翻译：

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Enzalutamide 对比氟他胺用于雄激素阻断联合比卡鲁胺治疗后去势抵抗性前列腺癌：OCUU-CRPC 研究。

背景技术在雄激素靶向治疗时代之前，氟他胺在日本被广泛用于去势抵抗性前列腺癌。恩杂鲁胺是目前推荐的治疗方法；然而，尚未对恩杂鲁胺和氟他胺与比卡鲁胺联合雄激素阻断治疗后的疗效和安全性进行比较。方法 接受比卡鲁胺联合雄激素阻断治疗的去势抵抗性前列腺癌患者被随机分配接受恩杂鲁胺或氟他胺。疗效的主要终点是 3 个月的前列腺特异性抗原反应率。该试验已在 ClinicalTrials.gov (NCT02346578) 和大学医院医学信息网络 (UMIN000016301) 注册。结果 总共招募了 103 名患者。3 个月（80.8% 对 35.3%；p < 0.001）和 6 个月（73.1% 对 31。4%；p < 0.001) 恩杂鲁胺组的前列腺特异性抗原反应率高于氟他胺组。恩杂鲁胺组和氟他胺组 3 个月的疾病进展率（放射学或前列腺特异性抗原进展）分别为 6.4% 和 38.8% [风险比 (HR)：0.16；95% 置信区间 (CI)：0.05-0.47；p < 0.001]；6 个月的比率分别为 11.4% 和 51.1%（HR 0.22；95% CI 0.09-0.50；p < 0.001）。与氟他胺相比，恩杂鲁胺提供了优越的前列腺特异性抗原无进展生存期（HR 0.29；95% CI 0.15-0.54；p < 0.001）。未达到前列腺特异性抗原无进展生存的中位时间，恩杂鲁胺组和氟他胺组分别为 6.6 个月。结论 作为比卡鲁胺联合雄激素阻断治疗失败的去势抵抗性前列腺癌患者的替代抗雄激素治疗，恩杂鲁胺与氟他胺相比提供了更好的临床结果。在这些患者中，恩杂鲁胺应优于氟他胺。