Armstrong Andrew J, Pandya Bhavik J, Bhadauria Hemant Singh, Ganguli Arijit, Daki Vagia, Moura Ana, Azad Arun A
Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC, USA.
Astellas Pharma Global Inc., Medical Affairs, Northbrook, IL, USA.
Future Oncol. 2025 Aug;21(19):2459-2469. doi: 10.1080/14796694.2025.2526324. Epub 2025 Jul 14.
To compare the efficacy of enzalutamide + androgen-deprivation therapy (ADT) versus darolutamide + ADT for treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) using a matching-adjusted indirect comparison (MAIC).
Individual patient data from ARCHES (NCT02677896; enzalutamide + ADT, = 1150) were weighted and adjusted to match published aggregated data on baseline characteristics from ARANOTE (NCT04736199; darolutamide + ADT, = 669). The MAIC was anchored on the common comparator, placebo + ADT, and provided a (matching-adjusted) hazard ratio (HR) of enzalutamide versus darolutamide.
Treatment with enzalutamide + ADT significantly prolonged the primary endpoint of radiographic progression-free survival (HR [95% confidence interval, CI]: 0.54 [0.32-0.93], = 0.03) and time to castration resistance (HR [95% CI]: 0.57 [0.34-0.94], = 0.03) compared with darolutamide + ADT (effective sample size: 319). Time to prostate-specific antigen progression (HR [95% CI]: 0.61 [0.29-1.30], = 0.20) and time to initiation of new antineoplastic therapy (HR [95% CI]: 0.65 [0.34-1.24], = 0.19) favored enzalutamide over darolutamide, albeit the difference was not statistically significant.
Enzalutamide + ADT showed better efficacy than darolutamide + ADT for treatment of patients with mHSPC. These findings can help inform treatment decisions in clinical practice.
采用匹配调整间接比较（MAIC），比较恩杂鲁胺联合雄激素剥夺治疗（ADT）与达罗他胺联合ADT治疗转移性激素敏感性前列腺癌（mHSPC）患者的疗效。
对ARCHES（NCT02677896；恩杂鲁胺联合ADT，n = 1150）的个体患者数据进行加权和调整，以匹配ARANOTE（NCT04736199；达罗他胺联合ADT，n = 669）公布的关于基线特征的汇总数据。MAIC以共同对照安慰剂联合ADT为基础，得出恩杂鲁胺与达罗他胺的（匹配调整）风险比（HR）。
与达罗他胺联合ADT相比，恩杂鲁胺联合ADT治疗显著延长了影像学无进展生存期的主要终点（HR [95%置信区间，CI]：0.54 [0.32 - 0.93]，P = 0.03）和去势抵抗时间（HR [95% CI]：0.57 [0.34 - 0.94]，P = 0.03）（有效样本量：319）。前列腺特异性抗原进展时间（HR [95% CI]：0.61 [0.29 - 1.30]，P = 0.20）和开始新的抗肿瘤治疗时间（HR [95% CI]：0.65 [0.34 - 1.24]，P = 0.19）倾向于恩杂鲁胺优于达罗他胺，尽管差异无统计学意义。
恩杂鲁胺联合ADT在治疗mHSPC患者方面显示出比达罗他胺联合ADT更好的疗效。这些发现有助于为临床实践中的治疗决策提供参考。
