Hadaschik Boris, Hellmis Eva
Urologische Universitätsklinik, Universitätsklinikum Essen, Hufelandstraße 55, 45147, Essen, Deutschland.
Urologicum Duisburg, Duisburg, Deutschland.
Urologe A. 2021 Jun;60(6):753-759. doi: 10.1007/s00120-021-01473-0. Epub 2021 Feb 11.
In patients with nonmetastatic castration-resistant prostate cancer (nmCRPC or M0CRPC) at high risk of progression (defined as prostate-specific antigen [PSA] doubling time ≤ 10 months), new androgen receptor inhibitors (ARI) in combination with continued androgen deprivation therapy (ADT) are considered the new standard of care. Apalutamide, enzalutamide, and darolutamide have been approved on the basis of improved metastasis-free survival (MFS) in the respective large pivotal studies SPARTAN, PROSPER and ARAMIS and now, with a longer follow-up period, were able to show also a statistically significant and clinically relevant overall survival advantage compared to placebo plus ADT. The data available to date indicate that all three ARIs are comparably effective, accompanied by good tolerability. Moreover, the generally good quality of life of this patient population, who usually has no tumor-related symptoms, was maintained. Comparative head-to-head trials of the three approved substances are not available yet.
对于有高进展风险（定义为前列腺特异性抗原[PSA]倍增时间≤10个月）的非转移性去势抵抗性前列腺癌（nmCRPC或M0CRPC）患者，新型雄激素受体抑制剂（ARI）联合持续雄激素剥夺治疗（ADT）被视为新的标准治疗方案。阿帕他胺、恩杂鲁胺和达罗他胺已分别在大型关键研究SPARTAN、PROSPER和ARAMIS中基于改善的无转移生存期（MFS）获得批准，现在，随着随访期延长，与安慰剂加ADT相比，也显示出具有统计学意义和临床相关性的总生存优势。迄今为止可得的数据表明，这三种ARI的疗效相当，耐受性良好。此外，该通常无肿瘤相关症状的患者群体的总体生活质量保持良好。目前尚无这三种已获批药物的对比性直接头对头试验。
