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Target Oncol. 2023 Sep;18(5):793-800. doi: 10.1007/s11523-023-00984-4. Epub 2023 Aug 5.
Darolutamide (NUBEQA) is an oral androgen receptor inhibitor (ARi) that is approved for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) and docetaxel. In a pivotal trial, darolutamide plus ADT and docetaxel was superior to placebo plus ADT and docetaxel in prolonging the primary endpoint of overall survival, with improvements also reported in most secondary endpoints. Treatment with darolutamide plus ADT and docetaxel was associated with a manageable tolerability profile. Furthermore, the adverse events reported with darolutamide plus ADT and docetaxel were generally consistent with the safety profiles previously reported for ADT and docetaxel. Darolutamide expands the availability of treatment options in mHSPC and may be useful as a treatment for high-volume disease (typically defined as ≥ 4 bone metastases with spread outside of the pelvis and vertebral column).
达罗他胺（NUBEQA）是一种口服雄激素受体抑制剂（ARi），已被批准与雄激素剥夺疗法（ADT）和多西他赛联合用于治疗转移性去势敏感前列腺癌（mHSPC）。在一项关键试验中，达罗他胺联合 ADT 和多西他赛在延长总生存期这一主要终点方面优于安慰剂联合 ADT 和多西他赛，大多数次要终点也有改善。达罗他胺联合 ADT 和多西他赛治疗的耐受性可管理。此外，达罗他胺联合 ADT 和多西他赛的不良反应通常与之前报告的 ADT 和多西他赛的安全性特征一致。达罗他胺扩大了 mHSPC 治疗方案的可及性，并且可能对高容量疾病（通常定义为骨盆和脊柱以外有≥4 处骨转移）有用。
