Cardiff University and Velindre Cancer Centre, Cardiff, UK.
Institut Gustave Roussy, University of Paris Saclay, Villejuif, France.
Prostate Cancer Prostatic Dis. 2024 Dec;27(4):786-789. doi: 10.1038/s41391-023-00740-9. Epub 2023 Oct 26.
In patients with metastatic castration-resistant prostate cancer, darolutamide was well tolerated for 25 months, but minimal long-term safety data are available.
Treatment-emergent adverse events (TEAEs) for patients receiving darolutamide for a median of 38 months (n = 13) are described in this pooled analysis of individual patient data from phase 1/2 studies.
All patients reported TEAEs (mostly grade 1/2). The most common TEAEs were diarrhea, abdominal pain, and nausea. Serious TEAEs were reported in six patients (none related to darolutamide). All treatment-related TEAEs (n = 5) were grade 1.
Long-term darolutamide treatment was well tolerated; no new safety signals observed. In patients with mCRPC, long-term darolutamide treatment was well tolerated and no new safety signals were observed. These findings are consistent with previous reports, demonstrating a favorable safety and tolerability profile of darolutamide.
在转移性去势抵抗性前列腺癌患者中，达罗他胺的耐受性良好，可长达 25 个月，但可用的长期安全性数据有限。
本汇总分析来自达罗他胺治疗的 1/2 期研究的个体患者数据，中位治疗时间为 38 个月（n=13），描述了这些患者的治疗中出现的不良事件（TEAEs）。
所有患者均报告了 TEAEs（多为 1/2 级）。最常见的 TEAEs 为腹泻、腹痛和恶心。6 名患者报告了严重 TEAEs（均与达罗他胺无关）。所有治疗相关 TEAEs（n=5）均为 1 级。
达罗他胺长期治疗耐受性良好；未观察到新的安全性信号。在 mCRPC 患者中，达罗他胺长期治疗耐受性良好，未观察到新的安全性信号。这些发现与之前的报告一致，表明达罗他胺具有良好的安全性和耐受性。
