Shore Neal D, Cruz Felipe, Nordquist Luke, Belkoff Laurence, Aronson William J, Tolia Bhupendra, Cinman Arnold, Sharifi Roohollah, Ortiz Jorge, Parkin Jacqueline, Srinivasan Shankar, Sarapohja Toni, Smith Matthew R
Carolina Urologic Research Center/Genesis Care, Myrtle Beach, SC 29577, USA.
Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo, 03102-002, Brazil.
Future Oncol. 2022 Dec;18(40):4473-4482. doi: 10.2217/fon-2022-0943. Epub 2023 Feb 8.
Darolutamide significantly improved metastasis-free survival (MFS) and overall survival (OS) versus placebo in the phase III ARAMIS study. We evaluated outcomes in Black/African-American patients in ARAMIS. Patients with nonmetastatic castration-resistant prostate cancer were randomized 2:1 to darolutamide (n = 955) or placebo (n = 554) plus androgen-deprivation therapy. The primary end point was MFS. Secondary end points included OS and safety. In 52 (3.4%) Black/African-American patients, darolutamide improved MFS (median: not reached vs 12.4 months) and OS (3-year survival rates: 100 vs 71%) versus placebo. The safety profile of darolutamide in Black/African-American patients was consistent with that of all ARAMIS patients. In Black/African-American patients, darolutamide improved MFS and OS and was well tolerated, consistent with the overall ARAMIS population.
在III期ARAMIS研究中，与安慰剂相比，达洛鲁胺显著改善了无转移生存期（MFS）和总生存期（OS）。我们评估了ARAMIS研究中黑人/非裔美国患者的治疗结果。将非转移性去势抵抗性前列腺癌患者按2:1随机分组，分别接受达洛鲁胺（n = 955）或安慰剂（n = 554）加雄激素剥夺治疗。主要终点是MFS。次要终点包括OS和安全性。在52名（3.4%）黑人/非裔美国患者中，与安慰剂相比，达洛鲁胺改善了MFS（中位数：未达到 vs 12.4个月）和OS（3年生存率：100% vs 71%）。达洛鲁胺在黑人/非裔美国患者中的安全性与所有ARAMIS患者一致。在黑人/非裔美国患者中，达洛鲁胺改善了MFS和OS，且耐受性良好，与整个ARAMIS人群一致。
