子宫内膜癌临床药物试验参与的差异:真实世界分析。
Disparities in Clinical Drug Trial Participation in Endometrial Cancer: A Real-World Analysis.
发表日期:2024 Sep 28
作者:
Anna Jo Bodurtha Smith, Sebastian Spataro, Jonathan Heintz, Fiona Simpkins, Emily M Ko
来源:
Am J Obstet Gynecol
摘要:
子宫癌临床试验参与方面的种族差异已有报道。我们试图研究美国当代真实世界人群中子宫内膜癌患者参与临床药物试验的差异。我们对晚期子宫内膜癌患者进行了一项回顾性队列研究或复发性子宫内膜癌患者从 2013 年至 2021 年使用代表美国约 800 个学术和社区实践站点的真实电子健康记录数据库进行诊断。我们使用多水平泊松回归模型来分析临床药物试验参与与患者、社会人口统计学、卫生系统和癌症因素的关联。在 4,423 名子宫内膜癌患者中,2,807 名(63.5%)为白人,649 名(14.7%)为黑人, 78 名 (1.8%) 为亚洲人,964 名 (21.8%) 为其他种族。总体而言,3.8% 的子宫内膜癌患者曾参加过临床药物试验。高风险组织学和居住在东南部与临床试验参与率增加相关(分别为 RR 2.28 95% CI 1.12-4.62 和 RR 2.59 95% CI 1.26-5.3)。按种族划分,试验参与者包括 123 名(72.4%)白人、18 名(10.6%)黑人、1 名(0.59%)亚裔和 28 名(16.4%)其他种族。虽然黑人患者的高风险组织学比例最高,但他们参加临床试验的可能性比白人患者低 50.0%(RR 0.50,95% CI 0.30-0.83)。黑人子宫内膜癌患者在临床试验中的代表性过低。临床药物试验,尽管侵袭性癌症组织学发生率较高。需要努力增加子宫内膜癌临床试验参与者的多样性。版权所有 © 2024 Elsevier Inc. 保留所有权利。
Racial disparities in clinical trial participation for uterine cancer have been reported.We sought to examine disparities of endometrial cancer patient participation in clinical drug trials in a contemporary, real-world population in the United States.We conducted a retrospective cohort study of patients with advanced or recurrent endometrial cancer patients diagnosed from 2013-2021 using a real-world electronic health record-derived database representing approximately 800 academic and community practice sites across the United States. We used multilevel Poisson regression modeling to analyze the association of clinical drug trial participation with patient, sociodemographic, health system, and cancer factors.Of 4,423 patients with endometrial cancer, 2,807 (63.5%) identified as white, 649 (14.7%) Black, 78 (1.8%) Asian, and 964 (21.8%) some other race. Overall, 3.8% of endometrial cancer patients ever participated in a clinical drug trial. High-risk histology and residence in the Southeast were associated with increased clinical trial participation (RR 2.28 95% CI 1.12-4.62 and RR 2.59 95% CI 1.26-5.3 respectively). By race, trial participants included 123 (72.4%) White, 18 (10.6%) Black, 1 (0.59%) Asian, and 28 (16.4%) some other race. While Black patients had the greatest proportion of high-risk histology, they were 50.0% less likely than white patients to participate in a clinical trial (RR 0.50, 95%CI 0.30-0.83).Black endometrial cancer patients were disproportionately under-represented in clinical drug trials, despite having higher rates of aggressive cancer histologies. Efforts to increase diversity in endometrial cancer clinical trial participants are needed.Copyright © 2024 Elsevier Inc. All rights reserved.