Smith Anna Jo Bodurtha, Spataro Sebastian, Heintz Jonathan, Simpkins Fiona, Ko Emily M
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Pennsylvania Health Systems, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania Health Systems, Philadelphia, PA; Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania Health Systems, Philadelphia, PA.
Leonard Davis Institute of Health Economics, University of Pennsylvania Health Systems, Philadelphia, PA; Rice University, Houston, TX; Population Aging Research Center, Penn Arts and Sciences Populations Studies Center, University of Pennsylvania, Philadelphia, PA.
Am J Obstet Gynecol. 2025 Apr;232(4):379.e1-379.e12. doi: 10.1016/j.ajog.2024.09.103. Epub 2024 Sep 28.
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 patients with endometrial cancer diagnosed from 2013 to 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 4423 patients with endometrial cancer, 2807 (63.5%) identified as white, 649 (14.7%) Black, 78 (1.8%) Asian, and 964 (21.8%) some other race. Overall, 3.8% of patients with endometrial cancer ever participated in a clinical drug trial. High-risk histology and residence in the Southeast were associated with increased clinical trial participation (risk ratio (RR) 2.28, 95% confidence interval (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 patients with endometrial cancer were disproportionately underrepresented in clinical drug trials, despite having higher rates of aggressive cancer histologies. Efforts to increase diversity in endometrial cancer clinical trial participants are needed.
已有报道称子宫癌临床试验参与方面存在种族差异。
我们试图在美国当代真实世界人群中研究子宫内膜癌患者参与临床药物试验的差异。
我们使用一个源自真实世界电子健康记录的数据库进行了一项回顾性队列研究，该数据库代表了美国约800个学术和社区医疗机构，研究对象为2013年至2021年诊断为晚期或复发性子宫内膜癌的患者。我们使用多水平泊松回归模型分析临床药物试验参与与患者、社会人口统计学、医疗系统和癌症因素之间的关联。
在4423例子宫内膜癌患者中，2807例（63.5%）为白人，649例（14.7%）为黑人，78例（1.8%）为亚洲人，964例（21.8%）为其他种族。总体而言，3.8%的子宫内膜癌患者曾参与过临床药物试验。高危组织学类型和居住在东南部与临床试验参与率增加相关（风险比（RR）2.28，95%置信区间（CI）1.12 - 4.62；RR 2.59，95% CI 1.26 - 5.3）。按种族划分，试验参与者包括123例（72.4%）白人，18例（10.6%）黑人，1例（0.59%）亚洲人，28例（16.4%）其他种族。虽然黑人患者高危组织学类型的比例最高，但他们参与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）。
尽管侵袭性癌症组织学类型的发生率较高，但黑人子宫内膜癌患者在临床药物试验中的代表性严重不足。需要努力增加子宫内膜癌临床试验参与者的多样性。
