Reh Nicole, Caston Nicole E, Williams Courtney P, Dwarampudi Sindhu R, Elkhanany Ahmed, Khoury Katia, Stringer-Reasor Erica, Jahan Nusrat, Rocque Gabrielle B, Gutnik Lily A
The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, AL, USA.
Cancer Care Quality Training Program, UNC Lineberger, Chapel Hill, NC, USA.
Ann Surg Oncol. 2025 Mar;32(3):2038-2044. doi: 10.1245/s10434-024-16607-9. Epub 2024 Dec 9.
Therapeutic clinical trials frequently lack diverse representation, hindering generalizability and exacerbating preexisting disparities in clinical outcomes. This study explored associations between breast cancer patient demographics, clinical trial eligibility, and enrollment in a National Cancer Institute (NCI)-designated cancer center.
This prospective cohort study included patients with breast cancer screened for therapeutic clinical trials from July 2020 to January 2024. Eligibility was determined by the provider and study coordinator. Patient characteristics were abstracted from the electronic medical record. Rurality and neighborhood disadvantage were mapped by address using rural-urban commuting area codes and area deprivation index (ADI), respectively. Likelihood of eligibility and enrollment by race, rurality, and neighborhood disadvantage were evaluated using risk ratios (RR) and 95% confidence intervals (CIs) from modified Poisson regression models.
Of 343 patients screened for therapeutic trials, the mean age was 56 years (SD 13), 33% were Black/other race, 22% lived in highly disadvantaged areas, and 16% in rural areas. Most patients were screened for one trial (87%). Overall, 54% of patients were eligible for trials, and of those, 58% enrolled. Similar likelihoods of eligibility and enrollment were seen by race and rurality. Though not significant, patients living in highly disadvantaged areas trended toward higher likelihood of enrollment (RR 1.24, 95% CI 0.99-1.55).
Over half of trial-eligible patients, even across race, rurality, or neighborhood disadvantage, enrolled, surpassing the national average. In contrast to national trends, there was higher enrollment among patients of higher ADI.
治疗性临床试验常常缺乏多样化的代表性，这阻碍了研究结果的普遍性，并加剧了临床结果中已有的差异。本研究探讨了乳腺癌患者人口统计学特征、临床试验资格与在一家美国国立癌症研究所（NCI）指定的癌症中心入组情况之间的关联。
这项前瞻性队列研究纳入了2020年7月至2024年1月期间接受治疗性临床试验筛查的乳腺癌患者。资格由医疗服务提供者和研究协调员确定。患者特征从电子病历中提取。分别使用城乡通勤区代码和区域贫困指数（ADI），根据地址确定患者所在地区的农村或城市属性以及邻里劣势程度。使用修正泊松回归模型的风险比（RR）和95%置信区间（CI）评估不同种族、农村或城市属性以及邻里劣势程度的患者符合试验资格和入组的可能性。
在343名接受治疗性试验筛查的患者中，平均年龄为56岁（标准差13），33%为黑人/其他种族，22%生活在高度贫困地区，16%生活在农村地区。大多数患者接受了一项试验的筛查（87%）。总体而言，54%的患者符合试验资格，其中58%入组。不同种族和农村或城市属性的患者符合试验资格和入组的可能性相似。虽然不显著，但生活在高度贫困地区的患者入组可能性有上升趋势（RR 为1.24，95% CI为0.99 - 1.55）。
超过一半符合试验资格的患者，即使跨越种族、农村或城市属性以及邻里劣势程度，都入组了，超过了全国平均水平。与全国趋势相反，ADI较高的患者入组率更高。
