Podany Emily L, Bulsara Shaun, Sanchez Katherine, Otte Kristen, Ellis Matthew J, Kinik Maryam
Baylor College of Medicine, Lester and Sue Smith Breast Center, Houston, TX, USA.
Washington University in St. Louis, St. Louis, MO, USA.
NPJ Breast Cancer. 2024 Aug 3;10(1):70. doi: 10.1038/s41523-024-00672-0.
This study was designed to determine the enrollment patterns in breast cancer clinical trials (CCTs) of patients with diverse backgrounds in an equal access setting and to evaluate the factors contributing to low rates of clinical trial accrual in patients of low socioeconomic status (SES). We performed a retrospective review of a prospectively maintained database of new patients seen at the Dan L. Duncan Comprehensive Cancer Center dating from 5/2015 to 9/2021, which included 3043 patients screened for breast CCTs. We compared the rate of CCT availability, eligibility, and enrollment between two patient populations: Smith Clinic, where most patients are of low SES and uninsured, and Baylor St. Luke's Medical Center (BSLMC) with mostly predominantly insured, higher income patients. We performed logistic regression to evaluate whether differences in age, clinic, race, trial type, and primary language may be underlying the differences in CCT enrollment. More patients were eligible for CCTs at Smith Clinic (53.7% vs 44.7%, p < 0.001). However, Smith Clinic patients were more likely to decline CCT enrollment compared to BSLMC (61.3% declined vs 39.4%, p < 0.001). On multivariate analysis, Black patients had a significantly higher rate of CCT refusal overall (OR = 0.26, 95% CI 0.12-0.56, p < 0.001) and BSLMC only (OR = 0.20, 95% CI 0.060-0.60, p = 0.006). Our data shows that it is likely an oversimplification to assume that equal access will lead to the elimination of CCT disparities. Efforts to diversify CCTs must include consideration of structural and institutional inequities as well as social needs.
本研究旨在确定在平等准入环境下不同背景乳腺癌患者参与乳腺癌临床试验(CCT)的入组模式,并评估导致社会经济地位(SES)较低患者临床试验入组率低的因素。我们对丹·L·邓肯综合癌症中心2015年5月至2021年9月前瞻性维护的新患者数据库进行了回顾性分析,该数据库包含3043名接受乳腺癌CCT筛查的患者。我们比较了两个患者群体的CCT可及性、合格性和入组率:史密斯诊所,大多数患者SES较低且未参保;贝勒圣卢克医疗中心(BSLMC),大多数患者主要参保且收入较高。我们进行了逻辑回归分析,以评估年龄、诊所、种族、试验类型和主要语言的差异是否可能是CCT入组差异的潜在原因。史密斯诊所更多患者符合CCT条件(53.7%对44.7%,p<0.001)。然而,与BSLMC相比,史密斯诊所患者更有可能拒绝参与CCT入组(61.3%拒绝,对39.4%,p<0.001)。多变量分析显示,黑人患者总体上CCT拒绝率显著更高(OR=0.26,95%CI 0.12 - 0.56,p<0.001),仅在BSLMC中也是如此(OR=0.20,95%CI 0.060 - 0.60,p = 0.006)。我们的数据表明,假设平等准入将消除CCT差异可能过于简单化。使CCT多样化的努力必须包括考虑结构和制度不平等以及社会需求。