Shi Julia J, Lei Xiudong, Chen Ying-Shiuan, Chavez-MacGregor Mariana, Bloom Elizabeth, Schlembach Pamela, Shaitelman Simona F, Buchholz Thomas A, Kaiser Kelsey, Ku Kimberly, Smith Benjamin D, Smith Grace L
University of Texas MD Anderson Cancer Center, Houston, Texas.
University of Texas MD Anderson Cancer Center, Houston, Texas.
Int J Radiat Oncol Biol Phys. 2023 May 1;116(1):122-131. doi: 10.1016/j.ijrobp.2023.01.037. Epub 2023 Jan 29.
Socioeconomic barriers contribute to breast cancer clinical trial enrollment disparities. We sought to identify whether socioeconomic disadvantage also is associated with decreased trial retention.
We performed a secondary analysis of 253 (of 287) patients enrolled in a randomized phase 3 trial of conventionally fractionated versus hypofractionated whole-breast irradiation. The outcome of trial retention versus dropout was defined primarily based on whether the patient completed breast cosmesis outcomes assessment at 3-year follow-up, and secondarily, at 5-year follow-up. Associations of retention with severity of socioeconomic disadvantage, quantified by patients' home neighborhood area deprivation index (ADI) rank (1 [least] to 100 [most deprivation]), were tested using the Kruskal-Wallis test and multivariate logistic regression. Associations of retention with patients' use of social resource assistance were analyzed using the χ test.
In total, 21.7% (n = 55) of patients dropped out by 3 years and 36.7% (n = 92) by 5 years. Median ADI was 36.5 (interquartile range, 22-57) for retained and 46.0 (interquartile range, 29-60) for dropout patients. Dropout was associated with more severe socioeconomic deprivation (ADI ≥45 vs <45) at 3 years (odds ratio, 3.63; 95% confidence interval, 1.62-8.15; P = .002) and 5 years (odds ratio, 2.55; 95% confidence interval, 1.37-4.76; P = .003). While on study, patients who ultimately dropped out were more likely to require resource assistance for practical (transportation, housing, financial) than psychological needs (distress, grief) or advance care planning (P = .03).
In this study, ADI was associated with disparities in clinical trial retention of patients with breast cancer receiving adjuvant radiation treatment. Results suggest that developing multidimensional interventions that extend beyond routine social determinants needs screening are needed, not only to enhance initial clinical trial access and enrollment but also to enable robust long-term retention of socioeconomically disadvantaged patients and improve the validity and generalizability of reported long-term trial clinical and patient-reported outcomes.
社会经济障碍导致乳腺癌临床试验入组存在差异。我们试图确定社会经济劣势是否也与试验保留率降低有关。
我们对一项关于常规分割与大分割全乳照射的随机3期试验中入组的287例患者中的253例进行了二次分析。试验保留与退出的结果主要根据患者在3年随访时是否完成乳房美容效果评估来定义，其次是在5年随访时。使用Kruskal-Wallis检验和多因素逻辑回归来检验保留率与社会经济劣势严重程度之间的关联，社会经济劣势严重程度通过患者家庭邻里地区贫困指数（ADI）排名（1[最不贫困]至100[最贫困]）来量化。使用χ检验分析保留率与患者使用社会资源援助之间的关联。
到3年时，共有21.7%（n = 55）的患者退出，到5年时为36.7%（n = 92）。保留患者的ADI中位数为36.5（四分位间距，22 - 57），退出患者为46.0（四分位间距，29 - 60）。在3年时（优势比，3.63；95%置信区间，1.62 - 8.15；P = 0.002）和5年时（优势比，2.55；95%置信区间，1.37 - 4.76；P = 0.003），退出与更严重的社会经济剥夺（ADI≥45 vs <45）相关。在研究期间，最终退出的患者在实际需求（交通、住房、财务）方面比心理需求（痛苦、悲伤）或预先护理计划方面更有可能需要资源援助（P = 0.03）。
在本研究中，ADI与接受辅助放疗的乳腺癌患者临床试验保留率的差异有关。结果表明，需要制定超越常规社会决定因素需求筛查的多维度干预措施，不仅要增加最初的临床试验机会和入组率，还要确保社会经济劣势患者能够长期稳定参与试验，并提高所报告的长期试验临床和患者报告结局的有效性及普遍性。
