1 Department of Health Behavior and Policy, Virginia Commonwealth University School of Medicine and VCU Massey Cancer Center, Richmond, Virginia.
2 Department of Health Behavior and Policy and Department of Biostatistics, Virginia Commonwealth University School of Medicine.
J Manag Care Spec Pharm. 2019 May;25(5):578-586. doi: 10.18553/jmcp.2019.25.5.578.
Adjuvant endocrine therapy (AET) is a critical therapy in that it improves survival in women with hormone receptor-positive (HR+) breast cancer (BC), but adherence to AET is suboptimal. The purpose of this study was to fill scientific gaps about predictors of adherence to AET among black and white women diagnosed with BC.
To assess AET adherence in black and white insured women using multiple measures, including one that uses an innovative statistical approach.
Black and white women newly diagnosed with HR+ BC were identified from 2 health maintenance organizations. Pharmacy records captured the type of oral AET prescriptions and all fill dates. Multivariable logistic regression was used to identify predictors of adherence defined in terms of proportion of days covered (PDC; ≥ 80%) and medication gap of ≤ 10 days. A zero-inflated negative binomial (ZINB) regression model was used to identify variables associated with the total number of days of medication gaps.
1,925 women met inclusion criteria. 80% were PDC adherent (> 80%); 44% had a medication gap of ≤ 10 days; and 24% had no medication gap days. Race and age were significant in all multivariable models. Black women were less likely to be adherent based on PDC than white women (OR = 0.72, 95% CI = 0.57-0.90, < 0.01), and they were less likely to have a medication gap of ≤ 10 days (OR = 0.65, 95% CI = 0.54-0.79, < 0.001). Women aged 25-49 years were less likely to be PDC adherent than women aged 65-93 years (OR = 0.65, 95% CI = 0.48-0.87, < 0.001). In the ZINB model, women were without their medication for an average of 37 days (SD = 50.5).
Racial disparities in adherence to AET in the study highlight a need for interventions among insured women. Using various measures of adherence may help better understand this multidimensional concept. There might be benefits from using both more common dichotomous measures (e.g., PDC) and integrating novel statistical approaches to allow tailoring adherence to patterns within a specific sample.
This research was funded by the National Institutes of Health (R01CA154848). It was also supported in part by the NIH-NCI Cancer Center Support Grant P30 CA016059, the Laboratory of Telomere Health P30 CA51008, and the TSA Award No. UL1TR002649 from the National Center for Advancing Translational Sciences. The contents of this study are solely the responsibility of the authors and do not necessarily represent official views of the National Center for Advancing Translational Sciences or the National Institutes of Health. Bosworth reports grants from Sanofi, Otsuka, Johnson & Johnson, and Blue Cross/Blue Shield of NC and consulting fees from Sanofi and Otsuka. The other authors have nothing to disclose. The datasets generated during and/or analyzed during the current study are not publicly available due to privacy reasons but are available from the corresponding author on reasonable request. The author does not own these data. Data use was granted to the author as part of a data use agreement between specific agencies and organizations.
辅助内分泌治疗（AET）是一种关键的治疗方法，因为它可以提高激素受体阳性（HR+）乳腺癌（BC）患者的生存率，但 AET 的依从性并不理想。本研究的目的是填补关于黑人和白人女性接受 BC 诊断后 AET 依从性预测因素的科学空白。
使用多种措施评估黑人女性和白人女性接受 AET 的依从性，包括使用创新统计方法的措施。
从 2 个健康维护组织中确定新诊断为 HR+BC 的黑人和白人女性。药房记录记录了口服 AET 处方的类型和所有配药日期。多变量逻辑回归用于确定依从性的定义（以比例覆盖天数（PDC；≥80%）和药物间隙≤10 天为准）的预测因素。零膨胀负二项（ZINB）回归模型用于确定与药物间隙总天数相关的变量。
1925 名女性符合纳入标准。80%的女性 PDC 依从性（>80%）；44%的女性药物间隙≤10 天；24%的女性没有药物间隙。种族和年龄在所有多变量模型中均有显著意义。黑人女性与白人女性相比，基于 PDC 的依从性较低（OR=0.72，95%CI=0.57-0.90，<0.01），药物间隙≤10 天的可能性也较低（OR=0.65，95%CI=0.54-0.79，<0.001）。25-49 岁的女性与 65-93 岁的女性相比，PDC 依从性较低（OR=0.65，95%CI=0.48-0.87，<0.001）。在 ZINB 模型中，女性平均有 37 天（SD=50.5）没有服用药物。
研究中 AET 依从性的种族差异突出表明需要在参保女性中进行干预。使用各种依从性衡量标准可能有助于更好地理解这一多维度概念。从使用更常见的二分法衡量标准（例如 PDC）和整合新颖的统计方法入手，以适应特定样本中的依从模式，可能会带来益处。
本研究由美国国立卫生研究院（R01CA154848）资助。它还得到了 NIH-NCI 癌症中心支持奖 P30 CA51008 的部分支持，以及来自国家转化医学推进中心 UL1TR002649 的 TSA 奖。本研究内容仅为作者的责任，不一定代表国家转化医学推进中心或美国国立卫生研究院的官方观点。Bosworth 报告了与 Sanofi、Otsuka、Johnson & Johnson 和 Blue Cross/Blue Shield of NC 的合作关系，并从 Sanofi 和 Otsuka 获得咨询费。其他作者没有什么可披露的。作者不拥有这些数据。由于隐私原因，在当前研究期间生成和/或分析的数据目前不可公开，但作者可以根据合理要求从相应作者处获得。作者不是这些数据的所有者。数据的使用是在特定机构和组织之间的一项数据使用协议的框架内授予作者的。
