PREDICTORS OF ADJUVANT ENDOCRINE THERAPY ADHERENCE IN WOMEN WITH BREAST CANCER

描述（申请人提供）：激素受体阳性乳腺癌的辅助激素治疗是常规癌症护理的重要组成部分；将复发率和死亡率分别降低26%和50%。然而，坚持激素治疗已被认为是一个严重的问题，其发生率低至50%。这种不遵医嘱与不良结果有关。由于大多数研究没有前瞻性地收集有关医疗服务或心理社会因素的详细数据，因此对解释患者不依从性的因素知之甚少。我们已经组建了一支优秀的调查小组来填补这些空白。这项研究的总体目标是有助于降低潜在的可避免的乳腺癌死亡率。在依从性模型的指导下，我们将对900名激素阳性乳腺癌的黑人和白人妇女进行纵向前瞻性队列研究，她们开始接受治疗并随访三年。我们将使用电子药房数据来记录女性在停止治疗前接受治疗的时间。基线访谈后，我们将在12个月、24个月和36个月进行随访访谈，以了解副作用的变化和新的合并症的出现。来自患者访谈的详细数据将与电子医疗记录和医疗保健利用数据合并。研究目的是：1)评估临床、医疗服务和心理社会因素对依从性的影响；2)确定Aim 1中确定的预测因子是否调节和/或调节种族与依从性之间的关系。在一个探索性的目的中，我们将评估CYP2D6多态性是否与服用他莫昔芬的女性的副作用有关，如果是的话，确定未来研究的效应大小估计。我们还将探讨样本提供中是否存在可能影响结论的种族差异。这项研究的结果有可能填补关于黑人和白人妇女不坚持辅助激素治疗的原因的知识空白。这些数据将用于告知临床实践中激素治疗的交付，确定最易出现不依从性的患者亚组，并制定行为干预措施。结果将广泛适用于占乳腺癌病例大多数的激素受体阳性乳腺癌妇女。

DESCRIPTION (provided by applicant): Adjuvant hormonal therapy is a critical part of routine cancer care for hormonal receptor positive breast cancers; reducing recurrence and mortality by 26 percent and 50 percent, respectively. However, adherence to hormonal therapy has been identified as a significant problem with rates as low as 50 percent. Such non-adherence has been linked to poor outcomes. Little is known about factors that explain reasons for patients' non-adherence since most studies have not prospectively collected detailed data regarding healthcare delivery or psychosocial factors. We have assembled an outstanding team of investigators to fill these gaps. The overall goal of this study is to contribute to the reduction of potential avoidable breast cancer mortality. Guided by the Adherence Model, we will conduct a longitudinal prospective cohort study of 900 Black and White women with hormonal positive breast cancer who initiate therapy and follow them for three years. We will use electronic pharmacy data to capture how long women remain on therapy before they stop treatment. After a baseline interview, we will conduct follow-up interviews at 12, 24, and 36 months to capture changes in side effects and the emergence of new co-morbidities. Detailed data from patient interviews will be merged with electronic medical records and healthcare utilization data. Study aims are to: 1) Evaluate the contribution of clinical, healthcare delivery and psychosocial predictors of adherence; and 2) Determine if predictors identified in Aim 1 moderate and/or mediate relationships between race and adherence. In an exploratory aim we will evaluate whether CYP2D6 polymorphisms are associated with side-effects among women on Tamoxifen, and if so, determine effect size estimates for future research. We will also explore if there are racial differences in sample provision that could affect conclusions. Results from this study have the potential to fill gaps in knowledge regarding reasons for non-adherence to adjuvant hormonal therapy in both Black and White women. Data will be used to inform delivery of hormonal therapy in clinical practice, identify subgroups of patients most at risk for non- adherence, and develop behavioral interventions. Results will be broadly transportable to women with hormonal receptor positive breast cancers which account for the majority of breast cancer cases. PUBLIC HEALTH RELEVANCE: The survival benefits of adjuvant hormonal therapy for women with hormonal receptor positive breast cancers are well documented. However, half of all breast cancer patients who start hormonal therapy discontinue treatment by the fifth year. Non-adherence to therapy has been shown to significantly increase mortality in breast cancer patients. Despite its importance, little is known about factors that explain why so many women fail to complete therapy. In this study, women who start hormonal therapy will be followed for 3 years of treatment to identify clinical, psychosocial, and healthcare delivery factors that predict their adherence. Because little information is known about ethnic differences in adherence to hormonal therapy, we will examine whether the predictors are similar in Black and White women. We will also explore the influence of pharmacogenetic factors and side effects. Study findings will be used to identify women most at risk for stopping treatment and to develop interventions to help women remain on therapy.