Patient-Centered Insights from the POWER Trial: Pre-Operative Window of Adjuvant Endocrine Therapy to Inform Radiation Therapy Decisions in Older Women with Early-Stage Breast Cancer

POWER 试验中以患者为中心的见解：辅助内分泌治疗的术前窗口为患有早期乳腺癌的老年女性做出放射治疗决策提供信息

• 批准号: 10577304
• 负责人: Shayna Lefrak Showalter
• 金额: $ 23.37万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10577304
• 关键词: Address; Adherence; Adjuvant Radiotherapy; Adjuvant Therapy; Advocacy; Age; Aromatase Inhibitors; Breast; Breast Cancer Patient; Breast-Conserving Surgery; Cancer and Leukemia Group B; Cessation of life; Clinical; Clinical Trials; Conflict (Psychology); Controlled Clinical Trials; DNA Resequencing; Data; Decision Making; Disease-Free Survival; Distant; Early treatment; Estrogen Receptors; Estrogen receptor positive; Fright; Future; Guidelines; Individual; Intervention; Ipsilateral; Life Expectancy; Light; Malignant Neoplasms; Mammary Neoplasms; Measures; National Comprehensive Cancer Network; Newly Diagnosed; Outcome; Patient Outcomes Assessments; Patient Preferences; Patients; Patterns of Care; Physicians; Population; Prediction of Response to Therapy; Preoperative Endocrine Therapy; Prior Therapy; Provider; Quality of life; Radiation; Radiation therapy; Randomized, Controlled Trials; Recommendation; Recurrent tumor; Regrets; Reporting; Risk; Risk Reduction; S-Phase Fraction; Surgical Oncologist; Tamoxifen; Testing; Time; Treatment Protocols; Treatment-related toxicity; United States; Update; Woman; Women' s Group; adherence rate; adjuvant endocrine therapy; age related; aged; cohort; comorbidity; demographics; design; experience; high risk; hormone therapy; improved; individual patient; individualized medicine; innovation; insight; malignant breast neoplasm; model design; novel; older patient; older women; optimal treatments; overtreatment; patient oriented; phase 2 study; preference; preservation; prevent; prospective; response; side effect; standard of care; systematic review; therapy adherence; therapy design; tool; treatment center; treatment planning; tumor

Our proposal aims to improve and individualize the treatment of early-stage breast cancer in women aged 65 years and older with a novel use of a three-month course of pre-operative endocrine therapy (pre-ET). Early- stage breast cancer is traditionally treated with breast conserving surgery (BCS) followed by adjuvant radiation therapy (RT) and a 5- to10-year course of adjuvant endocrine therapy (AET). Long-term data from two randomized controlled trials demonstrate that omission of RT in older women with estrogen receptor positive, early-stage breast cancer who are treated with AET does not result in a decreased survival. However, over 70% of women still receive RT, due in part to physician and patient reluctance to omit a treatment in light of concerns about AET toxicity and adherence. Optimal choices for older breast cancer patients require considering data-based recommendations, life expectancy, co-morbidities and patient preferences. We will evaluate the use of pre-ET as a novel experiential tool to inform adjuvant therapy decisions, predict long-term AET adherence and to reduce decisional conflict and regret, addressing the following specific aims: Aim 1: To assess whether pre-ET changes patients’ and treating physicians’ preference for adjuvant RT. This test exposure will provide patients with the information they need to choose among the treatment options after BCS. We hypothesize that a 3-month course of pre-ET will reduce patients’ and physicians’ preferences for adjuvant RT by 10% from baseline preferences. We will also assess whether patient-reported outcomes during pre-ET predict AET adherence at 2 years. We will obtain exploratory data on tumor response to pre-ET by evaluating tumor proliferation indices before and after pre-ET. Aim 2: To measure the effect of pre-ET on decisional outcomes for adjuvant therapy after BCS. We will apply the Ottawa Decision Support Framework to evaluate the effects of a trial of endocrine therapy on decisional conflict and decisional regret, framing pre-ET as a decision support intervention. We will measure decisional regret at 1 and 2 years after BCS. We hypothesize that pre-ET will reduce decisional conflict and regret, and that decisional conflict and regret scores will be associated with 1- and 2-year adherence to AET. The use of pre-ET in the proposal represents a patient-centered treatment approach and may ultimately lead to a paradigm shift in the way that early-stage breast cancer is treated in older women, allowing for optimization assignment of adjuvant therapy, increased adherence to planned treatment regimens and decreased decisional regret.

我们的建议旨在改善和个性化65岁女性的早期乳腺癌治疗 通过新的三个月术前内分泌疗法（PRE-ET）的新方法使用新的年代。早期的- 阶段乳腺癌传统上是通过乳房保存手术（BC）进行治疗的，然后进行调整辐射 治疗（RT）和5至10年的可调节性内分泌疗法（AET）。来自两个的长期数据 随机对照试验表明，雌激素受体阳性的老年女性的RT省略， 接受AET治疗的早期乳腺癌不会导致生存率降低。但是，结束了 70％的妇女仍会收到RT，部分原因是身体和患者不愿意根据 对AET毒性和依从性的担忧。老年乳腺癌患者的最佳选择需要 考虑基于数据的建议，预期寿命，合并症和患者偏好。我们将 评估PRE-ET作为一种新颖的工具来告知调整治疗决策的新型工具，预测长期 AET依从性并减少决策冲突和遗憾，解决以下具体目的：目标1： 评估PE-ET是否会改变患者的偏爱和治疗医师对调整RT的偏爱。这个测试 接触将为患者提供他们需要在治疗选择中选择的信息 BCS。我们假设一个3个月的Pre-ET课程将减少患者和医生对 根据基线偏好调整RT 10％。我们还将评估患者报告期间的结果 Pre-ET预测2年的AET依从性。我们将通过 预先ET前后评估肿瘤增殖指数。目标2：测量pre-et的效果 BCS后调整治疗的决策结果。我们将应用渥太华的决策支持 评估内分泌疗法试验对决策冲突和决策遗憾的影响的框架， 将pre-et框架作为决策支持干预措施。我们将在1和2年后衡量决策的遗憾 BCS。我们假设pre-et将减少决策冲突和遗憾，而决策冲突和 遗憾的分数将与AET的1年和2年遵守有关。在提案中使用pre-et 代表一种以患者为中心的治疗方法，最终可能导致范式转变 老年妇女治疗了早期乳腺癌，可以优化调整疗法的分配， 增加对计划治疗方案的依从性和决定性的遗憾。