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治疗65岁女性早期乳腺癌 岁及以上患者，新使用了3个月的术前内分泌治疗（pre-ET）。早- 乳腺癌的传统治疗方法是保乳手术（BCS），然后进行辅助放疗 治疗（RT）和5- 10年的辅助内分泌治疗（AET）。两个长期数据 随机对照试验表明，在雌激素受体阳性的老年妇女中， 接受AET治疗的早期乳腺癌不会导致生存率降低。但在 70%的女性仍然接受RT，部分原因是医生和患者不愿意忽略治疗， 关注AET毒性和依从性。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ET前作为一种新的经验工具的使用，以告知辅助治疗决策，预测长期 AET的遵守和减少决策冲突和遗憾，解决以下具体目标：目标1： 评估ET前是否改变患者和治疗医生对辅助RT的偏好。 暴露将为患者提供他们需要的信息，以便在治疗后选择治疗方案。 BCS。我们假设3个月的ET前疗程将减少患者和医生对 辅助RT从基线偏好降低10%。我们还将评估患者报告的结果是否在 ET前可预测2年时的AET依从性。我们将通过以下方法获得关于肿瘤对ET前反应的探索性数据： 评价ET前、后肿瘤增殖指数。目的2：检测ET前对大鼠脑缺血再灌注损伤的影响。 BCS后辅助治疗的决策结果。我们将应用渥太华决策支持 评估内分泌治疗对决策冲突和决策后悔的影响的框架， 将ET前作为决策支持干预。我们将在1年和2年后测量决策后悔， BCS。我们假设ET前会减少决策冲突和后悔，而决策冲突和 后悔评分与AET的1年和2年依从性相关。在提案中使用ET前 代表了以患者为中心的治疗方法，并可能最终导致范式转变， 在老年妇女中治疗早期乳腺癌，允许优化辅助治疗的分配， 增加对计划治疗方案的依从性，减少决策后悔。