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

我们的建议旨在改善65岁女性早期乳腺癌的治疗并使其个体化。 6岁及以上，并新颖地使用了为期三个月的术前内分泌治疗(Pre-ET)。早些时候- 晚期乳腺癌的传统治疗方法是保乳手术(BCS)，然后辅以放射治疗。 治疗(RT)和5-10年的辅助内分泌治疗(AET)。来自两家公司的长期数据 随机对照试验表明，雌激素受体阳性的老年妇女的RT遗漏， 接受AET治疗的早期乳腺癌患者的存活率不会降低。然而，结束了 70%的女性仍在接受RT，部分原因是医生和患者不愿忽略针对以下情况的治疗 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。我们会 评估预ET作为一种新的经验性工具在辅助治疗决策、预测长期疗效方面的应用 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前是否改变了患者和治疗医生对辅助RT的偏好。这项测试 暴露将为患者提供他们需要在治疗方案中选择的信息 BCS。我们假设，为期3个月的ET前疗程将降低患者和医生对 佐剂RT从基线偏好增加10%。我们还将评估患者报告的结果是否在 Pre-ET预测AET依从性为2年。我们将通过以下方式获得肿瘤对预置ET反应的探索性数据 检测移植前和移植后肿瘤增殖指数。目的2：测量预置胎盘对心脏功能的影响 BCS术后辅助治疗的决策结果。我们将申请渥太华的决定支持 评估内分泌治疗试验对决策冲突和决策后悔的影响的框架， 将Pre-ET作为决策支持干预。我们将在一年和两年后测量决策后悔 BCS。我们假设，预置将减少决策冲突和后悔，决策冲突和 后悔分数将与坚持AET一年和两年有关。在建议书中使用预试用法 代表了一种以患者为中心的治疗方法，并可能最终导致范式的转变 早期乳腺癌在老年妇女中得到治疗，从而实现了辅助治疗的最佳分配， 增加了对计划治疗方案的坚持，减少了决策后悔。

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.