Breast cancer neoadjuvant endocrine therapy during the Covid-19 pandemic: Opportunity for a new treatment paradigm?

Covid-19大流行期间的乳腺癌新辅助内分泌治疗:新治疗模式的机会?

基本信息

  • 批准号:
    10589922
  • 负责人:
  • 金额:
    $ 21.37万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2022
  • 资助国家:
    美国
  • 起止时间:
    2022-03-10 至 2024-06-30
  • 项目状态:
    已结题

项目摘要

Neoadjuvant endocrine therapy (NET; pre-surgical treatment with an anti-endocrine drug) has been suggested as a promising support system for addressing surgical delays among breast cancer patients, but a better understanding of the impact of NET among a broad cross-section of patients is needed before it can be integrated into usual care. Surgery is a standard treatment for breast cancer, but up to 36% of patients in the US do not receive surgery within the recommended time period. Delaying surgery by >6 weeks has been associated with an 82% relative increase in breast cancer death, thus bridging this gap in care with alternative treatments such as NET may substantially improve survival among this subset of patients. NET produces similar rates of clinical and radiologic response when compared with the more commonly used neoadjuvant chemotherapy and has strong potential as a treatment for patients with hormone receptor-positive (HR+) breast cancer, particularly those who are not expected to derive any benefit from chemotherapy. NET was rare (~3% of stage II-III HR+) before the COVID-19 pandemic, and was generally reserved for patients needing cytoreduction prior to surgery. As such, most prior studies evaluating the relationship between the NET and treatment endpoints, such cellular proliferation (i.e., Ki-67 expression), tumor size, estrogen receptor, and nodal status, over-represented patients with large tumors and a later stage at diagnosis. There are few data to address whether NET-associated changes to prognostic factors observed in past studies can be generalized to the broader population of patients with HR+ breast cancer, including those with the smaller and earlier stage tumors that are characteristic of HR+ disease. Therefore, the objective of this study is to evaluate the prognostic impact of NET in a non-clinical trial population of 155 patients with HR+ breast cancer who were treated in the University of North Carolina Health system during the Covid-19 pandemic, including those with early stage disease. Our underlying hypothesis is that patients will experience a positive response to NET treatment, but that the magnitude of the response will vary by demographic and socioeconomic characteristics. Using a within-person design (pre-/post-NET comparison), we will (Aim 1) quantify the effect of NET on Ki-67, radiologic tumor size, estrogen receptor expression [%], nodal status, and the composite pre-operative prognostic index (PEPI); and (Aim 2) identify individual-level and structural factors that are associated with NET response (i.e., change in the prognostic factors described in Aim 1). Timely access to surgical care is not always feasible. The development of alternative treatment strategies that mitigate the effects of surgical delays may reduce the risks of greater breast cancer morbidity while long-term solutions are developed. The proposed study will help fill this gap by demonstrating the real-world effects of NET in a general population of patients with HR+ breast cancer.
建议进行新辅助内分泌治疗(NET;使用抗内分泌药物进行术前治疗) 作为解决乳腺癌患者手术延误问题的一个有前途的支持系统,但更好的 需要先了解 NET 对广大患者的影响,然后才能 融入日常护理。手术是乳腺癌的标准治疗方法,但高达 36% 的乳腺癌患者 美国不会在建议的时间内接受手术。手术推迟超过 6 周 与乳腺癌死亡率相对增加 82% 相关,从而弥补了护理方面的差距 NET 等替代疗法可能会显着提高这部分患者的生存率。 与更常用的方法相比,NET 产生相似的临床和放射学反应率 新辅助化疗,具有治疗激素受体阳性患者的强大潜力 (HR+) 乳腺癌,特别是那些预计不会从化疗中获得任何益处的乳腺癌。网 在 COVID-19 大流行之前,这种情况很少见(约占 II-III 期 HR+ 的 3%),并且通常保留给患者 手术前需要进行细胞减灭术。因此,大多数先前的研究评估了两者之间的关系 NET 和治疗终点,例如细胞增殖(即 Ki-67 表达)、肿瘤大小、雌激素受体、 和淋巴结状态,患有大肿瘤和诊断较晚的患者比例过高。有几个 数据来解决过去研究中观察到的与 NET 相关的预后因素变化是否可以 推广到更广泛的 HR+ 乳腺癌患者群体,包括那些患有 较小且早期的肿瘤是 HR+ 疾病的特征。因此,本研究的目的 旨在评估 NET 对 155 名 HR+ 乳腺患者的非临床试验人群的预后影响 在 Covid-19 大流行期间在北卡罗来纳大学卫生系统接受治疗的癌症患者, 包括那些患有早期疾病的人。我们的基本假设是患者会经历积极的 对 NET 治疗的反应,但反应的程度会因人口和人口的不同而有所不同 社会经济特征。使用内部设计(网络前/后比较),我们将(目标 1) 量化 NET 对 Ki-67、放射学肿瘤大小、雌激素受体表达 [%]、淋巴结状态和 综合术前预后指数(PEPI); (目标 2)确定个人层面和结构性因素 与 NET 反应相关的变化(即目标 1 中描述的预后因素的变化)。及时 获得手术治疗并不总是可行的。开发替代治疗策略以减轻 手术延迟的影响可能会降低乳腺癌发病率增加的风险,而长期解决方案 已开发。拟议的研究将通过展示 NET 在现实世界中的影响来帮助填补这一空白。 HR+ 乳腺癌患者的一般人群。

项目成果

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Sarah Jane Nyante其他文献

Sarah Jane Nyante的其他文献

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{{ truncateString('Sarah Jane Nyante', 18)}}的其他基金

Impact of the COVID-19 pandemic on newly-diagnosed breast cancer
COVID-19 大流行对新诊断乳腺癌的影响
  • 批准号:
    10359555
  • 财政年份:
    2022
  • 资助金额:
    $ 21.37万
  • 项目类别:
Breast cancer neoadjuvant endocrine therapy during the Covid-19 pandemic: Opportunity for a new treatment paradigm?
Covid-19大流行期间的乳腺癌新辅助内分泌治疗:新治疗模式的机会?
  • 批准号:
    10425018
  • 财政年份:
    2022
  • 资助金额:
    $ 21.37万
  • 项目类别:
Impact of the COVID-19 pandemic on newly-diagnosed breast cancer
COVID-19 大流行对新诊断乳腺癌的影响
  • 批准号:
    10544316
  • 财政年份:
    2022
  • 资助金额:
    $ 21.37万
  • 项目类别:
Understanding the biological basis for the association between parenchymal texture features and breast cancer risk
了解实质纹理特征与乳腺癌风险之间关联的生物学基础
  • 批准号:
    10697306
  • 财政年份:
    2019
  • 资助金额:
    $ 21.37万
  • 项目类别:
Understanding the biological basis for the association between parenchymal texture features and breast cancer risk
了解实质纹理特征与乳腺癌风险之间关联的生物学基础
  • 批准号:
    10241446
  • 财政年份:
    2019
  • 资助金额:
    $ 21.37万
  • 项目类别:
Understanding the biological basis for the association between parenchymal texture features and breast cancer risk
了解实质纹理特征与乳腺癌风险之间关联的生物学基础
  • 批准号:
    10472712
  • 财政年份:
    2019
  • 资助金额:
    $ 21.37万
  • 项目类别:
Understanding the biological basis for the association between parenchymal texture features and breast cancer risk
了解实质纹理特征与乳腺癌风险之间关联的生物学基础
  • 批准号:
    9975109
  • 财政年份:
    2019
  • 资助金额:
    $ 21.37万
  • 项目类别:

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阐明新的 WNT4 调节轴作为妇科癌症健康差异的驱动因素
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