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: 10589922
• 负责人: Sarah Jane Nyante
• 金额: $ 21.37万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 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
• 来源: https://reporter.nih.gov/project-details/10589922
• 关键词: Address; Adjuvant Chemotherapy; Affect; Aftercare; Age; Area; Aromatase Inhibitors; Biopsy; Body mass index; Breast Cancer Patient; Breast Cancer Treatment; COVID-19 pandemic; Cancer Burden; Cancer Prognosis; Caring; Cell Proliferation; Cessation of life; Characteristics; Clinical/Radiologic; Data; Development; Diagnosis; Disease; Disease Progression; Disparity; Endocrine; Equipment; Estrogen Receptors; Ethnic Origin; General Population; Health Insurance; Health system; Individual; Insurance Coverage; Knowledge; Malignant Neoplasms; Medical; Meta-Analysis; Mission; Morbidity - disease rate; Neoadjuvant Therapy; Newly Diagnosed; Nodal; North Carolina; Operative Surgical Procedures; Outcome; Patients; Performance; Persons; Pharmaceutical Preparations; Population; Postmenopause; Predictive Factor; Preoperative Endocrine Therapy; Prognosis; Prognostic Factor; Public Health; Race; Radiology Specialty; Recommendation; Recurrence; Research; Retrospective cohort; Risk; Stage at Diagnosis; Subgroup; Support System; Tamoxifen; Time; Tumor stage; Universities; Woman; adjuvant endocrine therapy; alternative treatment; cancer surgery; cancer survival; chemotherapy; deprivation; design; experience; hormone receptor-positive; hormone therapy; improved; indexing; infection management; infection risk; low and middle-income countries; malignant breast neoplasm; mortality; mortality risk; pandemic disease; patient population; patient prognosis; patient subsets; preservation; prevent; prognostic; prognostic index; receptor expression; response; rural residence; socioeconomics; standard care; structural determinants; therapy duration; therapy outcome; treatment as usual; treatment response; treatment strategy; tumor

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.

新辅助内分泌治疗（NET；术前抗内分泌药物治疗）已被建议