Clinical breast cancer risk prediction models for women with a high-risk benign breast diagnosis

高风险良性乳腺诊断女性的临床乳腺癌风险预测模型

• 批准号: 10719777
• 负责人: Brian L Sprague
• 金额: $ 84.03万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10719777
• 关键词: Address; Affect; Age; Benign; Biopsy; Breast; Breast Cancer Detection; Breast Cancer Risk Factor; Breast Cancer Surveillance Consortium; Breast Diseases; Breast biopsy; Caring; Case Management; Characteristics; Chemoprevention; Clinical; Clinical Management; Core Biopsy; Data; Databases; Decision Analysis; Descriptor; Detection; Development; Diagnosis; Diagnostic Imaging; Ensure; Excision; Future; Geography; Goals; Guidelines; Harm Reduction; Health Personnel; Health care facility; Healthcare Systems; Incidence; Infrastructure; Institution; Intervention; Learning; Lesion; Literature; Malignant - descriptor; Malignant Neoplasms; Mammography; Medical Records; Modeling; Multicenter Studies; Needles; Non-Malignant; Noninfiltrating Intraductal Carcinoma; Normal Range; Operative Surgical Procedures; Outcome; Palpable; Pathologic; Pathology Report; Patients; Policy Maker; Population; Prevention; Qualitative Methods; Radiologic Finding; Radiology Specialty; Recommendation; Records; Regional Cancer; Registries; Reporting; Reproducibility; Risk; Sample Size; Sampling; Specific qualifier value; Statistical Models; Symptoms; Time; Uncertainty; Vacuum; Validation; Woman; Work; breast cancer diagnosis; breast density; breast imaging; breast lesion; breast pathology; calcification; cancer diagnosis; cancer risk; clinical practice; cohort; cost; disease diagnosis; evidence based guidelines; high risk; improved; insight; interest; learning strategy; malignant breast neoplasm; mammography registry; model development; multidisciplinary; neoplasm registry; predictive modeling; risk prediction model; side effect; stakeholder perspectives; surveillance imaging

PROJECT SUMMARY/ABSTRACT Over 1.7 million core needle breast biopsies are performed in the U.S. every year among women with either a palpable mass or a suspicious finding on breast imaging.1 Benign breast disease is diagnosed in 75% of these biopsies2 and comprises a spectrum of diagnoses ranging from normal or non-proliferative changes to proliferative changes with or without atypical features. Early studies demonstrated that ~10-30% of women with specific benign breast disease diagnoses (referred to as “high-risk lesions”) had cancer identified on surgical excision of their lesion (referred to as “upgrade”).3,4 Thus, aggressive management with surgical excision is common for these high-risk lesions to rule out malignancy.1 However, there is widespread interest in avoiding surgery for high-risk lesions, the majority of which will not yield a malignant diagnosis on excision.5 Single- institution studies have identified various patient, pathologic, and radiologic variables associated with risk of upgrade on excision, but insufficient evidence is available to inform evidence-based guidelines as to which patients with high-risk lesions can safely avoid excision.5-7 There is also uncertainty about long-term breast cancer risk and the need for enhanced prevention and detection strategies among women who do not undergo excision, or who undergo excision without upgrade.8-10 Our goal is to provide definitive new evidence to guide clinical management recommendations for high-risk breast lesions. We propose a comprehensive study leveraging the rich infrastructure and longitudinal data of the Breast Cancer Surveillance Consortium, a large U.S. alliance of breast imaging and pathology registries. We will supplement the existing BCSC database with newly collected data from breast imaging reports, pathology reports, and other clinical medical records for over 7,000 high-risk lesions diagnosed at more than 100 healthcare facilities since 2010. Using an ensemble learning approach we will develop and validate prediction models for risk of upgrade on excision (Aim 1) and 5- year breast cancer incidence among women with high-risk lesions (Aim 2) based on patient, pathologic, and radiologic factors. In Aim 3 we will use a decision analysis framework paired with qualitative study of stakeholder perspectives to evaluate the potential population impact and acceptability of risk-based strategies for managing high-risk lesions. Our results will facilitate identification of women with acceptably low risk of upgrade on excision who can be safely managed by imaging surveillance, and identify women with elevated risk of a future cancer diagnosis who need enhanced long-term imaging surveillance and/or chemoprevention. The proposed study will be far larger and more representative of clinical practice in the U.S. than any study conducted to date, and will be the first to comprehensively evaluate patient, biopsy, pathologic, and radiologic factors in relation to high-risk lesion outcomes in a multicenter study. Evidence generated by this study will inform clinical recommendations for the management of high-risk lesions diagnosed with core needle biopsy, resulting in improved care and reduced harms for the >100,000 women diagnosed annually in the U.S.

项目概要/摘要 美国每年对患有以下任一疾病的女性进行超过 170 万例乳房芯针活检： 可触及肿块或乳腺影像学可疑发现。1 其中 75% 被诊断为良性乳腺疾病 活检2，包括一系列诊断，从正常或非增殖性变化到 早期研究表明，约 10-30% 的女性患有增殖性变化，伴有或不伴有非典型特征。 特定良性乳腺疾病诊断（称为“高风险病变”）在手术中发现癌症 切除病变（称为“升级”）。3,4 因此，通过手术切除进行积极治疗是 对于这些高风险病变来说很常见，以排除恶性肿瘤。1然而，人们普遍有兴趣避免 对高风险病变进行手术，其中大多数切除后不会产生恶性诊断。5 机构研究已经确定了与以下风险相关的各种患者、病理和放射学变量： 切除升级，但没有足够的证据来指导基于证据的指南 有高风险病变的患者可以安全地避免切除。5-7 长期乳房也存在不确定性 未接受癌症治疗的女性的癌症风险以及加强预防和检测策略的必要性 切除术，或接受切除术但未升级的患者。8-10 我们的目标是提供明确的新证据来指导 我们提出了一项针对高风险乳腺病变的临床管理建议。 利用乳腺癌监测联盟丰富的基础设施和纵向数据 美国乳腺影像和病理登记联盟将补充现有的 BCSC 数据库。 从乳腺影像报告、病理报告和其他临床医疗记录中新收集的数据超过 自 2010 年以来，在 100 多家医疗机构诊断出 7,000 个高风险病变。使用整体 我们将开发和验证切除升级风险的预测模型（目标 1）和 5- 根据患者、病理和情况，患有高风险病变的女性的乳腺癌发病率（目标 2） 在目标 3 中，我们将使用决策分析框架与定性研究相结合。 利益相关者的观点来评估基于风险的战略的潜在人口影响和可接受性 我们的结果将有助于识别具有可接受的低风险的女性。 升级切除术，可以通过影像监测安全管理，并识别患有升高的女性 未来癌症诊断的风险，需要加强长期影像监测和/或化学预防。 拟议的研究将比任何研究规模更大、更能代表美国的临床实践 迄今为止进行的，并将是第一个全面评估患者、活检、病理和放射学的 本研究产生的证据将与高风险病变结果相关。 为通过空心针活检诊断出的高风险病变的管理提供临床建议， 为美国每年超过 100,000 名被诊断的女性提供更好的护理并减少伤害