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Individualization of Locoregional Management for Early-Stage Breast Cancer

早期乳腺癌局部区域管理的个体化

基本信息

批准号：
8374168
负责人：
Reshma Jagsi
金额：
$ 32.97万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-01 至 2017-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8374168
关键词：
Address Adoption Age Attitude Axillary Lymph Node Dissection BRCA1 gene Breast Breast Cancer Treatment Breast-Conserving Surgery Cancer Patient Caring Characteristics Clinical Communication Contralateral Data Decision Making Diagnosis Disease Ethnic Origin Evaluation Extranodal Face Family Family history of Genetic screening method Health Benefit Histology Instruction Intervention Knowledge Magnetic Resonance Imaging Malignant Neoplasms Mastectomy Modeling Mutation Neoplasm Metastasis New Jersey Newly Diagnosed Nodal Operative Surgical Procedures Outcome Patients Pattern Process Public Health Quality of life Radiation Radiation therapy Recording of previous events Recurrence Registries Reporting Research Research Personnel Role Sentinel Lymph Node Sentinel Lymph Node Biopsy Socioeconomic Status Staging Surgeon Surveys Testing cancer care cancer type clinical practice evidence base improved irradiation malignant breast neoplasm population based preference prophylactic randomized trial satisfaction standard care treatment effect uptake

项目摘要

Individualizing the locoregional management of breast cancer is challenging for both patients and their clinicians. The acceleratetd pace of introduction and adoption of evaluative tests to inform management of breast cancer may facilitate individualization, but the patterns of use and impact of these tests is not sufficiently understood. Standard treatments include breast conserving surgery (BCS) with whole breast radiation vs mastectomy, which have been shown to yield equivalent clinical outcomes in mature randomized trials. However, patients may now also receive more aggressive approaches, including contralateral prophylactic mastectomy, or less aggressive approaches, such as BCS with partial breast irradiation (PBI) or omission of axillary lymph node dissection (ALND) for limited metastases on sentinel node biopsy. The health benefits of the rapidly evolving approaches for breast cancer locoregional management cannot be maximized without ongoing population-based research to track and evaluate how these tests and treatments are used to better individualize care. Individualized care in this context is achieved when 1) evaluative tests are ordered in clinically appropriate patients, 2) treatment receipt is largely driven by evidence-based clinical indications that address expected benefit in terms of disease-free and overall survival, and 3) patients are informed, satisfied with the process, and their preferences and values are incorporated into decisions. The project proposed here is a population-based study of patients newly diagnosed with breast cancer and reported to the SEER registries of New Jersey and Georgia, as well as their surgeons. Aim 1 is to examine the use of newer evaluative tests (breast MRI and genetic testing for BRCA1/2 mutation) for patients diagnosed with breast cancer and the patient and clinician correlates of testing. Aim 2 is to examine the receipt of contralateral prophylactic mastectomy, omission of ALND, and PBI, and the patient and clinician correlates of uptake of these emerging approaches for locoregional management of breast cancer. As part of this aim, we will evaluate the effects of newer evaluative tests on receipt of treatments. Aim 3 is to explore the individualization of decision-making by evaluating the extent to which patients are informed about tests and treatments and are satisfied with the decision-makino process.

乳腺癌局部区域的个体化治疗对患者和临床医生都是一个挑战。加速引入和采用评估性检测来告知乳腺癌的管理可能有助于个体化，但这些检测的使用模式和影响尚未得到充分理解。标准治疗包括保乳手术（BCS）和全乳放疗与乳房切除术，在成熟的随机试验中已显示其产生等同的临床结局。然而，患者现在也可以接受更积极的方法，包括对侧预防性乳房切除术，或不太积极的方法，如BCS与部分乳房照射（PBI）或省略腋窝淋巴结清扫（ALND）的前哨淋巴结活检有限的转移。如果不进行以人群为基础的研究来跟踪和评估如何使用这些检测和治疗来更好地个性化护理，快速发展的乳腺癌局部区域管理方法的健康益处就无法最大化。在这种情况下，当1）在临床上适当的患者中进行评价性测试时，可以实现个性化护理，2）治疗接收主要由基于证据的临床适应症驱动，这些适应症解决了无病生存期和总生存期方面的预期获益，3）患者被告知，对过程感到满意，并且他们的偏好和价值观被纳入决策。这里提出的项目是一项基于人群的研究，研究对象是新诊断的乳腺癌患者，并向新泽西和格鲁吉亚的SEER登记处报告，以及他们的外科医生。目的1是检查使用新的评估测试（乳腺MRI和BRCA 1/2突变基因检测）诊断为乳腺癌患者和患者和临床医生相关的测试。目的2是检查接受对侧预防性乳房切除术，ALND和PBI的遗漏，以及患者和临床医生对这些新兴方法用于乳腺癌局部管理的相关性。作为这一目标的一部分，我们将评估更新的评估测试对接受治疗的影响。目的3是通过评估患者被告知检查的程度来探索决策的个体化和治疗，并满意的决策-牧野过程。