HORMONE REPLACEMENT THERAPY AND BREAST CANCER

激素替代疗法与乳腺癌

• 批准号: 6724772
• 负责人: PATRICIA A CARNEY
• 金额: $ 41.97万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-03-01 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6724772
• 关键词: breast neoplasms; cancer registry /resource; cancer risk; clinical research; estrogens; female; hormone therapy; human subject; longitudinal human study; mammography; neoplasm /cancer epidemiology; postmenopause; prognosis; quality of life; women' s health

The long-term objective of this study is to evaluate the relationships between hormone replacement therapy (HRT) and breast cancer detection, breast cancer risk, breast tumor prognostic characteristics and health-related quality of life. Although the results of numerous case-control and follow-up studies suggest that hormone replacement therapy modestly increases breast cancer risk, most studies have been unable to adjust adequately for frequency of mammographic screening. This is an important limitation because more frequent use of mammography screening among women who maintain hormone replacement prescriptions through regular physician visits may lead to increased detection of breast cancer relative to women who do not use hormone replacement therapy. Our study design, which involves an existing cohort identified through the New Hampshire Mammography Network (NHMN) - a statewide, population-based mammography registry comprising more than 150,000 women - overcomes this limitation. Using a baseline survey, administered at the time of mammography, we have already obtained breast cancer risk factor information, including current HRT use, from all women in the NHMN registry. Through NHMN we have already identified 74,200 women who are pre- or post-menopausal including approximately 26,700 current HRT users. We will follow these women for four years prospectively to ascertain new cases of breast cancer. All NHMN enrollees have already provided permission to link medical, radiologic and pathology data, and consented to further contact for research purposes. We will implement a supplemental survey in Years 1 and 4 to obtain a detailed history of HRT use, additional risk factor information and health-related quality of life. All other data will be obtained from the well established NHMN. Our primary specific aims are to evaluate the impact of HRT on 1) mammography performance (i.e., sensitivity and specificity of screening mammography, proportion of uninterpretable mammograms and consequent use of other imaging procedures); 2) breast cancer incidence (especially combination therapies); 3) breast cancer tumor prognostic characteristics (e.g., TNM stage, tumor grade, axillary lymph node status and estrogen receptor status). As more women consider use of HRT to prevent osteoporosis and other diseases, understanding its impact on quality of life is imperative. Therefore, a secondary aim is to assess the impact of HRT on health- related quality of life. Results of the proposed study will benefit radiologists who interpret mammograms, and women and their health care providers, who must balance the complex issues of disease risk and health-related quality of life when deciding whether or not to use hormone replacement therapy.

本研究的长期目标是评估激素替代疗法（HRT）与乳腺癌检测、乳腺癌风险、乳腺肿瘤预后特征和健康相关生活质量之间的关系。尽管大量病例对照和随访研究的结果表明，激素替代疗法适度增加乳腺癌的风险，但大多数研究无法充分调整乳房X线筛查的频率。这是一个重要的限制，因为在通过定期医生就诊维持激素替代处方的妇女中更频繁地使用乳房X线摄影筛查可能导致相对于不使用激素替代疗法的妇女乳腺癌的检测增加。我们的研究设计，包括通过新罕布什尔州乳腺X线摄影网络（NHMN）确定的现有队列，这是一个全州范围内，基于人群的乳腺X线摄影登记，包括超过150，000名妇女，克服了这一限制。使用基线调查，在乳房X光检查时，我们已经获得了乳腺癌的危险因素信息，包括目前HRT的使用，从所有妇女在NHMN登记。 通过NHMN，我们已经确定了74，200名绝经前或绝经后的妇女，包括大约26，700名目前的HRT使用者。我们将对这些妇女进行为期四年的前瞻性随访，以确定乳腺癌的新病例。 所有NHMN的注册者都已经提供了链接医疗、放射学和病理学数据的许可，并同意为研究目的进一步联系。我们将在第1年和第4年实施补充调查，以获取HRT使用的详细历史、其他风险因素信息和与健康相关的生活质量。所有其他数据将从完善的NHMN获得。我们的主要具体目标是评估HRT对1）乳房X线摄影性能（即，筛查性乳房X线照相术的灵敏度和特异性，不可解释的乳房X线照相术的比例和随后使用其它成像程序）; 2）乳腺癌发病率（尤其是联合治疗）; 3）乳腺癌肿瘤预后特征（例如，TNM分期、肿瘤分级、腋窝淋巴结状态和雌激素受体状态）。随着越来越多的女性考虑使用HRT来预防骨质疏松症和其他疾病，了解其对生活质量的影响势在必行。因此，第二个目的是评估HRT对健康相关生活质量的影响.拟议研究的结果将有利于解释乳房X光片的放射科医生，以及妇女及其医疗保健提供者，他们在决定是否使用激素替代疗法时必须平衡疾病风险和健康相关生活质量的复杂问题。