HORMONE REPLACEMENT THERAPY AND BREAST CANCER

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、乳腺癌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，激素替代疗法略微增加了乳腺癌的风险，但大多数研究无法充分调整乳房X光检查的频率。这是一个重要的限制，因为在通过定期看医生来维持激素替代处方的女性中，更频繁地使用乳房X光检查可能会导致相对于不使用激素替代疗法的女性，乳腺癌的检测率更高。我们的研究设计，包括通过新汉普郡乳房X光摄影网络(NHMN)确定的现有队列-全州范围的、基于人口的乳房X光检查登记，包括超过15万名妇女-克服了这一限制。使用在乳房X光检查时进行的基线调查，我们已经从NHMN登记中的所有女性获得了乳腺癌风险因素信息，包括目前HRT的使用情况。通过NHMN，我们已经确定了74,200名绝经前或绝经后的妇女，其中包括大约26,700名目前正在接受HRT的妇女。我们将对这些妇女进行四年的前瞻性跟踪，以确定新的乳腺癌病例。所有NHMN参与者已经提供了将医疗、放射和病理数据联系起来的许可，并同意出于研究目的进行进一步联系。我们将在第一年和第四年进行补充调查，以获得HRT使用的详细历史、额外的风险因素信息和与健康相关的生活质量。所有其他数据将从建立良好的NHMN获得。我们的主要目标是评估HRT对1)乳房X光检查表现的影响(即筛查乳房X光检查的灵敏度和特异度、无法解释的乳房X光图像的比例以及随后使用的其他成像程序)；2)乳腺癌发病率(尤其是联合治疗)；3)乳腺癌的预后特征(例如，TNM分期、肿瘤分级、腋窝淋巴结状况和雌激素受体状况)。随着越来越多的女性考虑使用激素替代疗法来预防骨质疏松症和其他疾病，了解其对生活质量的影响是当务之急。因此，第二个目标是评估激素替代疗法对健康相关生活质量的影响。拟议的研究结果将有利于解释乳房X光检查的放射科医生，以及妇女和她们的医疗保健提供者，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与健康相关的生活质量这两个复杂问题。

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.