ABC: Antidepressants and Breast Cancer Pharmacoepidemiology

ABC：抗抑郁药和乳腺癌药物流行病学

基本信息

批准号：
8059706
负责人：
Reina Haque
金额：
$ 56.05万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-04-15 至 2013-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8059706
关键词：
Address Adjuvant Adverse effects American Antidepressive Agents Antihypertensive Agents Atypical hyperplasia Body mass index Breast Breast Cancer Treatment California Cancer Patient Cancer Survivor Characteristics Clinical Clinical Research Comorbidity Comprehensive Health Planning Cytochrome P-450 CYP2D6 Cytochrome P450 Data Databases Diagnosis Diagnostic Disease Drug Interactions Effectiveness Electronics Endogenous depression Enzymes Estrogen receptor positive Ethnic Origin Family Family history of First Degree Relative Goals Guidelines Health Health Maintenance Organizations Health Planning Hormone replacement therapy Hot flushes Investigation Journals Label Life Link Manufacturer Name Marketing Measures Medical Menopause Mental Depression Metabolism Molecular Nested Case-Control Study Night Sweating Outcome Paroxetine Patients Pharmaceutical Preparations Pharmacoepidemiology Pharmacologic Substance Pharmacy facility Physicians Positioning Attribute Primary Neoplasm Publications Quality of life Race Recording of previous events Recurrence Reporting Risk Safety Selective Serotonin Reuptake Inhibitor Sleep Staging Stroke Symptoms System Tamoxifen Time Vasomotor Venous Thrombosis Woman Women&apos s Group breast cancer diagnosis cancer recurrence cancer risk cohort depressive symptoms electronic data evidence base experience health care service utilization inhibitor/antagonist innovation lifestyle factors malignant breast neoplasm member mortality prevent public health priorities public health relevance success tumor tumor registry

项目摘要

DESCRIPTION (provided by applicant): ABC: Antidepressants & Breast Cancer Treatment Pharmacoepidemiology Tens of thousands of American women with breast cancer are taking tamoxifen to reduce their chances of developing a recurrence or second primary breast cancer. Many of these women also take antidepressants. Because tamoxifen has side effects that diminish a woman's quality of life and quality of sleep including hot flashes, night sweats, and depression, and because hormone replacement therapy is contraindicated for women with breast cancer, antidepressants increasingly have been used to relieve symptoms caused by tamoxifen. In addition, antidepressants are commonly prescribed for approximately 50% of women experiencing depression subsequent to a breast cancer diagnosis. Recent evidence suggests selective serotonin reuptake inhibitor (SSRI) antidepressants may reduce the metabolism of tamoxifen to its active form, which could reduce tamoxifen's protection against recurrent or a second primary breast cancer. This possibility needs investigation. As result of a few small studies, some recent reports caution physicians against prescribing SSRI medications concurrently with tamoxifen. However, findings from two clinical studies are ambiguous. Only one small study reported an association between antidepressants and breast cancer mortality in women taking tamoxifen while another found no association. Importantly, to date no study has adequately measured antidepressant use. Because tens of thousands of women are likely taking both tamoxifen and antidepressants, it is critical to determine if SSRIs indeed decrease the protection of tamoxifen against subsequent breast cancer among breast cancer survivors. The goal of this project is to investigate whether concomitant use of antidepressants and tamoxifen increases the risk of subsequent breast cancer (recurrence or second primary tumor) among women who have been diagnosed with a first primary breast cancer, compared to similar women treated only with tamoxifen. From a SEER-affiliated electronic tumor registry serving over 6 million members, we will assemble a large cohort of over 25,000 women diagnosed with a first early stage estrogen receptor positive breast cancer and treated with tamoxifen (of whom approximately 12,000 were exposed to antidepressants). Using a health plan's comprehensive pharmacy database, we will determine which women were also treated with SSRI or other antidepressants. We will then identify all women who developed a subsequent breast cancer and those who remained breast-cancer free in this cohort to determine if SSRIs or other antidepressant use is associated with an increased risk of subsequent breast cancer. Finally, using a case-control nested study within the cohort, we will determine if certain factors confound or modify the association. This innovative "ABC" (Antidepressants & Breast Cancer) study presents the first real opportunity to determine if women who take both tamoxifen and antidepressants following their initial breast cancer have a greater likelihood of developing subsequent breast cancer than women exposed to tamoxifen who do not take SSRIs or other antidepressants. PUBLIC HEALTH RELEVANCE: This study will determine if combined use of antidepressants (including SSRIs or other types) and tamoxifen poses serious health threats among breast cancer survivors by elevating subsequent breast cancer risks, compared to women who were only exposed to tamoxifen. As both depression and hot flashes are common in breast cancer patients, information about the safety or the adverse effects of combined tamoxifen and antidepressant use would have far reaching clinical implications in treating the depression and hot flashes after a diagnosis of breast cancer. If an association is not found, this would provide reassurance to continue prescribing certain antidepressant medications to women diagnosed with breast cancer.

描述（由申请人提供）：ABC：抗抑郁药和乳腺癌治疗药物学药物学成千上万的美国乳腺癌妇女正在采用他莫昔芬，以减少出现复发或第二次原发性乳腺癌的机会。这些女性中的许多人也服用抗抑郁药。由于他莫昔芬的副作用会降低女性的生活质量和睡眠质量，包括潮热，夜汗和抑郁症，并且由于乳腺癌妇女越来越多地禁忌使用激素替代疗法，因此越来越多地使用抗抑郁药来缓解由他莫昔芬引起的症状。此外，通常在乳腺癌诊断后发生抑郁症的女性中，通常会开处方抗抑郁药。最近的证据表明，选择性5-羟色胺再摄取抑制剂（SSRI）抗抑郁药可能会将他莫昔芬的代谢降低为其活性形式，这可以减少他莫昔芬对反复发生或第二个原发性乳腺癌的保护。这种可能性需要调查。由于一些小型研究，一些最近的报告警告医生不要与他莫昔芬同时开处方SSRI药物。但是，两项临床研究的发现是模棱两可的。只有一项小型研究报告了服用他莫昔芬的女性抗抑郁药与乳腺癌死亡率之间的关联，而另一项则没有发现关联。重要的是，迄今为止，尚无对抗抑郁药的充分测量。由于成千上万的女性可能同时服用他莫昔芬和抗抑郁药，因此必须确定SSRI是否确实会减少他莫昔芬对乳腺癌幸存者中随后的乳腺癌的保护。该项目的目的是研究抗抑郁药和他莫昔芬的同时使用是否会增加被诊断出患有第一次原发性乳腺癌的妇女的随后乳腺癌（复发或第二次原发性肿瘤），而与仅接受他莫昔芬治疗的类似妇女相比。从为超过600万成员服务的SEER附属电子肿瘤注册中心，我们将组建一大批被诊断出患有第一阶段雌激素受体阳性乳腺癌并用他莫昔芬治疗的妇女（其中约12,000名暴露于抗抑郁药）。使用健康计划的综合药房数据库，我们将确定哪些女性也接受了SSRI或其他抗抑郁药的治疗。然后，我们将确定所有患有随后乳腺癌的妇女，以及那些在该队列中保持乳腺癌的人，以确定SSRIS或其他抗抑郁药是否与随后乳腺癌的风险增加有关。最后，使用队列中的案例对照嵌套研究，我们将确定某些因素是否混淆或修改关联。这项创新的“ ABC”（抗抑郁药和乳腺癌）研究提供了第一个真正的机会，即确定最初乳腺癌后同时服用他莫昔芬和抗抑郁药的妇女是否比暴露于未服用SSRIS或其他抗抑郁药的他莫昔芬的妇女更可能患上随后的乳腺癌。公共卫生相关性：这项研究将确定抗抑郁药（包括SSRI或其他类型）是否合并使用，与仅暴露于他莫昔芬的女性相比，与仅接触到他莫昔芬的女性相比，他通过提高乳腺癌的风险来对乳腺癌幸存者构成严重的健康威胁。由于抑郁症和炎热在乳腺癌患者中都是常见的，因此有关他莫昔芬和抗抑郁药的安全性或抗抑郁药的不利影响的信息将在治疗乳腺癌后治疗抑郁症和炎热的临床意义。如果找不到关联，这将提供保证，以继续为被诊断为乳腺癌的妇女开出某些抗抑郁药。