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：
8250850
负责人：
Reina Haque
金额：
$ 49万
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 2014-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8250850
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流行病学数以万计的美国乳腺癌女性正在服用他莫昔芬以减少复发或第二原发性乳腺癌的机会。其中许多女性还服用抗抑郁药。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、盗汗和抑郁，并且由于激素替代疗法对于患有乳腺癌的女性是禁忌的，因此抗抑郁药越来越多地被用来缓解他莫昔芬引起的症状。此外，大约 50% 的乳腺癌诊断后出现抑郁症的女性通常会服用抗抑郁药。最近的证据表明，选择性血清素再摄取抑制剂（SSRI）抗抑郁药可能会减少他莫昔芬的活性代谢，这可能会降低他莫昔芬对复发性或第二原发性乳腺癌的保护作用。这种可能性需要调查。一些小型研究的结果是，最近的一些报告警告医生不要将 SSRI 药物与他莫昔芬同时开出。然而，两项临床研究的结果并不明确。只有一项小型研究报告称，服用他莫昔芬的女性抗抑郁药与乳腺癌死亡率之间存在关联，而另一项研究则没有发现任何关联。重要的是，迄今为止还没有研究充分衡量抗抑郁药物的使用情况。由于数以万计的女性可能同时服用他莫昔芬和抗抑郁药，因此确定 SSRI 是否确实会降低他莫昔芬对乳腺癌幸存者随后患乳腺癌的保护作用至关重要。该项目的目标是调查与仅接受他莫昔芬治疗的类似女性相比，同时使用抗抑郁药和他莫昔芬是否会增加已诊断出患有第一原发性乳腺癌的女性随后患乳腺癌（复发或第二原发性肿瘤）的风险。我们将从 SEER 附属的电子肿瘤登记处（为超过 600 万会员提供服务）中收集超过 25,000 名被诊断患有第一例早期雌激素受体阳性乳腺癌并接受他莫昔芬治疗的女性（其中约 12,000 名女性接受过抗抑郁药物治疗）组成的大型队列。利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，我们将确定该队列中所有随后患乳腺癌的女性以及未患乳腺癌的女性，以确定 SSRI 或其他抗抑郁药物的使用是否与后续乳腺癌风险增加相关。最后，在队列中使用病例对照巢式研究，我们将确定某些因素是否会混淆或改变这种关联。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来确定在初次患乳腺癌后同时服用他莫昔芬和抗抑郁药的女性是否比接触过他莫昔芬但不服用抗抑郁药的女性更有可能患上乳腺癌SSRIs 或其他抗抑郁药。公共健康相关性：本研究将确定与仅接触他莫昔芬的女性相比，联合使用抗抑郁药（包括 SSRI 或其他类型）和他莫昔芬是否会增加随后患乳腺癌的风险，从而对乳腺癌幸存者构成严重的健康威胁。由于抑郁症和潮热在乳腺癌患者中都很常见，因此有关他莫昔芬和抗抑郁药联合使用的安全性或不良反应的信息将对乳腺癌诊断后治疗抑郁症和潮热具有深远的临床意义。如果没有发现关联，这将为继续向诊断患有乳腺癌的女性开出某些抗抑郁药物提供保证。