Impact Of Genomic and Personalized Medicine in Women Under 65 With Breast Cancer

基因组和个性化医疗对 65 岁以下乳腺癌女性的影响

基本信息

批准号：
8725081
负责人：
Arnold L Potosky
金额：
$ 15.14万
依托单位：
GEORGETOWN UNIVERSITY
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 2018-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8725081
关键词：
Address Adjuvant Chemotherapy Adoption Adverse effects Age Antineoplastic Agents Biological Assay Blue Cross Blue Shield Cardiac Caucasoid Race Clinical Clinical Markers Communities Community Practice Comorbidity Costs and Benefits Data Data Sources Databases Diagnosis Diagnostic tests Drug Costs Effectiveness Ensure Epidermal Growth Factor FDA approved Foundations Future Gene Expression Profile Gene Expression Profiling General Practices Genes Genomics Guidelines Health Health Benefit Health Planning Healthcare Human Individual Inpatients Insurance Intervention Investigation Knowledge Licensing Link Literature Malignant Neoplasms Manufacturer Name Measures Medicine Metastatic/Recurrent Molecular Monitor Names Newly Diagnosed Observational Study Oncologist Outcome Outpatients Patient Care Patients Pattern Persons Physicians Population Positive Lymph Node Prognostic Factor Proteins Public Health Quality of life Race Recurrence Research Research Infrastructure Retrospective Studies Risk Risk Factors Roche brand of trastuzumab Side Socioeconomic Status Staging Subgroup Surgeon Technology Test Result Testing Toxic effect Trastuzumab Uncertainty Use Effectiveness Variant Woman anticancer research base cancer care cancer genomics cancer therapy care delivery chemotherapy clinical risk cohort comparative effectiveness cost design effectiveness research high risk improved malignant breast neoplasm member neoplasm registry novel population based prognostic response tumor

项目摘要

DESCRIPTION (provided by applicant): Genomic and personalized medicine (GPM) offers the ability to tailor treatments to an individual's unique genomic profile, potentially maximizing effectiveness and minimizing side effects. Despite the promise for GPM to revolutionize care delivery, few studies assess dissemination and impact in community practice beyond small studies from specialized referral centers. Population-based studies are necessary to assess the use and effects of GPM in diverse patient sub-groups and delivery settings. However, the lack of data sources that combine clinical variables, genomic test results, and cancer therapies delivered in both inpatient and outpatient settings has limited the monitoring of the population impact of GPM for persons diagnosed with cancer. To address these gaps in knowledge of GPM in breast cancer, we propose a population-based observational study to assess the recent dissemination of two recently introduced GPM technologies for women under age 65. The first GPM technology is Oncotype DX(R), a gene expression profile assay, which was first incorporated by professional guidelines in 2007. This test is used, along with other prognostic variables, to refine recurrence estimates for selected patient sub-groups to help guide chemotherapy decisions. We will first evaluate patient and health care setting predictors of Oncotype testing; second, we will assess how test results influence chemotherapy use in general practice. Our third aim is to evaluate predictors of a second GPM- based technology, the tailored anti-cancer agent trastuzumab (trade name Herceptin), for women whose tumors fit a specific genomic profile. Trastuzumab has been proven efficacious among women whose tumors over-express the human epidermal growth factor 2 (HER2) proteins, and has been FDA approved and recommended since 2006 for women with HER2 positive, early-stage breast cancer. We will address these 3 aims in an incident cohort of newly diagnosed women under age 65 who are members of WellPoint-affiliated health plans in 5 states. To accomplish our aims, we will create a linked cancer research database consisting of 5 state cancer registries linked with complete insurance claims data, and linked with Oncotype test results. The resulting unique linked database (total cohort n=45,000) will be used to evaluate breast cancer care in our cohort from 2005 through 2010. Our research strategy creates an infrastructure for future comparative effectiveness research on these and other cancer GPM technologies.

描述（由申请人提供）：基因组和个性化医学（GPM）提供了针对个人独特的基因组概况量身定制治疗的能力，可能会最大程度地提高有效性并最大程度地减少副作用。尽管GPM有望彻底改变护理服务，但很少有研究能够评估专业推荐中心的小型研究以外的社区实践的传播和影响。基于人群的研究对于评估GPM在多种患者子组和分娩环境中的使用和影响是必要的。但是，缺乏结合临床变量，基因组测试结果以及在住院和门诊环境中提供的癌症疗法的数据源限制了监测GPM对诊断患有癌症患者的人口影响。为了解决乳腺癌中GPM知识知识的这些差距，我们提出了一项基于人群的观察性研究，以评估最近对65岁以下妇女的两种最近引入的两种gpm技术的传播。第一个GPM技术是DX（R），基因表达概况（R），一种基因表达概况，该基因表达分析是一种用于2007年专业指南的概述。子组有助于指导化学疗法决策。我们将首先评估患者和医疗保健设置的癌症测试预测指标；其次，我们将评估测试结果如何影响一般实践中的化学疗法使用。我们的第三个目的是评估基于GPM的第二种技术的预测因素，即量身定制的抗癌剂Trastuzumab（商品名Herceptin），这些肿瘤符合特定的基因组特征。曲妥珠单抗已被证明是在肿瘤过度表达人类表皮生长因子2（HER2）蛋白的妇女中有效的，并且自2006年以来已被FDA批准并推荐给HER2阳性，早期乳腺癌的女性。我们将在一个新诊断的65岁以下妇女的事件中解决这三个目标，这些妇女是5个州与井点附属健康计划的成员。为了实现我们的目标，我们将创建一个链接的癌症研究数据库，该数据库由5个与完整的保险索赔数据相关的州癌症注册机构组成，并与OnCotype测试结果相关联。从2005年到2010年，将使用所得独特的链接数据库（总数n = 45,000）来评估我们的同类乳腺癌护理。我们的研究策略为对这些和其他癌症GPM技术的未来比较有效性研究创建了基础设施。