Impact of Genomic and Personalized Medicine in Women under 65 with Breast Cancer - Supplement

基因组和个性化医疗对 65 岁以下乳腺癌女性的影响 - 补充材料

• 批准号: 9336052
• 负责人: Arnold L Potosky
• 金额: $ 14.99万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 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/9336052
• 关键词: Address; Adjuvant Chemotherapy; Adoption; Adverse effects; Age; Antineoplastic Agents; Biological Assay; Blue Cross; Blue Shield; Cardiac; Caucasians; Clinical; Clinical Markers; Communities; Community Practice; Community of Practice; Comorbidity; Cost utility; 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; 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; 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; community center; comparative effectiveness; cost; design; effectiveness research; genomic profiles; high risk; improved; individual patient; individualized medicine; malignant breast neoplasm; member; neoplasm registry; novel; personalized genomic medicine; personalized medicine; population based; prognostic; response; tumor

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)提供了根据个人独特的基因组特征量身定做治疗方案的能力，潜在地最大化了疗效并将副作用降至最低。尽管GPM有望使护理提供发生革命性变化，但除了专门转诊中心的小型研究外，很少有研究评估社区实践中的传播和影响。以人群为基础的研究是必要的，以评估GPM在不同的患者亚组和分娩环境中的使用和效果。然而，缺乏将临床变量、基因组测试结果和在住院和门诊环境中提供的癌症治疗相结合的数据源，限制了对GPM对被诊断为癌症的人的人口影响的监测。为了解决乳腺癌中GPM知识的这些差距，我们建议进行一项基于人群的观察性研究，以评估最近推出的两种GPM技术在65岁以下女性中的传播情况。第一项GPM技术是Oncotype DX(R)，这是一种基因表达谱分析，于2007年首次纳入专业指南。这项测试与其他预后变量一起用于精炼选定患者亚组的复发估计，以帮助指导化疗决定。我们将首先评估肿瘤型测试的患者和医疗保健环境预测因素；其次，我们将评估测试结果如何影响全科医学中化疗的使用。我们的第三个目标是评估第二种基于GPM的技术-定制抗癌药物曲妥珠单抗(商标为Herceptin)-的预测因子，该技术适用于肿瘤符合特定基因组特征的女性。曲妥珠单抗已被证明对肿瘤过度表达人表皮生长因子2(HER2)蛋白的女性有效，自2006年以来一直被FDA批准并推荐用于HER2阳性的早期乳腺癌女性。我们将在一个事故队列中解决这三个目标，这些新诊断的65岁以下女性是5个州的WellPoint附属医疗计划的成员。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，由5个州的癌症登记机构组成，与完整的保险索赔数据相联系，并与Oncotype测试结果相联系。由此产生的唯一链接数据库(总队列n=45,000)将用于评估我们队列中从2005年到2010年的乳腺癌护理。我们的研究战略为这些和其他癌症GPM技术未来的比较有效性研究创造了基础设施。