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

描述（由申请人提供）：基因组和个性化医学（GPM）提供了根据个体独特的基因组图谱定制治疗的能力，可能最大化有效性并最小化副作用。尽管GPM有望彻底改变医疗服务，但除了专业转诊中心的小型研究外，很少有研究评估其在社区实践中的传播和影响。有必要进行基于人群的研究，以评估GPM在不同患者亚组和分娩环境中的使用和效果。然而，缺乏结合临床变量、基因组检测结果和住院和门诊癌症治疗的数据来源，限制了对GPM对诊断为癌症的人的人群影响的监测。为了解决乳腺癌中GPM知识的这些空白，我们提出了一项基于人群的观察性研究，以评估最近在65岁以下女性中引入的两种GPM技术的传播情况。第一个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。该测试与其他预后变量一起用于改进选定患者亚组的复发估计，以帮助指导化疗决策。我们将首先评估患者和卫生保健环境的预测因素的Oncotype检测；其次，我们将评估测试结果如何影响化疗在一般实践中的应用。我们的第三个目标是评估第二种基于GPM的技术的预测因子，定制抗癌药物曲妥珠单抗（商品名赫赛汀），用于肿瘤符合特定基因组图谱的女性。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，曲妥珠单抗已被FDA批准并推荐用于HER2阳性早期乳腺癌女性。我们将在5个州参加wellpoint附属健康计划的65岁以下新诊断妇女的事件队列中解决这3个目标。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个州的癌症登记处组成，与完整的保险索赔数据相关联，并与Oncotype测试结果相关联。由此产生的独特关联数据库（总队列n=45,000）将用于评估2005年至2010年我们队列中的乳腺癌护理。我们的研究策略为这些和其他癌症GPM技术的未来比较有效性研究创造了基础设施。

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.