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 i s 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.

Public Health Relevance

There is great excitement in the scientific community over personalized medicine, which includes the use of information at an individual patient's genomic level to select that patient's care. In order for the public health benefits of breast cancer personalized medicine to be realized, it is necessary to understand how genomic- based diagnostic testing and treatments are currently being used in the "real world" of community practice. Our study is designed to measure the dissemination of 2 specific GPM technologies in women under the age of 65 with newly diagnosed breast cancer since 2005. These technologies may improve the quality of life and survival of women with early stage breast cancer. Our study of dissemination helps to ensure the effective implementation of personalized medicine in general practice.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project (R01)
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Health Services Organization and Delivery Study Section (HSOD)
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Warren, Joan
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Georgetown University
Internal Medicine/Medicine
Schools of Medicine
United States
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