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CancerGen's First Comparative Effectiveness Trial to Study Oncotype DX in Node-Positive Breast Cancer

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By Turna Ray

The first clinical trial conducted at the newly founded Center for Comparative Effectiveness Research in Cancer Genomics, or CancerGen, will investigate the predictive ability of Genomic Health's Oncotype DX test to determine which node-positive breast cancer patients will benefit from a tamoxifen-based chemotherapy regimen.

Earlier this month, the National Cancer Institute awarded $4 million under the federal stimulus package to the Fred Hutchinson Cancer Research Center for the development of CancerGen, which will focus on assessing the predictive and prognostic value of genomic tools in treating cancer. The collaborative consortium will be led by Scott Ramsey of the Fred Hutchinson Cancer Research Center and involve researchers from the Center for Medical Technology Policy, University of Washington, and the Southwest Oncology Group.

"CancerGen will create a comprehensive process to evaluate emerging cancer genomics technologies and identify those that are most promising," the University of Michigan said in a statement. SWOG, one of the largest NCI-funded clinical trial cooperative groups, is headquartered at UM in Ann Arbor, Mich.

CancerGen will also partner with the Center for Medical Technology Policy to identify comparative effectiveness research priorities for cancer genomics technologies.

Genomic Health's Oncotype DX test is a prognostic test that gauges whether node-negative breast cancer patients' disease will recur, and predicts if a patient will respond to tamoxifen-based chemotherapy. Since launching the test in 2004, the company has invested heavily in studies to support the clinical validity and utility of the test in the node-negative setting. As a result of these positive studies, the test is covered broadly by many national and local payors, and the test is included in the American Society of Clinical Oncology's and National Comprehensive Cancer Network's breast cancer treatment guidelines.

Currently, Oncotype DX is not indicated for patients whose cancer has spread to the lymph nodes. The trial being conducted at CancerGen, SWOG 0930, is a Phase III clinical trial that will attempt to determine whether Oncotype DX has the same predictive value for patients with node-positive breast cancer as it does for node-negative breast cancer patients. It is estimated that last year approximately one-third of the 184,000 women with breast cancer in the US had the disease spread to their lymph nodes at the time of diagnosis.

A University of Michigan spokesperson told Pharmacogenomics Reporter this week that the Oncotype DX study proposal is for a prospective follow-up to a completed retrospective study in the node-positive population and will likely be published in a peer-reviewed journal later this year.

While Oncotype DX costs around $3,500 per test, chemotherapy routinely given to node-positive breast cancer patients costs $50,000 annually. "If the Oncotype DX assay does prove to predict which node-positive patients will see no benefit from this chemotherapy, it could spare thousands of women the grisly effects of a course of chemotherapy that will not help lengthen their life, while at the same time saving hundreds of millions of dollars in health care costs each year," UM said in a statement.

Comparative effectiveness research as a means to control healthcare costs by providing coverage for the most beneficial, cost-effective drugs, is a strategy that has the backing of the Obama Administration and has received funding under the American Recovery and Reinvestment Act of 2009. As part of the ARRA, the US Congress granted $400 million to the NIH, $300 million to the Agency for Healthcare Research & Quality, and $400 million to the Office of the HHS Secretary to create the Federal Coordinating Council for Comparative Effectiveness Research.

In a report released earlier this year, the Federal Coordinating Council for Comparative Effectiveness Research broadly acknowledged the importance of studying patient subgroups to help doctors and patients make informed healthcare decisions. In the report, released June 30, the council cites comparative effectiveness research into treatments for certain populations and subgroups as a funding priority for HHS Secretary Kathleen Sebelius [see PGx Reporter 07-08-2009].

At the same time the Federal Coordinating Council released its report on CER, the Institute of Medicine released its 100 top CER priorities, which include some proposals for comparing the effectiveness of using pharmacogenetic strategies and standard methods to guide treatment, promote behavior change, and improve clinical outcomes.

However, personalized medicine advocates have criticized that federal comparative effectiveness research efforts have not focused on genomic strategies as much as they should.

The Patient-Centered Outcomes Research Act of 2009, introduced in the Senate in June, would create a center for comparative effectiveness which would employ personalized medicine and genomics strategies, and would require the Centers for Medicare and Medicaid Services to meet certain criteria before using CER to make coverage decisions. The bill does not limit how CER is used by private payors.

As a result of pending legislation and ongoing efforts in Congress to restrict the use of CER in reimbursement decisions, it is unclear how data coming out of CancerGen's comparative effectiveness study with Oncotype Dx will impact the test's reimbursement prospects.

The Oncotype DX study is the only trial that has been announced as part of the CancerGen launch. "Others will certainly follow, and we are putting together a coalition of stakeholders to identify the most important tests to evaluate," the University of Michigan spokesperson said.

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