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$4 million NCI grant funds comparative effectiveness research at Southwest Oncology Group

ANN ARBOR, Mich. A $4 million National Cancer Institute (NCI) grant will help position the Southwest Oncology Group, one of the largest NCI-funded clinical trial cooperative groups, as a national leader in comparative effectiveness research on cancer.

The Grand Opportunities (GO) award supports the development of the Center for Comparative Effectiveness Research in Cancer Genomics, or CANCERGEN, under the direction of Scott Ramsey, M.D., Ph.D., of the Fred Hutchinson Cancer Research Center in Seattle. Researchers at the University of Washington, Cancer Research And Biostatistics (CRAB) in Seattle, and the Center for Medical Technology Policy in Baltimore will co-lead the effort.

CANCERGEN will create a comprehensive process to evaluate emerging cancer genomics technologies and identify those that are most promising. The University of Michigan-based Southwest Oncology Group, or SWOG, will use this process to help it select and launch those clinical trials that will have the greatest impact.

"CANCERGEN will provide us objective tools to determine which proposed trials are most likely to have a significant clinical benefit for patients," says SWOG Group Chair Laurence H. Baker, D.O., "and we will commit to doing only those trials that meet this new standard."

Comparative effectiveness research, or CER, has gained national attention and a surge of federal stimulus funding because it is seen as a means of slowing the growth of runaway health care costs in the U.S. by moving the system away from expensive but marginally effective treatments.

A recent Institute of Medicine report on comparative effectiveness research has influenced many of the health care reform proposals now wending their way through the U.S Congress.

"Realizing [CANCERGEN's] vision will go a long way to help achieve the health care reform goal of making cancer treatment more effective and less expensive," says the Hutchinson's Ramsey.

The first SWOG clinical trial proposal slated for support under CANCERGEN will assess whether a genetic test known as the Oncotype DX assay can predict which patients with node-positive breast cancer breast cancer that has spread to their lymph nodes will benefit from chemotherapy and which patients will not.

The study was one of five comparative effectiveness trial proposals NCI Director John Niederhuber, M.D., submitted to the National Institutes of Health in January of 2009 as candidates for federal stimulus funding. It is expected to serve as a model for future comparative effectiveness studies of cancer genomics technologies.

More about CANCERGEN's first trial:

The Oncotype DX genetic assay is now routinely used to test the tumors of patients whose breast cancer has not spread to their lymph nodes node-negative breast cancer. By measuring the expression or activity level of 21 specific genes within the tumor, the assay helps oncologists decide on treatment options by predicting whether a patient is likely to benefit from a course of chemotherapy.

SWOG 0930 is a proposed nationwide phase 3 clinical trial to determine whether this genetic test has the same predictive value for patients with node-positive breast cancer -- those whose cancer has spread to their lymph nodes. In 2008 about one-third of the 184,000 women diagnosed with breast cancer in the U.S. had cancer that had spread to their lymph nodes at the time of diagnosis.

The genetic assay is expensive, costing about $3,500 per test. Yet the chemotherapy treatment now routinely given to node-positive breast cancer patients costs on the order of $50,000 per year. 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.


Contact: Frank DeSanto
University of Michigan Health System

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