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$4 million NCI grant funds comparative effectiveness research at Southwest Oncology Group
Date:10/15/2009

>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 milli
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Contact: Frank DeSanto
fdesanto@umich.edu
734-998-0114
University of Michigan Health System
Source:Eurekalert

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