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New evidence report finds most genomic tests to identify or treat ovarian cancer have not shown clinical value

Many genomic tests that are currently used to diagnose and guide treatment of ovarian cancer are not shown to decrease the number of women who die from the disease or improve their quality of life, according to a new evidence report supported by a partnership of the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Disease Control and Prevention's Division of Cancer Prevention and Control and National Office of Public Health Genomics.

Ovarian cancer causes more deaths than any other cancer of the female reproductive system. Over 20,000 women are diagnosed with the disease annually, and approximately 15,000 die from it. The risk for ovarian cancer increases with age and most often is diagnosed in white women over the age of 50. If diagnosed during stage I, ovarian cancer has a survival rate of over 90 percent. However, most cases are diagnosed in advanced stages, when the cancer has spread to other organs.

Physical exams, ultrasounds, and other routine screening efforts for reducing the number of women affected by the disease, and, in turn, the number who die from it, have been unsuccessful compared with similar efforts aimed at other causes of cancer deaths in women. Because current strategies have not proven to be effective, there is tremendous interest in identifying the disease in its earliest stages by looking at genes, gene expression levels, proteins, and tumor markers. These tests focus on detecting a gene-based tumor marker, such as CA-125, or identifying genetic mutations such as BRCA1 and BRCA2 that indicate increased risk for developing cancer, or identifying genetic changes that predict response to therapy in women with ovarian cancer.

Researchers performed a comprehensive review of the literature and found few studies that evaluated genetic tests other than CA-125 or BRCA1 and BRCA2 to diagnose ovarian cancer or identify women at risk. No studies were found showing that changing treatment based on test results reduced deaths or improved the quality of life in women who were diagnosed with ovarian cancer. There are few data on the harms of gene-based tests for ovarian cancer, including the psychological impact of false-positive tests or delays in treatment that can result from a false-negative test.

A computer simulation model developed by the researchers suggests that screening, even with the highly accurate tests, will not result in large reductions in deaths from ovarian cancer unless testing is very frequent (less than 1 year between tests). However, such frequent screening would also yield a large number of false-positive test results. Research aimed at improving treatment options and the discovery of treatment, lifestyle, or dietary choices that could prevent ovarian cancer would likely offer greater promise for major reductions in deaths from the disease.

The report was prepared by a team of researchers led by Evan Myers, M.D., M.P.H., of AHRQ's Duke University Evidence-based Practice Center in Durham, North Carolina. Genomic Tests for Ovarian Cancer Detection and Management can be found online at http://www.ahrq.gov/clinic/tp/genovctp.htm. Printed copies of the report (AHRQ Publication No. 07-E001) are also available from the AHRQ Publications Clearinghouse.

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