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Rochester Physician Named to National Breast Cancer Panel

Monday, October 20, 2008

David Hicks, M.D., professor of Pathology and Laboratory Medicine at the University of Rochester Medical Center, has been appointed to a panel that is developing national guidelines for breast cancer testing.

Hicks, who is chief of surgical pathology at Strong Memorial Hospital, is part of a panel seeking to improve the accuracy of one of the most important medical tests given to women diagnosed with breast cancer. The panel, created by the American Society of Clinical Oncology and the College of American Pathologists, is developing guidelines for testing the estrogen receptor in women who have the disease.

The test plays an important role in determining the type of treatment that the approximately 200,000 women in the United States who are diagnosed with breast cancer each year receive.

Knowing whether the estrogen receptor is present in a woman’s breast cancer is one of the most important factors doctors and patients can use to decide on treatment options. If testing shows that the estrogen receptor plays a role in a woman’s tumor – as it does in about 70 percent of patients – she will receive treatment either with the drug tamoxifen or a class of drugs called aromatase inhibitors, both of which are designed to counteract the effects of estrogen in hormonally sensitive tumor cells.

The ASCO/CAP panel is designed to cut down on inconsistency in testing. There are a number of variables that help ensure the accuracy of such tests, Hick said, including issues related to standardized tissue handling, assay performance, and interpretation of results. Hicks said these efforts will require greater interactions between clinical groups such as surgeons and radiologists who collect the tissue samples and the pathology laboratory, which processes the tissue and performs the tests.

Later this year the panel will publish guidelines designed to standardize testing and cut down on “false positives,” where a test falsely indicates that the estrogen receptor is involved, and on “false negatives,” where a test falsely indicates that the receptor is not involved.

“We have this tremendous potential to identify factors in breast cancer that are likely to allow us to more accurately predict whether the disease will be more or less aggressive, but that capability hinges on our ability to actually perform tissue-based diagnostic tests accurately,” said Hicks, who oversees tens of thousands of tests of patients at Strong Memorial Hospital every year, including breast cancer patients at the James P. Wilmot Cancer Center.

The panel is similar to one convened two years ago by ASCO and CAP that created strict guidelines for another crucial test for breast cancer, the HER2 test. High levels of the protein HER2 are associated with breast tumors that are more aggressive than tumors without it, and the presence of high levels of HER2 – which occur in about 20 to 25 percent of cases of breast cancer – call for treatment with the drug Herceptin.

The drug is very effective for those patients who have excessive HER2 activity, cutting in half a woman’s risk of having the cancer recur. But the drug can have severe side effects, and getting the correct test result is crucial so that some women aren’t subjected unnecessarily to severe side effects, and so that women who are at risk for having aggressive breast cancer do receive the potential benefit of having appropriate treatment. Unfortunately, such scenarios aren’t so far-fetched: A major study done before the panel’s work found that nearly 20 percent of test results for HER2 performed in community hospital laboratories were inaccurate.

The HER2 guidelines recommended by the panel, which were published in January 2007, were reviewed by Hicks and others, and following the guidelines is now a mandatory part of the professional accreditation process for every laboratory that does HER2 testing. In a recent analysis, Hicks’ lab at Strong Memorial Hospital achieved nearly 100-percent accuracy in testing for HER2 when validated against parallel testing performed at an outside reference laboratory.

A native of Albion, Hicks received his bachelor’s degree from Canisius College and his medical degree from the University of Rochester School of Medicine and Dentistry. He did his residency at the University of Pennsylvania, where in the early 1980s he took part in research conducted in one of the pioneering laboratories in molecular pathology.

When scientists discovered the role of HER2 in breast cancer later that decade, Hicks spotted an opportunity to put his research skills to use, and he gradually changed the focus of his research from bone to breast cancer.

“New discoveries in molecular biology offered the opportunity to dig deeper into tumors, to understand their underlying biology, and how we might use that knowledge to improve the lives of patients. It was a very exciting time,” said Hicks.

Hicks served on the University faculty from 1996 to 1999, then held appointments at Rochester General Hospital, the Cleveland Clinic, and Roswell Park Cancer Institute before rejoining the University last year.  

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