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Molecular test predicts risk of breast cancer recurrence and who will benefit from chemotherapy

A new test can predict both the risk of breast cancer recurrence and may identify women who will benefit most from chemotherapy, according to research supported by the National Cancer Institute (NCI), part of the National Institutes of Health, and performed in collaboration with the National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health Inc. These results suggest that almost half of over 50,000 U.S. women diagnosed with estrogen-dependent, lymph-node negative breast cancer* every year are at low risk for recurrence and may not need to go through the discomfort and side effects of chemotherapy.

The test is based on levels of expression (increased or decreased) of a panel of cancer-related genes. This panel is used to predict whether estrogen-dependent breast cancer will come back, according to a study that will be published online in the New England Journal of Medicine on Friday, December 10, 2004**. Scientists on this study also will present new results on that day at San Antonio Breast Cancer Symposium indicating that the same test can predict which women benefit most from chemotherapy. Women with low risk of breast cancer recurrence--about half of the women in the recent study--do not appear to derive much benefit from chemotherapy.

The researchers used tissue samples and medical records from women enrolled in clinical trials of the cancer drug tamoxifen, which blocks the effect of estrogen on breast cancer cells. These women had a kind of breast cancer defined as estrogen receptor-positive, lymph node-negative. Each year, over 50,000 women are diagnosed with this kind of breast cancer, which needs estrogen to grow but has not spread to the lymph nodes. Currently, many women with this type of breast cancer in the United States do receive chemotherapy in addition to hormonal therapy.

Using samples from 447 patients and a collection of 250 genes in three independent preliminary studies, 16 cancer-related genes we
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Contact: NCI Press Officers
ncipressofficers@mail.nih.gov
301-496-6641
NIH/National Cancer Institute
10-Dec-2004


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