03/01/2005
According to a recent article published in the Lancet, a gene expression profile
including 76 genes has been identified that can help predict the risk of distant
metastasis in patients with node-negative breast cancer. Results from this
profile may help aid patients and physicians in treatment decisions, as a large
portion of patients with this disease are treated unnecessarily.
Breast cancer is diagnosed in approximately 250,000 women annually in the United
States alone. Node-negative breast cancer, or cancer that has not spread from
its site of origin, is highly curable with standard therapeutic approaches.
Treatment typically includes the surgical removal of the cancer, followed by
chemotherapy and/or hormone therapy. However, current research indicates that
approximately 60%-70% of patients with this stage of disease receive more
treatment than necessary for their individual case, as they are cured following
surgery alone. These patients experience side effects caused by chemotherapy or
hormone therapy, with no gain in outcomes. Researchers are evaluating ways to
determine which patients will derive benefit from additional therapy and which
patients are being over-treated. One test already approved by the FDA is
Oncotype DX?, which analyzes genetic sequences in patients with early,
hormone-positive breast cancer. This test can help to categorize patients into
low, intermediate, or high risk of developing a cancer recurrence following
surgery and the use of the anti-estrogen agent tamoxifen. Patients at a high
risk of developing a recurrence according to Oncotype DX? have improved survival
with chemotherapy, whereas those at a low risk do not derive much benefit from
extra therapy. Researchers continue to evaluate different genetic or protein
sequences or profiles, in an attempt to determine the most accurate profiles to
aid in the treatment for patients.
Researchers from the Netherlands recently conducted a clinical trial in an
attempt to identify an additional gene expression profile that was accurate in
predicting outcomes in patients with node-negative breast cancer. This study
included samples from cancer of 286 patients who had not received chemotherapy
and/or hormone therapy and who were followed for approximately 5 years. A gene
signature including 76 genes (60 genes for hormone-positive breast cancer and 16
genes for hormone-negative cancer) was identified that accurately predicted 93%
of patients who developed distant metastasis (cancer spread to distant sites in
the body) within 5 years. Overall, patients with the identified profile had an
approximately 6-fold risk of developing distant metastasis within 5 years
compared to their counterparts.
The researchers concluded that newly identified gene-expression profile appears
to quite accurately predict which patients with node-negative breast cancer will
develop distant metastasis within 5 years if they do not receive systemic
therapy. Patients at a high risk may wish to pursue aggressive systemic
therapies, whereas those at a low risk may not benefit from the additional
therapy. Future studies are necessary to confirm the effectiveness of this
76-gene expression profile. Patients with node-negative breast cancer may wish
to speak with their physician regarding the risks and benefits of
gene-expression profiling, or the participation in a clinical trial further
evaluating gene-expression profiling. Two sources of information regarding
ongoing clinical trials include the National Cancer Institute (cancer.gov) and
www.cancerconsultants.com. Personalized clinical trial searches are also
performed on behalf of patients at cancerconsultants.com.
Reference: Wang Y, Klign J, Zhang Y, et al. Gene-expression profiles to predict
distant metastasis of lymph-node-negative primary breast cancer. The Lancet.
2005; 365: 671-79.
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