New Test For Breast Cancer Will Help Guide Treatment Choices
Main Category: Breast CancerAlso Included In: Cancer / Oncology
Article Date: 10 Feb 2009 - 2:00 PDT
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One in eight women in the United States will receive a diagnosis of breast cancer in their lifetime, and it is the second leading cause of cancer-related death in women. Now a new test will help physicians determine the best possible treatment for each patient.
"Our research shows that there is a subset of women who can be cured without getting any treatment at all, other than a lumpectomy," explains Philip Bernard, M.D., an investigator at the University of Utah's Huntsman Cancer Institute and one of the senior authors on a multicenter study published in the Feb. 9 issue of the Journal of Clinical Oncology. "In women whose tumors have spread, we can predict with very high accuracy which women are going to respond to chemotherapy and which type of chemotherapy will work."
Only recently have scientists known that there are different breast cancer subtypes that lead to differences in outcome. The group narrowed down 50 genes that play an important role in identifying subtypes of breast cancer. By measuring the expression level of these genes in the tumors, they could determine how each individual will respond to standard therapies.
"This will give women peace of mind knowing that we're diagnosing cancer more accurately than ever before. We can tell them if they are likely to benefit from chemotherapy. If chemo isn't going to be beneficial, we shouldn't be giving it," Bernard says.
The research translates into a simple test that will be available nationwide this summer. The test has been validated on thousands of women with breast cancer and has shown to be useful in many different clinical situations.
Based on the type of tumor, doctors now will be able to prescribe only the treatment that will be most beneficial. For some patients that could mean no chemotherapy at all. For others it will mean targeted treatments that work best for that patient, and they will no longer have to endure needless chemotherapy.
Women whose tumors indicate a resistance to current treatments will be referred to clinical trials of investigational drugs and treatments, opening the door to more effective medications in the future.
The group is currently designing prospective clinical trials using the test, which they refer to as the Breast Bioclassifier. Bernard plans to run these trials at Huntsman Cancer Institute and collaborating institutions.
The research took 10 years to complete and involved cooperation among several research institutions. The multicenter study was led by researchers at the University of Utah Huntsman Cancer Institute, Salt Lake City, Utah (Philip Bernard, M.D., assistant professor of pathology and medical director of molecular pathology at ARUP Laboratories); the University of North Carolina's Lineberger Comprehensive Cancer Center at Chapel Hill, N.C. (Charles Perou, Ph.D., associate professor of genetics and pathology); the University of British Columbia, Vancouver (Torsten Nielsen, M.D., Ph.D., associate professor of pathology); and Washington University Siteman Cancer Center, St. Louis, Mo. (Matthew Ellis, M.D., professor of medicine).
Bernard is one of the inventors of the test and has patents pending for the technology described in this news release. Additionally, he is a partner in the company University Genomics, along with colleagues at the Lineberger Comprehensive Cancer Center and Siteman Cancer Center. The company is working to commercialize the test.
The mission of Huntsman Cancer Institute (HCI) at The University of Utah is to understand cancer from its beginnings, to use that knowledge in the creation and improvement of cancer treatments, to relieve the suffering of cancer patients, and to provide education about cancer risk, prevention, and care. HCI is a National Cancer Institute-designated cancer center, which means that it meets the highest national standards for cancer care and research and receives support for its scientific endeavors. HCI is also a member of the National Comprehensive Cancer Network (NCCN) a not-for-profit alliance of the world's leading cancer centers. The alliance is dedicated to improving the quality and effectiveness of care provided to patients with cancer.
Huntsman Cancer Institute
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Breast Bioclassifier
posted by Gregory D. Pawelski on 10 Feb 2009 at 6:22 pmHopefully, the University of Utah Huntsman Cancer Institute's genetic test will go the same way as other commercialized multigene prognostic and predictive tests, like Oncotype DX and MammaPrint, in telling physicians which high risk breast cancer patients will likely benefit from chemotherapy (identify patients who are likely to have a recurrence if treated with surgery alone) and which ones do not need to be unnecessarily exposed to toxic chemotherapy cocktails.
The Breast Bioclassifier is a genetic analysis that scans thousands of genes to identify patterns of gene activity in individual tumors that indicate a patient is likely to suffer a recurrence of disease. It is based on RNA microarry analysis and is an appropriate application of a genomic strategy to estimate prognosis, by identifying early stage cancer patients who may benefit from adjuvant chemotherapy.
These microarray-based tests measure differences in gene sequence, gene expression or protein expression in biological samples. Microarrays may be used to compare gene or protein expression under different conditions, such as cells found in cancer.
If these genetic tests find a patient to be at high-risk, then a suitable platform can be used to utilize cell-based tests to better select a repertoire of available drugs to improve the efficacy of chemotherapy. None of the genetic tests can predict clinical responders. Further cell-based pre-tests can help see what treatments have the best opportunity of being successful.
The headlong rush to develop tests to identify molecular predisposing mechanisms whose presence still does not guarantee that a drugs (or combinations of drugs) will be effective for an individual patient. Nor can they, for any patient or even large group of patients, discriminate the potential for clinical activity among different agents of the same class.
Microarray profiling tests, important in order to identify new therapeutic targets and thereby to develop useful drugs, still cannot work successfully in predicting treatment response for individual patients. Perhaps this is because they are performed on formalin-fixed, paraffin-embedded tissues or fresh-frozen tissue samples or unfrozen samples stored in RNA-preserving solution that were never actually exposed to the drugs whose activity they are trying to assess.
It will never be as effective as the cell-based "function" method, which exists today and is not hampered by the problems associated with gene or protein expression tests. That is because functional methodology measures the net effect of all processes within the cancer, acting with and against each other in real-time, and it tests living (fresh) cells actually exposed to drugs and drug combinations of interest.
The key to understanding the genome is understanding how cells work. The ultimate driver is a functional assay (is the cell being killed regardless of the mechanism) as opposed to a target assay (does the cell express a particular target that the drug is supposed to be attacking). While a target assay tells you whether or not to give one drug, a functional assay can find other compounds and combinations and can recommend them from the one assay.
The core of the functional assay is the cell, composed of hundreds of complex molecules that regulate the pathways necessary for vital cellular functions. If a targeted drug could perturb any one of these pathways, it is important to examine the effects of the drug within the context of the cell. Because genomics are far too limited in scope to encompass the vagaries and complexities of human cancer biology, these targeted therapies require the determination of cellular endpoints. Cell-based functional assays are being used for screening compounds for efficacy and biosafety.
However, all of these laboratory tests are used as a tool for the oncologist. The oncologist should take advantage of all the tools available to him/her to treat a patient. These tests have enormous implications for the short-term future of cancer research in general, and is one of the truly great cancer breakthroughs of our time. DNA microarray will prove to be highly complementary to the parellel breakthrough efforts in targeted therapy through cell-based functional assays.
Source: Cell Function Analysis
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