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Breast Cancer

Current Status of Prognostic Profiling in Breast Cancer

Department of Breast Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA

Key Words. Breast cancer • Microarray • Gene profiling • Molecular analysis • Prognostic indicator • Predictive indicator • Prognostic profiling

Correspondence: Lajos Pusztai, M.D., D.Phil., Department of Breast Medical Oncology, UT M.D. Anderson Cancer Center, P.O. Box 301439, Houston, Texas 77230-1439, USA. Telephone: 713-792-2817; email: lpusztai{at}mdanderson.org

Disclosure: L.P. owns stock in and has served as an officer or member of the Board for Nuvera Biosciences, Inc., and has acted as a consultant to Roche, Pfizer, and Bristol-Myers Squibb. No other potential conflicts of interest were reported by the author, planners, reviewers, or staff managers of this article.

Breast cancer is a clinically heterogeneous disease that can affect individuals with seemingly identical clinicopathologic parameters differently. This clinical heterogeneity is driven to a large extent by abnormal gene expression within tumors. Investigators now have the ability to identify the gene-expression fingerprint of an individual's tumor. This information may be used to rationally design therapeutic targets in the future, and also to predict the clinical course of an individual's disease, including response to a specific treatment. Genetic profiles of tumors are now being correlated with clinical outcome, and several prognostic and predictive indicators have emerged based on this research. There are at least four commercially available predictive or prognostic tests, and several more are looming on the horizon. The data gathered from these tests augment standard diagnostic and prognostic information obtained from traditional clinical pathological variables. The advent of gene-profiling technologies started to change the conduct of clinical trials. In the not too distant future, prospective tissue collection for molecular analysis may become routine in order to stratify patients for treatment arms and to optimize treatment strategies based on molecular features of the cancer. Coordinated efforts among oncologists, pathologists, surgeons, laboratory scientists, statisticians, and regulators will be essential in the quest to incorporate genetic profiling and molecular hypotheses into clinical trial planning and conduct.

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