The Evolving Role of Multi-Gene Tests in Breast Cancer Management - Cancer Network
The Evolving Role of Multi-Gene Tests in Breast Cancer Management
By Rachel C. Jankowitz, MD1, Adrian V. Lee, PhD1,2 |11 de marzo de 2013
1Department of Medicine, University of Pittsburgh School of Medicine (UPSOM), University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania,2Department of Pharmacology and Chemical Biology, UPSOM and Magee-Womens Research Institute, Pittsburgh
The current review by Drs. Zelnak and O’Regan aptly summarizes multi-gene tests (MGTs), their prognostic role, and how gene expression profiling has aided the definition of molecular breast cancer subtypes. However, while the current role of MGTs in the clinical care of breast cancer patients is evolving, it remains somewhat unclear. For instance, the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group (EWG), established by the Centers for Disease Control and Prevention (CDC), determined in 2009 that there was “insufficient evidence to make a recommendation for or against the use of tumor gene expression profiles to improve outcomes in defined populations of women with breast cancer.” The group stated they believed that until the TAILORx (Trial Assigning IndividuaLized Options for Treatment [Rx]) and MINDACT (Microarray In Node-Negative Disease may Avoid ChemoTherapy) trials are reported, they were not able to offer firm guidance on the use of these tests. Additionally, all of the commercial assays for breast cancer prognostication are laboratory-developed, contain proprietary information, and with the exception of the MammaPrint test that has been approved by the US Food and Drug Administration (FDA), have not been fully independently evaluated.
Conversely, the 21-gene recurrence score ([RS] Oncotype DX) has reached a level 1B evidence score according to the proposed Simon modification to the marker utility grading system, based on its development using archived specimens from a prospective trial.[1] Moreover, it is listed as an option for clinicians to aid in chemotherapy decision-making in the National Comprehensive Cancer Network (NCCN) guidelines.
Conversely, the 21-gene recurrence score ([RS] Oncotype DX) has reached a level 1B evidence score according to the proposed Simon modification to the marker utility grading system, based on its development using archived specimens from a prospective trial.[1] Moreover, it is listed as an option for clinicians to aid in chemotherapy decision-making in the National Comprehensive Cancer Network (NCCN) guidelines.
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