Abstract
Several gene-expression-based reference laboratory tests are now available for prognostication of patients diagnosed with breast cancer. For clinical oncologists, it is important to understand the clinical contexts for which these assays were developed in order to use them properly. This Review is aimed at providing a conceptual and technical overview of the steps involved in the development of gene-expression profiling-based prognostic assays. MammaPrint® and Oncotype DX®, two widely utilized assays, are compared with respect to differences in the clinical contexts for their development, technologies used, and clinical utilities with the aim of providing a guide to clinical oncologists for utilization of these assays.
Key Points
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Clinical prognostic tests are most useful when developed and validated for a specific clinical context with a clear cut-off point for decision-making
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There are two commercial reference laboratory tests based on gene-expression profiling (MammaPrint® and Oncotype DX®) that are either agency-approved or widely-accepted by the oncology community
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These tests are not perfect and performances are similar
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Their clinical utility should be determined based on specific clinical contexts
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Oncotype DX® assay requires routinely processed formalin-fixed paraffin-embedded tumor tissue block, whereas the MammaPrint® assay requires snap-frozen tumor tissue or fresh tumor tissue procured in a special buffer
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More studies are needed to examine the influence of intratumor heterogeneity or previous needle biopsy procedures on the performance of these assays
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Dr. Soonmyung Paik declares he is a patent holder for the Oncotype DX® assay, produced by Genomic Health Inc. Dr. Paik is listed as one of the inventors for the Oncotype DX® assay but all rights have been assigned to the NSABP Foundation and Dr. Paik has no financial relationship with the company nor has he received any royalty based on the patent. C. Kim declares no competing interests.
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Kim, C., Paik, S. Gene-expression-based prognostic assays for breast cancer. Nat Rev Clin Oncol 7, 340–347 (2010). https://doi.org/10.1038/nrclinonc.2010.61
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DOI: https://doi.org/10.1038/nrclinonc.2010.61
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