A Systematic Review of the Evidence for the Decipher Genomic Classifier in Prostate Cancer.

Molecular biomarkers aim to address the established limitations of clinicopathologic factors to accurately risk stratify patients with prostate cancer (PCa). Questions remain as to whether sufficient evidence supports adoption of these biomarkers for clinical use.

To perform a systematic review of the available evidence supporting the clinical utility of the Decipher genomic classifier (GC).

The review was performed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines by searching PubMed and conference abstracts from January 2010 to June 2020. Evidence was then graded using the criteria of Simon et al (Simon RM, Paik S, Hayes DF. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst 2009;101:1446-52) and American Urology Association (AUA) criteria.

In total, 42 studies and 30407 patients were included. GC performance data were available for localized, postprostatectomy, nonmetastatic castration-resistant, and metastatic hormone-sensitive PCa as part of retrospective studies (n=12141), prospective registries (n=17053), and prospective and post hoc randomized trial analyses (n=1213). In 32 studies (n=12600), the GC was independently prognostic for all study endpoints (adverse pathology, biochemical failure, metastasis, and cancer-specific and overall survival) on multivariable analysis and improved the discrimination over standard of care in 24 studies (n=8543). GC use changed the management in active surveillance (number needed to test [NNT]=9) and postprostatectomy (NNT=1.5-4) settings in five studies (n=4331). Evidence strength was levels 1 and 2 by the Simon criteria for all disease states other than high-risk PCa, and grades A and B by AUA criteria depending on disease state.

Consistent data are now present from diverse levels of evidence, which when viewed together, have demonstrated clinical utility of the GC in PCa. The utility of the GC is strongest for intermediate-risk PCa and postprostatectomy decision-making.

In this paper, we review the evidence of the Decipher genomic classification tool for men with prostate cancer. We found consistent evidence that the test helps identify which cancers are more or less aggressive, which in turn aids in personalized treatment decision-making.

European urology. 2020 Dec 05 [Epub ahead of print]

Neil K Jairath, Alan Dal Pra, Randy Vince, Robert T Dess, William C Jackson, Jeffrey J Tosoian, Sean M McBride, Shuang G Zhao, Alejandro Berlin, Brandon A Mahal, Amar U Kishan, Robert B Den, Stephen J Freedland, Simpa S Salami, Samuel D Kaffenberger, Alan Pollack, Phuoc Tran, Rohit Mehra, Todd M Morgan, Adam B Weiner, Osama Mohamad, Peter R Carroll, Matthew R Cooperberg, R Jeffrey Karnes, Paul L Nguyen, Jeff M Michalski, Jonathan D Tward, Felix Y Feng, Edward M Schaeffer, Daniel E Spratt

Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA., Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, FL, USA., Department of Urology, University of Michigan, Ann Arbor, MI, USA., Department of Radiation Oncology, Memorial Sloan Kettering, New York, NY, USA., Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, ON, Canada., Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, FL, USA; McGraw-Patterson Center for Population Sciences, Dana-Farber Cancer Institute, Boston, MA, USA., Department of Radiation Oncology, UCLA, Los Angeles, CA, USA., Department of Radiation Oncology, Thomas Jefferson, Philadelphia, PA, USA., Division of Urology, Department of Surgery, Cedars Sinai, Los Angeles, CA, USA; Section of Urology, Durham VA Medical Center, Durham, NC, USA., Department of Radiation Oncology, Johns Hopkins University, Baltimore, MD, USA., Department of Pathology, University of Michigan, Ann Arbor, MI, USA., Department of Urology, Northwestern University, Chicago, IL, USA., Department of Radiation Oncology, University of California San Francisco, San Francisco, CA, USA., Department of Urology, University of California San Francisco, San Francisco, CA, USA., Department of Urology, Mayo Clinic, Rochester, MN, USA., Department of Radiation Oncology, Dana Farber, Boston, MA, USA., Department of Radiation Oncology, Washington University St Louis, St. Louis, MO, USA., Department of Radiation Oncology, University of Utah, Salt Lake City, UT, USA., Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA. Electronic address: .

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