@article{7e1e09ed34594f99b078811a1a79af1b,
title = "A Systematic Review of the Evidence for the Decipher Genomic Classifier in Prostate Cancer",
abstract = "Context: 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. Objective: To perform a systematic review of the available evidence supporting the clinical utility of the Decipher genomic classifier (GC). Evidence acquisition: 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. Evidence synthesis: In total, 42 studies and 30 407 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 = 12 141), prospective registries (n = 17 053), and prospective and post hoc randomized trial analyses (n = 1213). In 32 studies (n = 12 600), 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. Conclusions: 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. Patient summary: 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.",
keywords = "Biomarkers, Decipher, Prognosis, Prostate cancer",
author = "Jairath, {Neil K.} and {Dal Pra}, Alan and Randy Vince and Dess, {Robert T.} and Jackson, {William C.} and Tosoian, {Jeffrey J.} and McBride, {Sean M.} and Zhao, {Shuang G.} and Alejandro Berlin and Mahal, {Brandon A.} and Kishan, {Amar U.} and Den, {Robert B.} and Freedland, {Stephen J.} and Salami, {Simpa S.} and Kaffenberger, {Samuel D.} and Alan Pollack and Phuoc Tran and Rohit Mehra and Morgan, {Todd M.} and Weiner, {Adam B.} and Osama Mohamad and Carroll, {Peter R.} and Cooperberg, {Matthew R.} and Karnes, {R. Jeffrey} and Nguyen, {Paul L.} and Michalski, {Jeff M.} and Tward, {Jonathan D.} and Feng, {Felix Y.} and Schaeffer, {Edward M.} and Spratt, {Daniel E.}",
note = "Funding Information: Financial disclosures: Daniel E. Spratt certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Neil K. Jairath, Alan Dal Pra, Randy Vince, Robert T. Dess, and William C. Jackson—none. Jeffrey J. Tosoian—leadership role, equity interest in LynxDx, Inc. Sean M. McBride—research funding from Janssen and Genentech, and honoraria from AstraZeneca. Shuang G. Zhao—patent applications with Decipher biosciences on molecular signatures in prostate cancer, for a molecular signature in breast cancer unrelated to this work and licensed to PFS genomics, and with Celgene unrelated to this work. Alejandro Berlin—research funding from Decipher Biosciences. Brandon Mahal—research funding from Prostate Cancer Foundation, Department of Defense, and ASTRO; travel honoraria from Prostate Health Education Network and the Exeter group; and equity interest from Novavax. Amar U. Kishan—consulting fees and honoraria from Varian Medical Inc., honoraria and research funding from ViewRay, Inc., consulting fees from Intelligent Automation, Inc., and member of the advisory board of Janssen. Robert B. Den—chief medical officer of Alpha Tau Medical. Stephen J. Freedland—wife is a consultant for Genomic Health. Simpa S. Salami, Samuel D. Kaffenberger, and Alan Pollack—none. Phuoc Tran—consulting fees from, medical advisory board member of, and/or personal fees from Janssen-Taris Biomedical, Noxopharm, and RefleXion Medical Inc.; and grants from RefleXion Medical, Bayer Healthcare, and Astellas Pharm. Rohit Mehra—none. Todd M. Morgan—advisory board member of and research funding from Myriad Genetics, and research funding from Decipher Biosciences and MDx Health. Adam B. Weiner—has a consulting agreement with Decipher Biosciences but has not received personal compensation from Decipher Biosciences to date. Osama Mohamad and Peter R. Carroll—none. Matthew R. Cooperberg—advisory board member of MDx Health. R. Jeffrey Karnes—none. Paul L. Nguyen—personal fees from Ferring, Janssen, Bayer, Astellas, Blue Earth, Dendreon, Augmenix, Boston Scientific, and Cota; and research funding from Janssen, Astellas, and Bayer. Jeff M. Michalski—honoraria from ViewRay Technologies, Blue Earth Diagnostics, Mevion Medical Systems, and Boston Scientific Inc. Jonathan Tward—grants and personal fees from Bayer and Myriad Genetics; personal fees from Blue Earth Diagnostics, Merck, Janssen, GenomeDX, and Astellas, outside the submitted work; and has a consulting agreement with Augmenix but has not received personal compensation from Augmenix to date. Felix Y. Feng—personal fees from Astellas, Bayer, BlueEarth Diagnostics, Celgene, Clovis, EMD Serono, Genentech, Janssen, Myovant, Ryovant, and Sanofi; and is a cofounder and has an ownership stake in PFS Genomics, patent applications with Decipher Biosciences on molecular signatures in prostate cancer, for a molecular signature in breast cancer unrelated to this work and licensed to PFS Genomics, and with Celgene unrelated to this work. Edward M. Schaeffer—none. Daniel E. Spratt—funding from Janssen, personal fees from Janssen, Blue Earth, AstraZeneca. Publisher Copyright: {\textcopyright} 2020 European Association of Urology",
year = "2021",
month = mar,
doi = "10.1016/j.eururo.2020.11.021",
language = "English",
volume = "79",
pages = "374--383",
journal = "European Urology",
issn = "0302-2838",
number = "3",
}