A 17-gene assay to predict prostate cancer aggressiveness in the context of gleason grade heterogeneity, tumor multifocality, and biopsy undersampling

European Urology

Volumn 66, Issue 3, 2014, Pages 550-560

  Klein, Eric A ^a   Cooperberg, Matthew R ^b,c   Magi Galluzzi, Cristina ^a   Simko, Jeffry P ^b,c   Falzarano, Sara M ^a   Maddala, Tara ^d   Chan, June M ^b,c   Li, Jianbo ^d   Cowan, Janet E ^b   Tsiatis, Athanasios C ^d   Cherbavaz, Diana B ^d   Pelham, Robert J ^d   Tenggara Hunter, Imelda ^b   Baehner, Frederick L ^c,d   Knezevic, Dejan ^d   Febbo, Phillip G ^d   Shak, Steven ^d   Kattan, Michael W ^a   Lee, Mark ^d   Carroll, Peter R ^b  

^a LERNER RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d Genomic Health Inc   (United States)

Author keywords

Clinical utility; Clinical validation; Gene expression; Genomic Prostate Score; Heterogeneity; Prostate neoplasms; Surgical pathology

Indexed keywords

TRANSCRIPTOME;

AGED; ALGORITHM; CANCER GRADING; CANCER STAGING; ENDOSCOPIC ULTRASOUND GUIDED FINE NEEDLE BIOPSY; GENE EXPRESSION; GENETICS; HUMAN; MALE; MIDDLE AGED; MORTALITY; PATHOLOGY; PROCEDURES; PROSTATE TUMOR; PROSTATECTOMY; RISK ASSESSMENT; TUMOR RECURRENCE; VALIDATION STUDY;

AGED; ALGORITHMS; ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION; GENE EXPRESSION; HUMANS; MALE; MIDDLE AGED; NEOPLASM GRADING; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; PROSTATECTOMY; PROSTATIC NEOPLASMS; RISK ASSESSMENT; TRANSCRIPTOME;

EID: 84905922873     PISSN: 03022838     EISSN: 18737560     Source Type: Journal    
DOI: 10.1016/j.eururo.2014.05.004     Document Type: Article

References (52)

1. S.A. Strope, and G.L. Andriole Prostate cancer screening: current status and future perspectives Nat Rev Urol 7 2010 487 493
2. I. Thompson, J.B. Thrasher, and G. Aus et al. Guideline for the management of clinically localized prostate cancer: 2007 update J Urol 177 2007 2106 2131
3. M.R. Cooperberg, J.M. Broering, and P.R. Carroll Time trends and local variation in primary treatment of localized prostate cancer J Clin Oncol 28 2010 1117 1123
4. M.G. Sanda, R.L. Dunn, and J. Michalski et al. Quality of life and satisfaction with outcome among prostate-cancer survivors N Engl J Med 358 2008 1250 1261
5. V.A. Moyer U.S. Preventive Services Task Force Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement Ann Intern Med 157 2012 120 134
6. A. Qaseem, M.J. Barry, T.D. Denberg, D.K. Owens, P. Shekelle Clinical Guidelines Committee of the American College of Physicians Screening for prostate cancer: a guidance statement from the clinical guidelines committee of the American College of Physicians Ann Intern Med 158 2013 761 769
7. M.R. Cooperberg, P.R. Carroll, and L. Klotz Active surveillance for prostate cancer: progress and promise J Clin Oncol 29 2011 3669 3676
8. M.R. Cooperberg, D.J. Pasta, and E.P. Elkin et al. The University of California, San Francisco Cancer of the Prostate Risk Assessment score: a straightforward and reliable preoperative predictor of disease recurrence after radical prostatectomy J Urol 173 2005 1938 1942
9. A.J. Stephenson, M.W. Kattan, and J.A. Eastham et al. Prostate cancer-specific mortality after radical prostatectomy for patients treated in the prostate-specific antigen era J Clin Oncol 27 2009 4300 4305
10. F. Dong, M.W. Kattan, and E.W. Steyerberg et al. Validation of pretreatment nomograms for predicting indolent prostate cancer: efficacy in contemporary urological practice J Urol 180 2008 150 154 discussion 154
11. G. Ploussard, J.I. Epstein, and R. Montironi et al. The contemporary concept of significant versus insignificant prostate cancer Eur Urol 60 2011 291 303
12. C.R. King, and J.P. Long Prostate biopsy grading errors: a sampling problem? Int J Cancer 90 2000 326 330
13. S.L. Conti, M. Dall'Era, V. Fradet, J.E. Cowan, J. Simko, and P.R. Carroll Pathological outcomes of candidates for active surveillance of prostate cancer J Urol 181 2009 1628 1633 discussion 1633-4
14. M. Müntener, J.I. Epstein, and D.J. Hernandez et al. Prognostic significance of Gleason score discrepancies between needle biopsy and radical prostatectomy Eur Urol 53 2008 767 776 discussion 775-6
15. S.A. Tomlins, R. Mehra, and D.R. Rhodes et al. Integrative molecular concept modeling of prostate cancer progression Nat Genet 39 2007 41 51
16. D.V. Makarov, S. Loeb, R.H. Getzenberg, and A.W. Partin Biomarkers for prostate cancer Annu Rev Med 60 2009 139 151
17. D. Singh, P.G. Febbo, and K. Ross et al. Gene expression correlates of clinical prostate cancer behavior Cancer Cell 1 2002 203 209
18. J.C. Cheville, R.J. Karnes, and T.M. Therneau et al. Gene panel model predictive of outcome in men at high-risk of systemic progression and death from prostate cancer after radical retropubic prostatectomy J Clin Oncol 26 2008 3930 3936
19. Z. Ding, C.J. Wu, and G.C. Chu et al. SMAD4-dependent barrier constrains prostate cancer growth and metastatic progression Nature 470 2011 269 273
20. J. Cuzick, D.M. Berney, and G. Fisher et al. Prognostic value of a cell cycle progression signature for prostate cancer death in a conservatively managed needle biopsy cohort Br J Cancer 106 2012 1095 1099
21. M.F. Berger, M.S. Lawrence, and F. Demichelis et al. The genomic complexity of primary human prostate cancer Nature 470 2011 214 220
22. J.A. Squire, P.C. Park, and M. Yoshimoto et al. Prostate cancer as a model system for genetic diversity in tumors Adv Cancer Res 112 2011 183 216
23. R.J. Gray Weighted analyses for cohort sampling designs Lifetime Data Anal 15 2009 24 40
24. K. Chen, and S. Lo Case-cohort and case-control analysis with Cox's model Biometrika 86 1999 755 764
25. L.M. McShane, D.G. Altman, and W. Sauerbrei et al. Reporting recommendations for tumor marker prognostic studies J Clin Oncol 23 2005 9067 9072
26. M.R. Cooperberg, J.E. Cowan, and J.F. Hilton et al. Outcomes of active surveillance for men with intermediate-risk prostate cancer J Clin Oncol 29 2011 228 234
27. J.I. Epstein, W.C. Allsbrook Jr., M.B. Amin, and L.L. Egevad The 2005 International Society of Urological Pathology (ISUP) consensus conference on Gleason grading of prostatic carcinoma Am J Surg Pathol 29 2005 1228 1242
28. C. Magi-Galluzzi, F. Baehner, and D. Dutta et al. RNA yields and RT-PCR gene expression profiles obtained from manual-microdissected, fixed-paraffin-embedded tissue (FPET) from prostate adenocarcinomas Mod Pathol 20 2007 352A
29. C. Magi-Galluzzi, C.L. Millward, and T. Maddala et al. RNA yields and RT-PCR gene expression profiles obtained from manual-microdissected fixed paraffin-embedded prostate cancer needle core biopsies Mod Pathol 23 2010 205A
30. D. Knezevic, A.D. Goddard, and N. Natraj et al. Analytical validation of the Oncotype DX prostate cancer assay - a clinical RT-PCR assay optimized for prostate needle biopsies BMC Genomics 14 2013 690
31. D.R. Cox Regression models and life tables J R Stat Soc Series B Stat Methodol 43 1972 187 220
32. L.J. Goldstein, R. Gray, and S. Badve et al. Prognostic utility of the 21-gene assay in hormone receptor-positive operable breast cancer compared with classical clinicopathologic features J Clin Oncol 26 2008 4063 4071
33. J.D. Storey, and R. Tibshirani Estimating the positive false discovery rate under dependence, with application to DNA microarrays. Technical Report No. 2001-28 2001 Stanford University Stanford, CA
34. M.R. Cooperberg, J.M. Broering, and P.R. Carroll Risk assessment for prostate cancer metastasis and mortality at the time of diagnosis J Natl Cancer Inst 101 2009 878 887
35. NCCN clinical practice guidelines in oncology (NCCN Guidelines). Prostate cancer, version 2.2013. National Comprehensive Cancer Network Web site. http://www.nccn.org/professionals/physician-gls/f-guidelines.asp#prostate.
36. A.J. Vickers, and E.B. Elkin Decision curve analysis: a novel method for evaluating prediction models Med Decis Making 26 2006 565 574
37. S.E. Eggener, P.T. Scardino, and P.C. Walsh et al. Predicting 15-year prostate cancer specific mortality after radical prostatectomy J Urol 185 2011 869 875
38. S.K. Hong, I.A. Sternberg, and G.E. Keren Paz et al. Definitive pathology at radical prostatectomy is commonly favorable in men following initial active surveillance Eur Urol 66 2014 214 219
39. M.J. Pencina, R.B. D'Agostino Sr., R.B. D'Agostino Jr., and R.S. Vasan Evaluating the added predictive ability of a new marker: from area under the ROC curve to reclassification and beyond Stat Med 27 2008 157 172 discussion 207-12
40. A.J. Vickers, E.B. Elkin, and E. Steyerberg Net reclassification improvement and decision theory Stat Med 28 2009 525 526 author reply 526-8
41. W. Gu, and M.S. Pepe Estimating the capacity for improvement in risk prediction with a marker Biostatistics 10 2009 172 186
42. T.J. Wilt, M.K. Brawer, and K.M. Jones et al. Radical prostatectomy versus observation for localized prostate cancer N Engl J Med 367 2012 203 213
43. N.M. Donin, J. Laze, M. Zhou, Q. Ren, and H. Lepor Gleason 6 prostate tumors diagnosed in the PSA era do not demonstrate the capacity for metastatic spread at the time of radical prostatectomy Urology 82 2013 148 152
44. P.A. Ganz, J.M. Barry, and W. Burke et al. NIH State-of-the-Science Conference Statement: role of active surveillance in the management of men with localized prostate cancer NIH Consens State Sci Statements 28 2011 1 27
45. A.C. Reese, J.E. Cowan, J.S. Brajtbord, C.R. Harris, P.R. Carroll, and M.R. Cooperberg The quantitative Gleason score improves prostate cancer risk assessment Cancer 118 2012 6046 6054
46. R.K. Nam, R. Saskin, and Y. Lee et al. Increasing hospital admission rates for urological complications after transrectal ultrasound guided prostate biopsy J Urol 183 2010 963 968
47. K. Fujita, P. Landis, B.K. McNeil, and C.P. Pavlovich Serial prostate biopsies are associated with an increased risk of erectile dysfunction in men with prostate cancer on active surveillance J Urol 182 2009 2664 2669
48. J.H. Hayes, D.A. Ollendorf, and S.D. Pearson et al. Active surveillance compared with initial treatment for men with low-risk prostate cancer: a decision analysis JAMA 304 2010 2373 2380
49. H.B. Carter, A.W. Partin, and P.C. Walsh et al. Gleason score 6 adenocarcinoma: should it be labeled as cancer? J Clin Oncol 30 2012 4294 4296
50. L.J. Esserman, I.M. Thompson Jr., and B. Reid Overdiagnosis and overtreatment in cancer: an opportunity for improvement JAMA 310 2013 797 798
51. K.L. Penney, J.A. Sinnott, and K. Fall et al. mRNA expression signature of Gleason grade predicts lethal prostate cancer J Clin Oncol 29 2011 2391 2396
52. M.R. Crager Gene identification using true discovery rate degree of association sets and estimates corrected for regression to the mean Stat Med 29 2010 33 45