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Gene Expression and Risk Refinement within Gleason Score 7 (GS7) Prostate Cancer at Biopsy Using a Validated 17 Gene Genomic Prostate Score
David Albala, MD1, Michael Bonham, MD, PhD2, Debbie McCullough, MS2, Ruixiao Lu, PhD2, John Bennett, MPH2, Phillip Febbo, MD2
1Associated Medical Professionals, Syracuse, NY, 2Genomic Health, Redwood City, CA

BACKGROUND: The Genomic Prostate Score (GPS) is clinically validated as an independent predictor of both adverse pathology(AP) at surgery and biochemical recurrence (BCR) in men with NCCN low and intermediate risk prostate cancer. A higher percentage of Gleason pattern 4 (GP4) disease and specific GP4 histological subtypes have each been associated with adverse long term outcomes in men with biopsy Gleason score 7 (GS7) prostate cancer. However, men with GS7 cancer on biopsy are downgraded at prostatectomy and outcomes for men with organ confined Gleason 3+4 cancer are considered favorable. METHODS: 1,143 GS7 prostate biopsies received at the Genomic Health Inc. clinical lab were centrally reviewed for percentage GP4 (%GP4) and GP4 morphologic subtype. Specimens were subdivided based on %GP4 and morphological subtype. The GPS was calculated based on the validated algorithm of 12 cancer-related and 5 reference genes for each specimen; median GPS was calculated for each sub-group.
RESULTS: 1005 (88%) and 138 (12%) of GS7 biopsies were 3+4 and 4+3, respectively. The median GPS value for 3+4 was 31 (IQR 23-40) and for 4+3 was 37 (IQR 27-47). Among cases with 3+4, the median GPS was 29 (IQR 22-38), 33 (IQR 26-43), and 35 (IQR 27-46) for men with a percentage of GP4 of 1-10%, 11-25%, and 26-50%, respectively. Poorly formed glands was the most common GP4 morphologic type (PFG, 54%, n=619), followed by fused glands (FG, 24%, n=270), cribriform (19%, n=214), and glomeruloid (3%, n=40). Cribriform morphology had the highest median GPS 34 (IQR 26-44), followed by PFG 32(IQR 24-41), FG 30 (IQR 22-40), andglomeruloid 25 (IQR 20-32). Overall, 78 (7%) of GS7 biopsies were found to have likelihood of favorable pathology more consistent with NCCN Low risk after incorporation of GPS. A morefavorable risk of adverse pathology consistent with NCCN low was identified within all %GP4 and GP4 morphologic categories. CONCLUSIONS: There is a positive association between GPS and higher %GP4. However, widely overlapping GPS values across %GP4 and GP4 morphologies suggest a biologic continuum beyond what can be determined by traditional pathologic measures. The GPS is able to refine risk classification in men within all GS7 categories, helping to identify more appropriate treatment options in NCCN Intermediate patients.


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