In a study reported in the Journal of Clinical Oncology, Daniel W. Lin, MD, and colleagues found that the 17-gene Oncotype DX Genomic Prostate Score was not associated with the finding of adverse pathology among men with prostate cancer undergoing radical prostatectomy after initial active surveillance.
Daniel W. Lin, MD
Study Details
The study involved a cohort of men from the Canary Prostate Active Surveillance Study with Genomic Prostate Score test results. The primary endpoint was adverse pathology—defined as Gleason Grade Group ≥ 3, ≥ pT3a—in men who underwent radical prostatectomy after initial surveillance.
Key Findings
Genomic Prostate Score results were obtained for 432 men, with a median follow-up of 4.6 years. Of these, 101 underwent radical prostatectomy after a median of 2.1 years of surveillance, with 52 having adverse pathology. A total of 167 (39%) had tumor upgrade at a subsequent surveillance biopsy.
In univariate analysis among the 101 men who underwent radical prostatectomy, Genomic Prostate Score was not significantly associated with adverse pathology (hazard ratio [HR] = 1.14; 95% confidence interval = 1.00–1.34, P = .062). Genomic Prostate Score was significantly associated with adverse pathology in analysis adjusted for diagnostic Gleason grade (HR per 5 Genomic Prostate Score units = 1.18, P = .030), but not in analysis also adjusted for prostate-specific antigen (PSA) density (HR = 1.85, P = .066).
“Adding Genomic Prostate Score to a model containing PSA density and diagnostic Gleason grade did not significantly improve stratification of risk for adverse pathology over the clinical variables alone.”— Daniel W. Lin, MD, and colleagues
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No association was observed between Genomic Prostate Score and upgrade on subsequent biopsy (P = .48).
As noted by the investigators, models containing PSA density and Gleason grade or PSA density, Gleason grade, and Genomic Prostate Score may stratify risk of adverse pathology better than a model containing just Genomic Prostate Score and Gleason grade.
The investigators concluded: “In our study, the independent association of Genomic Prostate Score with [adverse pathology] after initial active surveillance was not statistically significant, and there was no association with upgrading in surveillance biopsy. Adding Genomic Prostate Score to a model containing PSA density and diagnostic Gleason grade did not significantly improve stratification of risk for adverse pathology over the clinical variables alone.”
Dr. Lin, of the Department of Urology, University of Washington, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the Canary Foundation, Department of Defense, National Institutes of Health, and Genomic Health. For full disclosures of the study authors, visit ascopubs.org.
