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INTRODUCTION: A dilemma that urologists face is how to determine which patients with prostate cancer need immediate intervention and which patients can be safely placed on active surveillance. Gene expression profile analysis of biopsy tissue has been proposed as a means of providing more accurate risk stratification for low risk prostate cancer. However, there is a general lack of acceptance and standardization around the integration of genomic testing in clinical practice. The Oncotype DX® prostate cancer assay is a commercially available tissue based assay that assesses the expression of key genes across multiple biological pathways predictive of prostate cancer aggressiveness from the diagnostic biopsy specimen, and reports an individual Genomic Prostate Score. METHODS: With the recommendations set forth in this article we aim to standardize operational best practices for the integration of the Genomic Prostate Score into clinical practice. Its purpose is to provide practical guidance to help physicians understand, run, interpret and communicate actionable results to patients. RESULTS: The Genomic Prostate Score reflects the biology of the underlying tumor to help guide initial treatment decisions at the time of biopsy. This article is based on real-world evidence from the authors' respective experiences at their institutions and practices. The authors were carefully selected based on their depth of experience and knowledge about the Genomic Prostate Score and, as such, it is their expertise that is being leveraged to support the best practices algorithm. CONCLUSIONS: This article provides easy to use, clear-cut and practical guidance for physicians on how to use the Genomic Prostate Score to inform decisions regarding active surveillance.
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BACKGROUND: To examine factors that affect accuracy and reliability of prostate cancer grade we compared Gleason scores documented in pathology reports and those assigned by urologic pathologists in a population-based study. METHODS: A stratified random sample of 318 prostate cancer cases was selected to ensure representation of whites and African-Americans and to include facilities of various types. The slides borrowed from reporting facilities were scanned and the resulting digital images were re-reviewed by two urologic pathologists. If the two urologic pathologists disagreed, a third urologic pathologist was asked to help arrive at a final "gold standard" result. The agreements between reviewers and between the pathology reports and the "gold standard" were examined by calculating kappa statistics. The determinants of discordance in Gleason scores were evaluated using multivariate models with results expressed as odds ratios (OR) and 95% confidence intervals (CI). RESULTS: The kappa values (95% CI) reflecting agreement between the pathology reports and the "gold standard," were 0.61 (95% CI: 0.54, 0.68) for biopsies, and 0.37 (0.23, 0.51) for prostatectomies. Sixty three percent of discordant biopsies and 72% of discordant prostatectomies showed only minimal differences. Using freestanding laboratories as reference, the likelihood of discordance between pathology reports and expert-assigned biopsy Gleason scores was particularly elevated for small community hospitals (OR = 2.98; 95% CI: 1.73, 5.14). CONCLUSIONS: The level of agreement between pathology reports and expert review depends on the type of diagnosing facility, but may also depend on the level of expertise and specialization of individual pathologists.
