Abstract
Background:Currently, there are multiple commercially available RNA-based biomarkers that are Medicare approved and suggested for use by the National Comprehensive Cancer Network guidelines. There is uncertainty as to which patients benefit from genomic testing and for whom these tests should be ordered. Here, we examined the correlation patterns of Decipher assay to understand the relationship between the Decipher and patient tumor characteristics.Methods:De-identified Decipher test results (including Decipher risk scores and clinicopathologic data) from 2 342 consecutive radical prostatectomy (RP) patients tested between January and September 2015 were analyzed. For clinical testing, tumor specimen from the highest Gleason grade was sampled using a 1.5 mm tissue punch. Decipher scores were calculated based on a previously locked model. Correlations between Decipher score and clinicopathologic variables were computed using Spearman's rank correlation. Mixed-effect linear models were used to study the association of practice type and Decipher score. The significance level was 0.05 for all tests.Results:Decipher score had a positive correlation with pathologic Gleason score (PGS; r=0.37, 95% confidence interval (CI) 0.34−0.41), pathologic T-stage (r=0.31, 95% CI 0.28−0.35), CAPRA-S (r=0.32, 95% CI 0.28−0.37) and patient age (r=0.09, 95% CI 0.05-0.13). Decipher reclassified 52%, 76% and 40% of patients in CAPRA-S low-, intermediate- and high-risk groups, respectively. We detected a 28% incidence of high-risk disease through the Decipher score in pT2 patients and 7% low risk in pT3b/pT4, PGS 8−10 patients. There was no significant difference in the Decipher score between patients from community centers and those from academic centers (P=0.82).Conclusions:Although Decipher correlated with baseline tumor characteristics for over 2 000 patients, there was significant reclassification of tumor aggressiveness as compared to clinical parameters alone. Utilization of the Decipher genomic classifier can have major implications in assessment of postoperative risk that may impact physician-patient decision making and ultimately patient management.
Highlights
The management of men with prostate cancer is continuously evolving
RNA-based genomic signatures are aiding patients and physicians in selection of primary therapy,[1,2] as well as with postoperative treatment options.[3,4,5,6,7,8,9,10,11]. While these assays provide important prognostic information, only the Decipher prostate cancer classifier has been shown to be predictive[12] and consideration for its use in the post-radical prostatectomy (RP) setting has been suggested by the National Comprehensive Cancer Network guidelines.[13]
MATERIALS AND METHODS Study cohort We identified 2 504 consecutive RP patients from academic and community health centers for whom the Decipher test was ordered between 1 January and 1 September 2015
Summary
The management of men with prostate cancer is continuously evolving. Significant controversy exists with regard to the appropriate utilization and timing of adjuvant vs salvage therapies. RNA-based genomic signatures are aiding patients and physicians in selection of primary therapy,[1,2] as well as with postoperative treatment options.[3,4,5,6,7,8,9,10,11] While these assays provide important prognostic information, only the Decipher prostate cancer classifier has been shown to be predictive[12] and consideration for its use in the post-radical prostatectomy (RP) setting has been suggested by the National Comprehensive Cancer Network guidelines.[13] Decipher has been validated for prediction of metastasis among patients who experience biochemical recurrence and in the salvage radiotherapy setting post RP.[10,14] The Decipher post-op test is marketed to patients with adverse clinical or pathologic findings (e.g., pathologic stage T2 with positive margins, any pT3 disease or biochemical recurrence). We examined the commercial correlation patterns of the Decipher assay to understand the relationship between the genomic classifier score and patients’ tumor characteristics and to gain insight into the potential impact on altering postoperative therapy decisions for this patient population. Utilization of the Decipher genomic classifier can have major implications in assessment of postoperative risk that may impact physician-patient decision making and patient management
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