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Decipher test predicts metastasis risk following radical prostatectomy
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The genomic classifier test Decipher independently improved prognostication over clinicopathologic variables for patients following a radical prostatectomy, according to a meta-analysis published in Journal of Clinical Oncology.
“Although Decipher [GenomeDx] only moderately correlates with clinicopathologic variables, it independently adds prognostic benefit over routine clinicopathologic variables to predict metastases and appears to add benefit across a number of clinically relevant subgroups,” Felix Y. Feng, MD, associate professor of radiation oncology at University of California, San Francisco, and colleagues wrote.
Decipher — which measures and analyzes the activity of 22 genetic markers expressed in the prostate cancer tumor — is intended to aid in the prognostication of men who have undergone radical prostatectomies and assist in treatment decisions following the procedures.
By pooling five studies, Feng and colleagues explored the correlation and performance of Decipher in a multi-institutional and multiethnic cohort of 855 men (median age, 60 years; 85.4% white, 12.4% black; median PSA level, 7.6) with adverse pathology at time of radical prostatectomy. Just over half of the patients (51.3%) received prostatectomy with no additional second-line therapy.
Determining the test’s ability to predict time to regional or distant metastases on multivariable analyses served as the study’s primary endpoint.
Median follow-up was 8 years (interquartile range, 5-11 years).
The cohort demonstrated a median Decipher score of 0.37 (interquartile range, 0.24-0.54). Decipher classified men as low (60.9%), intermediate (22.6%) and high risk (16.5%).
Eighty-two patients developed metastasis during the study. Decipher categories significantly stratified risk for metastases; the 10-year cumulative incidence metastases rates were 5.5% for low risk, 15% for intermediate risk and 26.7% for high risk (P < .001).
An analysis that pooled study-specific HRs across all five studies showed each 0.1 unit increase in Decipher score increased risk for metastasis (HR = 1.52; 95% CI, 1.39-1.67; I2 = 0%).
Decipher remained a statistically significant predictor of metastasis after adjusting for clinicopathologic variables (HR per 0.1-unit increase = 1.35; 95% CI, 1.14-1.47). Further, the addition of the Decipher to the clinical model alone increased the C-index for 10-year distant metastasis from 0.76 to 0.81.
Researchers acknowledged the selection criteria included only patients with adverse clinicopathologic features and that the use of Decipher in lower-risk prostate cancer needs further investigation.
“Decipher should be considered an additive validated test to improve prognostication in high-risk men after radical prostatectomy and to aid clinical decision-making and future clinical trial design,” Feng and colleagues wrote.
Up to 16.5% with a high-risk Decipher score may benefit from the test, Anthony V. D’Amico, MD, PhD, chief of genitourinary radiation oncology at Dana-Farber Cancer Institute, wrote in an accompanying editorial.
“However, it remains unknown whether the assessment of the time after radical prostatectomy when these patients were observed to develop metastatic disease was consistent, or whether they would already have been classified at being high risk for the development of metastatic prostate cancer on the basis of clinical indices, and how use of adjuvant and/or salvage radiation therapy and/or androgen deprivation therapy affected the predictive value of the Decipher score in these men,” D’Amico wrote.
Future studies should entail obtaining the Decipher test in men who do not already have a high-risk factor, D’Amico wrote.
“Until such information is available, it does not seem that the Decipher test is ready for use in clinical practice or to select men who are at high risk for developing metastatic prostate cancer for randomized postradical prostatectomy adjuvant therapy trials,” D’Amico concluded. – by Chuck Gormley
Disclosure: Feng reports consultant/advisory roles with Dendreon, EMD Serono, GenomeDx Biosciences, Medivation/Astellas and Sanofi. Please see the full study for a list of all other researchers’ relevant financial disclosures. D’Amico reports no relevant financial disclosures.
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