Validation of the Decipher Test for Predicting Distant Metastatic Recurrence in Men with High-risk Nonmetastatic Prostate Cancer 10 Years After Surgery.
Aged
Biomarkers, Tumor
/ genetics
Case-Control Studies
Europe
/ epidemiology
Follow-Up Studies
Gene Expression Profiling
/ instrumentation
Humans
Incidence
Male
Middle Aged
Neoplasm Recurrence, Local
/ diagnosis
Prognosis
Prostate
/ pathology
Prostatectomy
Prostatic Neoplasms
/ genetics
Reagent Kits, Diagnostic
Retrospective Studies
Risk Assessment
/ methods
Risk Factors
United States
/ epidemiology
Decipher
Prognosis
Prostate cancer
Prostatectomy
Risk assessment
Journal
European urology oncology
ISSN: 2588-9311
Titre abrégé: Eur Urol Oncol
Pays: Netherlands
ID NLM: 101724904
Informations de publication
Date de publication:
09 2019
09 2019
Historique:
received:
16
09
2018
revised:
27
11
2018
accepted:
14
12
2018
pubmed:
15
8
2019
medline:
20
6
2020
entrez:
15
8
2019
Statut:
ppublish
Résumé
Decipher is a genomic classifier designed to predict the development of distant metastases after surgical treatment of prostate cancer (PC). Its long-term prognostic role in a high-risk PC population has not been investigated previously. To determine the prognostic role of the Decipher genomic classifier in two high-risk PC case-control studies. Patients who developed distant metastases after surgery for high-risk, nonmetastatic PC in a European tertiary referral center from 1991 to 2011 were matched to patients not developing distant metastases (n=54). A validation study (n=298) was performed using a similar US case-control cohort. Formalin-fixed, paraffin-embedded tissue blocks from the index PC lesion were used for RNA extraction and gene expression analysis. The outcome investigated was the development of distant metastasis within 10-yr follow-up. Multivariable logistic regression analysis was performed, with statistical significance considered at p<0.05. In both the European and US case-control studies, the median Decipher scores were higher in the population that developed metastases. In the multivariable analysis, each 10% increase in Decipher score translated to an increase in the risk of distant metastases within 10-yr follow-up, with an odds ratio of 1.53 (95% confidence interval [CI] 1.06-2.22; p=0.025) and 1.58 (95% CI 1.31-1.92; p<0.001) for the European and US cohorts, respectively. Median follow-up for the European cohort was 12yr (interquartile range 8-12). The study limitation is the small size of the European cohort. Our study validates Decipher as a predictor for metastatic recurrence even in patients with high-risk, nonmetastatic PC within 10-yr follow-up. Decipher is a test based on gene expression profiles in primary tumors in prostate cancer. It has already been proven to predict cancer recurrence after surgery, but this has not yet been shown for patients with high-risk prostate cancer. This is the first study confirming that Decipher predicts a patient's risk of developing cancer recurrence after surgery for high-risk prostate cancer.
Sections du résumé
BACKGROUND
Decipher is a genomic classifier designed to predict the development of distant metastases after surgical treatment of prostate cancer (PC). Its long-term prognostic role in a high-risk PC population has not been investigated previously.
OBJECTIVE
To determine the prognostic role of the Decipher genomic classifier in two high-risk PC case-control studies.
DESIGN, SETTING, AND PARTICIPANTS
Patients who developed distant metastases after surgery for high-risk, nonmetastatic PC in a European tertiary referral center from 1991 to 2011 were matched to patients not developing distant metastases (n=54). A validation study (n=298) was performed using a similar US case-control cohort. Formalin-fixed, paraffin-embedded tissue blocks from the index PC lesion were used for RNA extraction and gene expression analysis.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The outcome investigated was the development of distant metastasis within 10-yr follow-up. Multivariable logistic regression analysis was performed, with statistical significance considered at p<0.05.
RESULTS AND LIMITATIONS
In both the European and US case-control studies, the median Decipher scores were higher in the population that developed metastases. In the multivariable analysis, each 10% increase in Decipher score translated to an increase in the risk of distant metastases within 10-yr follow-up, with an odds ratio of 1.53 (95% confidence interval [CI] 1.06-2.22; p=0.025) and 1.58 (95% CI 1.31-1.92; p<0.001) for the European and US cohorts, respectively. Median follow-up for the European cohort was 12yr (interquartile range 8-12). The study limitation is the small size of the European cohort.
CONCLUSIONS
Our study validates Decipher as a predictor for metastatic recurrence even in patients with high-risk, nonmetastatic PC within 10-yr follow-up.
PATIENT SUMMARY
Decipher is a test based on gene expression profiles in primary tumors in prostate cancer. It has already been proven to predict cancer recurrence after surgery, but this has not yet been shown for patients with high-risk prostate cancer. This is the first study confirming that Decipher predicts a patient's risk of developing cancer recurrence after surgery for high-risk prostate cancer.
Identifiants
pubmed: 31411980
pii: S2588-9311(18)30215-3
doi: 10.1016/j.euo.2018.12.007
pii:
doi:
Substances chimiques
Biomarkers, Tumor
0
Reagent Kits, Diagnostic
0
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
589-596Informations de copyright
Copyright © 2018. Published by Elsevier B.V.