-VANDAAM study findings confirm test predicts aggressive prostate cancer in African American men -
San Francisco, CA (UroToday.com) -- Veracyte, Inc. announced new data from two studies that further demonstrate the Decipher® Prostate Genomic Classifier (GC) provides prognostic information that can help physicians tailor treatment decisions for men with prostate cancer. The findings will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, which is being held virtually June 4-8, 2021.
In an oral presentation on June 8, researchers will share initial results from the ongoing, prospective VANDAAM (Validation Study on the Impact of Decipher Testing on Treatment Recommendations in African American and Non-African American Men with Prostate Cancer) Study (Abstract 5005). The findings confirm that the Decipher GC predicts aggressive prostate cancer in African American men (AAM) with the same accuracy as in non-African American men (NAAM), and performs better than standard clinical-risk factors or nomograms in this population.
"Our findings show that integrating the Decipher Genomic Classifier into the standard clinical workup for African American men with prostate cancer could improve accuracy in disease-risk classification and optimize treatment recommendations," said Kosj Yamoah, M.D., Ph.D., of Moffitt Cancer Center, who will present the study findings. "These findings are important because they are the first to confirm the Decipher test’s performance among African American men with prostate cancer – a population that previous data have shown to be more susceptible to aggressive forms of the disease."
Using the Decipher GC, researchers assessed risk of disease metastasis among a robustly matched cohort of 207 (102 AAM, 107 NAAM) prostate cancer patients who were newly diagnosed with low to intermediate clinical-risk disease as defined by National Comprehensive Cancer Network (NCCN) guidelines for the management of prostate cancer. Analysis revealed significant genomic differences between AAM and NAAM across NCCN risk groups. Among men with NCCN low to favorable-intermediate clinical-risk disease, 49% of AAM harbored high genomic-risk tumors, as compared to only 10% of NAAM (p=0.02). Additionally, AAM were 3.9 times more likely to be reclassified as high risk for distant metastasis as compared to NAAM (RR = 3.99, 95% CI, 1.15-13.86, p=0.02) using a clinico-genomic risk classifier that comprised both Decipher score and clinical variables.
Additional Decipher GC findings to be presented at ASCO include new data from a retrospective analysis of samples in the Phase 3 randomized Swiss Group for Clinical Cancer Research (SAKK) 09/10 trial (Abstract 5010), which evaluated conventional-dose (64Gy) salvage radiotherapy (SRT) vs. a dose-escalated SRT regimen (70Gy) in men with biochemical recurrence after radical prostatectomy (RT). In both arms of the study, patients received SRT without concurrent androgen deprivation therapy (ADT). Researchers tested samples from 226 SAKK 09/10 study participants using the Decipher GC to evaluate its ability to predict freedom from prostate specific antigen (PSA) recurrence, as well as clinical progression-free survival (CPFS) and progression to use of ADT.
"For men experiencing a biochemical recurrence following radical prostatectomy, it has been unclear which will have favorable outcomes from SRT without concurrent ADT, and which men should receive concurrent ADT in order to reduce their likelihood of progression," said Alan Dal Pra, M.D., of Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, who will present the study findings. "This first-of-its-kind analysis validates Decipher GC in a contemporary cohort of patients providing valuable, objective information to help physicians make confident treatment decisions that could optimize patient outcomes."
Study results show that patients with a Decipher high-risk score receiving SRT without concurrent hormone therapy were more than twice as likely as those with a Decipher low- or intermediate-risk score to experience biochemical progression (HR 2.10 ([95% CI 1.34-3.30], p=0.001) and clinical progression (HR 2.26 [95% CI 1.36-3.75], p=0.002), and almost three times as likely to progress to usage of ADT (HR 2.75 ([95% CI 1.48-5.11], p=0.002). Decipher high-risk patients who received conventional SRT had a five-year freedom from biochemical progression of 51% (95% CI 32-70) vs. 39% for those who received dose-escalated SRT (95% CI 20-59); for Decipher low-risk patients, five-year freedom from biochemical progression was 75% (95% CI 65-84) among those who received conventional SRT vs. 69% (95% CI 59-78) among those who received dose-escalated SRT.
"By independently assessing the underlying biology of prostate tumors, the Decipher Prostate Genomic Classifier accurately predicts individual patients’ disease prognosis to enable more informed therapeutic decisions," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "The VANDAAM and SAKK 09/10 studies provide additional, highly credible evidence of the test’s clinical value, and should solidify it as standard-of-care for men with prostate cancer."
Source Version on businesswire.com: https://www.businesswire.com/news/home/20210525005397/en/"