GenomeDx Biosciences today announced that data presented at the 2015 American Society of Clinical Oncology Annual Meeting demonstrate that the Decipher® Prostate Cancer Classifier is a significant predictor of metastasis in patients treated with postoperative salvage radiation therapy. Importantly, patients with a low Decipher score had excellent outcomes overall, independent of whether they received early or late salvage radiation, and with or without concurrent hormone therapy. In contrast, patients with a high Decipher score had comparatively worse outcomes, although they had improved metastasis-free survival with early salvage radiation.
In the study led by investigators at Thomas Jefferson University and the Durham VA, which evaluated 170 patients who received radiation therapy for a postoperative rising PSA or biochemical recurrence, only 2.7% of men with a low Decipher score had metastatic disease within 5 years. Metastasis occurred in 8.4% of men with an intermediate Decipher score and 33.1% of men who had a high Decipher score. While, in the lower Decipher risk group there were no significant differences in metastasis incidence, in the men with higher Decipher risk who received early salvage radiation had only 7.8% metastasis incidence compared to 28.7% for men who received late salvage radiation (p=0.031). The study, titled "Validation of a genomic classifier for prediction of metastasis following postoperative salvage radiation therapy", was presented today by Adam Dicker, M.D., Ph.D., Chair of Radiation Oncology at the Sidney Kimmel Cancer Center at Thomas Jefferson University.
"Based on these data, we believe that this predictive technology, using precision medicine, can help us tailor treatment approaches to fit an individual patient's risk," Dr. Dicker said. "This may mean avoiding concurrent hormone therapy and delaying radiation for patients with a low Decipher score, and recommending earlier radiation and intensification of therapy for patients with higher Decipher scores."
Also highlighted today, Ashley Ross, M.D., of The Brady Urologic Institute at Johns Hopkins School of Medicine, presented data from a study titled "Tissue Based Genomics Augment Post-Prostatectomy Risk Stratification in a Natural History Cohort". The study showed that a high Decipher score was predictive of metastasis after radical prostatectomy in a cohort of men that received no postoperative therapy prior to metastatic onset. Decipher was able to predict metastasis free survival at 10 years in this 'natural history' cohort of 260 intermediate and high-risk men. In the study, the cumulative incidence of metastasis at 10 years was significantly higher for those men with a high Decipher score (47%) versus those with low scores (12%). Two additional abstracts were accepted for publication in the 2015 ASCO Annual Meeting Proceedings.
The commercially available Decipher Prostate Cancer Classifier is covered by Medicare and evaluates 22 genomic markers to accurately & independently predict metastatic onset after radical prostatectomy for patients with adverse pathology. The Decipher test was developed by interrogating billions of genomic data points collected from clinical studies published in over 20 peer-reviewed articles.
SOURCE GenomeDx Biosciences