New results presented at the 2017 American Urological Association (AUA) Annual Meeting from a large, community-based, multicenter clinical validation study conducted at Kaiser Permanente confirmed that the Oncotype DX Genomic Prostate Score (GPS) test is a strong independent predictor of prostate cancer-specific death and disease progression at 10 years in men with localized prostate cancer across all National Comprehensive Cancer Network (NCCN) clinical risk groups.
“By measuring cancer aggressiveness based on tumor tissue from the diagnostic biopsy, the Oncotype DX GPS test provides physicians and their patients with an individualized risk of having adverse pathology, developing metastases, and dying of prostate cancer,” said Phil Febbo, MD, Chief Medical Officer, Genomic Health. “These strongly positive results complement our previously published validation studies, and provide further confirmation that the GPS test can provide patients, physicians, and payers with individualized information above and beyond clinical and pathologic factors to make a quality treatment decision.”
Using a high-quality, longitudinal patient database from Kaiser Permanente's Northern California region, researchers evaluated biopsy tissue from 259 patients across all clinical risk categories who were treated with radical prostatectomy, which was standard of care at the time, and followed for a median of approximately 10 years. The study included a broad spectrum of patients by clinical risk, age, and race to reflect a typical contemporary clinical community-based setting. Patient samples were tested at the Genomic Health laboratory to produce GPS results in a blinded fashion.
Results showed a wide range of GPS scores within each NCCN risk group and confirmed that the GPS score was strongly associated with prostate cancer–specific death (P < .001) and metastases (P < .001) in multivariable analysis. Notably, a key finding was that patients in this study with very low–, low-, or intermediate-risk prostate cancer and a GPS result of less than 20 did not develop metastatic disease or die from prostate cancer following radical prostatectomy. These latest data add to the growing body of clinical evidence supporting the value and utility of the Oncotype DX GPS test to guide treatment decisions in men with localized prostate cancer.
“When we select emerging biomarkers, genomic assays, and radiologic technologies to enhance patient care, it is important to evaluate evidence-based data in order to ensure that we are optimally assessing a patient's cancer risk and therapeutic outcomes,” said Neal D. Shore, MD, FACS, Medical Director of the Carolina Urologic Research Center, who is not affiliated with this study. “Newly presented data at AUA 2017 augment prior published findings and clearly demonstrate the value and utility of the Oncotype DX Genomic Prostate Score test in providing information for physicians and patients to enhance decision making for newly diagnosed, localized prostate cancer.”
About the Oncotype DX Genomic Prostate Score (GPS) Test
Designed by Genomic Health based on results from multiple studies led by Cleveland Clinic and the University of California, San Francisco, the Oncotype DX Genomic Prostate Score test analyzes 17 genes across four biologic pathways from tumor tissue removed during biopsy to provide an individual score that, in combination with other clinical factors, further clarifies the current and future risk of the cancer prior to treatment intervention. The test enables confident treatment decisions to provide the opportunity for low- and intermediate-risk patients to avoid prostatectomy or radiation—and their side effects—while identifying men who need immediate definitive treatment.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.