At the recent annual meeting of the Society of Urologic Oncology (SUO), in Rockville, Md, three studies presented new clinical data about use of the Prolaris prostate cancer test by Myriad Genetics Inc, Salt Lake City. The new data show that the Prolaris test could save the healthcare system $6 billion over 10 years, and that physicians are using the test appropriately to personalize treatment options for their patients.
Michael Brawer, MD
“Improving patient care is our highest priority, and we strive to prevent the overtreatment of men with low-risk prostate cancer and the undertreatment of high-risk patients,” says Michael Brawer, MD, vice president of medical affairs at Myriad. “Based on the new data and our prior studies, it is clear that the Prolaris test improves health outcomes, reduces healthcare costs, and aids physicians in providing clinical care for their patients.”
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease progression in prostate cancer patients. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease progression in men who may be candidates for active surveillance; high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy.
E. David Crawford, MD
In a study that evaluated the economic impact of the Prolaris test, researchers found the test reduced costs by $2,850 per patient tested, which over a 10-year period could save the healthcare system $6 billion. For a health plan of approximately 30 million members, this would translate into savings of more than $48 million. It is estimated that two-thirds of these savings would be achieved in the first year after testing.
The cost savings were driven by greater use of active surveillance among low- and intermediate-risk patients, and by lower rates of disease progression among high-risk patients who received more-extensive treatment.
Mark A. L. Gonzalgo, MD, PhD
The company also presented interim results from Procede 1000, the largest prospective clinical utility study to date that evaluates the effect of the Prolaris test on personalizing prostate cancer treatment. The interim data analysis of 816 patients demonstrated that physicians changed their treatment decisions in 44% of cases based on results from the Prolaris test. In 32% of patients, the Prolaris test score led to a reduction in treatment, while 12% of patients received more-aggressive treatment based on their test score.
Myriad also presented a clinical study that validated an active surveillance threshold for Prolaris in 585 conservatively managed men with localized prostate cancer. The clinical endpoint for the study was prostate cancer mortality. The results showed that there were no observed cancer deaths among patients who fell below the defined threshold. In a separate analysis of 1,718 patients from a commercial cohort, approximately 55% of the patients qualified for active surveillance based on the threshold.
“The validation of an active surveillance threshold will help us identify many more men who are good candidates for surveillance than appear to be, based on their clinical features alone. For men considering deferred treatment, falling below the threshold will give them confidence that active surveillance is a realistic option instead of a more aggressive treatment,” says Brawer. “Prolaris is rapidly becoming the leading molecular prognostic test to determine if patients have aggressive prostate cancer or not and to help physicians personalize treatment decisions.”
Myriad’s poster presentations at the 2014 Society of Urologic Oncology meeting included the following:
Evaluation of the Economic Impact of the CCP Assay in Localized Prostate Cancer. E. David Crawford, MD, University of Colorado Denver School of Medicine
Impact of CCP Test on Personalizing Treatment Decisions: Results from a Large Prospective Registry of Newly Diagnosed Prostate Cancer Patients. Mark A. L. Gonzalgo, MD, PhD, University of Miami Health System
Validation of an Active Surveillance Threshold for the CCP Score in Conservatively Managed Men with Localized Prostate Cancer. Steven Stone, PhD, Myriad Genetics
For more information visit Myriad Genetics.
