Oncotype DX Predicts Outcomes In Prostate Cancer Patients, Significantly Changes Treatment Recommendations

Genomic Health, Inc.

today announced results from two studies of the Oncotype DX® prostate cancer test demonstrating its value in low- and intermediate-risk prostate cancer to enable physicians and patients to avoid over- and under-treatment of the disease. Both studies will be presented today, December 3, at the Society of Urologic Oncology (SUO) Annual Meeting, in Bethesda, Md. Results from the latest clinical validation study, published in European Urology this month online, show that the Oncotype DX test predicts near- and longer-term outcomes in a racially diverse group of men with clinically localized prostate cancer. The analyses, conducted in collaboration with the Uniformed Services University of the Health Sciences' Center for Prostate Disease Research (CPDR), reconfirmed the biopsy-based Oncotype DX prostate cancer test as a predictor of whether adverse pathology would be found if the prostate were removed by surgery. Additionally, for the first time, the Oncotype DX prostate cancer test was validated as a strong independent predictor of biochemical recurrence, which is a rise in PSA following surgery. Furthermore, the study, in which 20 percent of patients were African-American men, demonstrated that Oncotype DX is similarly predictive of outcomes in both Caucasian and African-American men. "Our recently conducted survey of African-American men showed that more than 70 percent think prostate cancer is best treated immediately and that their loved ones would want them to do so," said Thomas A. Farrington, founder and president of the Prostate Health Education Network (PHEN). "These statistics highlight a significant potential for prostate cancer over-treatment and underscore the need for more knowledge about genomic tests like Oncotype DX, which provides a scientifically precise assessment of each patient's prostate cancer aggressiveness, and can help relieve the anxiety experienced by men and their families in making the proper treatment decision." "Each year, 240,000 men are diagnosed with prostate cancer in the Unites States alone. Importantly, more than half of these men have low-risk disease and can be candidates for active surveillance," said Phil Febbo, M.D., chief medical officer, Genomic Health. "With eleven prostate cancer studies in more than 1,500 patients, Genomic Health has developed and validated the only genomic test that has met the most actionable endpoint of adverse pathology, giving physicians the confidence to put many low- to intermediate-risk patients on active surveillance, while identifying those patients who might be missed by conventional measures and could benefit from more aggressive treatment." Separately, the results of the first Oncotype DX prostate cancer test decision impact study showed that the use of the test significantly changed treatment recommendations. Conducted in collaboration with academic and community practices at Columbia University, Delaware Valley Urology and Orange County Urology, this prospective study in a contemporary population of men with low- or intermediate-risk disease showed that the use of the test substantially increased the number of men who would be eligible for active surveillance. Additionally, use of the test increased physician confidence in their treatment recommendations. "Prostate cancer comes in many different forms and having confidence in your treatment recommendation and decision is crucial," said Ketan K. Badani, M.D., lead investigator of the study and vice chairman of Urology and Robotic Operations at Mount Sinai Health System, New York. "Nearly half of prostate cancer is not aggressive and now we have more advanced tools like genomic profiling with the Oncotype DX test to determine a man's individual risk." The complete results of this first Oncotype DX clinical utility study in prostate cancer have been accepted for publication in Urology Practice, an official journal of the American Urological Association.