May 14, 2014
Peer Review Studies Find Decipher® Genomic Test Significantly Changes Postoperative Treatment Recommendations for Prostate Cancer Patients and Increases Confidence in Treatment Decisions
Two new clinical utility studies of Decipher published in BJU International and Current Medical Research and Opinion
SAN DIEGO, May 14, 2014 /PRNewswire/ -- GenomeDx Biosciences today announced data from two new clinical utility studies demonstrating that Decipher® Prostate Cancer Classifier significantly changed treatment decisions and increased confidence in treatment decision-making for men considering adjuvant therapy following prostate surgery. The studies are being published in upcoming issues of the journals Current Medical Research and Opinion (CMRO) and the British Journal of Urology International (BJUI), respectively.
"The American Urological Association has issued clinical guidelines recommending adjuvant radiation therapy to all prostate cancer patients with adverse pathology after surgery, despite that most men in this group did not develop metastasis or die of prostate cancer," noted John Hornberger, M.D., Principal of Cedar Associates, LLC, adjunct faculty at Stanford and senior author on the study published in CMRO. "By providing a more objective, individualized estimate of metastasis risk based on a quantitative laboratory assay, adoption of the Decipher prostate cancer test may reduce inappropriate or inconsistent use of adjuvant treatment in this population."
In the PRO-ACT study published in CMRO, 15 board-certified, community-based urologists who had ordered the Decipher test to inform management of their current patients were asked to provide treatment recommendations before and after receiving their patients' Decipher test results and then complete a decision conflict scale, a measure designed to assess confidence in treatment recommendations. Prior to receiving the Decipher test results, physicians were asked to make treatment decisions based on clinical risk factors such as Gleason score and tumor stage. Following the receipt of Decipher results, physicians changed their treatment recommendations for 30.8 percent of patients (95% CI, 23-39%). Among the 102 patients for whom observation was initially recommended, physicians changed recommendations to adjuvant radiation for 18 of those patients. Conversely, 17 of the 40 patients who were initially slated for adjuvant radiation saw recommendations change to observation. The genomic information provided by Decipher test results significantly influenced which patients were recommended adjuvant treatment (p<0.001). In addition, decisional conflict with regard to physicians' decision to treat with adjuvant radiation therapy was significantly less with the use of Decipher results than without (p<0.0001).
"Making secondary treatment decisions after our patients have had surgery is not cut and dry. Most men who do not need additional treatment would prefer to avoid the side effects," said Ketan Badani, M.D., urologic oncologist at Columbia University in New York. "The ASSESS-D study clearly demonstrates that adding a test like Decipher, that gives physicians a readout of the genomic fingerprint of a patient's prostate cancer and provides a more precise measure of the biologic risk of developing metastasis, can help physicians make more appropriate treatment decisions, and be more confident in those decisions."
In the ASSESS-D study, a multi-center, prospective decision impact study published in BJUI, 51 community urologists reviewed and provided adjuvant treatment recommendations for randomly selected patient cases considered by clinical practice guidelines to be high risk for metastasis following prostate surgery. Overall, 31 percent (95% CI: 27-35%) of treatment recommendations were changed after reviewing the Decipher results. Among adjuvant radiation therapy recommendations without Decipher results, 40% (n=77) changed to observation (95% CI: 33-47%) following knowledge of Decipher results. For patient cases recommended for observation, 13% (n=38) (95% CI: 9%-17%) were changed to adjuvant radiation therapy with Decipher. Case histories with low Decipher results were recommended observation 81% of the time (n=276), while for those with high Decipher results, 65% were recommended for treatment (n=118, p<0.0001). Treatment intensity was strongly correlated with the Decipher-predicted probability of metastasis (p<0.001) and the Decipher test was the dominant risk factor driving decisions in multivariable analysis (OR=8.6, 95% CI: 5.3-14.3%, p<0.0001).
The Decipher® Prostate Cancer Classifier directly measures a patient's biological risk of developing metastatic prostate cancer. By assessing the activity of multiple genomic markers associated with metastatic disease, Decipher provides information about the aggressiveness of a patient's tumor - information distinct from that provided by PSA and other clinical risk factors. Decipher continues to demonstrate that it can accurately predict aggressive disease and help physicians make more informed treatment decisions for men with prostate cancer.
Decipher is covered by multiple private insurance plans and is available to eligible US patients through their physicians. To learn more about ordering the Decipher test please visit www.deciphertest.com.
About GenomeDx Biosciences
GenomeDx Biosciences is focused on transforming patient management by putting usable genomic information in the hands of patients and their physicians. GenomeDx has developed the Decipher® Prostate Cancer Classifier, the first and only commercially available genomic test that predicts the risk of developing metastatic prostate cancer independently of PSA and other conventional risk assessment tools. GenomeDx is based in San Diego, California and Vancouver, British Columbia. To learn more visit www.genomedx.com
SOURCE GenomeDx Biosciences