POSTED: September 04, 2015

OncoTypeDX: PCa Risk Assessment Tool

Dr. Eric KleinDr. Eric Klein is the Chairman of the Glickman Urological & Kidney Institute at the Cleveland Clinics. Klein was the National Medical Study Coordinator for the National Cancer Institute sponsored Selenium and Vitamin E Cancer Prevention Trial (SELECT) and is the editor of the prestigious journal, Urology. He was also the lead author of the study on the OncoType DX prostate cancer test.

Dr. Klein recently spoke with Prostate Forum about OncoType and how it fits into the array of currently available risk assessment tools. To read the entire conversation, download Prostate Forum Volume 15 Number 12.

PROSTATE FORUM: Is it true that the OncoType biopsy sample needs to be less than 6 months old?   

Dr. ERIC KLEIN: No. It can work on anything. The issue is what is clinically relevant. If I see a patient in the office and I want to make a decision about how to manage him now, I need information about the current state of his tumor. It doesn’t make sense to assay a biopsy from three years ago, because that doesn’t tell me what is happening now. But technically speaking, we did experiments that showed you can get a signal on a tumor that is 20 years old.

PROSTATE FORUM: Is the test generally covered by insurance?

Dr. ERIC KLEIN: My understanding is, at least in Cleveland, at least 15% of patients’ insurance companies paid for it and the other 85% have not. The company has been offering the test to those whose insurance has not paid for it at a steep discount. That isn’t unusual for these kinds of tests. When a new test comes on the market, insurance companies want to see how clinicians are using it and how it impacts care for a while before they make a determination about whether or not they will cover it. OncoTypeDX for breast cancer went through that and I can tell you now that every major insurer in the United States and around the world covers the breast cancer test. OncoTypeDX for breast cancer is actually incorporated into the NCCN oncology guidelines as an appropriate element in the standard of care for assessing women who will benefit from chemotherapy after breast cancer. We’ll get there for one or more of these prostate tests.

This is a complicated story. The clinical challenge is that we’re over-diagnosing low grade cancers because of widespread PSA screening. Most of them don’t need to be treated. Despite that, for a variety of reasons, most men get treated. So we have over-diagnosis, or finding non-lethal cancers. We have over-treatment, which is treating non-lethal cancer, that leads to cost and morbidity. And active surveillance is not being pursued appropriately in most men who are candidates.

These are first generation tools that move prostate cancer for the first time into the realm of precision medicine, which is defined as making a clinical management decision based on the specific molecular characteristics of an individual patient’s cancer. We’re getting there for all cancers. These tests help us get there for prostate cancer.

This is incredibly exciting. I just hope the community will learn about these and adopt the tools and that patients learn about them and ask their doctors. We can make more accurate and more informed decisions. Hopefully, we’ll see more patients go on surveillance and fewer over-treated. That is really the main message. I believe we’re there biologically. The tests on the market are all are first generation tests, so they’re only going to get better with time. As we use them in the clinic, we’ll learn the pitfalls and refine our approach. 


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