MedicalResearch.com Interview with:
Adam Berger, MD, FACS
Vice Chair for Clinical Research
Thomas Jefferson University Hospital
Philadelphia , PA
MedicalResearch.com: What is the background for this study?
Dr. Berger: Perhaps the most important point for consideration in the adoption of a new diagnostic test is: “Will this test impact patient management decisions for the patient that is sitting in front of me?” If the answer is no, then I would not order the test. If this answer is yes, the next question is how does it alter or impact patient management.
The DecisionDx-Melanoma test is a 31-gene expression profile test that has been shown to accurately separate or stratify patients with cutaneous melanoma identified to be at high risk of metastasis (“Class 2” test result) from those who are at an extremely low risk of disease progression (“Class 1” test result).
In two peer-reviewed publications from 2015 and three studies presented between April and June of this year, the DecisionDx-Melanoma test showed a Negative Predictive Value of 98% or 99% for death from melanoma or disease free-survival in patients with Stage I and II melanoma.
MedicalResearch.com: What are the main findings?
Dr. Berger:This study, published in Current Medical Research and Opinion, was performed to document the impact of the DecisionDx-Melanoma test on patient management. It reviewed 156 patients who were consecutively tested with the DecisionDx-Melanoma test from six practices – three surgical oncology practices and three dermatology practices. The study showed that 53% of follow-up management plans were changed following the receipt of the test results and of these changes 94% were consistent with the test classification – that is, patients who received a low risk Class 1 result had a reduction in intensity and frequency of their post-surgery surveillance and follow-up management plan while those with a high risk Class 2 test result had an increase in their post-surgery and follow-up management plan. In short, this means that the other co-authors and I adopted the DecisionDx-Melanoma test for clinical management.
As a point of reference, a 53% impact on change in management is very significant for any single test and greater than we see with similar tests that are available for use in breast cancer.
Additionally, of the 47% of patients with no documented change in patient management, 94% of the management plans were consistent with the test result – so patients with low risk clinicopathologic staging factors and a Class 1 result were managed with a low intensity surveillance plan, while patients with high risk clinicopathologic staging factors and a Class 2 result were managed with a high intensity surveillance and management plan.
MedicalResearch.com: What should readers take away from your report?
Dr. Berger: We are seeing improved outcomes in patients with cutaneous melanoma – marked in particular by the advances in immuno-oncology therapies. In fact, studies show that patients who benefit the most from these new, effective therapies are those who begin treatment when their tumor burden is lowest. The conundrum has been in identifying patients who are at high risk for disease progression. So, while the traditional sentinel lymph node biopsy procedure is good at finding some patients who are at risk of progression, the data show that two-thirds to three-quarters of patients who will progress and die from melanoma are those who are sentinel lymph node negative.
This is where the DecisionDx-Melanoma test comes in. It interrogates the biology of the tumor to find high risk patients who should receive increased surveillance and follow-up plans among those who are traditionally seen as low risk based upon clinicopathologic factors alone. Intensifying surveillance in high-risk patients gives us the chance to identify metastatic disease when the burden is lower and has a better chance of response to immunotherapies.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Berger: There are two areas to focus on:
1) The first is gathering additional data on the use of this test in patients who are Stage III – basically those patients with a positive sentinel lymph node and locoregional disease. We know that this group is heterogeneous as it relates to which patients will really progress and be at risk of death versus those that will have a stable disease course. Having a test to better stratify these patients will help in reducing over-treatment interactions in the Class 1 patients and support appropriate treatment in the Class 2 patients.
2) The next area would be to use the test to identify high risk Stage I and II patients who may benefit from adjuvant treatment with these newer immune-oncology therapies. It is my understanding that both of these lines of clinical use are either ongoing or being reviewed.
MedicalResearch.com: Is there anything else you would like to add? Maybe a final overarching thought?
Dr. Berger: We have had, since 2004, tests like this available for more common malignancies like breast cancer. While melanoma is an aggressive disease, it is much less common than breast, prostate, colon cancer and so on. It’s great to see advances being made in the accuracy of prognosis in early stage melanoma that are paralleling the treatment advances seen in late stage melanoma. These two areas are converging – which is good for patient care today, and we hope great for them tomorrow.
Clinical impact of a 31-gene expression profile test for cutaneous melanoma in 156 prospectively and consecutively tested patients.
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