Long-Term Follow-Up of Cytologically Indeterminate Nodules with Afirma GEC Benign Results


Thursday, September 22
9:45 AM MT

Interview with Jennifer A. Sipos, M.D., The Ohio State University



Dr. Jennifer Sipos is an endocrinologist at The Ohio State University’s Division of Endocrinology where she sees patients and specializes in research on thyroid nodules and thyroid cancer. Her institution participated in the multicenter clinical validation study for the Afirma Gene Expression Classifier and was among the first in the country to use the genomic test in clinical practice when it became available in 2011. 

Q: Why did you do this study? 

Dr. Sipos: Recently updated society guidelines for thyroid nodule management included comments indicating that long-term data on the Afirma GEC weren’t available. My colleagues and I knew that these studies did in fact exist and we wanted to highlight what they found. So, we looked at six published clinical utility studies with a median follow-up time of seven months or more, and focused primarily on the three studies that followed patients for more than a year. 

Q: And what did you find? 

Dr. Sipos: We found that the vast majority of patients – 85 percent -- who had Afirma GEC-benign results following indeterminate cytopathology findings on their thyroid nodules remained un-operated on over a year later. And those who did undergo surgery did so mainly because of the large size of the nodule or because of patient preference. 

Q: How many patients were included in the studies? 

Dr. Sipos: The three studies we focused on involved 411 patients with Afirma GEC-benign results who were followed for a median of 13, 19 and 26 months, respectively. Two of the studies were multicenter and one involved a single center. 

Q: What are the implications of your findings on patient care? 

Dr. Sipos: As clinicians, when it comes to patients with indeterminate thyroid nodules, we want to know who doesn’t need surgery. Before using a molecular test to provide this information, physicians want to know that it performs well. Our findings showed that nodules that are Afirma GEC-benign don’t change over time (compared to cytology-benign nodules), which speaks to the durability of the test’s results. This should give clinicians more confidence in using this test with their patients. 

Q: Do you have any other thoughts to share? 

Dr. Sipos: We are acquiring more information about this test in the real world, which is helpful to physicians in terms of when to use – and not use – it on patients.

For example, if a patient has a large, compressive nodule that is impacting their quality of life, they will likely be going to surgery anyway, so this test would not be that helpful. However, for many patients who can potentially avoid an unnecessary surgery, the Afirma GEC is changing how we provide care.

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