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Long-Term Nonoperative Rate of Thyroid Nodules with Benign Results on the Afirma Gene Expression Classifier
Institution:1. From The Ohio State University, Columbus, Ohio;2. Texas Diabetes and Endocrinology, Austin, Texas;3. Endocrine Associates of Dallas, Dallas, Texas;4. Endocrinology Associates, PC, Scottsdale, Arizona;5. Wellspan Health, Gettysburg, Pennsylvania;6. Carolina Endocrine, PA, Raleigh, North Carolina;7. Section of Endocrine Surgery, Duke University School of Medicine, Durham, North Carolina.;1. From the Division of Diabetes and Endocrinology Metabolism, University of Minnesota, Minneapolis, Minnesota;2. Occupational and Environmental Medicine, Health Partners, Minneapolis, Minnesota;3. Medicine Department, HCMC, Minneapolis, Minnesota;4. Endocrinology Department, HCMC, Minneapolis, Minnesota.;1. Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York, NY, USA;2. James J. Peters VA Medical Center, Bronx, NY, USA;1. From the Endocrinology and Nutrition Service. University Hospital of Valladolid. IEN-University of Valladolid, Valloadolid, Spain;2. Endocrinology and Nutrition Investigation Center, School of Medicine, IEN-University of Valladolid, Valladolid, Spain;3. Internal Medicine Service, Hospital Rio Hortega IEN-University of Valladolid, Valladolid, Spain.
Abstract:Objective: The primary objective was to assess the operative rate in patients with a benign result from the Afirma gene expression classifier (GEC) during long-term follow-up at nonacademic medical facilities. The secondary endpoint of this study was the treating physician's opinion regarding the safety of GEC use compared to the hypothetical situation of providing thyroid nodule management without the GEC.Methods: This was a retrospective study of nonacademic medical practices utilizing the GEC. Those clinicians utilizing the GEC testing who had three or more ‘benign’ results during the data collection period (September 2010 through June 2014) were invited to participate. Operative status and patient demographics were documented for patients with GEC testing at least 36 months (± 3 months) prior to the date of data collection. A survey also was administered to the treating physicians to assess their perceived safety of using the GEC in patient care.Results: During 36 months (± 3 months) of follow-up, 17 of 98 patients (17.3%) with a ‘benign’ GEC result underwent surgery. Within the first 2 years after a ‘benign’ GEC, 88% of surgeries were performed. Regarding safety of the GEC, the treating physicians reported that patient safety was improved by using the GEC compared to not using the GEC in 78 of 91 cases (86%).Conclusion: It appears that a ‘benign’ result on the GEC is associated with a reduction in the rate of thyroid surgeries compared to published data when patients are followed for 36 months after testing. A nonoperative approach to follow-up was felt to be a safe alternative to diagnostic surgery by the majority of responsible physicians in the study.Abbreviations:AUS = atypia of undetermined significanceFLUS = follicular lesion of undetermined significanceFN = follicular neoplasmFNA = fine-needle aspirationGEC = gene expression classifier
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