Testing for Afirma in Thyroid Nodules with High-Risk Indeterminate Cytology (TIR3B): First Italian Experience

Abstract

A percentage of 15 to 30% of thyroid fine-needle aspiration (FNA) is indeterminate, i.e., TIR3A and TIR3B according to the Italian consensus for thyroid cytology. Afirma, a molecular analysis of thyroid FNA specimens, has recently gained popularity as an adjunct to microscopic cytological evaluation, in order to avoid diagnostic surgery in patients with indeterminate thyroid cytology. We described the first Italian experience with Afirma tests in a single Italian institution and assessed the performance of the Afirma test in TIR3B. Moreover, this is a preliminary study to assess the patient response to the offer of Afirma testing. The Afirma test was proposed to 67 patients with thyroid nodules that had yielded TIR3B cytology. Fifty-one patients (76.1%) chose the Afirma test, 25/51 underwent the test but the remaining 26 did not because of cost. A total of 41/67 (61.2%) patients underwent surgery, and 22/41 (53.7%) nodules were carcinomas. Of the 25 tested by Afirma, 9 (36%) were classified as Afirma-suspicious (Afirma-S); seven of them underwent surgery, and in 6/7 (85.7%), a cancer was proven at histology. Afirma is the procedure that many Italian patients with TIR3B lesions would choose. However, its routine clinical application in Italy is currently limited by high costs for the patient. When Afirma is performed in this setting of patients, the cancer risk of suspicious result is higher than that expected in all the series of TIR3B. Therefore, testing for Afirma in these nodules may be useful for managing patients and tailoring their surgical approach.

Keywords: Afirma; Genetics; Papillary thyroid carcinoma; TIR3B; Thyroid cancer.