Abstract
IntroductionThe management of patients with indeterminate thyroid nodules, which account for 10–25% of thyroid fine needle aspiration biopsies (FNABs), is still very challenging.AimTo verify the utility of the seven-gene panel in combination with ultrasound features in the clinical management of indeterminate thyroid nodules.ResultsThe study group included 188 indeterminate thyroid nodules, divided into TIR3A (56.4%) and TIR3B (43.6%). A significant correlation between US categories and both cytological and molecular results was observed. In detail, TIR3B cytology was more frequent in EU-TIRADS 4 and 5 nodules (54.7 and 50%, respectively) than in EU-TIRADS 2 and 3 nodules (31%, p = 0.04). Similarly, the rate of a nodule with a mutation increased with the increase of US risk class (6.0% in EU-TIRADS 2 and 3, 9.3% in EUTIRADS-4 and 27.8% in EUTIRAD-5, p = 0.01). Among thyroid nodules submitted to surgery, final histology was benign in 61.4% nodules, while malignancy was diagnosed in 38.6% nodules. Using US score as tool for decision-making in TIR3A subgroup, we correctly classified 64.5% of thyroid nodules. The second tool (seven-gene panel test) was used in the subgroup of US high-risk nodules. By multiple tests with a series approach (US in all cases and US plus seven-gene panel in US high risk nodules) 84% of cases were correctly classified. In TIR3B nodules, using only seven-gene panel as tool for decision making, we correctly classified 61.9% of indeterminate nodules. By multiple tests with series approach (seven-gene panel in all cases and seven-gene panel plus US score in non-mutated nodules) only a slight improvement of thyroid nodule classification (66.6%) was observed.ConclusionsUS score seems able to correctly discriminate between TIR3A nodules in which a conservative approach may be used, and those in which additional test, such as molecular test, may be indicated. On the contrary, in TIR3B nodules both US risk stratification and seven-gene panel seem to be of little use, because the risk of thyroid cancer remains high regardless of US score and mutational status.
Highlights
The management of patients with indeterminate thyroid nodules, which account for 10–25% of thyroid fine needle aspiration biopsies (FNABs), is still very challenging
Among the 503 indeterminate thyroid nodules, cytological diagnosis of TIR3 was confirmed in 386/503 (76.7%) nodules
Since ultrasound and follow-up data were not available for all patients, the subsequent analyses were performed in a subgroup of 188 TIR3 thyroid nodules from 182 patients followed at the Section of Endocrinology of University of Siena
Summary
The management of patients with indeterminate thyroid nodules, which account for 10–25% of thyroid fine needle aspiration biopsies (FNABs), is still very challenging. Based on the low sensitivity, the seven-gene panel cannot “rule-out” cancer and a negative molecular result cannot avoid diagnostic surgery limiting their cost-effectiveness [7]. The availability of molecular markers enhanced was significantly increased by the advent of generation sequencing technology, and the gene expression classifier has added a valuable contribution in the diagnosis of thyroid nodules [8, 9]. These tools are not routinely used in Europe because of the high cost [10]. In indeterminate thyroid nodules at high risk of malignancy, the utility of this approach may be limited [18]
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