Abstract
BackgroundThe role of serum TSH concentrations as a predictor of malignancy of thyroid nodule remains unclear.ObjectiveTo prospectively evaluate the usefulness of serum TSH levels as a predictor of malignancy in thyroid nodules.MethodsPatients with thyroid nodule(s) who underwent fine-needle aspiration biopsy under ultrasonographic guidance in a tertiary, university-based hospital were consecutively evaluated. Patients with known thyroid cancer and/or patients receiving thyroid medication were excluded. Serum TSH levels were measured by two differents methodologies, chemiluminescent (CLIA) and electrochemiluminscent immunoassay (ECLIA). Anatomopathological exam of tissue samples obtained at thyroidectomy was considered the gold standard for the diagnosis of thyroid cancer.ResultsA total of 615 patients participated in the study. The mean age was 55.9±14.7 years, and 544(88.5%) were female. The median TSH values were 1.48 and 1.55 μU/mL, using CLIA and ECLIA, respectively. One-hundred-sixty patients underwent thyroidectomy and the final diagnoses were malignant in 47(29.4%) patients. TSH levels were higher in patients with malignant than in those with benign nodules in both TSH assays: 2.25 vs. 1.50; P = 0.04 (CLIA) and 2.33 vs. 1.27; P = 0.03 (ECLIA). Further analysis using binary logistic regression identified elevated TSH levels, a family history of thyroid cancer, the presence of microcalcifications, and solitary nodule on US as independent risk factors for malignancy in patients with thyroid nodules. Additional analyses using TSH levels as a categorical variable, defined by ROC curve analysis, showed that the risk of malignancy was approximately 3-fold higher in patients with TSH levels ≥2.26 μU/mL than in patients with lower TSH levels (P = 0.00).ConclusionsHigher serum TSH levels are associated with an increased risk of thyroid cancer in patients with thyroid nodules. Using TSH levels as an adjunctive diagnostic test for stratifying the risk of malignancy associated with a thyroid nodule may help on defining the best therapeutic approaches.
Highlights
Palpable thyroid nodules are a common disorder detected in 4–7% of adults in the general population and in 19–67% of patients who undergo high-resolution ultrasound [1,2,3,4,5]
Serum TSH levels were measured by two differents methodologies, chemiluminescent (CLIA) and electrochemiluminscent immunoassay (ECLIA)
TSH levels were higher in patients with malignant than in those with benign nodules in both TSH assays: 2.25 vs. 1.50; P = 0.04 (CLIA) and 2.33 vs. 1.27; P = 0.03 (ECLIA)
Summary
Palpable thyroid nodules are a common disorder detected in 4–7% of adults in the general population and in 19–67% of patients who undergo high-resolution ultrasound [1,2,3,4,5]. The challenge for clinicians, is to distinguish malignant (5–10%) from benign thyroid nodules[4,5]. Fine-needle aspiration biopsy (FNAB) is the gold standard for evaluating patients with thyroid nodules, and it is currently the most reliable diagnostic technique for evaluating thyroid nodules under ultrasound guidance[5,7]. Only 10–20% of the thyroid nodules with indeterminate cytology (Bethesda III and IV) are malignant[8,12,13,14]. New diagnostic approaches based on thyroid cancer molecular biomarkers have recently been studied, and some are already introduced in clinical settings. The use of these molecular tools have been validated in some studies, these tests are expensive (and not cost-effectivity depending of thyroid cancer prevalence), and their impact on patient management remains debatable[17,18,19,20]. The role of serum TSH concentrations as a predictor of malignancy of thyroid nodule remains unclear
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