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Preoperative Diagnosis of Benign Thyroid Nodules with Indeterminate Cytology Full Text
New England Journal of Medicine, 07/03/2012
Alexander EK et al. – The data suggest consideration of a more conservative approach for most patients with thyroid nodules that are cytologically indeterminate on fine–needle aspiration and benign according to gene–expression classifier results.
Methods- The authors performed a 19-month, prospective, multicenter validation study involving 49 clinical sites, 3789 patients, and 4812 fine-needle aspirates from thyroid nodules 1 cm or larger that required evaluation.
- They obtained 577 cytologically indeterminate aspirates, 413 of which had corresponding histopathological specimens from excised lesions.
- Results of a central, blinded histopathological review served as the reference standard.
- After inclusion criteria were met, a gene-expression classifier was used to test 265 indeterminate nodules in this analysis, and its performance was assessed.
- Of the 265 indeterminate nodules, 85 were malignant.
- The gene-expression classifier correctly identified 78 of the 85 nodules as suspicious (92% sensitivity; 95% confidence interval [CI], 84 to 97), with a specificity of 52% (95% CI, 44 to 59).
- The negative predictive values for “atypia (or follicular lesion) of undetermined clinical significance,” “follicular neoplasm or lesion suspicious for follicular neoplasm,” or “suspicious cytologic findings” were 95%, 94%, and 85%, respectively.
- Analysis of 7 aspirates with false negative results revealed that 6 had a paucity of thyroid follicular cells, suggesting insufficient sampling of the nodule.