Usage trends and performance characteristics of a “gene expression classifier” in the management of thyroid nodules: An institutional experience

Samulski, T. Danielle; LiVolsi, Virginia A.; Wong, Lawrence Q.; Baloch, Zubair W.

doi:10.1002/dc.23559

Cited by 41 publications

(34 citation statements)

References 18 publications

(96 reference statements)

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“…The ideal treatment of AUS nodules is debated, 3 and repeat cytologic assessment is endorsed as one management strategy. 2,3,[45][46][47] In the current cohort, 36% of nodules had repeat cytology performed before GEC evaluation. On repeat FNA, nodules with AUS-C were more likely to remain AUS than AUS-A nodules, which were more frequently SFN.…”

Section: Discussionmentioning

confidence: 88%

“…48 Data from others have suggested that nodules with 2 AUS aspirates have a higher risk of malignancy than those with a single AUS result, both in general and for GEC-tested nodules. 29,39,45,46 In a recent report, the PPV increased from approximately 66% to 91% for nodules that had 1 versus 2 AUS results. 39 The data presented here demonstrate an identical malignant risk for a single versus repeated AUS cytology result in GEC-suspicious thyroid nodules and statistically similar results for a single AUS versus repeated indeterminate cytology of either kind (AUS or SFN).…”

Section: Discussionmentioning

confidence: 96%

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Qualifiers of atypia in the cytologic diagnosis of thyroid nodules are associated with different Afirma gene expression classifier results and clinical outcomes

Baca

Wong

Strickland

et al. 2017

Cancer Cytopathology

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BACKGROUNDThyroid nodules with atypia of undetermined significance (AUS) on fine‐needle aspiration (FNA) have a low risk of malignancy that appears to vary based on specific features described in the AUS diagnosis. The Afirma gene expression classifier (GEC) is a molecular test designed to improve preoperative risk stratification of thyroid nodules, but its performance for different patterns of AUS has not been defined. The objective of this study was to assess GEC results and clinical outcomes in AUS nodules with architectural atypia (AUS‐A), cytologic atypia (AUS‐C) or both (AUS‐C/A).METHODSThis was a retrospective review of all thyroid nodules with AUS cytopathology that underwent GEC testing at the authors' institution over a period of >4 years.RESULTSIn 227 nodules that had AUS cytology results and Afirma GEC testing, the rate of benign GEC results was higher in AUS‐A nodules (70 of 107; 65%) than in AUS‐C/A nodules (25 of 65; 38%; P = .0008), and AUS‐C nodules exhibited an intermediate rate of benign results (27 of 55 nodules; 59%). The risk of cancer among patients who had GEC‐suspicious nodules, 86% of whom underwent resection, was 19% (6 of 25) for AUS‐A nodules compared with 57% (21 of 37) for AUS‐C/A nodules (P = .003) and 45% (10 of 22) for AUS‐C nodules (P = .07). In nodules that had an indeterminate repeat cytology result, no difference was observed in the rate of benign GEC results or in the malignancy rate compared with nodules that had a single cytology result.CONCLUSIONSThe performance characteristics of Afirma GEC testing vary, depending on qualifiers of cytologic atypia. Recognition of these differences may enable clinicians to provide improved counseling and treatment recommendations to patients. Cancer Cytopathol 2017;125:313–322. © 2017 American Cancer Society.

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Section: Discussionmentioning

confidence: 88%

Section: Discussionmentioning

confidence: 96%

Qualifiers of atypia in the cytologic diagnosis of thyroid nodules are associated with different Afirma gene expression classifier results and clinical outcomes

Baca

Wong

Strickland

et al. 2017

Cancer Cytopathology

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“…20 The initial prospective validation of GEC did not consider noninvasive FVPTC, 11 and to our knowledge the impact of the novel concept of NIFTP on the performance of GEC has only been evaluated in 3 recent studies with a smaller sample size. [21][22][23] In the current study, we retrospectively examined the distribution of GEC results in histologically confirmed cases of NIFTP, evaluated the changes to the overall performance of the test, and assessed the potential influence on clinical management.…”

Section: Introductionmentioning

confidence: 99%

The impact of noninvasive follicular thyroid neoplasm with papillary‐like nuclear features on the performance of the Afirma gene expression classifier

Hang

Westra

Cooper

et al. 2017

Cancer Cytopathology

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BACKGROUND: A recent revision in thyroid tumor nomenclature has resulted in a change from a malignant diagnosis (noninvasive follicular variant of papillary thyroid carcinoma) to one that is nonmalignant (noninvasive follicular thyroid neoplasm with papillary-like nuclear features [NIFTP]). The objective of the current study was to evaluate the impact of this change on the performance of the Afirma gene expression classifier (GEC). METHODS: The authors retrospectively analyzed consecutive thyroid fine-needle aspiration specimens with indeterminate diagnoses on which GEC was performed. Surgical pathology material was reviewed with the reclassification of nodules into NIFTP. RESULTS: GEC testing was performed on 384 fine-needle aspiration specimens diagnosed as atypia of undetermined significance (AUS) (304 cases) and suspicious for a follicular neoplasm (SFN) (80 cases) and yielded a suspicious result in 152 of the AUS cases (50%) and 50 of the SFN cases (63%). Thyroidectomy was performed on 177 patients. After reclassifying NIFTP, the positive predictive value of GEC decreased from 42% (95% confidence interval [95% CI], 39%-45%) to 24% (95% CI, 22%-26%) in the AUS group and from 23% (95% CI, 19%-27%) to 13% (95% CI, 9%-18%) in the SFN group. Total thyroidectomy was performed more frequently than a partial thyroidectomy in patients with AUS with a suspicious GEC result compared with pre-GEC controls (68% vs 49%; P 5.037). CONCLUSIONS: Reclassification of NIFTP significantly decreases the positive predictive value of GEC in indeterminate thyroid nodules. Nevertheless, the majority of patients with indeterminate thyroid nodules with a suspicious GEC result in the study institution have undergone total thyroidectomy. This finding raises concerns over reliance on a suspicious GEC result by clinicians to justify total thyroidectomy. Cancer Cytopathol 2017;125:683-91.

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“…26,27 Designed to lower patient morbidity and the cost of care by decreasing unnecessary surgery for benign thyroid nodules, the majority of studies have demonstrated the utility of the Afirma GEC, whereas others have questioned the actual cost-benefit analysis of reflexively incorporating it into clinical care. 8,[28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44] Behind some of the various interpretations of the performance of the GEC are the inherent differences in agreement among thyroid cytopathologists. 7 However, another concern is the lack of a true "gold standard" in the subsequent validation studies, for which very few of the GEC benign cases have histologic correlation.…”

Section: A "Rule-in" Test: Gene Mutation Panelmentioning

confidence: 99%

“…[51][52][53] ThyroSeq v2.1 has added potential benefit for expanding presurgical risk stratification by providing specific results for identified mutations. 29,30 Prognosis and staging-based treatment decisions have been extensively studied for the BRAF mutation. Multivariate analysis in some but not all studies [54][55][56][57][58][59][60] have demonstrated that BRAF is an independent predictor of recurrence.…”

Section: Thyroseq Ngs Assaymentioning

confidence: 99%

Molecular testing for thyroid nodules: Review and current state

Roth

Witt

Steward

2017

Cancer

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Thyroid nodules affect nearly two-thirds of the world population. Fine-needle biopsy with cytologic evaluation remains the diagnostic test of choice to distinguish benign from malignant thyroid nodules yet fails to discriminate as benign or malignant in up to one-third of cases. This review discusses the limitation of current cytopathologic evaluation, the development of thyroid molecular testing, and the strengths and limitations of commercially available tests. Initial cytomolecular testing sought to identify specific gene mutations associated with thyroid cancer. Although the presence of a mutation was strongly associated with cancer, the likelihood of identifying a mutation was low; therefore, the test had low sensitivity. Subsequent tests developed have sought to improve the accuracy of cytomolecular testing for thyroid fine-needle aspirations, both to reassure patients and providers when malignancy may be absent and to confirm the malignancy when present. The development of cytomolecular testing for thyroid nodules has informed and improved current understanding of thyroid nodule formation and progression. When used appropriately and with clear understanding of the advantages and disadvantages, cytomolecular testing has the potential to improve patient care in the setting of indeterminate thyroid nodules by helping to guide both the need for and the extent of thyroid surgery. Cancer 2018;124:888-98. © 2017 American Cancer Society.

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Usage trends and performance characteristics of a “gene expression classifier” in the management of thyroid nodules: An institutional experience

Abstract: The GEC showed improved performance characteristics when coupled with a repeat FNA. It continues to be of low specificity and positive predictive value in oncocytic follicular lesions. Diagn. Cytopathol. 2016;44:867-873. © 2016 Wiley Periodicals, Inc.

Cited by 41 publications

References 18 publications

Qualifiers of atypia in the cytologic diagnosis of thyroid nodules are associated with different Afirma gene expression classifier results and clinical outcomes

Qualifiers of atypia in the cytologic diagnosis of thyroid nodules are associated with different Afirma gene expression classifier results and clinical outcomes

The impact of noninvasive follicular thyroid neoplasm with papillary‐like nuclear features on the performance of the Afirma gene expression classifier

Molecular testing for thyroid nodules: Review and current state

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