Afirma Benign Thyroid Nodules Show Similar Growth to Cytologically Benign Nodules During Follow-Up

Angell, Trevor E.; Frates, Mary C.; Medici, Marco; Liu, Xiaoyun; Kwong, Norra; Cibas, Edmund S.; Kim, Matthew I.; Marqusee, Ellen

doi:10.1210/jc.2015-2658

Cited by 31 publications

(19 citation statements)

References 35 publications

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“…The ideal application of the Afirma GEC is still uncertain and has been the subject of many reports . A PPV of 37% to 38% for AUS and SFN nodules was initially found, but subsequent investigations have raised concerns about the PPV of GEC testing both generally and in specific circumstances .…”

Section: Discussionmentioning

confidence: 99%

“…This test classifies nodules as "benign" or "suspicious," which have a negative predictive value of 95% (95% confidence interval [CI], 85%-99%) and a positive predictive value (PPV) of 38% (95% CI, 27%-50%) for malignancy in AUS nodules. 16 The accuracy of a benign GEC result is comparable to that of benign cytopathology, 17 and surveillance is generally recommended in these patients, [18][19][20] whereas diagnostic thyroid surgery is most often undertaken for a suspicious GEC result. 20,21 Given the rapid evolution of this field, investigations are ongoing to determine how best to utilize the Afirma test and to define its performance in specific clinical and cytologic settings.…”

Section: Introductionmentioning

confidence: 99%

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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: 99%

Section: Introductionmentioning

confidence: 99%

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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“…However, the fact that only 8 cases with a benign Afirma result were surgically confirmed limited the accuracy of the sensitivity, specificity and NPV of the Afirma GEC test obtained in the current study, the results of which should therefore be interpreted with caution. One recent study investigated 90 thyroid nodules with indeterminate cytology and benign Afirma during a median follow-up period of 13 months and found that these nodules demonstrated a similar growth on sonogram to nodules with benign cytology, suggesting that the assessment of thyroid nodules with indeterminate cytology and benign Afirma may be performed similarly to those with benign cytology [20]. Two other recent studies evaluated the long-term management patterns and thyroid surgery rates of Afirma-benign patients compared to cytopathology-benign patients and found that patients with benign Afirma and cytopathology diagnoses were managed similarly and a nonoperative approach to follow-up was considered to be a safe alternative to diagnostic surgery by the majority of physicians [21,22].…”

Section: Discussionmentioning

confidence: 99%

Impact of the Afirma Gene Expression Classifier Result on the Surgical Management of Thyroid Nodules with Category III/IV Cytology and Its Correlation with Surgical Outcome

et al. 2016

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Objective: The Afirma gene expression classifier (GEC) is a molecular test to further classify indeterminate fine-needle aspiration (FNA) as benign or suspicious for malignancy. Study Design: A total of 158 FNAs with Bethesda category III/IV cytology were sent for an Afirma GEC test. We correlated the Afirma GEC results with surgical outcome and also compared the data after Afirma's implementation with the data before. Results: Among the 158 FNAs, the Afirma result was benign in 63 (40%), suspicious in 85 (54%) and unsatisfactory in 10 (6%). In total, 73 (86%) suspicious Afirma cases had surgery and 28 (38%) showed carcinoma. In contrast, only 8 (13%) benign Afirma cases had surgery and all of them were benign. The sensitivity, specificity, negative predictive value and positive predictive value (PPV) of Afirma were 100, 15, 100 and 38%, respectively. The PPV was 20% in cases with follicular lesion of undetermined significance, but was 50% in cases suspicious for follicular neoplasm (SFN). The surgical excisional rate was significantly decreased in SFN cases after the Afirma test. Conclusions: The Afirma GEC is useful for further risk stratifying SFN cases.

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“…Although the NPV with ThyroSeq v2.1 is able to rule out malignancy with greater than 95% accuracy for both Bethesda III and Bethesda IV nodules while maintaining a relatively high PPV (approximately 75%), it is similar to the PPV for nodules deemed cytologically suspicious for malignancy but not as high as that for nodules cytologically diagnosed as malignant (>90%). In addition, ongoing research into the correlation of specific mutations with specific histopathologic correlations may help further guide surgical planning when a preoperative diagnosis of an indolent versus aggressive tumor mutation is identified …”

Section: Comprehensive Tests To Improve Overall Accuracymentioning

confidence: 99%

“…In addition, ongoing research into the correlation of specific mutations with specific histopathologic correlations may help further guide surgical planning when a preoperative diagnosis of an indolent versus aggressive tumor mutation is identified. [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.…”

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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Afirma Benign Thyroid Nodules Show Similar Growth to Cytologically Benign Nodules During Follow-Up

Cited by 31 publications

References 35 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

Impact of the Afirma Gene Expression Classifier Result on the Surgical Management of Thyroid Nodules with Category III/IV Cytology and Its Correlation with Surgical Outcome

Molecular testing for thyroid nodules: Review and current state

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