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ATA Guideline in Thyroid Nodule Management

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1 ATA Guideline in Thyroid Nodule Management
Zohreh Mousavi Endocrine Research Center Mashhad university of Medical Sciences Isfahan 4th International Congress of Endocrine & Metabolism Updates April 2017

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3 Scope of Problem Thyroid nodules are extremely common. An estimated 4% of the population have a palpable thyroid nodule, and more than 50% have a nodule detectable by ultrasonography. With the frequent use of computed tomographic scans and carotid ultrasound studies, many thyroid nodules are found in asymptomatic patients. In my practice, this has generated more than one-third of referrals for consultation regarding a thyroid nodule. Each of the guidelines addresses which nodules necessitate a biopsy and which can be safely monitored or ignored

4 Thyroid Nodules: Palpable thyroid nodules: 5% of general population and up to 30-40% above age 50. Thyroid incidentalomas on autopsy: 8-65%. Thyroid US depicts nodules in up to 67% of the population and % of children Thyroid cancer is present in 5-15% of thyroid nodules.

5 A. Overdetection: 4 cancers
An epidemic of diagnosis, not an epidemic of cancer! Prostate Cancer Thyroid Cancer Breast Cancer Melanoma Recommendations are likely to continue to evolve as detection rates of thyroid cancers rise, adding to the pressing need for more evidence to help guide clinical decision making, Dr Bible stressed. "There is an 'epidemic' of papillary thyroid cancer noted worldwide, particularly in developed countries, apparently arising primarily due to increased detection of minute papillary cancers, either from intentional thyroid-cancer screening (for instance, in South Korea) or by incidental detection from the increasing use of medical imaging (for instance, in the United States)," he explained. "Available data suggest that the vast majority of these micropapillary cancers would not have previously been recognized and furthermore suggest that most appear to be indolent and not requiring of aggressive therapy — but more evidence is required to define how to respond most appropriately Source: AIHW

6 Too much testing? The discovery of a thyroid nodule, should prompt a careful history taking and physical examination, measurement of thyrotropin levels, and an ultrasonographic examination “A normal person is someone who has not had enough tests” Dean at John Hopkins Medical School

7 A. Overdetection: thyroid cancer
Thyroid cancer tripled in 25 years; no more deaths

8 Guide the decision to perform fine-needle aspiration
Nodule size Clinical context Ultrasonographic characteristics Nodule size, clinical context, and ultrasonographic characteristics guide the decision to perform fine-needle aspiration

9 Strategies and Evidence
Pertinent History and Physical Examination Laboratory Studies Imaging Studies Fine-Needle Aspiration of the Thyroid Molecular Analysis of Thyroid Fine-Needle Aspiration Management

10 Clinical Findings Associated with an Increased Risk That a Thyroid Nodule Is Malignant.
Table 1 Clinical Findings Associated with an Increased Risk That a Thyroid Nodule Is Malignant. Burman KD, Wartofsky L. N Engl J Med 2015;373:

11 Evaluation History Physical Examination Rapid growth Family history
Irradiation Cancer syndromes Physical Examination Fixed, hard mass Vocal cord paralysis Cervical lymphadenopathy Obstructive symptoms Irradiation as a child of head and neck or total body irradiation from bone marrow transplant

12 KSTR : Korean Society of Thyroid Radiology
ATA AACE KSTR : Korean Society of Thyroid Radiology Three sets of guidelines regarding management of thyroid nodules have been published during the past 3 years. The first set was issued by the American Thyroid Association (ATA),[1] the second was by the American Association of Clinical Endocrinologists (AACE), in collaboration with the Associazione Medici Endocrinologi (AME) and the European Thyroid Association (ETA),[2] and the most recent was by the Korean Society of Thyroid Radiology (KSTR).[3] These guidelines have many similarities, but each set takes a slightly different approach to recommending which nodules should undergo biopsy

13 Evaluation Low  Thyroid scintigraphy
TSH Low  Thyroid scintigraphy Not low  US to select for FNA biopsy; evaluate for hypothyroidism Ultrasound High risk of cancer: hypoechoic, microcalcifications, increased central vascularity, irregular margins, taller than wide, documented enlargement, size >3cm Low risk of cancer: hyperechoic, peripheral vascularity, pure cyst, comet-tail shadowing Higher TSH = higher rate of malignancy and more advanced stage of cancer

14 Patient #1 48 yo male incidental 8 mm thyroid nodule Suspicious sonographic pattern, no abnormal LN

15 Thyroidectomy Calcitonin Active surveillance Ignore

16 What test(s) would you order ?

17 Which thyroid nodule should be biopsied
Which thyroid nodule should be biopsied? Which thyroid nodule does not need a biopsy?

18 Thyroid sonography with survey of the cervical lymph nodes should be performed in all patients with known or suspected thyroid nodules Recommendation 6

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21 THYROID ULTRASOUND CATEGORIES
1-Composition 2-Echogenicity 3-shape 4-Margins 5-Echogenic foci 6-size

22 Composition Solid Predominantly solid Predominantly cystic Cystic
Spongiform : predominately of tiny cystic spaces The echogenicity of the solid component of a nodule should be compared with normal-appearing thyroid tissue, usually immediately adjacent to the nodule. In the setting of background abnormal thyroid tissue echogenicity, such as in Hashimoto’s thyroiditis, the echogenicity of the solid component should still be described relative to the adjacent thyroid tissue, but it may be noted that the background tissue is of altered echogenicity

23 What is the malignancy risk of the nodule
Most of the malignant thyroid tumors are solid (81.6–93%) malignancy risk of the solid nodules is higher (24.1–34.7%) than that of the partially cystic nodules (3.3–7.1%) *Isoechoic Spongiform Nodule is benign When a spongiform nodule was defined as “the aggregation of multiple microcystic components in more than 50% of the volume of the nodule,”only one in 52 spongiform nodules was malignant [15]. When a spongiform nodule was defined as tiny cystic spaces involving the entire nodule, all 210 spongiform nodules were benign on FNA biopsy[16].

24 Echogenicity Hyperechoic Isoechoic Hypoechoic Very hypoechoic
* If the nodule is of mixed echogenicity, it can be described as “predominantly” hyperechoic, isoechoic, or hypoechoic The echogenicity of the solid component of a nodule should be compared with normal-appearing thyroid tissue, usually immediately adjacent to the nodule. In the setting of background abnormal thyroid tissue echogenicity, such as in Hashimoto’s thyroiditis, the echogenicity of the solid component should still be

25 Would you biopsy this nodule?
Thyroid Nodule: 2.7 cm, predominantly solid, hypoechoic, circumscribed, marked vascularity, wider than tall, no microcalcifications Would you biopsy this nodule? What do guidelines say?

26 Would you biopsy this nodule?
Thyroid Nodule: 1.7 cm, mixed solid and cystic, isoechoic, circumscribed, vascular, wider than tall, no microcalcifications Would you biopsy this nodule? What do guidelines say?

27 Would you biopsy this nodule?
Thyroid Nodule: 3.5 cm, spongiform, isoechoic, circumscribed, peripheral vascularity, wider than tall, no microcalcifications Would you biopsy this nodule? What do guidelines say?

28 Shape Term: taller-than wide
A taller-than-wide shape is defined as a ratio of >1 in the anteroposterior diameter to the horizontal diameter when measured in the transverse plane Suspicious or suggestive of malignancy This finding is seen in 12% of thyroid nodules Sensitivity: 40-68% specificity: 82-93% Taller-than-wide shape is a major feature for the ratio of >1 categorization of thyroid nodules that are suspiciou or suggestive of malignancy. The corresponding pathologic feature leading to this appearance isthought to be decreased compressibility. This finding is seen in 12% of thyroid nodules [8]. Sensitivity ranges between 40% and 68%, specificity between 82% and 93%, positive predictive value between 0.58 and 0.73, and negative predictive value between 0.77and 0.88

29 Suspicious US features:
Solid hypoechoic nodule with non-parallel orientation.

30 Margins Smooth: Uninterrupted, well-defined, curvilinear edge typically forming a spherical or elliptical shape Irregular margin: The outer border of the nodule is spiculated, jagged, or with sharp angles with or without clear soft tissue protrusions into the parenchyma Lobulated: Border has focal rounded soft tissue protrusions that extend into the adjacent parenchyma Ill-defined: Border of the nodule is difficult to distinguish from thyroid parenchyma; the nodule lacks irregular or lobulated margins Hallo Extrathyroidal extension Halo: Border consists of a dark rim around the periphery of the nodule. The halo can be described as completely or partially encircling the nodule. In the literature, halos have been further characterized as uniformly thin, uniformly thick, or irregular in thickness

31 Suspicious US features:
Solid hypoechoic nodule with spiculated/microlobulated margin.

32 Ill-defined Malignant Thyroid Nodule: ill-defined, hypoechoic, solid nodule with prominent internal vascularity

33 Echogenic Foci Punctate echogenic foci: “Dot-like” foci having no posterior acoustic posterior artifacts Macrocalcifications Peripheral calcifications Comet-tail artifacts

34 Colloid cyst: mostly cystic nodule with punctate echogenicities that show posterior ring-down artifact, indicating colloid crystals and a high likelihood that the nodule is benign

35 High-Risk Ultrasound Features ATA 2015
• Marked hypoechogenicity • Microcalcifications • Irregular (speculated) margins • More tall than wide ( AP>TR ) • Extracapsular growth • Suspicious regional lymph node

36 Ultrasonographic Images of Thyroid Nodules.
Figure 2 Ultrasonographic Images of Thyroid Nodules. Panel A shows a papillary thyroid carcinoma with hypoechogenicity. The other panels show nodular features that raise suspicion for cancer. Panel B shows a thyroid nodule with blurred or indistinct margins. Panel C shows a nodule that is higher (2.5 cm) than it is wide (1.6 cm). Panel D shows a nodule with microcalcifications. Burman KD, Wartofsky L. N Engl J Med 2015;373:

37 Large cystic nodal mass.
Small focal cystic change and hyperechogenicity in lymph node. Hyperechogenicity and macrocalcifications in lymph node. D. Multifocal hyperechogenicity (black arrows) and microcalcification (white arrow) in lymph node A. Large cystic nodal mass. B. Small focal cystic change and hyperechogenicity in lymph node. C. Hyperechogenicity and macrocalcifications in lymph node. D. Multifocal hyperechogenicity (black arrows) and microcalcification (white arrow) in lymph node. E. Hyperechogenicity, microcalcification, and abnormal hypervascularity in lymph node. Diagnosis: metastatic papillary carcinoma

38 Intermediate suspicion

39 A. Solid hypoechoic nodule without suspicious US features
A. Solid hypoechoic nodule without suspicious US features. Diagnosis: benign follicular nodule. B. Solid isoechoic (predominantly isoechoic) nodule with microcalcification. Diagnosis: benign follicular nodule. C. Predominantly solid hypoechoic nodule with multiple microcalcifications. Diagnosis: papillary carcinoma. D. Predominantly cystic hypoechoic nodule with microcalcification (arrow). Diagnosis: papillary carcinoma. (intermediate suspicion

40 Low Risk Nodule A. Solid isoechoic nodule. Diagnosis: follicular variant papillary carcinoma. B. Predominantly solid and isoechoic nodule. Diagnosis: benign follicular nodule. C. Predominantly solid and hypoechoic nodule. Diagnosis: benign follicular nodule. D. Predominantly cystic and isoechoic nodule. Diagnosis: benign follicular nodule low suspicious

41 Very Low Risk Nodule

42 Spongiform nodule A. Spongiform nodule. Diagnosis: benign (FNA not performed). B. Spongiform nodule with tiny microcystic changes. Diagnosis: benign follicular nodule. C. Predominantly cystic nodule with multiple comet tail artifacts. Diagnosis: benign follicular nodule with colloid. D. Cyst with comet-tail artifact. Diagnosis: benign (colloid cyst, FNA not performed) Benign

43 cystic nodule with multiple comet tail artifacts

44 Algorithm of K-TIRADS for malignancy risk stratification based on solidity and echogenicity of thyroid nodules Na et al. Thyroid 2016;26: (25)

45 Algorithm of K-TIRADS for malignancy risk stratification based on solidity and echogenicity of thyroid nodules

46 Quantification of cancer risk of each clinical and ultrasonographic suspicious feature of thyroid nodules: a systematic review and meta-analysis Campanella P, Ianni F, Rota CA, Corsello SM, et al Eur J Endocrinol 2014;170:R203-R211 The highest risk was found for nodule height greater than width, absent halo sign, and microcalcifications for ultrasonographic features and family history of thyroid carcinoma for clinical features. A meta-analysis-derived grading system of TN malignancy risk, validated on a large prospective cohort, could be a useful tool in TN diagnostic work-up

47 Figure 2 Forest plot for the meta-analysis of studies reporting on the association with the risk of thyroid cancer of (a) nodule height greater than width, (b) absent halo sign, (c) microcalcifications, (d) irregular margins, (e) hypoechogenicity, (f) solid nodule structure, (g) intranodular vascularization, (h) nodule size ≥4 cm, and (i) single nodule. Forest plot for the meta-analysis of studies reporting on the association with the risk of thyroid cancer of (a) nodule height greater than width, (b) absent halo sign, (c) microcalcifications, (d) irregular margins, (e) hypoechogenicity, (f) solid nodule structure, (g) intranodular vascularization, (h) nodule size ≥4 cm, and (i) single nodule. The overall estimate of the effect is represented by a diamond in each plot. Paolo Campanella et al. Eur J Endocrinol 2014;170:R203-R211 © 2014 European Society of Endocrinology

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49 Recommendation 8 Nodules >1 cm in greatest dimension with high suspicion sonographic pattern (Strong recommendation, Moderate-quality evidence)

50 Recommendation 8 Nodules > 1 cm in greatest dimension with intermediate suspicion sonographic pattern. (Strong recommendation, Low-quality evidence)

51 Recommendation 8 Nodules > 1.5 cm in greatest dimension with
low suspicion sonographic pattern. (Weak recommendation, Low-quality evidence)

52 Recommendation 8 Thyroid nodule diagnostic FNA may be considered for
Nodules > 2 cm in greatest dimension with very low suspicion sonographic pattern (e.g., spongiform). *Observation without FNA is also a reasonable option. (Weak recommendation, Moderate-quality evidence)

53 Low-risk lesion ATA Benign Very low suspicion Low suspicion
* Purely cystic nodules (no solid component) Very low suspicion *Spongiform or partially cystic nodules without any of the US features described in low-, intermediate- or high-suspicion patterns Low suspicion *Isoechoic or hyperechoic solid nodule, or partially cystic nodule with eccentric solid area without: • Microcalcifications • Irregular margin • Extrathyroidal extension • Taller than wide shape

54 Low-risk lesion AACE/ACE-AME
• Mostly cystic nodules with reverberating artifacts and not associated with suspicious US signs • Isoechoic spongiform nodules, either confluent or with regular halo

55 Intermediate suspicion
Hypoechoic solid nodule with smooth margins without: • Microcalcifications • Extrathyroidal extension • Or taller than wide shape

56 High-risk thyroid lesion AACE/ACE-AME
• Marked hypoechogenicity (vs. prethyroid muscles) • Spiculated or lobulated margins • Microcalcifications • Taller-than-wide shape (AP>TR) • Extrathyroidal growth • Pathologic adenopathy

57 "Importantly, [both guidelines] highlight pattern recognition"

58 Patient #1 48 yo male incidental 8 mm thyroid nodule Suspicious sonographic pattern, no abnormal LN

59 Active surveillance

60 FNA Recommendations(Recommendation 8)
Recommendations for diagnostic FNA based on sonographic features: A) Nodules > 1 cm with high suspicion sonographic pattern (Strong recommendation, Moderate-quality evidence) B) Nodules > 1cm with intermediate suspicion sonographic pattern (Strong recommendation, Low-quality evidence) C) Nodules > 1.5 cm with low suspicion sonographic pattern (Weak recommendation, Low-quality evidence) D) Nodules > 2 cm with very low suspicion sonographic pattern (e.g. - spongiform) (Weak recommendation, Moderate-quality evidence) E) FNA is not required for thyroid nodules that do not meet the above criteria, including all nodules < 1 cm (Strong recommendation, Moderate-quality evidence) F) FNA is not required for purely cystic nodules (Weak recommendation, Low- quality evidence) Ito Y, Thyroid 13:381-7, 2003 Ito Y, World J Surg 34:28-35, 2010

61 What is the role of fine-needle aspiration (FNA), cytology interpretation and molecular testing

62 Thyroid Fine-Needle Aspiration Specimens.
Figure 3 Thyroid Fine-Needle Aspiration Specimens. The figure shows nodules in five different categories of the Bethesda System for Reporting Thyroid Cytopathology.29 Panel A shows a benign nodule. The thyroid follicular cells are evenly spaced and have a small and uniform nuclear size. Panel B shows atypia of undetermined significance. In an otherwise benign aspirate, rare groups of follicular cells show nuclear enlargement. The patient underwent a thyroidectomy, and final pathological analysis showed benign nodular hyperplasia. Panel C shows a follicular neoplasm. Smears contain a cellular aspirate with only scant colloid. The follicular cells are of normal size but form microfollicles (abnormal architecture). Final pathological analysis showed follicular adenoma. Panel D shows a nodule “suspicious for malignancy” (papillary carcinoma). Aspirate shows some features of papillary carcinoma, such as hypercellularity, nuclear enlargement, hyperchromasia, and an increased nuclear-to-cytoplasmic ratio. However, no definitive nuclear pseudoinclusions were identified. Thyroidectomy was performed, and the final pathological analysis showed a follicular variant of papillary carcinoma. Panel E shows a malignant nodule (papillary carcinoma). Smears show a cellular aspirate with numerous abnormal follicular cells containing enlarged hyperchromatic nuclei. Nuclear pseudoinclusions are present (arrow). Burman KD, Wartofsky L. N Engl J Med 2015;373:

63 Thyroid fine-needle aspiration (FNA) is the most useful
screening test for evaluating a thyroid nodule and stratifying risk of malignancy. Unfortunately, the lack of a standardized reporting format has caused confusion and ambiguity in inter-preting these results. To address this need, the 2007 National Cancer Institute Thyroid Fine Needle Aspiration State of the Science Conference and the subsequent Bethesda System for Reporting Thyroid Cytopathology proposed a uniform classification scheme with 6 distinct diagnostic categories.

64 Bongiovanni M, et al. Acta Cytol 2012; 56:333-9.
The Bethesda System for Reporting Thyroid Cytopathology: A Meta-Analysis Bongiovanni M, et al. Acta Cytol 2012; 56:333-9.

65 The Bethesda System for Reporting Thyroid Cytopathology: A Meta-Analysis

66 The Bethesda System for Reporting Thyroid Cytopathology (TBSRTC )
Satisfactory for interpretation:89-95% Definitively benign :55-74% Definitively malignant : 2-5% AUS/FLUS : 2-18% FN : 2%–25%, SUSP : 1%–6% 89%–95% of samples being satisfactory for interpretation and 55%–74% reported as definitively benign and 2%–5% as definitively malignant (101–104). The remaining samples are cytologically indeterminate, including AUS/FLUS in 2%–18% of nodules, FN in 2%–25%, and SUSP in 1%–6%. Ref

67 False-negative results 5-10%
1-Inadequate sample 2-Cytophatologist experience 3-Nodule size

68 Diagnostic Categories of Thyroid Nodules and Risk of Cancer
Table 2 Diagnostic Categories of Thyroid Nodules and Risk of Cancer. Burman KD, Wartofsky L. N Engl J Med 2015;373:

69 Recommendation 16 AUS/FLUS
Repeat FNA Molecular testing Diagnostic surgery Active surveillance * Consider : patient preference and feasibility (Weak recommendation, Moderate-quality evidence) Based on the Bethesda System, this diagnostic category is reserved for specimens that contain cells with architectural and/or nuclear atypia that is more pronounced than expected for benign changes but not sufficient to be placed in one of the higher risk diagnostic categories (99;190). Although this diagnostic category has been recommended for limited use and has an expected frequency in the range of 7%, recent reports based on the Bethesda System have found this cytologic diagnosis to be used in 1-27% of all thyroid FNA samples (105;191

70 Clinical Outcome for Atypia of Undetermined Significance in Thyroid Fine-Needle Aspirations
Retrospective analysis years Of 4,691 thyroid FNAs, 512 (10.9%) had a diagnosis of AUS Repeat FNA From 331 cases (64.6%), of which 240 (72.5%) were benign 91 (27.5%) were malignant VanderLaan Paul A et al, Am J Clin Pathol ;135: Abstract In the Bethesda System for reporting thyroid fineneedle aspirations (FNAs), atypia of undetermined significance (AUS) is a category with limited reported follow-up and outcome data

71 No significant differences between groups
single AUS diagnosis (37/90 [41%]) 2 successive AUS FNA diagnoses (22/51 [43%]) and patients with a benign aspirate after AUS (2/7 [29%]) We report c analysis of our institution’s experience during nearly 4.5 years with a tiered classification scheme conforming to the Bethesda System in which repeated FNA was recommended for most patients with an initial AUS diagnosis. Of 4,691 thyroid FNAs, 512 (10.9%) had a diagnosis of AUS. Cytologic or histologic outcome data were available for 331 cases (64.6%), of which 240 (72.5%) were benign and 91 (27.5%) were malignant. Of patients with a surgical diagnosis, there was no statistically significant difference in malignancy rate among patients who went directly to surgery after a single AUS diagnosis (37/90 [41%]), patients having 2 successive AUS FNA diagnoses (22/51 [43%]), and patients with a benign aspirate after AUS (2/7 [29%]). Although AUS confers an intermediate risk of malignancy, guidelines recommending repeated FNA for most cases should be reevaluated.

72 AUS/FLUS: A second opinion review of the cytopathology slides by a high-volume cytopathologist
Unfortunately, there is a relatively high intra-observer variability in this difficult diagnostic category Ann Intern Med. 2013;159: Ref 106

73 core-needle biopsy: requires further investigation and is not justified

74 Surgery for AUS Repeated AUS diagnosis
Suspicious or malignant diagnosis on repeated FNA

75 What is the utility of 18FDG-PET scanning to predict malignant or benign disease when FNA cytology is indeterminate (AUS/FLUS, FN, SUSP)? Not routinely indicated RECOMMENDATION 18 18FDG-PET imaging is not routinely recommended for the evaluation of thyroid nodules with indeterminate cytology. (Weak recommendation, 8 studies that subject of 2 meta analysis )

76 AUS/FLUS If repeat FNA cytology and/or molecular testing are not performed or inconclusive, either surveillance or diagnostic surgical excision may be performed for an AUS/FLUS thyroid nodule, depending on clinical risk factors, sonographic pattern, and patient preference

77 MAPK and PI3K-AKT-MTOR pathways—genetic alterations

78 A hotly debated area: molecular markers
And tests for molecular markers for thyroid cancer, a hotly debated area, are treated differently in the two guidelines, Dr Gharib noted. The ATA guidelines suggest that clinicians should order these tests if cytology findings are atypical, whereas the AACE guideline uses more cautious wording: "At present, no single cytochemical or genetic marker can definitely rule out malignancy in indeterminate nodules. Nevertheless, these tools should be considered together with clinical data.“ More recently, molecular testing to improve the diag- nostic assessment of indeterminate nodules has become commercially available (14–16). The Afirma gene expres- sion classifier (GEC) (Veracyte, Inc) analyzes the mRNA expression of 167 genes in aspiration material and pro- Vides a benign or suspicious result toimprove preoperative risk stratification

79 Algorithm for management of thyroid nodules on the basis of FNAB and molecular marker tests
Depending on the cytology categories, molecular tests with high sensitivity and NPV (eg, gene expression classifier) or high specificity and PPV (eg, BRAF mutation) are chosen. Extent of surgery should be decided on the basis of the combined assessment of clinical, imaging, cytological, and molecular marker data. FNAB=fine needle aspiration biopsy. AUS/FLUS=atypia of undetermined significance/follicular lesion of undetermined significance. FN/SFN=follicular neoplasm/suspicious for follicular neoplasm. PTC=papillary thyroid cancer. NPV=negative predictive value. PPV=positive predictive value. Tx=total/near total thyroidectomy. LND=lymph node dissection Xing M, et al.Lancet March 23; 381(9871): 1058–1069

80 What are the principles of the molecular testing of FNA samples?

81 Molecular testing : NCCN Tumor Marker Task Force
Analytic validity : accuracy and reproducibility Clinical validity : sensitivity, specificity, predictively Clinical utility : decision making * “improves patient outcomes sufficiently to justify its incorporation into routine clinical practice” Ref : 158 ATA

82 Molecular testing using theAfirma GEC in AUS/FLUS
95% NPV (95% CI 79%-99%) 37% PPV (95% CI 23%-52%) Alexander EK et al, 2012;N Engl J Med 367:

83 AUS/FLUS or FN, and ‘suspicious’167 GEC have an estimated 37-44% risk of malignancy which is slightly higher than the risk based upon the Bethesda classification alone (Table 7) (163;171)

84 Summary ATA about molecular tests
In summary, there is currently no single optimal molecular test that can definitively rule in or rule out malignancy in all cases of indeterminate cytology, and long-term outcome data proving clinical utility are needed. Page 43

85 based on a recent meta-analysis of performance of the Bethesda system)
Ideal ‘‘rule-out’’ test : NPV similar to a benign cytologic diagnosis (96.3%) (predictive value estimates based on a recent meta-analysis of performance of the Bethesda system) Ideal ‘‘rule-in’’test would have a PPV for histopathologically proven malignancy similar to a malignant cytologic diagnosis (98.6%), Bongiovanni M et al 2012 The Bethesda System for Reporting Thyroid Cytopathology: a meta-analysis. Acta Cytol 56:333–339.

86 Molecular Testing for miRNA, mRNA, and DNA on Fine-Needle Aspiration Improves the Preoperative Diagnosis of Thyroid Nodules With Indeterminate Cytology 2. Expected surgical histopathology outcomes in thyroid nodules with AUS/FLUS or FN/SFN cytopathology after diagnostic surgery or after preoperative molecular testing. The size of each box and the associated percentages represent the expected proportions of benign/malignant outcomes (white/black boxes) or molecular results (white/dark gray boxes) at 32% (A) or 24% (B) thyroid cancer prevalence. The residual risk of malignancy (ROM) in nodules with negative/benign molecular results is [1-NPV] and the ROM in nodules with positive/malignant molecular results is PPV. The rate of unnecessary or potentially avoidable surgeries is the proportion of surgeries performed on nodules subsequently classified as benign by surgical histology. Abbreviations: B, benign; Mal, malignant.

87 Molecular Testing for miRNA, mRNA, and DNA on Fine-Needle Aspiration Improves the Preoperative Diagnosis of Thyroid Nodules With Indeterminate Cytology

88 New Platform "One of the key challenges is when you have a suspicious nodule, you have to determine whether it's benign or malignant to determine if the patient has to go to surgery. After fine-needle aspiration, about 20% to 30% are indeterminate. What we have done is come up with a new approach, which is a combination test — for the first time, we are able to both rule in and rule out malignancy," Dr Labourier told Medscape Medical News

89 Molecular Testing for miRNA, mRNA, and DNA on Fine-Needle Aspiration Improves the Preoperative Diagnosis of Thyroid Nodules With Indeterminate Cytology Conclusions: Multiplatform testing for DNA, mRNA, and miRNA can accurately classify benign and malignant thyroid nodules, increase the diagnostic yield of molecular cytology, and further improve the preoperative risk-based management of benign nodules with AUS/FLUS or FN/SFN Labourier E, et al 2015; J Clin Endocrinol Metab 100:

90 J Clin Endocrinol Metab. 2014;99(8):2674-2682
From: Cost-Effectiveness of Molecular Testing for Thyroid Nodules With Atypia of Undetermined Significance Cytology J Clin Endocrinol Metab. 2014;99(8): doi: /jc J Clin Endocrinol Metab. 2014;99(8): Figure Legend: Overview of cost-effectiveness model. The squares represent decision nodes, circles represent chance nodes, rectangles represent procedures, and ovals represent health states. J Clin Endocrinol Metab. 2014;99(8): 90

91 "These tests are often very expensive and when used inappropriately add undue expense to an already burdened health care system"

92 A 2015 Survey of Clinical Practice Patterns in the Management of Thyroid Nodules
AUS/FLUS resulting in molecular testing (38.8% of respondents), repeat FNA cytology (31.5%), or immediate referral for thyroid surgery (24.4%) Fn/SFN : are referred for thyroid surgery by 61.2% of respondents (46.6 % lobectomy, 14.6 % total thyroidectomy) or molecular testing (29.0 %). SUSP : thyroid surgery (86.0%) and rarely undergo molecular testing (9.5%). J Clin Endocrinol Metab (2016) Burch H ,Burman K, Cooper D 101 (7): Respondents in general have a lower threshold for FNA of thyroid nodules than that recommended in the updated ATA CPG. Management depends on the FNA result, with follicular lesion of undetermined significance/atypia of undetermined significance resulting in molecular testing (38.8% of respondents), repeat FNA cytology (31.5%), or immediate referral for thyroid surgery (24.4%). Nodules showing follicular neoplasm by FNA are referred for thyroid surgery by 61.2% of respondents (46.6 % lobectomy, 14.6 % total thyroidectomy) or molecular testing (29.0 %). Nodules found suspicious but not conclusive for malignancy (Bethesda category V), are referred for thyroid surgery (86.0%) and rarely undergo molecular testing (9.5%). During pregnancy, only 47.6% of respondents would perform FNA in the absence of nodular growth, with most respondents deferring FNA until after pregnancy. Endocrinologists are 64.2% less likely to perform FNA in an octogenarian than a younger patient with a comparable thyroid nodule. Striking international differences were identified in the routine measurement of calcitonin and in the use of molecular testing of thyroid nodules

93 Diagnostic surgical excision is the long-established standard of care for the management
FN/SFN

94 Patient #2 Case Vignette
40 yo woman presents with a thyroid nodule, 2.0 cm by 2.0 cm on palpation. No history of childhood radiation exposure or family history of thyroid abnormalities. No Suspicious sonographic pattern, no abnormal LN

95 What would you do ?

96 FNA : Benign

97 How should be managed?

98 The natural history of thyroid nodules is variable
JAMA 2015 The discovery of a thyroid nodule may be stressful for the patient, but more than 90% of the detected nodules are clinically insignificant benign lesions. Fine-needle aspiration cytology is the procedure of choice to identify suspicious lesions that require thyroid surgery. Established criteria for initial biopsy include nodule size and sonographic characteristics. Nodules measuring less than 1 cm, the majority of which are discovered incidentally, do not require initial aspiration unless they exhibit suspicious features on ultrasonography.

99 The Natural History of Benign Thyroid Nodules
To resolve these questions, we conducted a prospective multicenter study of the natural history of cytologically benign and sonographically nonsuspicious thyroid nodules We reportdata fromthe first 5years of follow-up, includingchanges in nodule size, baseline factors associatedwithnodule growth, the appearance of new thyroid nodules, and the incidence of thyroid cancer diagnosis. Changes in Thyroid Nodule Size and Volume During the First 5 Years of Follow-upNodule growth occurred in 174 (11.1%) of the 1567 nodules present at baseline; 1188 (75.8%) remained stable and 205 (13.1%) shrank. Graphs represent the estimated mean with 95% CIs of the maximum diameters and volumes of thyroid nodules. An analysis of variance for repeated measures was carried out to evaluate the change in thyroid nodule size over 5 years of follow-up. JAMA. 2015;313(9):

100 Significant growth has been defined as an increase of 20% or more in at least 2 nodule diameters, with a minimum increase of 2mm

101 local compressive symptoms or cosmetic concerns

102 Would this patient be a candidate for medical therapy?
IMPORTANCE Detection of asymptomatic thyroid nodules has increased. Consensus is lacking regarding the optimal follow-up of cytologically proven benign lesions and sonographically nonsuspicious nodules JAMA Current guidelines recommend serial ultrasound examinations and reassessment of cytology if significant growth is observed

103

104 Key Clinical Points Thyroid nodules are common; the majority are benign. • Thyroid ultrasonographic characteristics and especially the results of ultrasonographically guided fine needle aspiration are helpful in determining whether a nodule is likely to be benign or malignant. • The risk of cancer is approximately 14% for a thyroid nodule that is interpreted as atypia of undetermined significance or follicular lesion of undetermined significance and approximately % for a nodule that is interpreted as follicular neoplasm or possible follicular neoplasm. Such nodules should be considered for molecular analysis. • In the absence of growth or suspicious clinical or radiologic findings, thyroid nodules with a benign finding on fine-needle aspiration can be managed by observation. • Patients whose fine-needle aspirates are interpreted as “suspicious for malignancy” or as malignant should be referred for a thyroidectomy


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