Thyroid American Thyroid Association Statement on Surgical Application of Molecular Profiling for Thyroid Nodules: current impact on perioperative decision-making (doi: 10.1089/thy.2014.0502) This article has been peer-reviewed and accepted for publication, but has yet to undergo copyediting and proof correction. The final published version may differ from this proof.

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American Thyroid Association Statement on Surgical Application of Molecular Profiling for Thyroid Nodules: current impact on perioperative decision-making Robert L. Ferris, MD, PhD1*, Zubair Baloch, MD, PhD2, Victor Bernet, MD3, Amy Chen, MD4, Thomas J. Fahey III, MD5, Ian Ganly, MD, PhD6, Steven P. Hodak, MD7, Electron Kebebew, MD8, Kepal N. Patel, MD9, Ashok Shaha, MD10, David L. Steward, MD11, Ralph P. Tufano, MD12, Sam M. Wiseman, MD13, and Sally E. Carty, MD14, for the ATA Surgical Affairs Committee 1

Division of Head and Neck Surgery, Dept. of Otolaryngology, University of Pittsburgh Cancer Institute 2 Department of Pathology, University of Pennsylvania Medical Center, Philadelphia, PA 3 Department of Endocrinology, Mayo Clinic, Jacksonville, FL 4 Department of Otolaryngology/Head and Neck Surgery, Emory University, Atlanta, GA 5 Department of Surgery, New York Presbyterian Hospital, New York, New York 6 Head and Neck Service, Memorial Sloan-Kettering Cancer Center, New York, NY 7 Division of Endocrinology, New York University Medical Center, New York, NY 8 Endocrine Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD 9 Division of Endocrine Surgery, Department of Surgery, New York University Medical Center 10 Head and Neck Service, Memorial Sloan-Kettering Cancer Center, New York, NY 11 Department of Otolaryngology/Head and Neck Surgery, University of Cincinnati Medical Center 12 Department of Otolaryngology/Head and Neck Surgery, Johns Hopkins University 13 Department of Surgery, Division of General Surgery, St. Paul’s Hospital & University of British Columbia, Canada 14 Division of Endocrine Surgery, Dept. of Surgery, University of Pittsburgh Medical Center Key words: Thyroid Cancer-Clinical, Thyroid Cancer-Genetic, Molecular Biology, Genetics, Surgery Running Title: Molecular Tests Guide Extent of Thyroid Surgery *Corresponding author

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Thyroid American Thyroid Association Statement on Surgical Application of Molecular Profiling for Thyroid Nodules: current impact on perioperative decision-making (doi: 10.1089/thy.2014.0502) This article has been peer-reviewed and accepted for publication, but has yet to undergo copyediting and proof correction. The final published version may differ from this proof.

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Abstract

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Background: Recent advances in research on thyroid carcinogenesis have yielded applications

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of diagnostic molecular biomarkers and profiling panels in the management of thyroid nodules.

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The specific utility of these novel, clinically available molecular tests is becoming widely

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appreciated, especially in perioperative decision-making by the surgeon regarding the need for

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surgery and the extent of initial resection.

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Methods: A task force was convened by the Surgical Affairs Committee of the American

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Thyroid Association and was charged with writing this article.

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Results/Conclusions: This review covers the clinical scenarios by cytologic category for which

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the thyroid surgeon may find molecular profiling results useful, particularly for cases with

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indeterminate fine needle aspiration (FNA) cytology. Distinct strengths of each ancillary test are

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highlighted to convey the current status of this evolving field, which has already demonstrated

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the potential to streamline decision making and reduce unnecessary surgery, with the

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accompanying benefits. However, the performance of any diagnostic test, i.e. its positive

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predictive value (PPV) and negative predictive value (NPV), are exquisitely influenced by the

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prevalence of cancer in that cytologic category, which is known to vary widely at different

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medical centers. Thus, it is crucial for the clinician to know the prevalence of malignancy within

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each indeterminate cytologic category, at one’s own institution. Without this information, the

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performance of the diagnostic tests discussed below may vary substantially.

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Thyroid American Thyroid Association Statement on Surgical Application of Molecular Profiling for Thyroid Nodules: current impact on perioperative decision-making (doi: 10.1089/thy.2014.0502) This article has been peer-reviewed and accepted for publication, but has yet to undergo copyediting and proof correction. The final published version may differ from this proof.

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Introduction Standardized interpretation of fine needle aspiration (FNA) cytology for thyroid nodules

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has improved since the advent of a tiered Bethesda classification scheme in 2007 (1-6). While

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concordance amongst cytopathologists is high (90%) for benign and malignant cytologic

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diagnoses, there is significant intra and inter-observer variability for any type of indeterminate

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cytologic diagnosis (75% and 64% concordance, respectively) (7). Further, lower volume

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cytopathologists appear more likely to categorize a nodule as indeterminate rather than benign

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(7, 8). At present, the Bethesda FNA cytology categories have been widely adopted at high-

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volume thyroid surgical centers, however, ambiguity still persists regarding management of

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cases reported in the three indeterminate diagnostic categories of a) atypia of uncertain

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significance/follicular lesion of undetermined significance (AUS/FLUS), b) follicular

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neoplasm/suspicious for follicular neoplasm (FN), and c) suspicious for malignant cells (SMC).

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Reported thyroid cancer risks for the indeterminate categories range greatly from 6-48% for

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AUS/FLUS (Category III) and 14-34% for FN (Category IV), to 53-87% for SMC (Category V)

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(9-12), with the greatest variability observed in the AUS/FLUS category (13-16). By contrast,

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the current acceptable false negative rates for benign cytology (Category I) are

American Thyroid Association Statement on Surgical Application of Molecular Profiling for Thyroid Nodules: Current Impact on Perioperative Decision Making.

Recent advances in research on thyroid carcinogenesis have yielded applications of diagnostic molecular biomarkers and profiling panels in the managem...
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