TY - JOUR
T1 - European experience with the Afirma Gene Expression Classifier for indeterminate thyroid nodules
T2 - A clinical utility study in the Netherlands
AU - Lončar, Ivona
AU - van Velsen, Evert F.S.
AU - Massolt, Elske T.
AU - van Kemenade, Folkert J.
AU - van Engen-van Grunsven, Adriana C.H.
AU - van Hemel, Bettien M.
AU - van Nederveen, Francien H.
AU - Netea-Maier, Romana
AU - Links, Thera P.
AU - Peeters, Robin P.
AU - van Ginhoven, Tessa M.
N1 - ACKNOWLEDGMENT:
Logistics of this investigator initiated research project was supported by an unrestricted research grant from Veracyte.
Publisher Copyright:
© 2023 The Authors. Head & Neck published by Wiley Periodicals LLC.
PY - 2023/9
Y1 - 2023/9
N2 - Background: The Gene Expression Classifier (GEC) and Genomic Sequencing Classifier (GSC) were developed to improve risk stratification of indeterminate nodules. Our aim was to assess the clinical utility in a European population with restrictive diagnostic workup. Methods: Clinical utility of the GEC was assessed in a prospective multicenter cohort of 68 indeterminate nodules. Diagnostic surgical rates for Bethesda III and IV nodules were compared to a historical cohort of 171 indeterminate nodules. Samples were post hoc tested with the GSC. Results: The GEC classified 26% as benign. Surgical rates between the prospective and historical cohort did not differ (72.1% vs. 76.6%). The GSC classified 59% as benign, but misclassified six malignant lesions as benign. Conclusion: Implementation of GEC in management of indeterminate nodules in a European country with restrictive diagnostic workup is currently not supported, especially in oncocytic nodules. Prospective studies with the GSC in European countries are needed to determine the clinical utility.
AB - Background: The Gene Expression Classifier (GEC) and Genomic Sequencing Classifier (GSC) were developed to improve risk stratification of indeterminate nodules. Our aim was to assess the clinical utility in a European population with restrictive diagnostic workup. Methods: Clinical utility of the GEC was assessed in a prospective multicenter cohort of 68 indeterminate nodules. Diagnostic surgical rates for Bethesda III and IV nodules were compared to a historical cohort of 171 indeterminate nodules. Samples were post hoc tested with the GSC. Results: The GEC classified 26% as benign. Surgical rates between the prospective and historical cohort did not differ (72.1% vs. 76.6%). The GSC classified 59% as benign, but misclassified six malignant lesions as benign. Conclusion: Implementation of GEC in management of indeterminate nodules in a European country with restrictive diagnostic workup is currently not supported, especially in oncocytic nodules. Prospective studies with the GSC in European countries are needed to determine the clinical utility.
UR - http://www.scopus.com/inward/record.url?scp=85165662542&partnerID=8YFLogxK
U2 - 10.1002/hed.27472
DO - 10.1002/hed.27472
M3 - Article
C2 - 37490544
AN - SCOPUS:85165662542
SN - 1043-3074
VL - 45
SP - 2227
EP - 2236
JO - Head and Neck
JF - Head and Neck
IS - 9
ER -