Polavarapu Preethi, Fingeret Abbey, Yuil-Valdes Ana, Olson Daniel, Patel Anery, Shivaswamy Vijay, Matthias Troy D, Goldner Whitney
Department of Internal Medicine, Division of Diabetes, Endocrinology, Metabolism, University of Nebraska Medical Center, Omaha, NE, USA.
Department of Internal Medicine, Division of Diabetes, Endocrinology, Metabolism, VA Nebraska-Western Iowa Health System, Omaha, NE, USA.
J Endocr Soc. 2021 Oct 7;5(11):bvab148. doi: 10.1210/jendso/bvab148. eCollection 2021 Nov 1.
Analysis of cytologically indeterminate thyroid nodules with Afirma Gene Expression Classifier (GEC) and Genomic Sequencing Classifier (GSC) can reduce surgical rate and increase malignancy rate of surgically resected indeterminate nodules.
Retrospective cohort analysis of all adults with cytologically indeterminate thyroid nodules from January 2013 through December 2019. We compared surgical and malignancy rates of those without molecular testing to those with GEC or GSC, analyzed test performance between GEC and GSC, and identified variables associated with molecular testing.
468 indeterminate thyroid nodules were included. No molecular testing was performed in 273, 71 had GEC, and 124 had GSC testing. Surgical rate was 68% in the group without molecular testing, 59% in GEC, and 40% in GSC. Malignancy rate was 20% with no molecular testing, 22% in GEC, and 39% in GSC ( = 0.022). GEC benign call rate (BCR) was 46%; sensitivity, 100%; specificity, 61%; and positive predictive value (PPV), 28%. GSC BCR was 60%; sensitivity, 94%; specificity, 76%; and PPV, 41%. Those with no molecular testing had larger nodule size, preoperative growth of nodules, and constrictive symptoms and those who underwent surgery in the no molecular testing group had higher body mass index, constrictive symptoms, higher Thyroid Imaging Reporting and Data System and Bethesda classifications. Type of provider was also associated with the decision to undergo surgery.
Implementation of GEC showed no effect on surgical or malignancy rate, but GSC resulted in significantly lower surgical and higher malignancy rates. This study provides insight into the factors that affect the real-world use of these molecular markers preoperatively in indeterminate thyroid nodules.
运用阿菲玛基因表达分类器（GEC）和基因组测序分类器（GSC）对甲状腺细针穿刺结果不确定的结节进行分析，可降低手术率，并提高手术切除的不确定结节的恶性率。
对2013年1月至2019年12月期间所有甲状腺细针穿刺结果不确定的成年患者进行回顾性队列分析。我们比较了未进行分子检测的患者与进行GEC或GSC检测的患者的手术率和恶性率，分析了GEC和GSC之间的检测性能，并确定了与分子检测相关的变量。
纳入468个甲状腺不确定结节。273个未进行分子检测，71个进行了GEC检测，124个进行了GSC检测。未进行分子检测组的手术率为68%，GEC组为59%，GSC组为40%。未进行分子检测时恶性率为20%，GEC组为22%，GSC组为39%（P = 0.022）。GEC的良性诊断率（BCR）为46%；敏感性为100%；特异性为61%；阳性预测值（PPV）为28%。GSC的BCR为60%；敏感性为94%；特异性为76%；PPV为41%。未进行分子检测的患者结节尺寸更大、术前结节有生长以及有压迫症状，未进行分子检测组中接受手术的患者体重指数更高、有压迫症状、甲状腺影像报告和数据系统以及贝塞斯达分类更高。医疗服务提供者的类型也与手术决策有关。
GEC的应用对手术率或恶性率无影响，但GSC可显著降低手术率并提高恶性率。本研究深入探讨了影响这些分子标志物在甲状腺不确定结节术前实际应用的因素。
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