Improving the diagnosis of AUS/FLUS thyroid nodules using an algorithm with combination of BRAF^V600E mutation analysis and ultrasound pattern-based risk stratification

Article type: Research Article

Authors: Zhou, Ya-Fang^{a; b; c; d; 1} | Zhang, Yi-Feng^{a; c; d; 1} | Fu, Hui-Jun^{c; d; e} | Yang, Wei-Ping^{b; *} | Zhao, Chong-Ke^{a; c; d; *} | Xu, Hui-Xiong^{a; c; d; *}

Affiliations: [a] Department of Medical Ultrasound, Shanghai Tenth People’s Hospital, Ultrasound Research and Education Institute, Tongji University Cancer Center, Shanghai Engineering Research Center of Ultrasound Diagnosis and Treatment, Tongji University School of Medicine, Shanghai, China | [b] Department of Medical Ultrasound, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China | [c] Thyroid Institute, Tongji University School of Medicine, Shanghai, China | [d] Shanghai Center for Thyroid Diseases, Shanghai, China | [e] Department of Pathology, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, Shanghai, China

Correspondence: [*] Corresponding authors: Hui-Xiong Xu, MD, PhD, Department of Medical Ultrasound, Shanghai Tenth People's Hospital, Tongji University School of Medicine, No. 301, Yanchangzhong Road, Shanghai 200072, China. E-mail: [email protected]. Chong-Ke Zhao, MD, Department of Medical Ultrasound, Shanghai Tenth People's Hospital, Tongji University School of Medicine, No. 301, Yanchangzhong Road, Shanghai 200072, China. E-mail: [email protected]. Wei- Ping Yang, MD, Department of Medical Ultrasound, Affiliated Cancer Hospital of Guangxi Medical University, No. 71 Hedi Rd, Nanning 530021, China. E-mail: [email protected].

Note: [1] Ya-Fang Zhou and Yi-Feng Zhang contributed equally to this work.

Abstract: PURPOSE:To propose a diagnostic algorithm for improving the diagnosis of atypia of undetermined significance or follicular lesion of undetermined significance (AUS/FLUS) thyroid nodules. METHODS:This study retrospectively enrolled 77 consecutive patients with 81 AUS/FLUS nodules who underwent preoperative BRAFV600E mutation analysis. A new diagnostic algorithm was proposed that BRAFV600E mutation analysis for the Fine-needle aspiration cytology specimen was firstly carried out, in which positive BRAFV600E mutation indicated malignancy and classification of the nodules with negative BRAFV600E mutation was further performed based on ultrasound pattern-based risk stratification of American Thyroid Association Guidelines. The diagnostic performance of the new diagnostic algorithm was evaluated. RESULTS:The sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and area under the receiver operating characteristic curve (AUROC) of new diagnostic algorithm were 94.6%, 84.0%, 91.4%, 86.9%, 90.1%, and 0.893, respectively. The proposed diagnostic algorithm significantly increased the diagnostic performances (AUROC: 0.893 vs. 0.837 and 0.795), sensitivity (94.6% vs. 71.4% and 75.0%), and accuracy (90.1% vs. 79.0% and 77.8%) compared with BRAFV600E mutation analysis alone and ultrasound pattern-based risk stratification alone (all P < 0.05). CONCLUSION:The proposed diagnostic algorithm is helpful for improving the diagnosis of AUS/FLUS nodules, which might be as a routine approach.

Keywords: Thyroid nodules, fine-needle aspiration cytology, AUS/FLUS nodule, BRAF, ^V600E analysis, ultrasound pattern-based risk stratification

DOI: 10.3233/CH-200985

Journal: Clinical Hemorheology and Microcirculation, vol. 77, no. 3, pp. 273-285, 2021