Evaluation of the Clinical Usefulness of BRAFV600E Mutation Analysis of Core-Needle Biopsy Specimens in Thyroid Nodules with Previous Atypia of Undetermined Significance or Follicular Lesions of Undetermined Significance Results.

BACKGROUND

The accurate diagnosis of thyroid nodules is important for making management decisions. The purpose of this study is to evaluate the clinical usefulness of BRAF(V600E) mutation analysis with core-needle biopsy (CNB+BRAF(V600E)) in thyroid nodules with previous atypia of undetermined significance (AUS) or follicular lesions of undetermined significance (FLUS) results.

MATERIALS AND METHODS

From January 2011 to December 2012, 590 CNB+BRAF(V600E) mutation analyses were performed. We analyzed 200 nodules from 200 patients with previous AUS/FLUS results (22 men, 178 women; mean age, 48.6 years). The clinical usefulness of CNB+BRAF(V600E) was assessed by comparing the rates of conclusive results, the additional value of BRAF(V600E) mutation analysis, diagnostic performances, and therapeutic/diagnostic surgery results with those of CNB alone. For the subgroup analysis, the study patients were divided into those with nodules with previous AUS results and those with previous FLUS results.

RESULTS

All CNB+BRAF(V600E) procedures were well-tolerated. CNB+BRAF(V600E) did not show significantly better diagnostic performance than CNB alone in thyroid nodules with previous AUS/FLUS results. However, the conclusive result rate of CNB+BRAF(V600E) was improved in thyroid nodules with previous AUS/FLUS results (76.5% vs. 73.0%, p=0.016), especially with previous AUS results (81.1% vs. 76.4%, p=0.031). Of the 56 previous AUS result thyroid nodules with surgical management, BRAF(V600E) mutation analysis led to therapeutic surgery in 5.4% by decreasing unnecessary diagnostic surgery.

CONCLUSIONS

In general, CNB+BRAF(V600E) did not show significantly higher diagnostic accuracy than CNB alone. Although CNB+BRAF(V600E) may add additional value in nodules with previous AUS results, routinely adding BRAF(V600E) mutation analysis to CNB is not recommended.