Longitudinal Assessment of Quality of Life Following Molecular Testing for Indeterminate Thyroid Nodules

Abstract

Background Molecular testing can refine the risk of malignancy in cytologically indeterminate thyroid nodules and can reduce the need for diagnostic thyroidectomy. However, quality of life (QOL) in patients mananged with molecular testing is not well studied. Objective We aimed to assess the QOL of patients undergoing surveillance after a benign molecular test result, or thyroidectomy after a suspicious molecular test result. Methods This prospective longitudinal follow-up of the Effectiveness of Molecular Testing Techniques for Diagnosis of Indeterminate Thyroid Nodules randomized trial utilized the Thyroid-Related Patient-Reported Outcome, 39-item version (ThyPro-39) to assess the QOL of patients with indeterminate cytology on thyroid fine needle aspiration (FNA) biopsy. All patients underwent molecular testing at the time of initial FNA. A mixed-effect model was used to determine changes in QOL over time. Results Of 252 eligible patients, 174 completed the assessment (69% response rate). Molecular test results included 72% (n = 124) benign and 28% (n = 50) suspicious. ThyPro-39 scores of benign molecular test patients were unchanged from baseline (following initial FNA and molecular test results) to 18 months of ultrasound surveillance. Baseline symptoms of goiter, anxiety, and depression were more severe for patients with suspicious compared with benign molecular test results. At a median of 8 months after thyroidectomy, suspicious molecular test patients reported improved symptoms of goiter, anxiety, and depression. Conclusion A benign molecular test provides sustained QOL throughout ultrasound surveillance, without worsening anxiety or depression relating to the risk of malignancy. Definitive surgery results in improvement of QOL in patients with suspicious molecular tests.

Papillary Thyroid Cancer Prognosis: An Evolving Field

“…The second molecular approach, named gene-expression classifier (GEC) (Veracyte Afirma GSC), was designed to identify benign, rather than malignant, nodules, through the analysis of the expression level of 167 genes in the RNA extracted from FNA biopsies [ 43 , 44 ]. From both tests, a negative result effectively refines the risk of malignancy of AUS/FLUS and FN/SFN diagnostic categories to about 3–4%, comparable to that observed for a benign BSRTC diagnosis [ 45 , 46 ]. Thus, the evaluation and clinical management of thyroid nodules with indeterminate cytology (AUS/FLUS and FN/SFN) should comprise, besides cytology, clinical (i.e., personal or family history of thyroid cancer, lesion size, US features, and elastography) and possibly molecular information.…”

“…Thus, a considerable number of patients might undergo unnecessary thyroid surgical procedures [ 26 , 39 , 40 ]. In this context, the great advance in the comprehension of the molecular pathogenesis of thyroid cancer progression has led to the generation of new molecular approaches capable of ameliorating the diagnostic accuracy of FNAC alone, and to support therapeutic decisions [ 41 , 42 , 43 , 44 , 45 , 46 ]. In particular, two distinct molecular tests to evaluate FNA samples have entered clinical practice for the management of thyroid nodules [ 42 , 44 ].…”

“…Thus, the evaluation and clinical management of thyroid nodules with indeterminate cytology (AUS/FLUS and FN/SFN) should comprise, besides cytology, clinical (i.e., personal or family history of thyroid cancer, lesion size, US features, and elastography) and possibly molecular information. This could lead to a reduction in the number of diagnostic thyroidectomy positively affecting patient’s quality of life [ 28 , 43 , 44 , 45 , 46 ]. It is finally worth considering that the accurate diagnosis of suspicious cervical lymph node (CLN) metastasis is also of great importance in guiding the primary surgical approach, as well as the prognostic stratification and follow-up of TC patients [ 28 , 47 , 48 ].…”

FDG-PET/CT in indeterminate thyroid nodules: cost-utility analysis alongside a randomised controlled trial

“…Patients under surveillance may experience some degree of cyclic psychological distress centering around their yearly follow-up visits, although evidence supporting that assumption is currently lacking and we have not observed it in the EfFECTS trial [ 26 ]. A recent study with a limited median 15-month follow-up found no evidence of such effects and showed sustained HRQoL in patients under surveillance following a negative molecular test [ 39 ]. We included the disutilities of both observation after HT and observation after a negative [ 18 F]FDG-PET/CT scan in our univariate sensitivity analysis.…”

Health-related quality of life following FDG-PET/CT for cytological indeterminate thyroid nodules

“…Patients who underwent diagnostic surgery for a suspicious molecular test result, showed deteriorated goitre, depression and anxiety scores at the first assessment after molecular testing, all of which had improved eight months after surgery. Short-term postoperative HRQoL measurements were not available (23).…”