Key Points
Question
Can the diagnosis of benign disease or cancer in thyroid nodules with indeterminate
cytology be established by molecular testing instead of diagnostic surgery?
Findings
This prospective, blinded, multicenter cohort study of a multigene genomic classifier
(ThyroSeq v3) test included 257 indeterminate cytology thyroid nodules with informative
test results. It demonstrated a high sensitivity (94%) and reasonably high specificity
(82%), with 61% of the nodules yielding a negative test result and only 3% residual
cancer risk in these nodules.
Meanings
Up to 61% of patients with indeterminate cytology thyroid nodules may avoid diagnostic
surgery by undergoing multigene genomic classifier testing.
Hypothesis-A cortisol response to adrenocorticotropin injection is the standard test for diagnosing adrenal insufficiency. Multiple steroid hormones can now be accurately measured by tandem mass spectrometry in a single sample. The study objective was to determine whether a steroid profile, created by simultaneous measurement of ten steroid hormones by tandem mass spectrometry, would help determine the cause of adrenal insufficiency.Design-A ten-steroid profile was measured by tandem mass spectrometry during the performance of a standard high dose cortrosyn stimulation test. The steroids were measured at baseline, and 30 and 60 minutes following synthetic adrenocorticotropin injection. Adrenal insufficiency was defined as a peak cortisol level of less than 20 μg/dL. Testing was conducted in the General Clinical Research Center of a University Medical Center. Normal volunteers, patients suspected of having adrenal insufficiency, and patients with known adrenal insufficiency participated.Results-Our results showed that adrenal insufficiency of any cause was adequately diagnosed using the response of 11-deoxycortisol, dehydroepiandrosterone, or these analytes combined in a two-steroid profile. A three-steroid profile yielded a test with 100% accuracy for discriminating primary adrenal insufficiency from normal status. Primary adrenal insufficiency was well separated from secondary adrenal insufficiency using only a single aldosterone value. 11-deoxycortisol, dehydroepiandrosterone, and a two-steroid profile each provided fair discrimination between secondary adrenal insufficiency and normal status.Conclusions-We conclude that stimulated levels of aldosterone, 11-deoxycortisol, dehydroepiandrosterone, and a two-or three-steroid profile provided additional discrimination between states of adrenal sufficiency and insufficiency. It is proposed that a steroid profile measuring
Objective: Our objective was to evaluate the efficacy and safety of sunitinib following at least one course of radioactive iodine treatment in patients with advanced differentiated thyroid cancer (DTC). The study endpoints included best response rate (including best objective response rate) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, measurement of serum thyroglobulin (Tg), and toxicity evaluation. Design and methods: This was a single center, nonrandomized, open-label, phase 2 clinical trial. In total, 23 patients were enrolled and were treated with a starting daily, oral dose of 37.5 mg sunitinib. Patients were evaluated with imaging, laboratory tests, and physical examination periodically per protocol. Results: The mean best response was a decrease of 17.2% (S.D. 22.8) in tumor sum from baseline. Six (26%) patients achieved a partial response (PR), and 13 (57%) had stable disease (SD) for a clinical benefit rate (PRCSD) of 83%. The overall median PFS was 241 days (interquartile limits, 114-518). No statistically significant difference was observed between the medians of the baseline and post-treatment Tg values (PZ0.24). The most common adverse events included grades 1 and 2 decreases in blood cell counts (especially leukocytes), diarrhea, fatigue, hand-foot skin reaction, nausea, musculoskeletal pain, and hypertension.Conclusions: These data demonstrate that sunitinib exhibits significant anti-tumor activity in patients with advanced DTC. Since sunitinib was relatively well-tolerated, there is the potential for clinical benefit in these patients, and further investigation of this agent is warranted.
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