Samantha Peiling Yang MBBS, Min En Nga MBBS, Manish Mahadeorao Bundele MBBS, Simion I. Chiosea MD, Sze Hwa Tan MBBS, Jeffrey H. Y. Lum MBBS, Rajeev Parameswaran MBBS, Ming Yann Lim MBBS, Hao Li MBBS, Wei Keat Cheah MBBS, Kathleen Su-Yen Sek MBBS, Andre Teck Huat Tan MBBS, Thomas Kwok Seng Loh MBBS, Kee Yuan Ngiam MBBS, Wee Boon Tan MBBS, Xinyong Huang MBBS, Thomas Wai Thong Ho MBBS, Keng Hua Lim MBBS, Chwee Ming Lim MBBS, Reyaz M. Singaporewalla MBBS, Anil Dinkar Rao MBBS, Nandini C. L. Rao MBBS, Dennis Yu Kim Chua MBBS, David Chao-Wu Chin MBBS, Abigail I. Wald PhD, Virginia A. LiVolsi MD, Yuri E. Nikiforov MD, PhD, E. Shyong Tai MBBS
{"title":"多基因基因组分类器和临床参数在预测东南亚细胞学不确定甲状腺结节患者恶性程度中的表现。","authors":"Samantha Peiling Yang MBBS, Min En Nga MBBS, Manish Mahadeorao Bundele MBBS, Simion I. Chiosea MD, Sze Hwa Tan MBBS, Jeffrey H. Y. Lum MBBS, Rajeev Parameswaran MBBS, Ming Yann Lim MBBS, Hao Li MBBS, Wei Keat Cheah MBBS, Kathleen Su-Yen Sek MBBS, Andre Teck Huat Tan MBBS, Thomas Kwok Seng Loh MBBS, Kee Yuan Ngiam MBBS, Wee Boon Tan MBBS, Xinyong Huang MBBS, Thomas Wai Thong Ho MBBS, Keng Hua Lim MBBS, Chwee Ming Lim MBBS, Reyaz M. Singaporewalla MBBS, Anil Dinkar Rao MBBS, Nandini C. L. Rao MBBS, Dennis Yu Kim Chua MBBS, David Chao-Wu Chin MBBS, Abigail I. Wald PhD, Virginia A. LiVolsi MD, Yuri E. Nikiforov MD, PhD, E. Shyong Tai MBBS","doi":"10.1002/cncy.22796","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Most thyroid nodules are benign. It is important to determine the likelihood of malignancy in such nodules to avoid unnecessary surgery. The primary objective of this study was to characterize the genetic landscape and the performance of a multigene genomic classifier in fine-needle aspiration (FNA) biopsies of cytologically indeterminate thyroid nodules in a Southeast Asian cohort. The secondary objective was to assess the predictive contribution of clinical characteristics to thyroid malignancy.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>This prospective, multicenter, blinded study included 132 patients with 134 nodules. Molecular testing (MT) with ThyroSeq v3 was performed on clinical or ex-vivo FNA samples. Centralized pathology review also was performed.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Of 134 nodules, consisting of 61% Bethesda category III, 20% category IV, and 19% category V cytology, and 56% were histologically malignant. ThyroSeq yielded negative results in 37.3% of all FNA samples and in 42% of Bethesda category III–IV cytology nodules. Most positive samples had <i>RAS</i>-like (41.7%), followed by <i>BRAF</i>-like (22.6%), and high-risk (17.9%) alterations. Compared with North American patients, the authors observed a higher proportion of <i>RAS</i>-like mutations, specifically <i>NRAS</i>, in Bethesda categories III and IV and more <i>BRAF</i>-like mutations in Bethesda category III. The test had sensitivity, specificity, negative predictive value, and positive predictive value of 89.6%, 73.7%, 84.0%, and 82.1%, respectively. The risk of malignancy was predicted by positive MT and high-suspicion ultrasound characteristics according to American Thyroid Association criteria.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Even in the current Southeast Asian cohort with nodules that had a high pretest cancer probability, MT could lead to potential avoidance of diagnostic surgery in 42% of patients with Bethesda category III–IV nodules. MT positivity was a stronger predictor of malignancy than clinical parameters.</p>\n </section>\n </div>","PeriodicalId":9410,"journal":{"name":"Cancer Cytopathology","volume":null,"pages":null},"PeriodicalIF":2.6000,"publicationDate":"2024-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cncy.22796","citationCount":"0","resultStr":"{\"title\":\"Performance of a multigene genomic classifier and clinical parameters in predicting malignancy in a Southeast Asian cohort of patients with cytologically indeterminate thyroid nodules\",\"authors\":\"Samantha Peiling Yang MBBS, Min En Nga MBBS, Manish Mahadeorao Bundele MBBS, Simion I. Chiosea MD, Sze Hwa Tan MBBS, Jeffrey H. Y. Lum MBBS, Rajeev Parameswaran MBBS, Ming Yann Lim MBBS, Hao Li MBBS, Wei Keat Cheah MBBS, Kathleen Su-Yen Sek MBBS, Andre Teck Huat Tan MBBS, Thomas Kwok Seng Loh MBBS, Kee Yuan Ngiam MBBS, Wee Boon Tan MBBS, Xinyong Huang MBBS, Thomas Wai Thong Ho MBBS, Keng Hua Lim MBBS, Chwee Ming Lim MBBS, Reyaz M. Singaporewalla MBBS, Anil Dinkar Rao MBBS, Nandini C. L. Rao MBBS, Dennis Yu Kim Chua MBBS, David Chao-Wu Chin MBBS, Abigail I. Wald PhD, Virginia A. LiVolsi MD, Yuri E. Nikiforov MD, PhD, E. Shyong Tai MBBS\",\"doi\":\"10.1002/cncy.22796\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Most thyroid nodules are benign. It is important to determine the likelihood of malignancy in such nodules to avoid unnecessary surgery. The primary objective of this study was to characterize the genetic landscape and the performance of a multigene genomic classifier in fine-needle aspiration (FNA) biopsies of cytologically indeterminate thyroid nodules in a Southeast Asian cohort. The secondary objective was to assess the predictive contribution of clinical characteristics to thyroid malignancy.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>This prospective, multicenter, blinded study included 132 patients with 134 nodules. Molecular testing (MT) with ThyroSeq v3 was performed on clinical or ex-vivo FNA samples. Centralized pathology review also was performed.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Of 134 nodules, consisting of 61% Bethesda category III, 20% category IV, and 19% category V cytology, and 56% were histologically malignant. ThyroSeq yielded negative results in 37.3% of all FNA samples and in 42% of Bethesda category III–IV cytology nodules. Most positive samples had <i>RAS</i>-like (41.7%), followed by <i>BRAF</i>-like (22.6%), and high-risk (17.9%) alterations. Compared with North American patients, the authors observed a higher proportion of <i>RAS</i>-like mutations, specifically <i>NRAS</i>, in Bethesda categories III and IV and more <i>BRAF</i>-like mutations in Bethesda category III. The test had sensitivity, specificity, negative predictive value, and positive predictive value of 89.6%, 73.7%, 84.0%, and 82.1%, respectively. The risk of malignancy was predicted by positive MT and high-suspicion ultrasound characteristics according to American Thyroid Association criteria.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>Even in the current Southeast Asian cohort with nodules that had a high pretest cancer probability, MT could lead to potential avoidance of diagnostic surgery in 42% of patients with Bethesda category III–IV nodules. 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Performance of a multigene genomic classifier and clinical parameters in predicting malignancy in a Southeast Asian cohort of patients with cytologically indeterminate thyroid nodules
Background
Most thyroid nodules are benign. It is important to determine the likelihood of malignancy in such nodules to avoid unnecessary surgery. The primary objective of this study was to characterize the genetic landscape and the performance of a multigene genomic classifier in fine-needle aspiration (FNA) biopsies of cytologically indeterminate thyroid nodules in a Southeast Asian cohort. The secondary objective was to assess the predictive contribution of clinical characteristics to thyroid malignancy.
Methods
This prospective, multicenter, blinded study included 132 patients with 134 nodules. Molecular testing (MT) with ThyroSeq v3 was performed on clinical or ex-vivo FNA samples. Centralized pathology review also was performed.
Results
Of 134 nodules, consisting of 61% Bethesda category III, 20% category IV, and 19% category V cytology, and 56% were histologically malignant. ThyroSeq yielded negative results in 37.3% of all FNA samples and in 42% of Bethesda category III–IV cytology nodules. Most positive samples had RAS-like (41.7%), followed by BRAF-like (22.6%), and high-risk (17.9%) alterations. Compared with North American patients, the authors observed a higher proportion of RAS-like mutations, specifically NRAS, in Bethesda categories III and IV and more BRAF-like mutations in Bethesda category III. The test had sensitivity, specificity, negative predictive value, and positive predictive value of 89.6%, 73.7%, 84.0%, and 82.1%, respectively. The risk of malignancy was predicted by positive MT and high-suspicion ultrasound characteristics according to American Thyroid Association criteria.
Conclusions
Even in the current Southeast Asian cohort with nodules that had a high pretest cancer probability, MT could lead to potential avoidance of diagnostic surgery in 42% of patients with Bethesda category III–IV nodules. MT positivity was a stronger predictor of malignancy than clinical parameters.
期刊介绍：
Cancer Cytopathology provides a unique forum for interaction and dissemination of original research and educational information relevant to the practice of cytopathology and its related oncologic disciplines. The journal strives to have a positive effect on cancer prevention, early detection, diagnosis, and cure by the publication of high-quality content. The mission of Cancer Cytopathology is to present and inform readers of new applications, technological advances, cutting-edge research, novel applications of molecular techniques, and relevant review articles related to cytopathology.
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