甲状腺细胞学模糊的临床应用: ThyroidPrint®。
ThyroidPrint®: clinical utility for indeterminate thyroid cytology.
发表日期:2023 Sep 01
作者:
Roberto Olmos, José Miguel Domínguez, Sergio Vargas-Salas, Lorena Mosso, Carlos E Fardella, Gilberto González, René Baudrand, Francisco Guarda, Felipe Valenzuela, Eugenio Arteaga, Pablo Florenzano, Flavia Nilo, Nicole Lustig, Alejandra Martínez, José M López, Francisco Cruz, Soledad Loyola, Augusto Leon, Nicolás Droppelmann, Pablo Montero, Francisco Domínguez, Mauricio Camus, Antonieta Solar, Pablo Zoroquiain, Juan Carlos Roa, Estefanía Muñoz, Elsa Bruce, Rossio Gajardo, Giovanna Miranda, Francisco Riquielme, Natalia Mena, Hernán E González
来源:
ENDOCRINE-RELATED CANCER
摘要:
分子检测有助于改善无法确定良恶性的甲状腺结节(ITN)的诊断。ThyroidPrint®是一种含有10个基因的分类器,旨在排除ITN的恶性病变。后续验证研究有助于确定ThyroidPrint®在患有ITN患者中的实际临床益处。进行了一项单中心、前瞻性、非干预性临床实用性研究,分析了ThyroidPrint®对医生对ITN的临床决策的影响。收集了人口特征、结节特征、良性鉴定率(BCR)和手术结果的数据。从切除的结节的外科活检中收集了组织病理学数据。在1272次穿刺细针抽吸(FNA)中,有109例(8.6%)为Bethesda III级和135例(10.6%)为Bethesda IV级。在244例ITN中进行了155例(63.5%)的分子检测,其中有104例被分类为良性(BCR为67.1%)。经过中位随访15个月后,有104例(99.0%)患有良性ThyroidPrint®的患者继续进行监测,其中1例患者接受了手术,为滤泡腺瘤。总共51例患有可疑ThyroidPrint®结果的患者进行了手术,56例未进行测试的患者也进行了手术,恶性率分别为70.6%和32.1%。在FLUS组中观察到较高的BCR(87%),与AUS组(58%)相比(p值<0.05)。假阳性病例包括四例良性滤泡结节、六例滤泡腺瘤和四例滴液样腺瘤。我们的结果显示,在良性ThyroidPrint®结果的所有患者中,医生选择积极监测而非诊断性手术,减少了术前诊断为ITN患者需要进行诊断性手术的比例,降低了67%。
Molecular testing contributes to improving the diagnosis of indeterminate thyroid nodules (ITN). ThyroidPrint® is a 10-gene classifier aimed to rule-out malignancy in ITN. Post-validation studies are necessary to determine the real-world clinical benefit of ThyroidPrint® in patients with ITN. A single center, prospective, non-interventional clinical utility study was performed, analyzing the impact of ThyroidPrint® in the physicians' clinical decisions for ITN. Demographics, nodule characteristics, benign call rates (BCR) and surgical outcomes were measured. Histopathological data was collected from surgical biopsies of resected nodules. Of 1272 fine needle aspirations (FNA), 109 (8.6%) were Bethesda III and 135 (10.6%) Bethesda IV. Molecular testing was performed in 155 of 244 ITN (63.5%), of which 104 were classified as benign (BCR of 67.1%). After a median follow-up of 15 months, 103 of 104 (99.0%) patients with a benign ThyroidPrint® remained under surveillance and one patient underwent surgery which was a follicular adenoma. Surgery was performed in all 51 patients with a suspicious ThyroidPrint® result and in 56 patients that did not undergo testing, with a rate of malignancy of 70.6% and 32.1%, respectively. A higher BCR was observed in FLUS (87%) compared to AUS (58%) (p-value <0.05). False-positive cases included four benign follicular nodules, six follicular and four oncotytic adenomas. Our results show that, physicians chose active surveillance instead diagnostic surgery in all patients with a benign ThyroidPrint® result, reducing the need for diagnostic surgery in 67% in patients with preoperative diagnosis of ITN.