Diagnostic Accuracy of Circulating Tumor HPV DNA Testing in Patients With a Lateral Neck Mass.

IF 6 1区医学 Q1 OTORHINOLARYNGOLOGY JAMA otolaryngology-- head & neck surgery Pub Date : 2024-09-19 DOI:10.1001/jamaoto.2024.2702

Rocco M Ferrandino, Joshua Barlow, Brandon Gold, Daniel Kraft, Scott A Roof, Marita S Teng, Mohemmed N Khan, Michael H Berger, Krzysztof J Misiukiewicz, Kunal K Sindhu, Richard L Bakst, Marshall R Posner, William H Westra, Eric M Genden, Raymond L Chai

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Abstract

Importance: The most frequent presenting symptom for patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC) is a lateral neck mass. Circulating tumor tissue-modified viral (TTMV)-HPV DNA is a unique biomarker produced by the fragmentation of HPV DNA during the degradation of HPV-associated tumors, and its detection and quantitation are currently being used as an adjunct to imaging in monitoring for disease recurrence and may have utility for diagnosis.

Objective: To measure the diagnostic characteristics of TTMV-HPV DNA compared with gold standard tissue biopsy for diagnosing HPV-OPSCC in patients presenting with an indeterminate lateral neck mass.

Design, setting, and participants: This prospective diagnostic test study enrolled patients 18 years or older who presented with a lateral neck mass to a large urban tertiary health care system from December 2021 to June 2023. Participants underwent standard-of-care testing to obtain a tissue diagnosis and a single TTMV-HPV DNA measurement.

Main outcomes and measures: The primary outcome of interest was sensitivity, while specificity, positive predictive value, and negative predictive value were secondary end points. A subset analysis was performed comparing test performance metrics between TTMV-HPV DNA testing and fine-needle aspiration.

Results: A total of 138 patients were included, of whom 80 (58.0%) were men, with median age of 57.5 years (IQR, 43.3-67.0 years). Of 138 patients, 87 (63.0%) had neck masses in level 2 and 47 (34.1%) had HPV-OPSCC. TTMV-HPV DNA testing exhibited a sensitivity of 95.7% (95% CI, 85.5%-99.5% [45 of 47 patients]), specificity of 97.8% (95% CI, 92.3%-99.7% [89 of 91 patients]), positive predictive value of 95.7% (95% CI, 85.5%-99.5% [45 of 47 patients]), and negative predictive value of 97.8% (95% CI, 92.3%-99.7% [89 of 91 patients]).

Conclusions and relevance: In this diagnostic study of patients presenting with a lateral neck mass, circulating TTMV-HPV DNA demonstrated excellent diagnostic test characteristics for the detection of HPV-OPSCC. Such testing may have particular utility for patients in whom obtaining adequate tissue is problematic, as is often the case with cystic neck masses and unknown primary tumors.

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颈侧肿块患者循环肿瘤 HPV DNA 检测的诊断准确性

重要性：人乳头瘤病毒（HPV）相关口咽鳞状细胞癌（OPSCC）患者最常见的症状是颈部外侧肿块。循环肿瘤组织修饰病毒（TTMV）-HPV DNA是HPV相关肿瘤降解过程中HPV DNA片段化产生的一种独特生物标记物，其检测和定量目前被用作影像学监测疾病复发的辅助手段，并可能用于诊断：目的：测量 TTMV-HPV DNA 与金标准组织活检相比在诊断颈部外侧不确定肿块患者的 HPV-OPSCC 时的诊断特性：这项前瞻性诊断检测研究招募了 2021 年 12 月至 2023 年 6 月期间因颈部外侧肿块前往大型城市三级医疗保健系统就诊的 18 岁及以上患者。参与者接受标准护理检测以获得组织诊断和一次 TTMV-HPV DNA 测定：主要结果是灵敏度，特异性、阳性预测值和阴性预测值是次要终点。对 TTMV-HPV DNA 检测和细针穿刺之间的检测性能指标进行了子集分析：共纳入 138 例患者，其中 80 例（58.0%）为男性，中位年龄为 57.5 岁（IQR，43.3-67.0 岁）。138名患者中，87人（63.0%）的颈部肿块位于2级，47人（34.1%）患有HPV-OPSCC。TTMV-HPV DNA 检测的敏感性为 95.7%（95% CI，85.5%-99.5% [47 例患者中的 45 例]），特异性为 97.8%（95% CI，92.3%-99.7% [91 例患者中的 89 例]），阳性预测值为 95.7%（95% CI，85.5%-99.5% [47 例患者中的 45 例]），阴性预测值为 97.8%（95% CI，92.3%-99.7% [91 例患者中的 89 例]）：在这项针对颈部外侧肿块患者的诊断研究中，循环 TTMV-HPV DNA 在检测 HPV-OPSCC 方面表现出了极佳的诊断测试特性。对于难以获得足够组织的患者，如颈侧囊性肿块和原发肿瘤不明的患者，这种检测可能具有特殊作用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

JAMA otolaryngology-- head & neck surgery OTORHINOLARYNGOLOGY-

CiteScore

9.10

自引率

5.10%

发文量

230

期刊介绍： JAMA Otolaryngology–Head & Neck Surgery is a globally recognized and peer-reviewed medical journal dedicated to providing up-to-date information on diseases affecting the head and neck. It originated in 1925 as Archives of Otolaryngology and currently serves as the official publication for the American Head and Neck Society. As part of the prestigious JAMA Network, a collection of reputable general medical and specialty publications, it ensures the highest standards of research and expertise. Physicians and scientists worldwide rely on JAMA Otolaryngology–Head & Neck Surgery for invaluable insights in this specialized field.