应用蛋白免疫层析法检测头颈部鳞状细胞癌中 HPV16/18 E6 癌蛋白。

Detection of HPV16/18 E6 Oncoproteins in Head and Neck Squamous Cell Carcinoma Using a Protein Immunochromatographic Assay.

机构信息

Department of Neurosciences, Regional Center for Head and Neck Cancer, University of Padova, Treviso, Italy.

Infections and Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany.

出版信息

Laryngoscope. 2021 May;131(5):1042-1048. doi: 10.1002/lary.29184. Epub 2020 Oct 26.

DOI:10.1002/lary.29184

PMID:33103777

Abstract

OBJECTIVES/HYPOTHESIS: The accurate diagnostic assessment of clinically relevant human papillomavirus (HPV) infections in patients with head and neck squamous cell carcinoma represents an urgent unmet medical need. The aim of this study was to determine feasibility, accuracy, and clinical significance of HPV16/18 E6 oncoprotein detection on cytological specimens from oropharyngeal squamous cell carcinoma (OPSCC) and neck lymph node metastasis of SCC from unknown primary tumor (CUP) via a protein immunochromatographic assay.

STUDY DESIGN

Cross-sectional study.

METHODS

Cytological specimens from primary tumor and neck metastases were collected from 34 patients with OPSCC or CUP and applied to a lateral flow format test that detects HPV16 and HPV18 E6 oncoproteins. E6 oncoprotein positivity or negativity in these specimens was compared to the specimens' "HPV-driven" reference status, defined by presence of HPV-DNA in combination with p16 overexpression and/or HPV E6 seropositivity.

RESULTS

Eighteen of 29 OPSCC (62%) and three of five CUP (60%) were HPV-driven according to our reference method. The E6 oncoprotein lateral flow test had a sensitivity of 94% (95% CI: 70%-100%) and a specificity of 100% (95% CI: 66%-100%) on primary tumor, and a sensitivity of 88% (95% CI: 64%-99%) and a specificity of 100% (95% CI: 74%-100%) on neck metastases. Test agreement between the E6 lateral flow test and the clinical reference method, HPV-DNA plus p16 was excellent, both for primary lesion and neck metastases.

CONCLUSIONS

We found the detection of HPV16/18 E6 oncoproteins to be a feasible, highly reliable, and low-invasive method to assess "HPV-driven" status in OPSCC and CUP.

LEVEL OF EVIDENCE

II Laryngoscope, 131:1042-1048, 2021.

摘要

目的/假设：对头颈鳞状细胞癌患者进行临床相关人乳头瘤病毒（HPV）感染的准确诊断评估是一种迫切未满足的医疗需求。本研究旨在通过蛋白免疫层析法检测口咽鳞状细胞癌（OPSCC）和未知原发灶的颈部鳞状细胞癌转移（CUP）的细胞学标本中 HPV16/18 E6 癌蛋白，确定其可行性、准确性和临床意义。

研究设计

横断面研究。

方法

收集 34 例 OPSCC 或 CUP 患者的原发肿瘤和颈部转移的细胞学标本，并应用侧向流动格式检测 HPV16 和 HPV18 E6 癌蛋白。这些标本中的 E6 癌蛋白阳性或阴性与标本的“HPV 驱动”参考状态进行比较，该状态通过 HPV-DNA 结合 p16 过表达和/或 HPV E6 血清阳性来定义。

结果

根据我们的参考方法，18 例 OPSCC（62%）和 5 例 CUP（60%）为 HPV 驱动。E6 癌蛋白侧向流动检测在原发肿瘤上的敏感性为 94%（95%可信区间：70%-100%），特异性为 100%（95%可信区间：66%-100%），在颈部转移上的敏感性为 88%（95%可信区间：64%-99%），特异性为 100%（95%可信区间：74%-100%）。E6 侧向流动检测与 HPV-DNA 加 p16 的临床参考方法之间的检测一致性非常好，无论是原发灶还是颈部转移。