Validation of a novel diagnostic standard in HPV-positive oropharyngeal squamous cell carcinoma.

Validation of a novel diagnostic standard in HPV-positive oropharyngeal squamous cell carcinoma.
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DOI:
10.1038/bjc.2013.63
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发表时间:
2013-04-02
影响因子:
8.8
通讯作者:
Robinson, M.
Robinson, M.
中科院分区:
医学1区
文献类型:
--
作者:
Schache, A. G.;Liloglou, T.;Risk, J. M.;Jones, T. M.;Ma, X-J;Wang, H.;Bui, S.;Luo, Y.;Sloan, P.;Shaw, R. J.;Robinson, M.

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人乳头瘤病毒(HPV)检测口咽鳞状细胞癌(OPSCC),现在提倡。在新鲜肿瘤组织中证明转录活性的高危HPV(HR-HPV)被认为是分析的“金标准”。临床试验主要集中在福尔马林固定石蜡包埋(FFPE)组织上,但牺牲了灵敏度和特异性。最近,一种新的RNA原位杂交试验(RNAscope)已被开发用于检测HR-HPV在FFPE组织;然而,验证对“金标准”尚未报道。使用HR-HPV RNAscope测试包含来自79个OPSCC的FFPE核心的组织微阵列。通过与参考检测进行比较,确定了分析准确性和预后能力;在匹配的新鲜冷冻样本上进行HR-HPV的qRT-PCR。高危型HPV RNAscope的敏感性和特异性分别为97%和93%。Kaplan-Meier估计的RNAscope疾病特异性生存期(DSS,P=0.001)和总生存期(OS,P<0.001)与参考检测(DSS,P=0.003,OS,P<0.001)相似,至少不劣于基于p16免疫组化+/− HR-HPV DNA的检测。HR-HPV RNAscope相对于“金标准”表现出出色的分析和预后性能。这些数据表明,该测试可以开发为HPV相关OPSCC的诊断提供“临床标准”。
Human papillomavirus (HPV) testing in oropharyngeal squamous cell carcinoma (OPSCC) is now advocated. Demonstration of transcriptionally active high-risk HPV (HR-HPV) in fresh tumour tissue is considered to be the analytical ‘gold standard'. Clinical testing has focused on formalin-fixed paraffin-embedded (FFPE) tissue at the expense of sensitivity and specificity. Recently, a novel RNA in situ hybridisation test (RNAscope) has been developed for the detection of HR-HPV in FFPE tissue; however, validation against the ‘gold standard' has not been reported. A tissue microarray comprising FFPE cores from 79 OPSCC was tested using HR-HPV RNAscope. Analytical accuracy and prognostic capacity were established by comparison with the reference test; qRT–PCR for HR-HPV on matched fresh-frozen samples. High-risk HPV RNAscope had a sensitivity and specificity of 97 and 93%, respectively, against the reference test. Kaplan–Meier estimates of disease-specific survival (DSS, P=0.001) and overall survival (OS, P<0.001) by RNAscope were similar to the reference test (DSS, P=0.003, OS, P<0.001) and at least, not inferior to p16 immunohistochemistry +/− HR-HPV DNA-based tests. HR-HPV RNAscope demonstrates excellent analytical and prognostic performance against the ‘gold standard'. These data suggest that the test could be developed to provide the ‘clinical standard' for assigning a diagnosis of HPV-related OPSCC.
DOI: 10.1158/1078-0432.ccr-11-0388
发表时间: 2011-10-01
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影响因子: --
作者:
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