title: Diagnosis of HPV-driven head and neck cancer with a single test in routine clinical practice.
abstract: Accurate screening of HPV-driven head and neck squamous cell carcinoma is a critical issue. Although there are commercial direct and indirect assays for HPV-related head and neck squamous cell carcinoma, none are ideal. Recently, a novel RNA in situ hybridization test (the RNAscope HPV-test) has been developed for the detection of high-risk HPV E6/E7 mRNA in formalin-fixed paraffin-embedded tissue. However, validation of this assay against the 'gold standard' (identification of high-risk HPV E6/E7 mRNA in fresh-frozen tissue by quantitative real-time (qRT)-PCR) has only been reported by one team. Formalin-fixed paraffin-embedded samples from 50 patients with tonsil or tongue base carcinoma were tested using the RNAscope HPV-test, p16 immunohistochemistry, and chromogenic in situ hybridization for high-risk HPV-DNA. The results were compared with those of qRT-PCR on matched fresh-frozen samples. Compared with the reference test, the sensitivity, specificity, positive, and negative predictive values of the RNAscope HPV-test and of p16 immunohistochemistry were 93%, 94%, 96%, 88% and 96%, 93%, 96%, and 93%, respectively. Five cases were discrepant between the RNAscope HPV-test and p16-immunohistochemisrty. The RNAscope HPV-test demonstrated excellent analytical performance against the 'gold standard' and is easier to interpret than chromogenic in situ hybridization. p16-immunohistochemistry also performed very well, however its main weakness is that it is an indirect marker of the presence of HPV. These data suggest that the RNAscope HPV-test is a promising test that could be developed as a clinical standard for the precise identification of HPV-driven oropharyngeal squamous cell carcinoma.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Haïtham
authors.initials: H
authors.lastname: Mirghani
authors.affiliation: Department of Biopathology, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Odile
authors.initials: O
authors.lastname: Casiraghi
authors.affiliation: Department of Otolaryngology, Peterborough City Hospital and Addenbrooke's Hospital, Cambridge, UK.
authors.forename: Furrat
authors.initials: F
authors.lastname: Amen
authors.affiliation: Advanced Cell Diagnostics, Hayward, CA, USA.
authors.forename: Mingxiao
authors.initials: M
authors.lastname: He
authors.affiliation: Advanced Cell Diagnostics, Hayward, CA, USA.
authors.forename: Xiao-Jun
authors.initials: XJ
authors.lastname: Ma
authors.affiliation: Laboratory of Translational Research, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Saulnier
authors.affiliation: Laboratory of Translational Research, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Ludovic
authors.initials: L
authors.lastname: Lacroix
authors.affiliation: Biobank, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Drusch
authors.affiliation: Department of Biopathology, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Aïcha
authors.initials: A
authors.lastname: Ben Lakdhar
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Hôpital Tenon, Assistance Publique-Hôpitaux de Paris, Paris, France.
authors.forename: Jean Lacau
authors.initials: JL
authors.lastname: Saint Guily
authors.affiliation: Department of Pathology, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Badoual
authors.affiliation: Department of Biopathology, Gustave Roussy Cancer Campus, Villejuif, France.|Laboratory of Translational Research, Gustave Roussy Cancer Campus, Villejuif, France.|Biobank, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Jean Yves
authors.initials: JY
authors.lastname: Scoazec
authors.affiliation: Department of Biopathology, Gustave Roussy Cancer Campus, Villejuif, France.|Laboratory of Translational Research, Gustave Roussy Cancer Campus, Villejuif, France.|Biobank, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Vielh
mesh_terms: D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis* / Q000821:virology*; D005260:Female; D006258:Head and Neck Neoplasms / Q000175:diagnosis* / Q000821:virology*; D006801:Humans; D017403:In Situ Hybridization / Q000379:methods*; D008297:Male; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis*; D016612:Paraffin Embedding; D012367:RNA, Viral / Q000032:analysis* / Q000302:isolation & purification; D012680:Sensitivity and Specificity; D000077195:Squamous Cell Carcinoma of Head and Neck; D016707:Tissue Fixation
chemical_list: D012367:RNA, Viral