title: Human papillomavirus status of head and neck cancer as determined in cytologic specimens using the hybrid-capture 2 assay.
abstract: OBJECTIVE
  A standardized assay to determine the HPV status of head and neck squamous cell carcinoma (HNSCC) specimens has not yet been established, particularly for cytologic samples. The goal of this study was to determine whether the hybrid capture-2 (HC-2) assay, already widely used for the detection of high risk HPV in cervical brushings, is applicable to cytologic specimens obtained from patients with suspected HNSCCs.
  
  
  METHODS
  Fine needle aspirates (FNA) of cervical lymph nodes were pre-operatively obtained from patients with suspected HNSCCs and evaluated for the presence of HPV using the HC-2 assay. HPV analysis was performed on the corresponding resected tissue specimens using p16 immunohistochemistry (IHC) and HR-HPV in situ hybridization (ISH). A cost analysis was performed using the Center for Medicare & Medicaid Services.
  
  
  RESULTS
  HPV status of the cervical lymph node metastases was correctly classified using the HC-2 assay in 84% (21/25) of cases. Accuracy was improved to 100% when cytologic evaluation confirmed the presence of cancer cells in the test samples. The estimated cost savings to CMS using the HC-2 assay ranged from $113.74 to $364.63 per patient.
  
  
  CONCLUSIONS
  HC-2 is a reliable method for determining the HPV status of HNSCCs. Its application to HNSCCs may reduce costs by helping to localize the primary site during the diagnostic work-up as well as decrease the interval time of determining the HPV status which would be relevant for providing prognostic information to the patient as well as determining eligibility for clinical trials targeting this unique patient population.
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States.
authors.forename: David F
authors.initials: DF
authors.lastname: Smith
authors.affiliation: Department of Pathology, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States.
authors.forename: Zahra
authors.initials: Z
authors.lastname: Maleki
authors.affiliation: Department of Economics, National University of Ireland, Galway, Ireland.
authors.forename: Diarmuid
authors.initials: D
authors.lastname: Coughlan
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Gooi
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States.
authors.forename: Belinda
authors.initials: B
authors.lastname: Akpeng
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States; Department of Otolaryngology - Head and Neck Surgery, Tohoku University School of Medicine, Sendai, Japan.
authors.forename: Takenori
authors.initials: T
authors.lastname: Ogawa
authors.affiliation: Department of Pathology, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States.
authors.forename: Justin A
authors.initials: JA
authors.lastname: Bishop
authors.affiliation: Department of Economics, National University of Ireland, Galway, Ireland; The Johns Hopkins Carey Business School, Baltimore, MD 21202, United States.
authors.forename: Kevin D
authors.initials: KD
authors.lastname: Frick
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States.
authors.forename: Nishant
authors.initials: N
authors.lastname: Agrawal
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States.
authors.forename: Christine G
authors.initials: CG
authors.lastname: Gourin
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States; The Milton J. Dance, Jr. Head and Neck Center, Greater Baltimore Medical Center, Baltimore, MD 21204, United States.
authors.forename: Patrick K
authors.initials: PK
authors.lastname: Ha
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States.
authors.forename: Wayne M
authors.initials: WM
authors.lastname: Koch
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States.
authors.forename: Jeremy D
authors.initials: JD
authors.lastname: Richmon
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States; Department of Pathology, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States; Department of Oncology, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States.
authors.forename: William H
authors.initials: WH
authors.lastname: Westra
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States; Department of Oncology, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States. Electronic address: sipai@mgh.harvard.edu.
authors.forename: Sara I
authors.initials: SI
authors.lastname: Pai
mesh_terms: D052685:Alphapapillomavirus / Q000235:genetics / Q000302:isolation & purification*; D044963:Biopsy, Fine-Needle; D004279:DNA, Viral / Q000235:genetics; D006258:Head and Neck Neoplasms / Q000473:pathology / Q000821:virology*; D006801:Humans; D017403:In Situ Hybridization; D008198:Lymph Nodes / Q000821:virology
chemical_list: D004279:DNA, Viral
keywords: Cytology; Fine needle aspiration; HPV; Head and neck cancer; Hybrid capture 2; Squamous cell carcinoma