Detection of HPV related oropharyngeal cancer in oral rinse specimens

Abstract

BackgroundThe majority of patients diagnosed with oropharyngeal squamous cell cancer (OPSCC) are due to HPV infection. At present, there are no reliable tests for screening HPV in patients with OPSCC. The objective of this study was to assess the Cobas® HPV Test on oral rinse specimens as an early, non-invasive tool for HPV-related OPSCC.MethodsOral rinse specimens were collected from 187 patients (45 with OPSCC, 61 with oral cavity SCC (OCSCC) and 81 control patients who had benign or malignant thyroid nodules) treated at MSKCC. The Cobas® HPV Test was used to detect 14 high-risk HPV types in these samples. Performance of the HPV Test was correlated with p16 tumor immunohistochemistry as gold standard.Results91.1% of the oropharynx cancer patients had p16 positive tumors compared to 3.3% of oral cavity cancer. Of the 81 control patients, 79 (97.5%) had no HPV in their oral rinse giving a specificity of the HPV test of 98%. For the combined oral cavity oropharynx cancer cohort, the sensitivity, specificity, positive predictive value and negative predictive value of the HPV Test were 79.1%, 90.5%, 85.0% and 86.4% respectively when p16 immunohistochemistry was used as the reference.ConclusionThe Cobas® HPV Test on oral rinse is a highly specific and potentially sensitive test for oropharyngeal cancer and may be a potentially useful screening test for early oropharyngeal cancer.ImpactWe describe an oral rinse test for the detection of HPV related oropharyngeal cancer.

An Occult HPV-Driven Oropharyngeal Squamous Cell Carcinoma Discovered Through a Saliva Test

“…It demonstrates that a screened individual can receive significantly less morbid treatment than would be required for the standard presentation at a more advanced stage. This report and previous studies (8,11,12,22), support the value of a salivary oral rinse test as a potential screening tool. Unlike previously published work, our study is the first to demonstrate that continuous monitoring of HPV-16 DNA in salivary oral rinse samples can detect occult OPC.…”

“…Salivary oral rinse samples of this individual were collected at baseline, 6, 12, 36 month, and 2 weeks after his bilateral tonsillectomy using previously published method (8)(9)(10). Briefly, participants were asked to swish and gargle for 1-2 min with 2 × 10 mL volumes of 0.9% saline, prior to expectorating the rinse sample into a 50 mL falcon tube.…”

Molecular Diagnostics in Human Papillomavirus-Related Head and Neck Squamous Cell Carcinoma

“…Tumor HPV status was determined by p16 IHC and/or HPV DNA ISH on tumor samples and PCR amplification of 37 different subtypes of HPV was performed on oral rinses. The authors concluded that the oral rinse test had a sensitivity of 72.2% and a specificity of 90%, similar to prior studies [72]. One publication has shown conflicting results regarding the utility of HPV detection in saliva, but definitive conclusions may be difficult to draw due to small sample size in that case-control study [73].…”

Oral testing for high‐risk human papillomavirus DNA and E6/E7 messenger RNA in healthy individuals at risk for oral infection

“…7 Importantly, an HPV mRNA evaluation represents the gold standard for identifying HPV-driven HNC because HPV DNA alone does not prove an HPVassociated etiology of the tumor. 3,8 Because of the simple and noninvasive nature of their collection, oral rinses and gargles (hereafter called oral rinses) have been used to search for a variety of HPVassociated biomarkers, such as HPV DNA [9][10][11][12][13][14] and HPVspecific antibodies, 15,16 in both healthy subjects and patients with HNC. In contrast, HPV mRNA detection in oral specimens is very challenging because mRNA is highly susceptible to degradation by the enzymes present in oral fluids.…”