Evaluation of p16 as a surrogate marker for transcriptionally active human papillomavirus status of oropharyngeal squamous cell carcinoma in an eastern Chinese population.

Abstract

The aim of this study was to characterize the clinicopathologic features of patients with oropharyngeal squamous cell carcinoma (OPSCC) in an eastern Chinese population and to evaluate the diagnostic validity of p16 immunochemistry (IHC) for HPV status detection in OPSCC. A total of 257 paraffin-embedded primary OPSCC specimens were collected from 2014 to 2019. HPV RNA in situ hybridization (ISH) was conducted as the gold standard for the detection of transcriptionally active HPV status and HPV DNA polymerase chain reaction (PCR), p16 IHC, next-generation-sequencing for TP53 exons were also performed and the results analyzed for comparison. The overall HPV infection rate was 18.29% (47 of 257) and the TP53 mutation frequency was 13.16% (5 of 38) and 94.74% (18 of 19) in patients with HPV-positive and HPV-negative OPSCC, respectively (P < .001). p16 IHC had the worst diagnostic ability and prognosis predictive value (disease-specific survival [DSS]; P=.405) compared with HPV DNA PCR as well as combination of p16 IHC and HPV DNA PCR. However, the diagnostic ability of p16 IHC was better in OPSCC without tobacco or alcohol exposure. Solitary p16 IHC is insufficient for HPV status detection in patients with OPSCC with tobacco and/or alcohol exposure but performs better in those without exposure, and additional HPV DNA specific testing may be necessary for accurate HPV status determination.