Dati preliminari sulla presenza di biomarcatori per il Papilloma Virus nei fluidi corporei (saliva e sangue)

The absence of precancerous lesions in the head and neck that can serve as monitors for HPV-related tumors requires the search for easy-to-find screening tools and methods that can effectively and inexpensively predict the presence of HPV and its possible role in the development of a cancer in this district. In this study, the presence of HPV DNA detected in gargles and oral swabs, together with circulating tumor DNA (ct) of HPV in plasma, was studied as a biomarker for HPV-related head and neck cancer. We identified 21 mucosal HPV types by a multiplex genotyping assay in matched plasma, saliva (gargles and swabs), and paraffin-embedded tumor tissue (FFPE) samples in patients with head and neck cancer (n = 132). To assess whether HPV DNA positivity in body fluids can predict HPV positivity in tissues, we examined the performance of each body fluid biomarker (blood, saliva gargle, or swab) compared to reference tests in FFPE tissues from patients with oropharyngeal squamous cell carcinoma (OPSCC, n=23). Our focus on OPSCC is particularly significant, as the oropharynx is the area where the association between cancer and HPV is most extensively studied and demonstrated. HPV16 was the most prevalent genotype in all biological samples. Overall, we observed 91.3% concordance between plasma and FFPE tissues for detecting HPV16 in oropharyngeal cancer (k=0.81; 95% CI 58.3-100). The agreement between gargles and tissues for the detection of HPV16 in the oropharynx was 91.3% (k=0.80; 95% CI, 55.5-100) while comparing oral swabs and tissue samples, the agreement reached 56.6% (k=0.25; 95% CI, 26.0-49.0). Detection of HPV16 DNA in gargles and/or plasma was found to be: (i) more sensitive in gargles (13.5%, n=19/141, 95% CI, 8.72-20.1) and plasma (11.3%, n=16/141, 95% CI, 7.01-17.7) than in oral swabs (5%, n=7, 95% CI, 2.23-10.0); (ii) a good marker for virus-related oropharyngeal cancer; (iii) high sensitivity for HPV16-positive early clinical stage cT1 oropharyngeal cancers: [100% (n=8/8) when plasma and gargles are used in combination, compared to 87.5% (n=7/8) in gargles alone and 75% (n=6/8) in plasma alone. CONCLUSION While our study demonstrates the potential of HPV DNA of HPV16 in plasma as a sensitive marker for oropharyngeal cancer, further prospective and multicenter validation studies are necessary due to the limited number of oropharyngeal cancer patients included in this pilot study and the number of HPV-positive samples.