Circulating tumor-tissue modified HPV DNA testing in the clinical evaluation of patients at risk for HPV-positive oropharynx cancer: The IDEA-HPV study

• Published in: Oral oncology Vol. 147; p. 106584
• Main Authors: Batool, Sana, Sethi, Rosh K.V., Wang, Annette, Dabekaussen, Kirsten, Egloff, Ann Marie, Del Vecchio Fitz, Catherine, Kuperwasser, Charlotte, Uppaluri, Ravindra, Shin, Jennifer, Rettig, Eleni M.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.12.2023
• Subjects: Carcinoma, Squamous Cell - genetics; Circulating tumor DNA; Cohort Studies; DNA, Viral - genetics; Early diagnosis; Female; Head and Neck cancer; Head and Neck Neoplasms - diagnosis; Hematology, Oncology, and Palliative Medicine; Human Papillomavirus; Humans; Male; Middle Aged; Oropharyngeal cancer; Oropharyngeal Neoplasms - pathology; Otolaryngology; Papillomaviridae - genetics; Papillomavirus Infections - complications; Papillomavirus Infections - diagnosis; Prognosis; Prospective Studies; Squamous Cell Carcinoma of Head and Neck - diagnosis; Tumor tissue-modified viral HPV DNA; Early diagnosis; Head and Neck cancer; Human Papillomavirus; Oropharyngeal cancer; Circulating tumor DNA; Tumor tissue-modified viral HPV DNA
• ISSN: 1368-8375; 1879-0593; 1879-0593
• DOI: 10.1016/j.oraloncology.2023.106584

•TTMV-HPV DNA testing to aid HPV-positive OPSCC diagnosis was prospectively evaluated.•Testing was feasible and perceived as clinically useful by treating physicians.•Among 3 subjects diagnosed with HPV-positive OPSCC, 2 had detectable TTMV-HPV DNA.•Undetectable TTMV-HPV DNA may not reliably indicate absence of disease.•Clinicians using this test should be aware of both its strengths and limitations. While survival outcomes are favorable for Human Papillomavirus (HPV)-positive oropharyngeal squamous cell carcinomas (OPSCCs), early diagnosis may minimize treatment-related morbidity and mortality. This study evaluated circulating tumor tissue-modified viral (TTMV)-HPV DNA plasma testing to facilitate early diagnosis of HPV-positive OPSCCs. In this prospective exploratory cohort study, patients presenting to an Otolaryngology-Head and Neck Surgery clinic with unexplained signs or symptoms considered high-risk for HPV-positive OPSCC were recruited between March 2021-October 2022. Circulating TTMV-HPV DNA testing was performed, and results were shared with subjects and treating clinicians. Clinicians were surveyed regarding the perceived clinical utility of the test. Thirty-nine subjects were included. Most subjects were women (N = 23, 59 %), white (N = 32, 82 %) and never-smokers (N = 20, 51 %) with median age 60 years. Circulating TTMV-HPV DNA was detected in 2/39 subjects, both subsequently diagnosed with HPV-positive OPSCC. Both were white men aged 70–80 years with a neck mass. One subject with undetectable TTMV-HPV DNA was also diagnosed with HPV-positive OPSCC through excisional neck mass biopsy. Other eventual diagnoses included 3 HPV-negative head and neck squamous cell carcinomas and 4 other malignancies. Testing was perceived as helpful in clinical decision-making for 26/38 (68 %) subjects, and useful for similar future patients for 32/37 (86 %) subjects. Circulating TTMV-HPV DNA testing is feasible and holds potential as a diagnostic aid for HPV-positive OPSCC alongside standard clinical workup. Clinicians should be cognizant of its limitations, as a negative test does not necessarily indicate the absence of disease. Further studies to evaluate its utility are warranted.