Abstract PO-001: Circulating tumor-tissue modified HPV DNA testing in the clinical workup of patients at risk for HPV-positive oropharynx cancer: The IDEA-HPV Study

Abstract Objectives: While outcomes are favorable for Human Papillomavirus (HPV)-positive oropharyngeal squamous cell carcinomas (OPSCCs), early diagnosis may be beneficial to reduce treatment-related morbidity and mortality. Circulating tumor-tissue-modified viral (TTMV) HPV DNA is detectable in approximately 90% of HPV-positive OPSCC patients and may be a useful diagnostic tool in the clinical evaluation of patients at-risk for the disease. Methods: 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 such as neck mass, tonsillar asymmetry or throat pain were recruited between March 2021 and October 2022. Circulating TTMV-HPV DNA testing was performed by a commercial laboratory (Naveris, Natick MA) and results were shared in real time with the subjects and treating clinicians. Clinicians were surveyed regarding the perceived clinical utility of the test. Medical record abstraction was performed to ascertain subsequent diagnoses. Results: Thirty-nine patients were enrolled. Most subjects were women (N=23, 59%), white (N=32, 82%) and never-smokers (N=20, 51%) with median age of 60 years. The most common presenting sign was tonsil asymmetry (N=24, 62%), while 16 (41%) subjects presented with a neck mass. Circulating TTMV-HPV DNA test results were returned within median 7 days (range, 4-21 days). TTMV-HPV DNA was detected in 2/39 subjects (5%), both subsequently diagnosed with HPV-positive OPSCC. Both were white men in their 70s presenting with a neck mass. One woman with undetectable TTMV-HPV DNA was subsequently diagnosed with HPV-positive OPSCC via excisional neck mass biopsy. Other eventual diagnoses relating to presenting signs and symptoms included 3 HPV-negative head and neck squamous cell carcinomas, 2 branchial cleft cysts, and 4 other malignancies. Treating clinician surveys indicated that while the test impacted clinical management only for 8/38 (21%) subjects, it was perceived as helpful in clinical decision-making for 26/38 (68%) subjects, and as useful for similar future patients in 32/37 (86%) subjects. Conclusion: Plasma TTMV-HPV DNA testing is feasible alongside standard clinical work-up for at-risk patients with particular potential for use as a diagnostic aid for HPV-positive OPSCC. Clinicians should, however, be cognizant of its limitations, and should not consider a negative test result to indicate absence of disease. Further studies to evaluate its utility are warranted. Citation Format: Sana Batool, Rosh K. V. Sethi, Annette Wang, Kirsten Dabekaussen, Ann Marie Egloff, Catherine Delvecchio Fitz, Ravindra Uppaluri, Jennifer Shin, Eleni M. Rettig. Circulating tumor-tissue modified HPV DNA testing in the clinical workup of patients at risk for HPV-positive oropharynx cancer: The IDEA-HPV Study [abstract]. In: Proceedings of the AACR-AHNS Head and Neck Cancer Conference: Innovating through Basic, Clinical, and Translational Research; 2023 Jul 7-8; Montreal, QC, Canada. Philadelphia (PA): AACR; Clin Cancer Res 2023;29(18_Suppl):Abstract nr PO-001.

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