Prospective validation of ctHPVDNA for detection of minimal residual disease and prediction of recurrence in patients with HPV-associated head and neck cancer treated with surgery.

• DOI: 10.1200/jco.2024.42.16_suppl.6010
• Publication Date: 2024-06-10T16:35:00Z
• Authors: Shun Hirayama; Yana Al-Inaya; Ling Aye; Michael E. Bryan; Dipon Das; Julia Mendel; Saskia Naegele; William C Faquin; Peter Sadow; Adam S. Fisch; Derrick Lin; Mark A Varvares; Allen Feng; Kevin S. Emerick; Daniel G. Deschler; Michael S. Lawrence; A. John Iafrate; Annie Chan; Jeremy Richmon; Daniel Faden
• Keywords: 03 medical and health sciences; 0302 clinical medicine

6010 Background: Prediction of minimal residual disease (MRD) following surgery, and thus the need for adjuvant therapy, is currently based on clinicopathologic risk factors which have poor individual prognostic capacity. We previously reported that MRD detection by ctHPVDNA droplet digital (dd)PCR as early post-operative day (POD) 1 predictive recurrence in stage I-II HPV+HNSCC patients. Here, we applied a significantly more sensitive custom whole genome hybrid-capture-based next generation sequencing assay, termed HPV-DeepSeek, to validate capacity explore optimal timing testing tested primary hypothesis patients with within 6 weeks surgery would inferior PFS at 2 years secondary positivity detected any point treatment completion years. Methods: 98 were prospectively enrolled mean follow-up 712 days. All underwent adjusted treatment. 10ml blood samples collected before period (POD 1-42), serially follow-up. was defined lack clearance during surgery. Cell free DNA extracted from plasma run existing ddPCR assays head comparisons. Results: 96/98 (98%) had detectable pre-treatment. 30/98 (31%) positive. Patients who positive worse compared negative (78% vs 98%, P=0.0009). Predictive performance improved limiting time points POD 7-42 (2 year 60% 97%, P<0.0001) fewer >1 week after suggesting use an ultra-sensitive assay such HPV-DeepSeek requires adjustment points. all 2-year without (0% P<0.0001). 7/98 cancer lead 207 days (35-518) clinical diagnosis. Conclusions: highly specific biomarker HPV+HNSCC, accurately predicts progression detects earlier than standard care clinical.