{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T22:46:49Z","timestamp":1793314009502,"version":"4.5.0"},"reference-count":40,"publisher":"American Medical Association (AMA)","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Otolaryngol Head Neck Surg"],"published-print":{"date-parts":[[2023,9,1]]},"abstract":"<jats:sec id=\"ab-ooi230038-4\"><jats:title>Importance<\/jats:title><jats:p>Head and neck squamous cell carcinoma is a highly lethal cancer that is often associated with human papillomavirus (HPV). Recent studies have shown promise in the use of HPV DNA detection in salivary rinses and plasma as a factor associated with a future diagnosis of HPV-positive oropharynx cancer (HPVOPC). However, the use of plasma and salivary HPV DNA detection in defining risk for recurrence in the context of a prospective, phase 3, clinical trial coupled with standardized clinical surveillance has not been reported.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ooi230038-5\"><jats:title>Objective<\/jats:title><jats:p>To identify patients with low-risk HPVOPC at risk for recurrence by detection of HPV16 DNA in plasma and salivary rinses.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ooi230038-6\"><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>In this cohort study, 233 low-risk patients were recruited from 32 head and neck treatment centers in Ireland (1 [3.1%]), the Netherlands (1 [3.1%]), and the UK (30 [93.8%]) as part of the DE-ESCALATE HPV trial, an open-label, phase 3 randomized clinical trial examining treatment with cetuximab vs cisplatin for HPVOPC. Patients were assayed for the presence of HPV16 DNA in plasma and salivary rinse via a quantitative polymerase chain reaction\u2013based assay.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ooi230038-7\"><jats:title>Main Outcomes and Measures<\/jats:title><jats:p>Assay results were associated with risk of recurrence and lead time from HPV16 DNA detection to recurrence.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ooi230038-8\"><jats:title>Results<\/jats:title><jats:p>Of 233 patients, 45 (19.3%) were women, and the mean (SD) age was 57.01 (8.45) years. A total 1040 salivary or blood samples were collected during the course of the study. With a median follow-up of 760 days, the sensitivity and specificity of combined plasma and salivary rinse HPV DNA assays for detecting recurrence were 65% and 87%, respectively. There was a median lead time of positive test to event\/recurrence date of 19 days (range, 0-536 days) and mean (SD) of 122 (169.8) days.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ooi230038-9\"><jats:title>Conclusion and Relevance<\/jats:title><jats:p>The results of this cohort study suggest that in the setting of a randomized, prospective, phase 3 trial for low-risk patients with HPVOPC, posttreatment presence of HPV DNA in plasma and salivary rinses is associated with recurrence; a lead time between test positivity and clinical recurrence offers a potential opportunity for earlier detection of recurrence.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamaoto.2023.1730","type":"journal-article","created":{"date-parts":[[2023,7,27]],"date-time":"2023-07-27T15:32:02Z","timestamp":1690471922000},"page":"812","source":"Crossref","is-referenced-by-count":20,"title":["Lead Time to Recurrence After Posttreatment Plasma and Saliva HPV DNA Testing in Patients With Low-Risk HPV Oropharynx 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