Tumor tissue-modified viral-HPV DNA testing demonstrated 100% specificity in both diagnosis and surveillance of HPV-associated oropharyngeal squamous cell carcinoma in a clinical setting, according to a study.
However, results published in JAMA Otolaryngology-Head & Neck Surgery showed nearly 10% of negative tumor tissue-modified viral (TTMV)-HPV DNA tests appeared to be false negatives after review of sensitivity data, researchers wrote.
They noted the need for additional study to validate the test’s performance.
espite growing interest in the use of circulating plasma tumor HPV DNA for diagnosis and surveillance of patients with HPV-associated oropharyngeal squamous cell carcinoma, few data exist on newer testing techniques.
Researchers conducted a retrospective, observational cohort study that included 399 patients with oropharyngeal squamous cell carcinoma in an effort to establish the clinical efficacy of plasma TTMV-HPV DNA testing in the diagnosis and surveillance of HPV-associated oropharyngeal squamous cell carcinoma.
Eligible patients included individuals who underwent TTMV-HPV DNA testing between April 2020 and September 2022 and had at least one TTMV-HPV DNA measurement prior to initiation of primary therapy.
Researchers assigned 163 patients (median age, 63 years; 87.1% male) to the diagnostic cohort and 290 (median age, 63 years; 81.7% male) to the surveillance cohort.
In the diagnostic cohort, 152 patients (93.3%) had HPV-associated oropharyngeal squamous cell carcinoma and 11 (6.7%) had HPV-negative disease. Results showed TTMV-HPV DNA testing had a pretreatment diagnosis sensitivity of 91.5% (95% CI, 85.8-95.4) and specificity of 100% (95% CI, 71.5-100).
Of the 290 patients in the surveillance cohort, 23 had molecularly confirmed pathologic recurrences. TTMV-HPV DNA testing showed a sensitivity of 88.4% (95% CI, 74.9-96.1) and sensitivity of 100% (95% CI, 99.3-100) in detecting these recurrences.
Researchers reported a positive predictive value of 100% (95% CI, 90.7-100) and a negative predictive value of 99.1% (95% CI, 97.9-99.7), and a median lead time from positive TTMV-HPV DNA testing to pathologic confirmation of 47 days (range, 0-507).
TTMV-HPV DNA testing can serve as a valuable tool for diagnosis and surveillance; however, additional studies are needed to refine its effectiveness, according to researchers.