Single-center prospective trial of circulating tumor HPV DNA for surveillance of HPV-positive oropharynx cancer recurrence

Observational studies suggest that circulating tumor HPV DNA may facilitate early detection of recurrent HPV-positive oropharynx cancer (OPC). A prospective study at Brigham and Women’s Hospital (Boston, MA) investigated whether biomarker-guided surveillance detects recurrence sooner that standard-of-care. Among 155 HPV-positive OPC patients undergoing curative-intent treatment with median follow-up 23 months, 15 recurred. Among these, 6 (40%; 95% CI 16-68) were ‘early true-positives’ for whom circulating tumor HPV DNA predated and prompted imaging and clinical workup that diagnosed recurrence (median lead time 132 days; range 47-280). Another 5 subjects (33%) were ‘confimary true-positives’, for whom detectable ct HPV DNA confirmed suspicious standard-of-care findings. Four subjects (27%) with recurrence were false-negatives, with low or undetectable circulating tumor DNA, and 3 were false-positives with prolonged ct HPV DNA without disease. Overall, sensitivity for recurrence was 73% (95% CI 45-92) with higher sensitivity (91%; 59-100) among 117 patients with HPV16 and detectable pretreatment ct HPV DNA. The authors conclude that biomarker-guided surveillance facilitates early detection of many HPV-positive OPC recurrences.