TY - JOUR
T1 - Detection of Occult Recurrence Using Circulating Tumor Tissue Modified Viral HPV DNA among Patients Treated for HPV-Driven Oropharyngeal Carcinoma
AU - Berger, Barry M.
AU - Hanna, Glenn J.
AU - Posner, Marshall R.
AU - Genden, Eric M.
AU - Lautersztain, Julio
AU - Naber, Stephen P.
AU - Del Vecchio Fitz, Catherine
AU - Kuperwasser, Charlotte
N1 - Funding Information:
B.M. Berger reports personal fees from Naveris, Inc. during the conduct of the study as well as personal fees from Naveris, Inc. outside the submitted work. G.J. Hanna reports personal fees from Naveris, Inc. during the conduct of the study as well as grants from Repertoire, KSQ Therapeutics, and American Society of Clinical Oncology (ASCO) Conquer Cancer Foundation outside the submitted work. M.R. Posner reports personal fees from Merck, Calliditas, Hookipa, Cel Sci, Coherus, Kura, Icon, BioNnet, and Naveris outside the submitted work. S.P. Naber reports personal fees from Naveris, Inc. during the conduct of the study as well as personal fees from Tufts Medical Center outside the submitted work. C. Del Vecchio Fitz reports personal fees from Naveris, Inc. during the conduct of the study. C. Kuperwasser reports personal fees and other support from Naveris, Inc. during the conduct of the study. No disclosures were reported by the other authors.
Publisher Copyright:
© 2022 The Authors.
PY - 2022/10/1
Y1 - 2022/10/1
N2 - Purpose: Despite generally favorable outcomes, 15% to 25% of patients with human papillomavirus (HPV)-driven oropharyngeal squamous cell carcinoma (OPSCC) will have recurrence. Current posttreatment surveillance practices rely on physical examinations and imaging and are inconsistently applied. We assessed circulating tumor tissue modified viral (TTMV)-HPV DNA obtained during routine posttreatment surveillance among a large population of realworld patients. Experimental Design: This retrospective clinical case series included 1,076 consecutive patients across 108 U.S. sites who were ≥ 3 months posttreatment for HPV-driven OPSCC and who had one or more TTMV-HPV DNA tests (NavDx, Naveris Laboratories) obtained during surveillance between February 6, 2020, and June 29, 2021. Test results were compared with subsequent clinical evaluations. Results: Circulating TTMV-HPV DNA was positive in 80 of 1,076 (7.4%) patients, with follow-up available on all. At first positive surveillance testing, 21 of 80 (26%) patients had known recurrence while 59 of 80 (74%) patients were not known to have recurrent disease. Among these 59 patients, 55 (93%) subsequently had a confirmed recurrence, 2 patients had clinically suspicious lesions, and 2 had clinically "no evidence of disease"(NED) at last follow-up. To date, the overall positive predictive value of TTMV-HPVDNA testing for recurrent disease is95% (N=76/80). Inaddition, the point-in-time negative predictive value is 95% (N = 1,198/1,256). Conclusions: These findings highlight the clinical potential for circulating TTMV-HPV DNA testing in routine practice. As a surveillance tool, TTMV-HPV DNA positivity was the first indication of recurrence in the majority of cases, pre-dating identification by routine clinical and imaging exams. These data may inform future clinical and guideline-endorsed strategies for HPV-driven malignancy surveillance.
AB - Purpose: Despite generally favorable outcomes, 15% to 25% of patients with human papillomavirus (HPV)-driven oropharyngeal squamous cell carcinoma (OPSCC) will have recurrence. Current posttreatment surveillance practices rely on physical examinations and imaging and are inconsistently applied. We assessed circulating tumor tissue modified viral (TTMV)-HPV DNA obtained during routine posttreatment surveillance among a large population of realworld patients. Experimental Design: This retrospective clinical case series included 1,076 consecutive patients across 108 U.S. sites who were ≥ 3 months posttreatment for HPV-driven OPSCC and who had one or more TTMV-HPV DNA tests (NavDx, Naveris Laboratories) obtained during surveillance between February 6, 2020, and June 29, 2021. Test results were compared with subsequent clinical evaluations. Results: Circulating TTMV-HPV DNA was positive in 80 of 1,076 (7.4%) patients, with follow-up available on all. At first positive surveillance testing, 21 of 80 (26%) patients had known recurrence while 59 of 80 (74%) patients were not known to have recurrent disease. Among these 59 patients, 55 (93%) subsequently had a confirmed recurrence, 2 patients had clinically suspicious lesions, and 2 had clinically "no evidence of disease"(NED) at last follow-up. To date, the overall positive predictive value of TTMV-HPVDNA testing for recurrent disease is95% (N=76/80). Inaddition, the point-in-time negative predictive value is 95% (N = 1,198/1,256). Conclusions: These findings highlight the clinical potential for circulating TTMV-HPV DNA testing in routine practice. As a surveillance tool, TTMV-HPV DNA positivity was the first indication of recurrence in the majority of cases, pre-dating identification by routine clinical and imaging exams. These data may inform future clinical and guideline-endorsed strategies for HPV-driven malignancy surveillance.
UR - http://www.scopus.com/inward/record.url?scp=85137358671&partnerID=8YFLogxK
U2 - 10.1158/1078-0432.CCR-22-0562
DO - 10.1158/1078-0432.CCR-22-0562
M3 - Article
C2 - 35576437
AN - SCOPUS:85137358671
SN - 1078-0432
VL - 28
SP - 4292
EP - 4301
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 19
ER -