Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-Associated Oropharyngeal Cancer
Autor: | Roi Dagan, Rebecca L. Green, S. Patel, Samip Patel, Emily C. Goldman, Jared Weiss, Nathan C. Sheets, Jeff Blumberg, Adam M. Zanation, Mark C. Weissler, Trevor Hackman, Gaorav P. Gupta, Sunil Kumar, William M. Mendenhall, Brian D. Thorp, Bhishamjit S. Chera, Colette J. Shen, Juneko E. Grilley-Olson, Xianming M. Tan, Wendell G. Yarbrough, Robert J. Amdur |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
0301 basic medicine
Adult Male Cancer Research Alphapapillomavirus Cancer recurrence Circulating Tumor DNA 03 medical and health sciences 0302 clinical medicine Clinical Trials Phase II as Topic medicine Human papillomavirus DNA Biomarkers Tumor Humans Longitudinal Studies Prospective Studies Human papillomavirus Oropharyngeal squamous cell carcinoma Prospective cohort study Aged Aged 80 and over Errata business.industry Squamous Cell Carcinoma of Head and Neck Papillomavirus Infections Cancer ORIGINAL REPORTS Middle Aged medicine.disease Head and Neck Cancer 3. Good health Hpv testing Oropharyngeal Neoplasms 030104 developmental biology Oncology 030220 oncology & carcinogenesis DNA Viral Cancer research Biomarker (medicine) Female Neoplasm Recurrence Local business |
Zdroj: | Journal of Clinical Oncology J Clin Oncol |
ISSN: | 1527-7755 0732-183X |
Popis: | PURPOSE Plasma circulating tumor human papillomavirus DNA (ctHPVDNA) is a sensitive and specific biomarker of human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC). We investigated whether longitudinal monitoring of ctHPVDNA during post-treatment surveillance could accurately detect clinical disease recurrence. METHODS AND MATERIALS A prospective biomarker clinical trial was conducted among patients with nonmetastatic HPV-associated (p16-positive) OPSCC. All patients were treated with curative-intent chemoradiotherapy (CRT). Patients underwent a 3-month post-CRT positron emission tomography/computed tomography scan and were thereafter clinically evaluated every 2-4 months (years 1-2), then every 6 months (years 3-5). Chest imaging was performed every 6 months. Blood specimens were collected every 6-9 months for analysis of plasma ctHPVDNA using a multianalyte digital polymerase chain reaction assay. The primary endpoint was to estimate the negative predictive value (NPV) and positive predictive value (PPV) of ctHPVDNA surveillance. RESULTS One hundred fifteen patients were enrolled, and 1,006 blood samples were analyzed. After a median follow-up time of 23 months (range, 6.1-54.7 months), 15 patients (13%) developed disease recurrence. Eighty-seven patients had undetectable ctHPVDNA at all post-treatment time points, and none developed recurrence (NPV, 100%; 95% CI, 96% to 100%). Twenty-eight patients developed a positive ctHPVDNA during post-treatment surveillance, 15 of whom were diagnosed with biopsy-proven recurrence. Sixteen patients had 2 consecutively positive ctHPVDNA blood tests, 15 of whom developed biopsy-proven recurrence. Two consecutively positive ctHPVDNA blood tests had a PPV of 94% (95% CI, 70% to 99%). Median lead time between ctHPVDNA positivity and biopsy-proven recurrence was 3.9 months (range, 0.37-12.9 months). CONCLUSION Detection of ctHPVDNA in two consecutive plasma samples during post-treatment surveillance has high PPV and NPV for identifying disease recurrence in patients with HPV-associated oropharyngeal cancer and may facilitate earlier initiation of salvage therapy. |
Databáze: | OpenAIRE |
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