Journal
MOLECULAR DIAGNOSIS & THERAPY
Volume 25, Issue 1, Pages 59-70Publisher
ADIS INT LTD
DOI: 10.1007/s40291-020-00502-6
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Funding
- Sao Paulo Research Foundation (FAPESP) [2015/01286-0]
- National Council for Technological and Scientific Development (CNPq) [445.053/2014-3]
- Barretos Cancer Hospital
- Public Ministry of Labor Campinas (Research, Prevention, and Education of Occupational Cancer)
- FAPES/CNPq/Decit-SCTIE-MS/SESA [03/2018, 83139940/2018]
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HPV DNA detection by ddPCR is highly specific but moderately sensitive for determining HPV status in OPSCC. Results show that combination of p16-IHC and ddPCR may improve clinical management in OPSCC patients.
Introduction High-risk human papillomavirus infection impacts staging and prognosis of oropharyngeal squamous cell carcinomas (OPSCCs). Determination of HPV status in tumor tissue by p16-immunohistochemistry (p16-IHC) can be challenging; therefore, complementary methodologies could be useful in a clinical setting. Objective To test for accuracy and clinical relevance of HPV-DNA detection in formalin-fixed and paraffin-embedded (FFPE) tumor samples by droplet digital PCR (ddPCR). Materials and Methods Fifty OPSCCs were tested for p16-IHC status followed by HPV-16/18 DNA detection/quantification in FFPE-recovered DNA using ddPCR. Accuracy for HPV status determination and association with patient information were also evaluated. Results 32.0% (16/50) of the cases were p16-IHC positive (p16 +), 42.0% (21/50) had detectable levels of HPV-16 DNA, and none were positive for HPV-18 DNA. A higher median viral load of HPV-16 DNA was observed in p16 + cases (p < 0.0001). Concordance between p16-IHC and HPV-16 DNA ranged from 78.0 to 86.0% and accuracy rates were between 78.0 and 86.0%. P16-IHC and HPV-16 DNA detection was associated with gender, smoking status, and tumor subsite, while only HPV-16 DNA was associated with cT stage. The combination of HPV positivity by p16-IHC and ddPCR showed higher overall survival rates in comparison with p16 + /HPV-DNA- and p16 - /HPV-DNA- results. Conclusions Type-specific HPV-DNA detection by ddPCR is highly specific but moderately sensitive for the determination of HPV status and showed clinical relevance, mainly when associated with p16-IHC status. Results highlight the importance of performing HPV-DNA testing in combination with p16-IHC for proper identification of HPV-associated OPSCC and to improve clinical management of OPSCC patients.
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