Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Weiland, T; Eckert, A; Tomazic, PV; Wolf, A; Pondorfer, P; Vasicek, S; Graupp, M; Holzmeister, C; Moser, U; Andrianakis, A; Kangler, G; Kiss, P; Brcic, L; Kappler, M; Wickenhauser, C; Haak, A; Krüger, M; Al-Nawas, B; Blatt, S; Brockmeyer, N; Skaletz-Rorowski, A; Potthoff, A; French, LE; Charnowski, S; Reinholz, M; Kaufmann, AM; Thies, S; Lambrecht, HG; Seliger, B; Wild, DC; Thurnher, D.
DRH1 - a novel blood-based HPV tumour marker.
EBioMedicine. 2020; 56:102804
Doi: 10.1016/j.ebiom.2020.102804
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- Führende Autor*innen der Med Uni Graz
- Weiland Thomas
- Co-Autor*innen der Med Uni Graz
- Andrianakis Alexandros
- Brcic Luka
- Holzmeister Clemens
- Kangler Georg Josef
- Kiss Peter
- Koiner-Graupp Matthias
- Moser Ulrich Christian
- Pondorfer-Schäfer Prisca
- Thurnher Dietmar
- Tomazic Peter Valentin
- Vasicek Sarah Marvis
- Wild Dominik
- Wolf Axel
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- Abstract:
- BACKGROUND: To date, no studies have successfully shown that a highly specific, blood-based tumour marker to detect clinically relevant HPV-induced disease could be used for screening, monitoring therapy response or early detection of recurrence. This study aims to assess the clinical performance of a newly developed HPV16-L1 DRH1 epitope-specific serological assay. METHODS: In a multi-centre study sera of 1486 patients (301 Head and Neck Squamous Cell Carcinoma (HNSCC) patients, 12 HIV+ anal cancer patients, 80 HIV-positive patients, 29 Gardasil-9-vaccinees, 1064 healthy controls) were tested for human HPV16-L1 DRH1 antibodies. Analytical specificity was determined using WHO reference-sera for HPV16/18 and 29 pre- and post-immune sera of Gardasil-9-vaccinees. Tumour-tissue was immunochemically stained for HPV-L1-capsidprotein-expression. FINDINGS: The DRH1-competitive-serological-assay showed a sensitivity of 95% (95% CI, 77.2-99.9%) for HPV16-driven HNSCC, and 90% (95% CI, 55.5-99.7%) for HPV16-induced anal cancer in HIV-positives. Overall diagnostic specificity was 99.46% for men and 99.29% for women ≥ 30 years. After vaccination, antibody level increased from average 364 ng/ml to 37,500 ng/ml. During post-therapy-monitoring, HNSCC patients showing an antibody decrease in the range of 30-100% lived disease free over a period of up to 26 months. The increase of antibodies from 2750 to 12,000 ng/ml mirrored recurrent disease. We can also show that the L1-capsidprotein is expressed in HPV16-DNA positive tumour-tissue. INTERPRETATION: HPV16-L1 DRH1 epitope-specific antibodies are linked to HPV16-induced malignant disease. As post-treatment biomarker, the assay allows independent post-therapy monitoring as well as early diagnosis of tumour recurrence. An AUC of 0.96 indicates high sensitivity and specificity for early detection of HPV16-induced disease. FUNDING: The manufacturer provided assays free of charge.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult - administration & dosage
- Aged - administration & dosage
- Aged, 80 and over - administration & dosage
- Anus Neoplasms - blood, virology
- Area Under Curve - administration & dosage
- Biomarkers, Tumor - blood
- Capsid Proteins - metabolism
- Carcinoma, Squamous Cell - blood, virology
- Carrier Proteins - blood
- Case-Control Studies - administration & dosage
- Cross-Sectional Studies - administration & dosage
- Female - administration & dosage
- HIV Infections - blood, virology
- Head and Neck Neoplasms - blood, virology
- Human papillomavirus 16 - immunology
- Humans - administration & dosage
- Male - administration & dosage
- Middle Aged - administration & dosage
- Neoplasms - blood, virology
- Oncogene Proteins, Viral - metabolism
- Papillomavirus Infections - immunology
- Papillomavirus Vaccines - immunology
- Prospective Studies - administration & dosage
- Sensitivity and Specificity - administration & dosage
- Find related publications in this database (Keywords)
- HPV16
- Antibodies
- Tumour marker
- Screening
- Blood test
- HNSCC