Double positivity for HPV-DNA/p16ink4a is the biomarker with strongest diagnostic accuracy and prognostic value for human papillomavirus related oropharyngeal cancer patients
Abstract:Double positivity for HPV-DNA/p16, a test that can be easily implemented in the clinical practice, has optimal diagnostic accuracy and prognostic value. Our results have strong clinical implications for patients' classification and handling and also suggest that not all the HPV-related OPC behave similarly.
“…This is one of the few studies that evaluated multiple biomarkers and their associated outcomes from a large population‐based cohort of OpSCC patients . Similarly, our results supported the prognostic significance of the presence of HR‐HPV in these patients.…”
Section: Discussionsupporting
confidence: 82%
“…However, in the other large‐scale study (n = 788), the authors found that HPV‐positive/p16 overexpression, not other tested markers, was a better outcome predictor. The different results may be due to different frequency of HPV positive in different geographic locations (10% in the Spain cohort vs 78% in our study) and different methods in HPV detection used (PCR‐based in Mena et al and in situ‐based in current study). We have also identified smoking history, tumor staging, and treatment as independent factors that can predict the outcomes.…”
“…This is one of the few studies that evaluated multiple biomarkers and their associated outcomes from a large population‐based cohort of OpSCC patients . Similarly, our results supported the prognostic significance of the presence of HR‐HPV in these patients.…”
Section: Discussionsupporting
confidence: 82%
“…However, in the other large‐scale study (n = 788), the authors found that HPV‐positive/p16 overexpression, not other tested markers, was a better outcome predictor. The different results may be due to different frequency of HPV positive in different geographic locations (10% in the Spain cohort vs 78% in our study) and different methods in HPV detection used (PCR‐based in Mena et al and in situ‐based in current study). We have also identified smoking history, tumor staging, and treatment as independent factors that can predict the outcomes.…”
“…Of the 17 institution‐matched OPSCC studies, the pooled proportion that was HPV‐positive was 0.60 (95%CI: 0.45–0.74), albeit with high heterogeneity of results across studies ( p heterogeneity <0.0001, I 2 = 0.99). On average, the HPV prevalence of OPSCC was 10% higher than SCCUPHN (95%CI: 1–19%; p < 0.0001; Fig.…”
Science searches, observational studies and clinical trials that reported survival rates of patients with SCCUPHN by HPV status were identified. Meta-analysis estimated the prevalence and prognosis (overall survival, OS; progression-free survival, PFS) of SCCUPHN by HPV status, and compared them to studies of oropharyngeal squamous cell carcinoma (OPSCC) from the same institutions and across continents. In 17 SCCUPHN studies (n = 1,149) and 17 institution-matched OPSCC studies (n = 6,522), the pooled HPV prevalence of SCCUPHN was 49%, which was only 10% (95%CI: 1-19%) lower than OPSCC prevalence in the underlying population. Estimated 5-year OS for HPV-negative SCCUPHN was 44% (95%CI: 36-51%) vs. HPV-positive SCCUPHN of 91% (95%CI: 86-96%); hazard ratio (HR) for OS was 3.25 (95%CI: 2.45-4.31) and PFS was 4.49 (95%CI: 2.88-7.02). HRs by HPV status for OPSCC were similar to that in SCCUPHN. While North American SCCUPHNs had higher HPV prevalence than European SCCUPHNs (OR = 2.68 (95%CI: 1.3-5.6)), HR of OS for HPV-negative vs. HPV-positive patients were similar in both continents (HRs of 3.78-4.09). Prevalence of HPV among SCCUPHN patients were lower than in OPSCC. The survival benefit conferred by being HPV-positive was similar in SCCUPHN as in OPSCCs, independent of continent.
“…Detection of HPV-DNA, in combination with p16 and/or HPV mRNA evaluation, represents one of the most reliable diagnostic approaches for the identification of HPV-driven OPSCCs. 15 Staining for p16 alone, without confirmation of HPV status with an HPV-specific test, will negatively affect the clinical management of p16 þ /HPV À patients. 16 Both direct and indirect methods for the detection of HPV-DNA on FFPE tissues have been used.…”
Context.— The improved survival and better response to treatments of human papillomavirus (HPV)–related oropharyngeal squamous cell carcinoma (OPSCC) highlight the need for effective tools in evaluating HPV status on formalin-fixed, paraffin-embedded (FFPE) cancer tissues. To date, there is no agreement regarding the most appropriate method for HPV testing on FFPE materials. Objective.— We aimed to investigate the performance of the Anyplex II HPV28 (Anyplex) on FFPE OPSCC tissues and to compare it with 2 other methods for HPV-DNA detection and p16 overexpression. Design.— One hundred sixty FFPE OPSCCs were evaluated, which had already been analyzed with the INNO-LiPA HPV assay, Xpert HPV assay, and p16 immunostaining. Results.— All the samples but 1 provided valid results with the Anyplex, which showed the highest HPV detection rate and a good concordance with all the other methods (κ = 0.75, 95% CI, 0.65–0.85 versus INNO-LiPA; κ = 0.80, 95% CI, 0.70–0.89 versus Xpert; κ = 0.76, 95% CI, 0.65–0.86 versus p16). Moreover, the HPV-driven fraction, based on HPV-DNA and p16 double positivity, was higher with Anyplex (83 of 159, 52.2%) than with the other 2 assays, that is, 78 of 156 (50.0%) for INNO-LiPA and 80 of 160 (50.0%) for Xpert. Conclusions.— Anyplex II HPV28 showed a higher HPV detection rate and HPV-associated fraction than the other methods used. This assay is suitable for HPV detection in archival OPSCC tissues.
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