HN 08-08: Diagnosis of HPV driven head and neck cancer: Comparing p16 based algorithms with the RNAscope HPV-test

22. HPV and oropharynx / Head and neck cancer
H. Mirghani 1, O. Casiraghi 2, M. Xiao-Jun 3, J. Lacau St Guly 4, C. Badoual 5, I. Borget 6, V. Dalstein 7, P. Vielh 8.
1Department of Otolaryngology – Head and Neck Surgery, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, Villejuif, France (France), 2Department of Pathology, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, Villejuif, France (France), 3Advanced Cell Diagnostics, 3960 Point Eden Way, Hayward, CA 94545, USA (United States), 4Department of Otolaryngology-Head and Neck Surgery, Hôpital Tenon, Assistance Publique-Hôpitaux de Paris, France. (France), 5Department of Pathology, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, France. (France), 6Department of Biostatistics and Epidemiology, Gustave Roussy Cancer Campus and University Paris-Sud, Villejuif, France (France), 7INSERM UMR-S 903, , SFR CAP-Santé FED 4231, Université de Reims Champagne-Ardenne, F-51100 Reims, France (France), 8Department of Biopathology, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, Villejuif, France (France)

Background / Objectives

Accurate identification of HPV-driven oropharyngeal cancer (OPC) is a major issue and none of the current diagnostic approaches is ideal. An in situ hybridization (ISH) assay that detects high-risk HPV E6/E7 mRNA, called the RNAscope HPV-test, has been recently developed. Studies have suggested that this assay may become a standard to define HPV-status.


Methods

To further assess this test, we compared its performance against the strategies that are used in routine clinical practice: p16 immunohistochemistry (IHC) as a single test and algorithms combining p16-IHC with HPV-DNA identification by PCR (algorithm-1) or ISH (algorithm-2). 


Results

105 OPC specimens were analyzed. The prevalence of HPV-positive samples varied considerably: 67% for p16-IHC, 54% for algorithm-1, 61% for algorithm-2 and 59% for the RNAscope HPV-test. Discrepancies between the RNAscope HPV-test and p16-IHC, algorithm-1 and 2 were noted in respectively 13.3%, 13.1%, and 8.6%.

The 4 diagnostic strategies were able to identify 2 groups with different prognosis according to HPV-status, as expected. However, the greater survival differential was observed with the RNAscope HPV-test [HR: 0.19, 95% confidence interval (CI), 0.07–0.51, p=0.001] closely followed by algorithm-1 (HR:0.23, 95% CI, 0.08–0.66, p=0.006) and algorithm-2 (HR:0.26, 95% CI, 0.1–0.65, p=0.004). In contrast, a weaker association was found when p16-IHC was used as a single test (HR: 0.33, 95% CI, 0.13–0.81, p=0.02).


Conclusion

Our findings suggest that the RNAscope HPV-test and p16-based algorithms perform better that p16 alone to identify OPC that are truly driven by HPV-infection. The RNAscope HPV-test has the advantage of being a single test. 


References