Diagnosis of HPV driven oropharyngeal cancers: Comparing p16 based algorithms with the RNAscope HPV-test

Publication date: November 2016
Source:Oral Oncology, Volume 62
Author(s): Haïtham Mirghani, Odile Casiraghi, Joanne Guerlain, Furrat Amen, Ming-Xiao He, Xiao-Jun Ma, Yuling Luo, Céline Mourareau, Françoise Drusch, Aïcha Ben Lakdhar, Antoine Melkane, Lacau St Guily, Cécile Badoual, Jean Yves Scoazec, Isabelle Borget, Anne Aupérin, Veronique Dalstein, Philippe Vielh
BackgroundAccurate 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.MethodsTo 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).Results105 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).ConclusionsOur 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.



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