Diagnosis of HPV driven oropharyngeal cancers: Comparing p16 based algorithms with the RNAscope HPV-test. (November 2016)

• Record Type: Journal Article
• Authors: Mirghani, Haïtham; Casiraghi, Odile; Guerlain, Joanne; Amen, Furrat; He, Ming-Xiao; Ma, Xiao-Jun; Luo, Yuling; Mourareau, Céline; Drusch, Françoise; Lakdhar, Aïcha Ben; Melkane, Antoine; St Guily, Lacau; Badoual, Cécile; Scoazec, Jean Yves; Borget, Isabelle; Aupérin, Anne; Dalstein, Veronique; Vielh, Philippe
• Is Part Of: Oral oncology. Volume 62(2016:Nov.)
• Page Start: 101
• Page End: 108
• Publication Date: 2016-11
• Subjects: Oropharyngeal -- Oropharynx -- Head and neck cancer -- Human papillomavirus 16 -- E6/E7 mRNA/ transcripts -- RNAscope HPV-test® -- P16 immunostaining -- In situ hybridization; Mouth -- Cancer -- Periodicals; Mouth -- Tumors -- Periodicals; Mouth Diseases -- Periodicals; Mouth Neoplasms -- Periodicals; Bouche -- Cancer -- Périodiques; Bouche -- Tumeurs -- Périodiques; Tumeurs -- Périodiques; Electronic journals; 616.9943105
• DOI: 10.1016/j.oraloncology.2016.10.009
• Languages: English
• ISSNs: 1368-8375

Abstract

Highlights: The RNAscope HPV-test is a recent assay that detects high-risk HPV E6/E7 mRNA in FFPE samples. It performs as well as p16-based algorithms to identify oropharyngeal cancers that are truly driven by HPV-infection. The RNAscope HPV-test has the advantage of being a single test. Abstract: Background: 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). Conclusions: 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.