927P - Preliminary results of the BROADEN study: Burden of human papillomavirus-related head and neck cancers

Background

Human papillomavirus (HPV) has emerged as a significant risk factor for some head and neck cancers (HNC). The BROADEN study estimates the HPV attributable fraction (HPV-AF) in oropharyngeal cancers (OPC) and non-oropharyngeal cancers (non-OPC) in two time periods in several countries using a combination of testing methods.

Methods

This observational study included pre-treatment tumor tissue from patients with a 1^st primary diagnosis of oropharynx, hypopharynx (HP), larynx (LX), nasopharynx (NP), and oral cavity (OC) cancers in 2008-2009 (period 1, P1) and 2018-2019 (P2). HPV was tested in central laboratories using p16^INK4a immunohistochemistry, HPV-DNA PCR, and HPV E6*I mRNA. HPV attributability was defined by HPV positivity in at least two tests for OPC and positivity in HPV-DNA and mRNA for non-OPC.

Results

The results presented are for Germany, Italy, Portugal, Spain, and Japan. Overall, 4492 patients were included at 63 hospitals, yielding 4023 valid samples. Patients were predominantly male (78.9%) with a mean age at diagnosis of 63.6 years. The table presents HPV-AF in % (95% CI) by country and anatomic location per period. Table: 927P

Conclusions

BROADEN is the world-wide largest observational study allowing direct comparison of HPV-AF across multiple HNC sites and countries over time. Although highlighting geographical differences, our results provide evidence for a common, notable rise in HPV-driven OPC within 10 years, and support HPV vaccination programs in both genders.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Merck Sharp & Dohme Corp.

Funding

Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc.

Disclosure

L. Alemany: Financial Interests, Advisory Board: Merck & Co; Financial Interests, Other: Roche, GSK, IDT, Hologic, Seegene. K. Nibu, N. Oridate: Financial Interests, Advisory Role: Merck & Co. E. Morais: Other, Affiliate: MSD France. C. Roberts, Y. Chen: Other, Affiliate: Merck & Co. J. Spitzer: Other, Personal and Institutional, Affiliate: Merck & Co. M. Roset, M.L. Torres, D. Cuadras: Other, Affiliate: IQVIA. H. Mehanna: Financial Interests, Personal and Institutional, Advisory Board: Merck & Co; Financial Interests, Other: AstraZeneca, Seagen, Nanobiotix; Financial Interests, Stocks/Shares: Warwickshire Head Neck Clinic, Docspert. H. Mirghani, A. Giuliano: Financial Interests, Advisory Board: Merck & Co. M. Pavón: Financial Interests, Advisory Board: Merck & Co; Financial Interests, Other: Roche, GSK, IDT, Hologic; Financial Interests, Officer: Seegene. T. Waterboer: Financial Interests, Advisory Board: Merck & Co.