Abstract 927P
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 1st 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 p16INK4a 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
| OPC | HP | LX | NP | OC | ||||||
| P1 n=669 | P2 n=923 | P1 n=213 | P2 N=271 | P1 n=293 | P2 n=346 | P1 n=141 | P2 n=166 | P1 n=436 | P2 n=565 | |
| Germany | 29.7 (23.1-36.9) | 48.1 (41.8-54.3) | 1.4 (0.0-7.5) | 5.1 (1.4-12.6) | 0 | 3.6 (1.2-8.3) | 18.2 (2.3-51.8) | 13.0 (2.8-33.6) | 1.2 (0.0-6.7) | 0 |
| Italy | 20.8 (12.4-31.5) | 37.2 (28.6-46.4) | 0 | 10.7 (2.3-28.2) | 1.9 (0.0-10.1) | 2.1 (0.1-11.1) | 6.7 (0.2-31.9) | 0 | 1.0 (0.0-5.2) | 0.9 (0.0-4.9) |
| Japan | 45.1 (38.3-52.0) | 52.3 (46.0-58.6) | 0 | 0 | 5.0 (0.6-16.9) | 0 | 3.4 (0.4-11.7) | 7.7 (2.5-17.0) | 0 | 0 |
| Portugal | 0 | 20.0 (11.6-30.8) | 0 | 0 | 5.1 (0.6-17.3) | 4.0 (0.5-13.7) | 0 | 12.5 (0.3-52.7) | 0 | 0 |
| Spain | 9.3 (5.4-14.7) | 24.2 (18.6-30.5) | 0 | 0 | 1.6 (0.0-8.7) | 1.6 (0.0-8.7) | 2.3 (0.1-12.0) | 5.3 (1.1-14.6) | 1.6 (0.2-5.6) | 1.2 (0.1-4.2) |
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.
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