The BROADEN study: The design of an observational study to assess the absolute burden of HPV-related head and neck cancers

Morais, Edith; Kothari, Smita; Chen, Ya-Ting; Roberts, C.S.; Gómez, David Rodríguez; Fenoll, Raquel; Lara, Núria; Pavón, Miquel Ángel; Waterboer, Tim; Mehanna, Hisham; Giuliano, Anna R.; Mirghani, Haïtham; Alemany, Laia

doi:10.1016/j.cct.2021.106631

Cited by 4 publications

(7 citation statements)

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“…BROADEN-China will not only contribute to global knowledge of HPV-AFs on OPC, but also NPC, especially in Southern China where NPC is more prevalent compared with Europe and the USA 21 23. In China, NPC is characterised by distinct gender, ethnic and geographical distribution, with 2.5 times greater prevalence in males than in females, and substantially higher rates observed among the Cantonese population in Southern China 24.…”

Section: Discussionmentioning

confidence: 99%

“…The inclusion and exclusion criteria, HNC identification algorithm and HPV testing are aligned with the BROADEN-Global publication 21. Briefly, we will include over 18-year-old patients with primary HNC with pretreatment specimens available for HPV testing during the defined study period.…”

Section: Methods and Analysismentioning

confidence: 99%

“…The study will further explore the time The inclusion and exclusion criteria, HNC identification algorithm and HPV testing are aligned with the BROADEN-Global publication. 21 Briefly, we will include over 18-year-old patients with primary HNC with pretreatment specimens available for HPV testing during the defined study period. We used a list of International Classification of Diseases, 10th revision (ICD-10) codes to define the HNC diagnosis for this study (online supplemental table 1).…”

Section: Methods and Analysis Study Design And Objectivesmentioning

confidence: 99%

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Assessing the burden of HPV-related head and neck cancers in mainland China: protocol of a nationwide, multisite, cross-sectional study

Wang,

Song,

et al. 2023

BMJ Open

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BackgroundPersistent human papillomavirus (HPV) infection is a known cause of a subset of head and neck cancers (HNCs). In the last two decades, the proportion of HNCs attributable to HPV infection has increased worldwide, notably the oropharyngeal cancers. However, the trend of HPV-related HNC burden is not clearly understood yet in China. Thus, the absoluteburdenof HPV-related head andneck cancers in China (BROADEN-China) will be conducted to estimate the proportion of HNCs attributable to HPV infection, per anatomic site, by genotype, in three time periods (2008–2009, 2013–2014 and 2018–2019).Methods and analysisBROADEN-China is a nationwide, multisite, cross-sectional study. A stratified, multistage, non-randomised cluster sampling method will be used to select 2601 patients with HNC from 14 hospitals across seven regions, based on population density in China. Patients with formalin-fixed paraffin-embedded tissue samples collected prior to treatment induction during three time periods will be included, and factors (eg, smoking status, alcohol consumption, betel nut chewing, Epstein-Barr virus, teeth loss, etc) associated with HNC will be assessed. HPV testing (HPV-DNA, HPV-mRNA and p16INK4aimmunohistochemistry) and histological diagnosis of the tissue samples will be conducted at a central laboratory.The study protocol and all required documents have been submitted for review and approval to the Independent Ethics Committees of all the participating sites. The informed consent was waived for all participants and all the recorded data will be treated as confidential.We have included 14 hospitals as our participating sites, of which Henan Cancer Hospital is the leading site. The study has been approved by the independent ethics committees of the leading site on 3 December 2020. The other 13 participating site names of ethics committee and IRB that have approved this study.

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Section: Discussionmentioning

confidence: 99%

Section: Methods and Analysismentioning

confidence: 99%

Section: Methods and Analysis Study Design And Objectivesmentioning

confidence: 99%

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Assessing the burden of HPV-related head and neck cancers in mainland China: protocol of a nationwide, multisite, cross-sectional study

Wang,

Song,

et al. 2023

BMJ Open

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“…Prevalence, incidence, and persistence of oral HPV in women and men, as well as the factors associated with oral infection, will be assessed in the PROGRESS study [50], whereas the main objective of the BROADEN study is to define the proportion of head and neck cancers attributable to HPV by anatomic site. [51]. The efficacy of the 9 valent HPV vaccine against persistent oral HPV in men will be evaluated in a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in which 6000 participants will be recruited [52,53].…”

Section: Discussionmentioning

confidence: 99%

A clinician’s dilemma: what should be communicated to women with oncogenic genital HPV and their partners regarding the risk of oral viral transmission?

et al. 2022

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Head and neck cancer, the sixth most common cancer worldwide, account for about 1 out of 20 malignant tumors. In recent years a reduction in the incidence of cervical cancer, but a concomitant major increase in the incidence of HPV-mediated oropharyngeal cancer caused by orogenital HPV transmission has been observed. Consequently, in wealthy countries oropharyngeal squamous-cell carcinomas (OPSCC) is now the most frequent HPV-related cancer, having overtaken cervical cancer. Without effective medical interventions, this incidence trend could continue for decades. As no specific precursor lesion has been consistently identified in the oral cavity and oropharynx, HPV vaccination is the logical intervention to successfully counteract also the rising incidence of OPSCCs. However, HPV vaccine uptake remains suboptimal, particularly in males, the population at higher risk of OPSCC. Alternative primary prevention measures, such as modifications in sexual behaviors, could be implemented based on knowledge of individual genital HPV status. Until recently, this information was not available at a population level, but the current gradual shift from cytology (Pap test) to primary HPV testing for cervical cancer screening is revealing the presence of oncogenic viral genotypes in millions of women. In the past, health authorities and professional organizations have not consistently recommended modifications in sexual behaviors to be adopted when a persistent high-risk HPV cervicovaginal infection was identified. However, given the above changing epidemiologic scenario and the recent availability of an immense amount of novel information on genital HPV infection, it is unclear whether patient counseling should change. The right of future partners to be informed of the risk could also be considered. However, any modification of the provided counseling should be based also on the actual likelihood of a beneficial effect on the incidence of HPV-associated oropharyngeal cancers. The risk is on one side to induce unjustified anxiety and provide ineffective instructions, on the other side to miss the opportunity to limit the spread of oral HPV infections. Thus, major health authorities and international gynecologic scientific societies should issue or update specific recommendations, also with the aim of preventing inconsistent health care professionals’ behaviors.

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“…The BROADEN Japan study is part of a large multi-country, noninterventional, cross-sectional study of patients diagnosed with HNC. 27 The present analysis is focused on the burden of HPV-driven HNC in Japan. This study was designed to estimate the fraction of HNC that was attributable to HPV per anatomic site (oropharynx, hypopharynx, larynx, nasopharynx, and oral cavity) during two different time periods (2008-2009 and 2018-2019).…”

Section: Study Design and Patientsmentioning

confidence: 99%

Human papillomavirus‐driven head and neck cancers in Japan during 2008–2009 and 2018–2019: The BROADEN study

Nibu,

Oridate,

Saito

et al. 2024

Cancer Science

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There is limited understanding of epidemiology and time trends of human papilloma virus (HPV)‐driven head and neck cancers (HNC) in Japan, especially outside of the oropharynx. To assess HPV‐driven HNC, a non‐interventional study (BROADEN) of HNC patients diagnosed in 2008–2009 and 2018–2019 was conducted in Japan. Adult patients with oropharyngeal, nasopharyngeal, laryngeal, hypopharyngeal or oral cavity cancers were included in this study. HPV was centrally tested using p16INK4a immunohistochemistry, HPV‐DNA PCR and HPV E6*I mRNA. HPV attributability required positivity in at least two tests (p16INK4a immunohistochemistry, HPV‐DNA PCR, HPV E6*I mRNA) in the oropharynx, and HPV‐DNA and HPV E6*I mRNA positivity for non‐oropharynx sites. Nineteen hospitals included a total of 1108 patients, of whom 981 had valid samples. Men accounted for 82% of HNC diagnoses. Patients in the earlier cohort were younger and included a higher percentage of smokers. There was an increasing trend of HPV‐driven oropharyngeal cancer over the last decade, from 44.2% to 51.7%. HPV attribution in nasopharyngeal cancers was 3.2% in 2008–2009 and 7.5% in 2018–2019; and 4.4% and 0% for larynx respectively. In total, 95.2% of HPV‐driven HNC were attributed to HPV genotypes included in the 9‐valent HPV vaccine being HPV16 the most prominent genotype. These results suggest that an epidemiologic shift is happening in Japan, with a decrease in smoking and alcohol use and an increase in HPV‐driven HNC. The increasing trend of HPV‐driven HNC in Japan highlights the need for preventive strategies to mitigate the rise of HPV‐driven HNC.

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The BROADEN study: The design of an observational study to assess the absolute burden of HPV-related head and neck cancers

Cited by 4 publications

References 32 publications

Assessing the burden of HPV-related head and neck cancers in mainland China: protocol of a nationwide, multisite, cross-sectional study

Assessing the burden of HPV-related head and neck cancers in mainland China: protocol of a nationwide, multisite, cross-sectional study

A clinician’s dilemma: what should be communicated to women with oncogenic genital HPV and their partners regarding the risk of oral viral transmission?

Human papillomavirus‐driven head and neck cancers in Japan during 2008–2009 and 2018–2019: The BROADEN study

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