Dataset Information

Human Papillomavirus and Oropharyngeal Cancer Among Indigenous Australians: Protocol for a Prevalence Study of Oral-Related Human Papillomavirus and Cost-Effectiveness of Prevention.

ABSTRACT:

Background

Oropharyngeal cancer is an important, understudied cancer affecting Aboriginal and Torres Strait Islander Australians. The human papillomavirus (HPV) is a significant risk factor for oropharyngeal cancer. Current generation HPV vaccines are effective against the 2 most common types of high-risk HPVs in cancer (hrHPVs 16/18).

Objectives

This study aims (1) to yield population estimates of oncogenic genotypes of HPV in the mouth and oropharynx of defined Aboriginal and Torres Strait Islander populations; (2) to estimate the proportion of oropharyngeal cancer attributable to HPV among these Australian citizens; (3) to estimate the impact of HPV vaccination as currently implemented on rates of oropharyngeal cancer among Aboriginal and Torres Strait Islander Australians; and (4) taking into account impact on oropharyngeal as well as cervical cancer, to evaluate efficacy and cost-effectiveness of targeted extended HPV vaccination to older ages, among our study population.

Methods

Our study design and operation is straightforward, with minimal impost on participants. It involves testing for carriage of hrHPV in the mouth and oropharynx among 1000 Aboriginal South Australians by simple saliva collection and with follow-up at 12 and 24 months, collection of sexual history at baseline, collection of information for estimating health state (quality-of-life) utilities at baseline, genotyping of viruses, predictive outcome and cost-effectiveness modeling, data interpretation and development of vaccination, and follow-up management strategies driven by the Aboriginal community.

Results

Participant recruitment for this study commenced in February 2018 and enrollment is ongoing. The first results are expected to be submitted for publication in 2019.

Conclusions

The project will have a number of important outcomes. Synthesis of evidence will enable generation of estimates of the burden of oropharyngeal cancer among Aboriginal and Torres Strait Islander Australians and indicate the likely effectiveness and cost-effectiveness of prevention. This will be important for health services planning, and for Aboriginal health worker and patient education. The results will also point to important areas where research efforts should be focused to improve outcomes in Aboriginal and Torres Strait Islander Australians with oropharyngeal cancer. There will be a strong focus on community engagement and accounting for the preferences of individuals and the community in control of HPV-related cancers. The project has international relevance in that it will be the first to systematically evaluate prevention of both cervical and oropharyngeal cancer in a high-risk Indigenous population taking into account all population, testing, and surveillance options.

Registered report identifier

RR1-10.2196/10503.

SUBMITTER: Jamieson L

PROVIDER: S-EPMC6015268 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Human Papillomavirus and Oropharyngeal Cancer Among Indigenous Australians: Protocol for a Prevalence Study of Oral-Related Human Papillomavirus and Cost-Effectiveness of Prevention.

Jamieson Lisa L Garvey Gail G Hedges Joanne J Mitchell Amanda A Dunbar Terry T Leane Cathy C Hill Isaac I Warren Kate K Brown Alex A Ju Xiangqun X Roder David D Logan Richard R Johnson Newell N Smith Megan M Antonsson Annika A Canfell Karen K

JMIR research protocols 20180608 6

<h4>Background</h4>Oropharyngeal cancer is an important, understudied cancer affecting Aboriginal and Torres Strait Islander Australians. The human papillomavirus (HPV) is a significant risk factor for oropharyngeal cancer. Current generation HPV vaccines are effective against the 2 most common types of high-risk HPVs in cancer (hrHPVs 16/18).<h4>Objectives</h4>This study aims (1) to yield population estimates of oncogenic genotypes of HPV in the mouth and oropharynx of defined Aboriginal and To ...[more]

PMID: 29884604

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Project description:IntroductionThe incidence of oropharyngeal squamous cell carcinoma (OPSCC) is increasing globally, reflecting an increase in human papillomavirus (HPV)-related lesions. Indigenous populations are disproportionately affected by OPSCCs. Currently, testing for oral HPV is not recommended as a screening tool to permit early detection of OPSCCs due to the high population prevalence of HPV infection. Periodontitis may be a marker of oral HPV infection, but previous research evaluating this association has been inconclusive. Here we report a large population-based study examining the association between high-risk oral HPV infection and periodontitis among Indigenous South Australians.MethodsWe utilised a large convenience sample of Indigenous South Australians aged 18+ years recruited between February 2018 and February 2020. Of the original cohort (n = 1011), 748 (73.9%) participants participated in the 12 month follow-up. Detailed information on sociodemographic characteristics, health-related behaviours, and sexual history were collected at enrolment. Saliva samples were collected at 12 months and tested for the presence of oral HPV DNA using the optimized general primer (GP) + PCR system. The primary outcomes were the prevalence of any high-risk oral HPV DNA, and separately, HPV 16 and/or 18. Periodontitis was assessed at follow-up by using validated self-reported periodontitis screening questions. Logistic regression analyses were undertaken to assess the association between self-reported periodontitis and oral HPV infection with adjustment for potential sociodemographic and behavioural confounders, with estimates presented as odds ratios (OR) and 95% confidence interval (CI).ResultsData on 673 participants (89.9% of the follow-up cohort) were available. Participants ranged in age from 18 to 80 (mean age 42.2, SD 14.7) and 31.5% were male. Overall, 115 (17.1%) participants had self-reported periodontitis, 40 (5.9%) had any high-risk oral HPV and 14 (2.1%) had HPV 16 and/or 18. Any high-risk HPV was detected among seven (17.5%) participants and HPV 16 and/or 18 was detected in three (21.4%) who self-reported periodontitis. In the regression analyses no significant association was found between self-reported periodontitis and high-risk oral HPV (adjusted OR: 1.10; 95% CI: 0.45-2.70) or HPV 16 and/or 18 (adjusted OR: 1.27; 95% CI: 0.32-5.03).ConclusionThis study did not find any association between self-reported periodontitis and high-risk oral HPV among Indigenous South Australians. Further targeted studies with standardized clinical measures of periodontal disease are needed to clarify the link between high-risk oral HPV and periodontal disease. If confirmed this would add further weight to the importance of recommendations about the utility of periodontitis screening to identify individuals at risk of carrying high-risk oral HPV, who may benefit from more intensive screening and ongoing monitoring.

Project description:PurposeOur aims are to: (1) estimate prevalence, incidence, clearance and persistence of oral human papillomavirus (HPV) infection among Indigenous Australians; (2) identify risk factors associated with oropharyngeal squamous cell carcinoma (OPSCC)-related HPV types (HPV 16 or 18); (3) develop HPV-related health state valuations and; (4) determine the impact on OPSCC and cervical cancers, and the cost-effectiveness of extending publicly-funded HPV vaccination among Indigenous Australians.ParticipantsParticipants were recruited from February 2018 to January 2019. Twelve-month follow-up occurred from March 2019 to March 2020. Participants provided socio-demographic characteristics, health-related behaviours including tobacco and alcohol use and sexual history. Health state preferences in regard to HPV vaccination, knowledge regarding HPV infection, OPSCC and cervical cancer were collected using a two-stage standard gamble approach. Participants provided saliva samples and DNA for microbial genotyping was extracted.Findings to dateOf the 910 participants who were positive for β-globin at baseline, 35% had any oral HPV infection. The most prevalent HPV types were 13 or 32 (Heck's disease; 23%). The second most prevalent types were associated with OPSCC (HPV 16 or 18; 3.3%). Of the 645 participants who were positive for β-globin at 12-month follow-up, 43% had any HPV infection. Of these, 33% were HPV types 13 or 32 and 2.5% were HPV 16 or 18. Some 588 participants had β-globin positive oral samples at baseline and 12-month follow-up. The prevalence of any oral HPV infection increased from 34% at baseline to 44% at 12-month follow-up; due to increases in HPV types 13 or 32 (20% at baseline and 34% at 12-month follow-up).Future plansFurther funding will be sought to continue follow-up of this cohort, and to include (after a full medical history) a thorough clinical examination of the external head and neck; a complete oral examination and examination of the oropharynx. Blood tests for early stage OPSCC will also be undertaken.

Project description:BackgroundOropharyngeal squamous cell carcinoma (OPSCC) is associated with high mortality. Human papillomavirus (HPV) infection is a significant risk factor for OPSCC. Utilities are fundamental values representing the strength of individuals' preferences for specific health-related outcomes. Our study aim was to work in partnership with Indigenous communities in South Australia to develop, pilot test and estimate utility scores for health states related to HPV, HPV vaccination, precursor OPSCC and its treatment, and early stage OPSCC among Indigenous Australians.MethodsDevelopment and pilot testing of hypothetical HPV and OPSCC health states, specifically through the lens of being Indigenous Australian, was conducted with an Indigenous Reference Group. Six health states were decided upon, with utility scores calculated using a two-stage standard gamble approach among a large convenience sample of Indigenous Australians aged 18+ years residing in South Australia. The rank, percentage of perfect health and utility score of each health state was summarised using means, and medians at 12 months and lifetime duration. Potential differences by age, sex and residential location were assessed using the Wilcox Rank Sum test.ResultsData from 1011 participants was obtained. The mean utility scores decreased with increasing severity of health states, ranging from 0.91-0.92 in 'screened, cytology normal, HPV vaccination' and 'screened, HPV positive, endoscopy normal', to less than 0.90 (ranging from 0.87-0.88) in lower grade conditions (oral warts and oral intraepithelial neoplasia) and less than 0.80 (ranging from 0.75-0.79) in 'early stage throat cancer'. Higher utility scores were observed for 'screened, cytology normal and HPV vaccination' among younger participants (18-40 years), for 'early stage invasive throat cancer' among females, and for 'oral intraepithelial neoplasia' and 'early stage invasive throat cancer' among metropolitan-dwelling participants.ConclusionAmong a large sample of Indigenous Australians, utility for oral HPV infection and OPSCC decreased with severity of health states. Older participants, as well as males and those residing in non-metropolitan locations, had decreased utility for high-grade cytology and early invasive cancer states. Our findings are an important contribution to cost-utility and disease prevention strategies that seek to inform policies around reducing HPV infection and OPSCC among all Australians.

Project description:ImportanceHuman papillomavirus-related oropharyngeal carcinoma (HPV-OPC) is increasing in incidence in the United States. Although HPV-OPC has favorable prognosis, 10% to 25% of HPV-OPCs recur. Detection of human papillomavirus (HPV) DNA in oral rinses is associated with HPV-OPC, but its potential as a prognostic biomarker is unclear.ObjectiveTo determine whether HPV DNA detection in oral rinses after treatment for HPV-OPC is associated with recurrence and survival.Design, setting, and participantsProspective cohort study of patients with incident HPV-OPC diagnosed from 2009 to 2013 at 4 academic tertiary referral cancer centers in the United States. Oral rinse samples were collected at diagnosis and after treatment (9, 12, 18, and 24 months after diagnosis), and evaluated for HPV DNA. Among an initial cohort of 157 participants with incident HPV-OPC treated with curative intent, 124 had 1 or more posttreatment oral rinses available and were included in this study.Main outcomes and measuresDisease-free survival (DFS) and overall survival (OS) were estimated by the Kaplan-Meier method, and the association of HPV DNA detection in oral rinses with survival was evaluated using Cox regression analysis.ResultsOral HPV type 16 (HPV16) DNA was common at diagnosis (67 of 124 participants [54%]). In contrast, oral HPV16 DNA was detected in only 6 participants after treatment (5%), including 5 with HPV16 DNA also detected at diagnosis (persistent oral HPV16 DNA). Two-year DFS and OS were 92% (95% CI, 94%-100%) and 98% (95% CI, 93%-99%). Persistent oral HPV16 DNA was associated with worse DFS (hazard ratio, 29.7 [95% CI, 9.0-98.2]) and OS (hazard ratio, 23.5 [95% CI, 4.7-116.9]). All 5 participants with persistent oral HPV16 DNA developed recurrent disease, 3 with local disease involvement. In contrast, just 9 of 119 participants (8%) without persistent oral HPV16 DNA developed recurrent disease, only 1 (11%) with local disease involvement. Median (range) time from earliest posttreatment oral HPV16 DNA detection to recurrence was 7.0 (3.7-10.9) months.Conclusions and relevanceHuman papillomavirus type 16 DNA in oral rinses is common at diagnosis but rare after treatment for HPV-OPC. Our data suggest that, although infrequent, persistent HPV16 DNA in posttreatment oral rinses is associated with poor prognosis and is a potential tool for long-term tumor surveillance, perhaps more so for local recurrence.

Dataset Information

Human Papillomavirus and Oropharyngeal Cancer Among Indigenous Australians: Protocol for a Prevalence Study of Oral-Related Human Papillomavirus and Cost-Effectiveness of Prevention.

Background

Objectives

Methods

Results

Conclusions

Registered report identifier

Publications

Human Papillomavirus and Oropharyngeal Cancer Among Indigenous Australians: Protocol for a Prevalence Study of Oral-Related Human Papillomavirus and Cost-Effectiveness of Prevention.

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