Impact of p16-overexpression on overall and progression-free survival outcomes in oral cavity squamous cell carcinomas: A semi-national, population-based study.

OBJECTIVES: Human papillomavirus infection and p16-overexpression is a principal cause and favorable prognostic factor for oropharyngeal squamous cell carcinomas but the value as prognostic marker in oral cavity squamous cell carcinomas (OSCC) is undetermined. MATERIALS AND METHODS: All patients diagnosed with OSCC in Eastern Denmark in the period 2008-2014 were enrolled. Survival estimates were evaluated as overall survival (OS) and progression free survival (PFS) by Kaplan-Meier survival curves and multivariate Cox-regression analyses. RESULTS: We included 575 patients from which 13% (n = 69) had p16-positive tumors. The 5-year OS were 55% and 62% for the p16-negative and p16-positive patients, respectively, and the 5-year PFS were 48% and 50%. In a multivariate survival analysis, p16-positivity showed no significant influence on OS (HR: 1.06 [0.67-1.70], p = 0.79) and PFS (HR: 1.11 [0.76-1.63], p = 0.58). CONCLUSION: In this population-based cohort of non-selected OSCC patients, we found no difference in survival outcomes when stratified on p16-overexpression status.

Reliability and validity of The Danish pediatric voice handicap index.

BACKGROUND: The pediatric voice handicap index (pVHI) questionnaire was developed in 2006 to provide parental information regarding the impact of a voice disorder on their child's life. OBJECTIVES: The aim of this study was to make a Danish version of the original American pVHI and to validate the Danish pVHI by evaluating its internal consistency and reliability. MATERIALS AND METHODS: The original version of the pVHI was translated into Danish. Nineteen parents of dysphonic children, diagnosed in a tertiary otolaryngology hospital department, and 43 parents of children without known voice disorder (control group) completed the questionnaire. The internal consistency, content validity including comparisons of the scores in the two groups and the test-retest reliability were assessed through statistical analysis. RESULTS: The total pVHI scores significantly differed between the group of parents with dysphonic children and the group of parents with children without known voice disorder (p < 0.001). The internal consistency showed an excellent consistency (Chronbach's α > 0.9) of the three subdomains score and the total pVHI score. The test-re-test reliability of the total pVHI score was "strong" with a Pearson's correlation coefficient of 0.97. CONCLUSIONS AND SIGNIFICANCE: The Danish pVHI is a valid and reliable instrument to assess the parents' perception of the impact of a voice disorder on a child's physical, social and emotional well-being.

The Copenhagen Oral Cavity Squamous Cell Carcinoma database: protocol and report on establishing a comprehensive oral cavity cancer database.

OBJECTIVE: The aim was to establish a large comprehensive database of patients with oral cavity squamous cell carcinoma (OSCC) to enable surveillance and research of the disease. METHODS: All patients diagnosed and/or treated for OSCC at Rigshospitalet, University of Copenhagen, Denmark in the period 2000-2014 were included. Rigshospitalet is a tertiary treatment center and covers the Eastern Denmark region, comprising nearly half of the approximately 5.8 million inhabitants of Denmark. Data on numerous variables regarding general information of the patients at diagnosis, their primary cancer, recurrence, treatment, prior cancers, and secondary cancers were collected from the Danish Pathology Register and by evaluation of medical charts. RESULTS: One thousand three hundred and ninety-nine OSCC patients were included in the database (62% males). The median age at diagnosis was 63 years (range: 23-99 years). The most common anatomical location was the floor of mouth (38%). Among patients with known stage, 70.0% were diagnosed in T-stage 1 or 2 and 64.9% were diagnosed in N-stage 0. Most patients were treated with primary surgery (81.7% among patients with known treatment), of these 44% received adjuvant radiotherapy after surgery. The overall age-standardized incidence of OSCC per 100,000 increased from 2.15 in 2000 to 3.04 in 2014, with a significant annual percent change of 3.2%. CONCLUSION: We have established a consecutive, population-based database of 1,399 OSCC patients. This creates a basis for multiple studies that will elaborate our understanding of OSCC, and hopefully improve diagnosis, treatment, and rehabilitation of OSCC patients.

Therapeutic human papillomavirus vaccines in head and neck cancer: A systematic review of current clinical trials.

OBJECTIVES: This systematic review provides an overview of the current clinical trials investigating therapeutic vaccines for HPV+ head and neck cancer and discusses the future directions of therapeutic vaccine therapy. MATERIALS AND METHODS: A systematic search was conducted in PubMed, EMBASE, Cochrane and clinicaltrials.gov for clinical trials involving therapeutic vaccines. We included studies initiated between 2000 and 2018 with patients diagnosed with HPV+ head and neck cancer and extracted data concerning type of vaccine therapy, adverse events, immunogenicity and clinical outcome measures (e.g. tumour response, progression-free survival and overall survival). RESULTS: We identified 11 studies (n = 376 patients) initiated between year 2005 and 2017. Four studies (n = 34) presented preliminary results in patients with incurable, recurrent loco-regional or distant metastatic disease indicating a positive immune response with 74% (n = 25/34 patients) having elevated antibody levels, IFN-γ and/or T-cell response. Five studies presented data on the vaccines' safety profile, demonstrating predominantly grade 1 and 2 toxicity. Three studies evaluated the clinical outcome - one study showed no complete or partial response, one study demonstrated stable disease as the best tumour response in 64% (n = 9/14 patients) and one study showed a 33% overall response rate: one patient with a complete response and seven patients with a partial response. CONCLUSIONS: Treatment with therapeutic vaccines is a promising and seemingly safe strategy for patients with HPV+ head and neck cancer. However, there are not enough data to draw any further conclusions and clinical outcome measures and tumour responses to the vaccines are still missing.