Recombinant Human Papilloma Virus type 51 L1 protein (VLP)

OBJECTIVE: To estimate whether targeted educational interventions can increase human papillomavirus (HPV) vaccine acceptability and knowledge among young women. METHODS: An exploratory phase of the study was conducted to determine baseline acceptance of the prophylactic HPV vaccine and barriers to acceptance. Based on the results of that phase of the study, a randomized controlled trial of women aged 12-26 at a single institution was completed. A sample size of at least 84 women in each of three study arms (control, educational handout, or educational video) was planned to detect a 20% difference in vaccine acceptability among arms. All participants completed a survey collecting data on demographics, HPV vaccine preferences, and HPV vaccine knowledge after completion of their randomization assignments. The primary outcome was HPV vaccine acceptability. The secondary outcome was HPV vaccine knowledge. RESULTS: From March 2017 through August 2017, 256 women were randomized to one of three study arms: control (n=85), educational handout (n=84), or educational video (n=87). Demographics were similar between study arms. Overall, 51.7% of participants in the educational video arm reported willingness to accept the HPV vaccine compared with 33.3% and 28.2% of participants in the educational handout and control arms, respectively (P<.01). Those in the educational video and handout arms had higher median HPV vaccine knowledge scores than those in the control arm (6 and 5 vs 3, P<.01). Both interventions were reported as helpful in learning (97.7% vs 92.9%, P=.15), but the educational video arm was more likely to be helpful in deciding on vaccination (86.2% vs 70.2%, P<.01). CONCLUSION: Targeted educational interventions increase HPV vaccine acceptability and knowledge among young women. Follow up studies are needed to determine whether these interventions also increase rates of vaccine uptake and series completion.

Key PointsQuestionWhat and when is the earliest sign of treatment-induced immunosuppression associated with survival in patients with human papillomavirus-negative oropharyngeal cancer? FindingsIn this cohort study of 108 patients undergoing treatment for oropharyngeal cancer, 19 of 65 (29.2%) had grades 3 to 4 lymphopenia 3 months after radiotherapy start, which was associated with worse recurrence-free and overall survival. MeaningPostradiotherapy immunosuppression may be used to identify patients at risk of recurrence. This cohort study assessed whether posttreatment lymphopenia and an elevated ratio of neutrophils to lymphocytes are associated with clinical outcomes in patients with human papillomavirus-negative oropharyngeal cancer after radiotherapy. ImportanceBetter biomarkers are needed for human papillomavirus (HPV)-negative oropharyngeal cancer (OPC) to identify patients at risk of recurrence. Lymphopenia and an elevated ratio of neutrophils to lymphocytes (NLR) have been associated with poor disease outcomes in a number of solid tumors. ObjectiveTo test the hypothesis that postradiotherapy lymphopenia and elevated NLR are associated with poor clinical outcomes. Design, Setting, and ParticipantsThis single-institution retrospective analysis included patients with HPV-negative OPC treated from January 1, 1997, through January 4, 2017. Median follow-up was 37 months (range, 2-197 months). A total of 108 patients with HPV-negative OPC and at least 1 complete blood cell count 2 to 12 months after the start of radiotherapy were included. Data were analyzed from August 26 to September 7, 2017. InterventionsSurgery followed by radiotherapy vs definitive radiotherapy, with or without chemotherapy. Main Outcomes and MeasuresAbsolute lymphocyte (ALC) and absolute neutrophil (ANC) counts were tested as variables affecting locoregional control, recurrence-free survival, and overall survival. ResultsOf a total of 108 patients included in the analysis (87.0% male; mean age, 56 years [range, 35-84 years]), 57 received surgery followed by postoperative radiotherapy and 51 received definitive radiotherapy. During treatment, 67 of 79 patients (84.8%) had grades 3 to 4 lymphopenia and 17 of 79 (21.5%) had grade 4 lymphopenia. The ANC recovered by 6 months after radiotherapy, but ALC remained depressed to 1 year after radiotherapy. Posttreatment lymphopenia and elevated NLR were associated with worse recurrence-free and overall survival. The estimated 3-year LRC in patients with and without grades 3 to 4 lymphopenia at 3 months after radiotherapy start was 73% vs 82% (hazard ratio [HR],0.58; 95% CI, 0.19-1.8); estimated 3-year recurrence-free survival, 36% vs 63% (HR,0.45; 95% CI, 0.23-0.87); and estimated 3-year overall survival, 34% vs 64% (HR,0.45; 95% CI, 0.23-0.88). In multivariable analysis, an association with worse overall survival was found for definitive radiotherapy (HR,3.3; 95% CI, 1.6-7.1) and grades 3 to 4 lymphopenia (HR,2.6; 95% CI, 1.3-5.5) at 3 months after radiotherapy. Conclusions and RelevanceLymphopenia and NLR as early as 3 months after treatment start may serve as biomarkers of clinical outcomes in patients with HPV-negative OPC. These patients may benefit from adjuvant treatment intensification or closer surveillance.