2021 ASCCP Poster Presentations : Journal of Lower Genital Tract Disease

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2021 ASCCP Poster Presentations

Journal of Lower Genital Tract Disease: April 2021 - Volume 25 - Issue 2S - p 9-11
doi: 10.1097/LGT.0000000000000602
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Anal/Perianal Disease

Poster #000891 Preliminary Results of a Phase 2 Study of VGX-3100 for the Treatment of HPV16 and/or HPV18 (HPV16/18) Related Anal HSIL

Pankti Bhatt2, Céline Bouchard1, Janille Bunney2, Stephen Goldstone3, Gary Bucher4, Michael Dallas2, Susan Duff2, Jan Pawlicki2, Kim Kraynyak2, and Prakash Bhuyan2. 1Centre Medical Sante Femme, 2Inovio Pharmaceuticals, 3Laser Surgery Care, 4Anal Dysplasia Clinic MidWest

Objective: The management of anal HSIL remains challenging. Treatment often involves lesion ablation, but this has a high recurrence rate of up to 50% [1]. This presentation will be the first report of efficacy of VGX-3100, a DNA-based HPV16/18-specific immunotherapy, in a population with anal HSIL. We will be reporting initial data from this Phase 2 proof of concept study.

Methods: VGX-3100 is composed of DNA plasmids encoding the E6 and E7 proteins of HPV types 16 and 18, and was administered IM followed by electroporation. 22 participants with HPV16/18 positive anal HSIL, but otherwise healthy, received at least 3 doses of VGX-3100. 6 months after VGX-3100 treatment, subjects underwent biopsy of the qualifying lesions and the histology-based endpoints were determined by at least two independent pathologists. Clinical efficacy was assessed based upon resolution of HSIL, undetectable HPV16/18, or a reduction in anal lesion number without increase in lesion size.

Results: At this time, all 22 currently enrolled participants received 3 doses and completed follow-up through 36 weeks. The proportion achieving both undetectable virus and regression of HSIL at the primary endpoint evaluation is shown in Table 1. Of these 22 subjects, 77% (17/22) showed a decrease in the number of HPV16/18 HSIL lesions, 50% (11/22) showed no HPV16/18 associated HSIL, and 48% (10/21) had a decrease in the total number of HSIL lesions. There has been 1 discontinuation due to an unrelated AE, and there have been no related SAEs. No cases of carcinoma have been observed.

Conclusions: Data from this ongoing study indicate that VGX-3100 has a therapeutic effect upon HPV16/18-associated anal HSIL. Given the high medical need and limitations of surgery, an immunotherapeutic approach would represent a significant advancement in the management of anal HSIL. Complete trial data will be based upon all enrolled subjects with follow up through 18 months after the third treatment dose (i.e. week 88).

Cervical Intraepithelial Lesions and Neoplasia

Poster #000962 Detecting Cervical Dysplasia With Folate Receptor-Mediated Detection Staining Agent

David Moos1, Luka Roškar2, and Nataša Borko Tavželj2. 1GY-Biotech, 2Murska Sobota General Hospital

Objective: Colposcopy is an essential method in the diagnosis of precancerous cervical lesions. In recent years, new adjunctive technologies have been emerging with an aim to increase the effectiveness of colposcopy. In our randomized pilot study, we tested the Folate Receptor-mediated Detection staining solution (FRD) on 10 patients who visited our colposcopic outpatient office.

Methods: In our randomized pilot study, ten patients were tested using the Folate Receptor-mediated Detection staining solution. In all ten patients, other established methods for detecting cervical changes (HPV Test, PAP Smear, and Colposcopy) were also performed. These four methods were evaluated in regards to the histopathological findings of the targeted biopsy.

Results: The sensitivity and specificity of FRD staining were 100% and 50%, respectively.

Conclusions: The advantage of this the FRD method is that the results are immediate. Another benefit of this test is that it can predict the location of cervical dysplasia both on the ectocervix and in the cervical canal itself.

Colposcopy

Poster #000902 Cervical Cancer Screening Early in Prenatal Care Associated With Higher Follow up With Colposcopy

Laura Dickmeyer1, Kelsey Roof1, Hannah Wichmann1, Minh Ly Nguyen1, and Lisa Flowers1. 1Emory University School of Medicine

Objective: To assess risk factors associated with loss to follow up in patients referred for colposcopy after abnormal Pap test during pregnancy in a Southern safety net hospital population.

Methods: An urban colposcopy center was queried for patients referred for follow up of abnormal Pap tests during pregnancy and postpartum period. Patients were identified through a standardized referral code in the electronic medical record. Multivariable logistic regression was used to compare patient characteristics between those that followed up for colposcopy and those lost to follow up. Independent risk factors assessed included age, parity, race, insurance, HIV status, history of mental illness, BMI, gestational age and trimester at screening, cytology, interval days until colposcopy, and biopsy histology.

Results: 1064 patients were identified, only 40.8% of patients completed referred colposcopy. Patient characteristics positively predictive for colposcopy followup included (odds ratio, confidence interval, p-value) maternal age > 30 (1.58; 1.21-2.08; < 0.001), gestational age < 18 weeks at abnormal pap smear (1.57; 1.22-2.01; <0.0001), maternal race non- African American (1.97; 1.48- 2.63; <0.0001) and Pap with high grade cytology (2.41; 1.80 -3.22; <0.0001). Table 1 denotes characteristics investigated.

Conclusions: In this population, inadequate follow up for abnormal cytology during pregnancy is observed, especially among those with younger maternal age, African American race, Pap smear completed at later gestational ages of pregnancy, and lower grade initial cytology. This data supports completing cervical cancer screening at early prenatal visit as opposed to waiting until the postpartum period. Higher no-show rate among African American patients supports well documented health disparities and need for further investigation.

Epidemiology

Poster #000919 Cervical HSIL Incidence & Temporal Trend in the HPV Vaccination Era in the US — A Retrospective Cohort Study

Timothy Herring2, Katherine Hughes1, Jennifer Song1, Robert Gately1, Lindsey Nowak3, Maria Kyrgiou4, Prakash Bhuyan2, and John Seeger1. 1Optum Epidemiology, 2Inovio Pharmaceuticals, Inc., 3Self, 4Imperial College London

Objective: As part of the EACH-WOMAN Project, we sought to quantify the annual incidence rates of diagnosed cervical HSIL and their temporal trend over a time period that includes changes to guidelines that define standard of care such as further refinement of routine screening and prophylactic HPV vaccination.

Methods: This study was conducted within a database of commercial health insurance claims representing approximately 4% of the US population. Women aged ≥18 years diagnosed with cervical HSIL from 2008 through 2018 were included. Annual incidence rates of diagnosed cervical HSIL were estimated as cases divided by person-time of women in the database. Timing of standard of care refinements and use of HPV vaccination and their potential effect on diagnosed HSIL was assessed.

Results: 65,527 women were diagnosed with cervical HSIL in the database and 11-year study period, leading to an incidence rate that initially declined from 2.34 cases per 1,000 person-years in 2008 (95% CI: 2.3-2.39) to 1.39 (1.35-1.43) in 2014. The rate then statistically stabilized from 2014 through 2018, remaining between 1.31 and 1.39 (Table).

Conclusions: The decline in incidence of diagnosed cervical HSIL from 2008 through 2014 likely represents the combined effects of improvements in screening along with use of prophylactic HPV vaccination. The subsequent stabilization in incidence suggests that the recent standard-of-care approaches have reached a limit of effect. Further reduction in HPV infection and resultant cervical HSIL diagnoses will require improvements to the existing standard-of-care.

HPV Diseases

Poster #000917 Efficacy of a Coriolus Versicolor-Based Vaginal Gel in HPV+ Women Older Than 40 Years: Sub-Analysis of Paloma Study

Javier Cortés1, Santiago Palacios1, Luis Serrano2, Yann Gaslain3, and Gilles Seydoux4. 1Private Practice, 2Centro Medico Gabinete Velazquez, 3Procare Health Iberia, 4Procare Health

Objective: To evaluate the effect of the Papilocare®, a Coriolus versicolor-based vaginal gel, on the repairing of low-degree HPV-dependent cervical lesions in women older than 40 years.

Methods: Paloma clinical trial (ClinicalTrials.gov NCT04002154) was a multicenter, randomized, open-label, parallel-group, usual practice-controlled clinical trial. Unvaccinated HPV positive women with cytology of ASCUS or LSIL and concordant colposcopy were randomized into 3 groups: A) Papilocare® 1 cannula/day for 1 month + 1 cannula/alternate days for 5 months; B) Papilocare® 1 cannula/day for 3 months + 1 cannula/alternate days for 3 months; C) Control group: no treatment (usual clinical practice). Primary endpoint: % of patients with normal cytology and concordant colposcopy after 6 months of treatment in the total population, high-risk HPV and very high-risk HPV (any combination of 16, 18 and 31) subpopulations. Cytology evaluations were blind and centrally conducted. Papilocare® arms were combined as treatment group.

Results: 41 out of 84 patients included in the clinical trial were older than 40 yo, of which 30 and 13 were high-risk HPV and 16-18-31 HPV patients, respectively. At 6 months, normal cytology and concordant colposcopy was observed in 92%, 90% and 75% of patients treated with Papilocare® vs 50%, 33% and 40% of patients in control group, in the total population, and high-risk and 16-18-31 subpopulations (p=0.0066; p=0.0031; p=0.2929, Fisher test) respectively.

Conclusions: Papilocare® showed efficacy in repairing low-degree HPV-dependent cervical lesions in women older than 40 years old, with a statistically significancy vs control group in the total and high-risk populations.

HPV Screening and Management

Poster #000951 HPV Status and Histopathologic Outcomes by Three HPV Testing Platforms in 1405 Women With HSIL Pap

Aofei Li1, Tiannan Wang2, and Chengquan Zhao3. 1UPMC, 2USC, 3Magee-Womens Hospital, UPMC

Objective: To evaluate histopathologic outcomes and high-risk human papillomavirus (hrHPV) infection status using 3 different platforms (HC2, Cervista, Aptima) in women with high-grade squamous intraepithelial lesion (HSIL) Pap.

Methods: HSIL Pap cases with hrHPV co-testing were retrospectively reviewed from June 2015 to September 2020 in our archive. Histopathological follow-ups within six months were also reviewed for correlation.

Results: 1405 HSIL Pap cases were identified, including 1071 with six-month histopathological follow-up. All 3 platforms show high positive detection rates in HSIL samples (>90%). 69.3% showed cervical intraepithelial neoplasia 2 or 3 (CIN2/3), and 4.9% showed carcinoma. Histological outcomes are distinct among the HC2, Cervista and Aptima results (p<0.01, chi-square test) except for similar positive Cervista and positive Aptima results (p=0.24). HrHPV positive group shows distinct outcomes compared to the hrHPV negative group (p<0.001) with higher percentage of CIN2+ (76.1% vs 47.1%). Aptima platform shows higher odds ratio of predicting CIN2+ (5.3) compared to HC2 and Cervista (2.4 and 1.8). Of all CIN2+ cases, 29 (or 3.9%) CIN2/3 cases and 4 (or 7.5%) carcinoma cases were hrHPV negative.

hrHPV status by three HPV testing platforms and histopathology outcomes in women with HSIL Pap test

Conclusions: This is the largest comparative study of HPV status and histopathological outcomes in HSIL Pap patients to our knowledge. While all 3 platforms have high positive detection rate in HSIL patients (>90%), positive Aptima better predicts histologically advanced lesion. A small but substantial portion (4.2%, 33/795) of histologically advanced lesions were diagnosed due to HSIL Pap, but would have been missed by hrHPV testing alone, signifying the benefit of Pap/hrHPV co-testing.

HPV Vaccination

Poster #000884 HPV Vaccination Rates at the Time of IUD Placement: A Quality Improvement Study

Stephanie Peace1 and Ashley Jennings1. 1UW Hospitals and Clinics

Objective: To improve rates of HPV vaccination among unvaccinated patients by utilizing a new Epic smart phrase for IUD insertion that includes documentation of HPV vaccination status.

Methods: This retrospective chart review compared preintervention (September 2019) and postintervention (January 2020) rates of HPV vaccination among women aged 26 or less who presented for IUD placement.

Results: Our institution had a higher rate of vaccinated patients among 19 to 26-year-olds compared with overall county data. In the postintervention period, unvaccinated patients were significantly less likely to have an up-to-date pap smear than vaccinated patients (p = 0.0005). Among previously unvaccinated patients, 0% were recommended HPV vaccination preintervention and 27% were recommended HPV vaccination postintervention. The new Epic smart phrase was adopted in 25% of patients and when it was used, 100% of patients were confirmed vaccinated or offered HPV vaccination.

Conclusions: Use of the new Epic smart phrase was correlated with an increase in appropriately recommending HPV vaccination to 27%. However, the uptake of smart phrase use was low at only 25%. More work needs to be done to improve uptake of the Epic smart phrase to further increase catch-up HPV vaccination rates. As most IUDs in our system are placed by NPs, targeting this provider group will likely have the most yield. Further QI efforts to improve HPV vaccination rate should target visits for colposcopy.

Poster #000894 Knowledge of the HPV Vaccine Among South Asian and South Asian-American Young Adults

Amal Amir5, Katherine Chua1, Masra Shameem2, Amal Amir3, and Joyce Varughese4. 1Saint Peter's University Hospital, 2University of Central Florida College of Medicine, 3Rowan University School of Osteopathic Medicine, 4Capital Health Surgical Group, 5RowanSOM

Objective: To determine barriers to HPV vaccination among South Asian young adults in the United States.

Methods: Participants 18-26 years old, South Asian descent, and English speaking were recruited to complete an online survey. Three scales were computed: Knowledge of HPV, Attitudes and Beliefs, and Efficacy of Vaccine. Bivariate analyses and multivariate linear regressions were conducted.

Results: Recruitment yielded a total of 253 participants with mean age of 23.3. 84.2% were of Indian ethnicity and 92.9% completed higher education. 194 participants received at least one dose of HPV vaccine, and 83.9% of these participants received it at their primary care office. 76.6% strongly disagreed that the HPV vaccine was unsafe. 25.4% strongly agreed that the vaccine lasts a person's lifetime. There were statistically significant differences in knowledge of efficacy and attitudes towards HPV vaccination. Vaccinated participants had more knowledge and positive attitudes. Multivariate linear regressions depicted vaccinated participants having a 0.508-point increase in knowledge scores compared to unvaccinated participants (CI: 0.021-0.996). Every one-year increase in age demonstrated a 0.25-point increase in knowledge score (CI: 0.133-0.366). Participants with higher education increased 1.03-points in knowledge scores on vaccine efficacy (CI: 0.213-1.84). Vaccinated participants were more likely to have more positive scores on the attitude scale (3.35, CI: 2.06-4.08).

Conclusions: Vaccinated young adults of South Asian descent had more knowledge and positive attitudes towards HPV vaccination compared to unvaccinated individuals. Age and education level influence knowledge and attitudes towards HPV vaccination. Availability of the vaccine was not a significant barrier to vaccination.

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Innovative Technology

Poster #000957 Multi-Site Comparative Study of the BD COR TM System and the BD ViperTM LT System Using the BD Onclarity TM HPV Assay

Benjamin von Bredow2, Wallace Greene1, Catherine Cammarata3, Stephanie Taylor3, Denise Diodene3, Elizabeth Lockamy4, Shelby Sunday4, and Michele Markward4. 1PennState Hershey Medical Center, 2UCLA Health, 3LSU Health Science, 4Becton Dickinson

Objective: The objective of this study was to assess the agreement between values generated by the BD COR System (“COR”) and the BD Viper LT System (“Viper”) when using the BD Onclarity HPV Assay (“Onclarity”).

Methods: Three test sites were each provided clinical and contrived panels. The clinical panels were prepared with characterized remnant BD SurePath and PreservCyt clinical samples. Contrived panels were prepared by spiking cell lines containing integrated HPV genotypes 16, 18, or 45 into HPV negative clinical samples. The positive panels were prepared so that each genotype (16, 18, 45, and 11 other) spanned the detection range of the assay with most of these samples near the limit of detection. These panels were tested on COR at three locations, two external diagnostic laboratories and internally, at a BD location. Results from Viper served as the study reference. All Viper testing was performed at a BD location. Each specimen was tested on both the COR and Viper Systems.

Results: Overall, the positive percent agreement between COR and Viper for the BD SurePath sample panels was 98.3% and the negative percent agreement was 95.3%. The positive percent agreement between COR and Viper for the PreservCyt sample panels was 98.6% and the negative percent agreement was 95.9%.

Conclusions: The results generated using Onclarity on Viper and compared to the results from COR at three distinct sites demonstrated equivalent positive and negative percent agreement.

Vulvar Intraepithelial Lesions and Neoplasia

Poster #000941 Preliminary Phase 2 Efficacy Results of VGX-3100 for Treatment of HPV-16 and/or 18 (HPV16/18) Associated Vulvar HSIL

Amanda Petrellis2, Prakash Bhuyan2, Robert Edwards1, Jessica Berger1, Kim Kraynyak2, Jan Pawlicki2, Tamara Howard2, Caitlin Baiduc2, and Michael Dallas2. 1University of Pittsburgh Medical Center, 2Inovio Pharmaceuticals, Inc.

Objective: Management of vulvar high-grade squamous intraepithelial lesions (HSIL) remains challenging. Surgical treatments are disfiguring and have a high recurrence rate (up to 34% at 6 months). This presentation reports initial efficacy and safety data from our Phase 2 study of VGX?3100, a DNA-based HPV16/18-specific immunotherapy, in a population with HPV16/18-associated vulvar HSIL.

Methods: Women with tissue-confirmed HPV16/18-related vulvar HSIL received 4 doses (0, 1, 3, and 6 months) of VGX-3100 intramuscularly with electroporation (EP) either alone (n=25) or with topical imiquimod thrice weekly for 20 weeks (n=8). The primary endpoint was proportion of subjects without vulvar HSIL and non-detectability of HPV16/18 (by SPF10) in vulvar tissue post-treatment compared to baseline.

Results: Among the women in the VGX-3100 group who completed their efficacy assessment 6 months following treatment, 3 of 20 (15%) resolved their vulvar HSIL and had no virus detectable in the healed area. As of submission of this abstract, there have been no related serious adverse events and no treatment discontinuations from adverse events.

Conclusions: Initial data from this ongoing study indicate VGX-3100 has a therapeutic effect on HPV16/18-associated vulvar HSIL. Given the high medical need and limitations of surgery, an immunotherapeutic approach would represent a significant advancement in managing vulvar HSIL.

Poster #000935 Vulvar Swabs as a Less Invasive Method for HPV Detection: Concordance Between HPV Types From Swabs and Biopsy Tissue

Prakash Bhuyan1, Kim Kraynyak1, Jan Pawlicki1, Amanda Petrellis1, Caitlin Baiduc1, and Linda Struijk2. 1Inovio Pharmaceuticals, Inc., 2DDL Diagnostic Laboratory

Objective: Identification and management of vulvar HSIL remains challenging; vulvar lesions vary in appearance, and confirmation via tissue biopsy may be needed. Tissue biopsy is invasive, and repeated biopsies are often necessary. There is interest in non-invasive methods to detect the presence of HPV, the underlying cause of vulvar HSIL. Vulvar swabs are less invasive, easier to perform, and minimize patient discomfort. Whether vulvar swabs can detect HPV with the same accuracy as vulvar tissue biopsies remains unknown. Here we present HPV concordance data between vulvar swab and biopsy samples obtained as part of a Phase 2 proof-of-concept efficacy study of VGX-3100, a DNA-based HPV16/18-specific immunotherapy, in a population of women with HPV16/18-associated vulvar HSIL.

Methods: Vulvar swabs and biopsies were collected from 22 women at study entry. HPV genotyping was performed using the HPV SPF10 PCR-DEIA (DNA enzyme immunoassay)-LiPA25 (Line probe assay) version 1 system. All SPF10 PCR/DEIA-positive specimens were subsequently tested for the presence of HPV16/18 using type-specific primers.

Results: Concordance between vulvar swabs and tissue biopsies for the detection of HPV16/18 was 86.4% (19/22) at baseline. Concordance of non-HPV16/18 HPV types between vulvar swabs and biopsies was 54.5% (12/22) at baseline, with more types detected by swabs.

Conclusions: Detection of HPV16/18 from vulvar swabs is more concordant with detection from vulvar tissue biopsies than non-16/18 HPV types. HPV16 and HPV18 are significant causes of vulvar carcinoma, so vulvar swabs may offer an effective and less-invasive screening strategy for the detection of HPV16/18 positive vulvar lesions.

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