Rettig, Eleni M.

ABSTRACTBackgroundArtificial intelligence (AI)‐based imaging analysis and circulating tumor‐associated DNA (ctDNA) are both being used diagnostically in HPV‐driven oropharynx squamous cell carcinoma (HPV‐OPSCC). We evaluated associations between AI‐measured tumor burden and ctDNA.MethodsWe analyzed 170 patients treated definitively for HPV‐OPSCC. All had pre‐treatment serum tumor‐tissue modified viral (TTMV) ctDNA levels. An AI algorithm measured tumor and lymph nodes on CT scans. Linear regressions detected associations between ctDNA (fragments/mL) and automated volumes, clinical tumor (T) and nodal (N) stage, and disease factors.ResultsAutomated tumor volume (coeff = 39.43, p < 0.001), nodal volume (coeff = 39.54, p < 0.001), T stage (coeff = 1031.09, p = 0.009), and N stage (coeff = 1840, p = 0.018) were associated with ctDNA. On multivariable analysis, tumor (coeff = 34.79, p = 0.001) and nodal volumes (coeff = 24.68, p = 0.022) were associated with ctDNA; T and N stage were not.ConclusionsAutomated volumetrics are independently and more strongly associated with ctDNA, compared with clinical stage. Automated volumetrics provide a practical correlate to ctDNA.

e15045 Background: Human papillomavirus (HPV) is an oncogenic driver of several human cancers, including those of the anal canal, uterine cervix, and head and neck (predominantly oropharynx). Despite advancements in our understanding of HPV-related cancers, there remains an unmet need for a comprehensive biomarker-driven registry to establish correlations between biomarker detectability and clinicopathologic features in patients diagnosed and treated for HPV-driven cancers. To address this need, the NAVigate-HPV Registry has been established to systematically collect and analyze integrated biomarker and clinical data from many U.S. cancer centers. Methods: NavDx (Naveris, Inc.) is a clinically validated blood-based assay detecting circulating cell-free tumor tissue modified viral (TTMV)-HPV DNA. The NAVigate-HPV Registry is a web-based data platform based on a centrally IRB approved protocol. Participating investigators will include providers that order NavDx tests in the routine clinical care of their patients and agree to the terms and conditions for use of the registry. Eligible subjects will have or have had an HPV-driven cancer (with an initial focus on HPV-driven oropharynx cancer with confirmatory tissue testing) and have received one or more NavDx blood tests during routine clinical care. Clinical data and TTMV-HPV DNA scores will be collected at enrollment and defined intervals over five years or until death. Results: In the initial phase, the registry has enlisted participation and established a steering committee composed of a representative from each of 14 institutions. These institutions are geographically diverse centers ranging from community hospitals to clinics and academic medical facilities. An IRB protocol governing the registry will maintain ethical standards, ensuring compliance and ethical conduct throughout the registry process. Data extraction methods have been previously established to evaluate an initial cohort of 543 patients (Hanna GJ, Roof SA, et. al 2023). Conclusions: Naveris and collaborators have together successfully launched the NAVigate-HPV registry with the aim of creating a robust database linking tumor biomarker results from NavDx with clinical outcomes data for HPV-related cancers. The NAVigate-HPV database is expected to encompass more than 1,000 patients within 1 year and grow to > 5,000 patients within 5 years, serving as a powerful tool for precision cancer medicine in this patient cancer population. Establishing this registry will deepen insights into HPV-related cancers and advance diagnostic and therapeutic approaches to improve patient outcomes.

ObjectivesTo describe pain experience and opioid use after major head and neck reconstructive surgery.Study DesignRetrospective cohort study.MethodsPatients undergoing major head and neck surgery with microvascular free tissue transfer (free flaps) at a tertiary academic center were included. Pain scores (0–10) and demographic and clinical data were ascertained from medical records. Discharge opioid prescriptions and refills obtained within 30 days were recorded. Patient characteristics were compared with pain scores using nonparametric rank‐sum tests and with likelihood of refill using logistic regression models to calculate adjusted odds ratios (aORs) with 95% confidence intervals (CIs).ResultsThe study population comprised 445 patients. Median age was 60 years (interquartile range 50–68). Most patients had cancer (N = 350, 78%). The majority of free flaps were fibula (N = 153, 34%) or radial forearm (N = 159, 36%). Older patients reported significantly lower pain scores, whereas patients with opioid tolerance, anxiety, current smokers, and those undergoing larger volume resections or boney free flaps reported significantly higher pain scores. One‐quarter (N = 115, 26%) of patients obtained opioid refills. Patients aged ≥ 60 years had one‐half the odds of obtaining a refill compared with patients aged < 60 years (adjusted odds ratio [aOR] = 0.52, 95% confidence interval [CI] = 0.33–0.84), whereas surgical defect volume ≥ 100 cm3 (aOR = 1.92, 95% CI = 1.21–3.07) and higher pain score (aOR = 1.19, 95% CI = 1.07–1.32 per 1 point increase) increased the odds of refill.ConclusionContinued opioid use after discharge is common among patients undergoing major head and neck reconstruction, particularly for younger patients and after more extensive surgery. Older patients reported lower pain intensity and were less likely to obtain opioid refills, highlighting the wisdom of judicious opioid use for this vulnerable population.Level of EvidenceIV Laryngoscope, 130: E469–E478, 2020

Objectives/HypothesisHuman papillomavirus (HPV)‐positive and HPV‐negative oropharyngeal squamous cell carcinoma (OPSCC) are distinct disease entities. Prognostic factors specific to each entity have not been adequately explored. Goals for this study were: 1) to determine whether HPV‐positive and HPV‐negative OPSCCs have distinct prognostic factors, and 2) to explore the prognostic significance of sex and race in OPSCC after HPV stratificationStudy DesignRetrospective case series.MethodsA retrospective review of 239 incident OPSCC patients from 1995 to 2012, treated at Johns Hopkins and University of California–San Francisco was conducted. Women and nonwhite races were oversampled. All analyses were stratified by tumor HPV in situ hybridization status. The effects of sex and race on survival were considered in Kaplan‐Meier and unadjusted and adjusted Cox regression models.ResultsOne hundred thirty‐four (56.1%) OPSCC patients were HPV positive. On univariate analysis, women had better overall survival than men among HPV‐positive (hazard ratio [HR]: 0.47, 95% confidence interval [CI]: 0.20‐1.07; P = .06) but not HPV‐negative (HR: 0.73, 95% CI: 0.43‐1.24; P = .24) OPSCCs. On multivariate analysis, women with HPV‐positive OPSCCs remained at lower risk of death (adjusted hazard ratio [aHR]: 0.34, 95% CI: 0.12‐0.96; P = .04). Survival did not vary significantly by race among HPV‐positive patients. Among HPV‐negative patients, Hispanic patients had significantly better survival in unadjusted (HR: 0.27, 95% CI: 0.08‐0.91; P = .04) but not adjusted (aHR: 0.93, 95% CI: 0.11‐7.36; P = .94) analysis.ConclusionsWomen with HPV‐positive OPSCC may have improved overall survival compared to men. Sex does not play a prognostic role in HPV‐negative OPSCC. There are no differences in prognosis by race among HPV‐positive or HPV‐negative patients.Level of Evidence4 Laryngoscope, E288–E296, 2018