Assessment of endpoint definitions in recurrent and metastatic mucosal head and neck squamous cell carcinoma trials: Head and Neck Cancer International Group consensus recommendations.

Transparent and precise endpoint definitions are a crucial aspect of clinical trial conduct and reporting, and are used to communicate the benefit of an intervention. Previous studies have identified inconsistencies in endpoint definitions across oncological clinical trials. Here, the Head and Neck Cancer International Group assessed endpoint definitions from phase 3 trials or trials considered practice-changing for patients with recurrent or metastatic mucosal head and neck squamous cell carcinoma, published between 2008 and 2021. We identify considerable and global heterogeneity in endpoint definitions, which undermines the interpretation of results and development of future studies. We show how fundamental components of even incontrovertible endpoints such as overall survival vary widely, highlighting an urgent need for increased rigour in reporting and harmonisation of endpoints.

Assessment of endpoint definitions in curative-intent trials for mucosal head and neck squamous cell carcinomas: Head and Neck Cancer International Group consensus recommendations.

Robust time-to-event endpoint definitions are crucial for the assessment of treatment effect and the clinical value of trial interventions. Here, the Head and Neck Cancer International Group investigated endpoint use in phase 3 trials and trials considered potentially practice-changing published between 2008 and 2021 in the curative-intent setting for patients with mucosal head and neck squamous cell carcinoma. Of the 92 trials reviewed, we show that all core components of endpoint reporting were heterogeneous, including definitions of common terms, such as overall survival and progression-free survival. Our report highlights the urgent need for harmonisation of fundamental components of clinical trial endpoints and the engagement of all stakeholders to ensure the transparent reporting of endpoint details.

Substance use and mental health burden in head and neck and other cancer survivors: A National Health Interview Survey analysis.

BACKGROUND: Tobacco dependence, alcohol abuse, depression, distress, and other adverse patient-level influences are common in head and neck cancer (HNC) survivors. Their interrelatedness and precise burden in comparison with survivors of other cancers are poorly understood. METHODS: National Health Interview Survey data from 1997 to 2016 were pooled. The prevalence of adverse patient-level influences among HNC survivors and matched survivors of other cancers were compared using descriptive statistics. Multivariable logistic regressions evaluating covariate associations with the primary study outcomes were performed. These included 1) current cigarette smoking and/or heavy alcohol use (>14 drinks per week) and 2) high mental health burden (severe psychological distress [Kessler Index ≥ 13] and/or frequent depressive/anxiety symptoms). RESULTS: In all, 918 HNC survivors and 3672 matched survivors of other cancers were identified. Compared with other cancer survivors, more HNC survivors were current smokers and/or heavy drinkers (24.6% [95% CI, 21.5%-27.7%] vs 18.0% [95% CI, 16.6%-19.4%]) and exhibited a high mental health burden (18.6% [95% CI, 15.7%-21.5%] vs 13.0% [95% CI, 11.7%-14.3%]). In multivariable analyses, 1) a high mental health burden predicted for smoking and/or heavy drinking (odds ratio [OR], 1.4; 95% CI, 1.0-1.9), and 2) current cigarette smoking predicted for a high mental health burden (OR, 1.7; 95% CI, 1.2-2.3). Furthermore, nonpartnered marital status and uninsured/Medicaid insurance status were significantly associated with both cigarette smoking and/or heavy alcohol use (ORs, 1.9 [95% CI, 1.4-2.5] and 1.5 [95% CI, 1.0-2.1], respectively) and a high mental health burden (ORs, 1.4 [95% CI, 1.1 -1.8] and 3.0 [95% CI, 2.2-4.2], respectively). CONCLUSIONS: Stakeholders should allocate greater supportive care resources to HNC survivors. The interdependence of substance abuse, adverse mental health symptoms, and other adverse patient-level influences requires development of novel, multimodal survivorship care interventions.

Long-term opioid use in patients treated with head and neck intensity-modulated radiotherapy.

PURPOSE: Acute and chronic pain during and after radiotherapy is an important driver of poor quality of life. We aimed to identify risk factors associated with increased chronic opioid use in head and neck squamous cell cancer survivors. METHODS: We performed a retrospective cohort analysis on head and neck squamous cell cancer patients treated with definitive or adjuvant intensity-modulated radiotherapy. We tracked their oncologic opioid prescription profile from initial presentation to the last follow-up date. We determined the incidences of 1- and 2-year opioid use and performed multivariate logistic regression for both outcomes. RESULTS: Our analytic cohort consisted of 403 head and neck squamous cell cancer survivors. The numbers of patients requiring opioids at 3 months, 6 months, and 1 year after treatment were 316 (78%), 203 (50%), and 102 (25%), respectively. On multivariate logistic regression, positive smoking history (95% CI 1.86 [1.03, 3.43], p = 0.04), unemployment (95% CI 2.33 [1.16, 4.67], p = 0.02), prior psychiatric illness (95% CI 2.15 [1.05, 4.40], p = 0.03), and opiate use before radiotherapy (95% CI 2.75 [1.49, 5.20], p = 0.01) were independently associated with significantly greater odds of opioid use at 1 year. CONCLUSIONS: Our institutional analysis has shown that a substantial amount of head and neck cancer survivors are chronically dependent on opioids following radiotherapy. We have identified a cohort at highest risk for long-term use, for whom early interventions should be targeted.

Smoking and other patient factors in HPV-mediated oropharynx cancer: A retrospective cohort study.

PURPOSE: To characterize the significance of patient-level influences, including smoking history, on oncologic outcomes in human papillomavirus (HPV)-mediated oropharyngeal cancer (OPC). MATERIALS AND METHODS: A bi-institutional retrospective cohort study of previously untreated, HPV+ OPC patients who underwent curative treatment from 1/1/2008 to 7/1/2018 was performed. The primary outcome was disease-free survival (DFS) and the primary exposure was ≤10 versus >10-pack-year (PY)-smoking history. RESULTS: Among 953 OPC patients identified, 342 individuals with HPV+ OPC were included. The median patient age was 62 years, 33.0% had a > 10-PY-smoking history, 60.2% had AJCC8 stage I disease, and 35.0% underwent primary surgery. The median follow-up was 49 months (interquartile range [IQR] 32-75 months). Four-year DFS-estimates were similar among patients with ≤10-PY-smoking history (78.0%, 95% CI:71.7%-83.1%) compared to >10-PYs (74.8%; 95% CI:65.2%-82.0%; log-rank:p = 0.53). On univariate analysis, >10-PY-smoking history did not correlate with DFS (hazard ratio[HR]:1.15;95% CI:0.74-1.79) and remained nonsignificant when forced into the multivariable model. On adjusted analyses, stage, treatment paradigm, and age predicted DFS. Neither >10-PYs, nor any other definition of tobacco use (e.g., current smoker or > 20-PYs) was predictive of DFS, overall survival, or disease-specific survival. Conversely, age nonsignificantly and significantly predicted adjusted DFS (adjusted HR[aHR]:1.02,95% CI:0.997-1.05, p = 0.08), overall survival (aHR 1.05; 95% CI: 1.02-1.08; p = 0.002) and disease-specific survival (aHR 1.04;95% CI: 0.99-1.09;p = 0.09). CONCLUSION: Other than age, patient-level influences may not be primary drivers of HPV+ OPC outcomes. Although limited by its modest sample size, our study suggests the significance of smoking has been overstated in this disease. These findings and the emerging literature collectively do not support risk-stratification employing the >10-PY threshold. LEVEL OF EVIDENCE: Level 4.

Oncologic outcomes in primary squamous cell carcinoma of the auricle: a retrospective cohort analysis.

PURPOSE: The prognostic significance of auricular location in cutaneous squamous cell carcinoma (cSCC) is controversial. We aimed to characterize risk factors for, and evaluate the cumulative incidence of, locoregional recurrence in a cohort of patients with primary auricular cSCC. METHODS: The study design was a single-institution retrospective cohort review from 1/2007 to 12/2016. RESULTS: Among 851 potentially eligible individuals, 178 patients with primary auricular cSCC met strict criteria for inclusion. Median follow-up was 32 months, 93% were AJCC 8th edition (AJCC8) stage I and 6% were AJCC8 stage II. Most underwent Mohs micrographic surgery (MMS; 97%) and the remainder underwent wide local excision ± parotidectomy ± neck dissection ± adjuvant therapy (3%). Recurrences occurred in seven patients (4%): six were local and one was regional. The 3-year cumulative incidence of local and regional recurrence for AJCC8 stage I-II tumors were 1% (95% CI 0-5%) and 0%, respectively. Among ten patients upstaged to pT3 disease who underwent MMS alone, none recurred locoregionally. Compared to their respective counterparts, advanced stage, PNI, and LVI associated with a significantly increased risk of locoregional recurrence. CONCLUSIONS: Our findings suggest that auricular location may not be a significant risk factor for cSCC staging systems. In the absence of other risk factors, unimodal therapy appears adequate for patients with primary, stage I-II auricular cSCC. The prognostic significance of pT3 auricular cSCC stage due to depth of invasion alone should be evaluated further.

Blood-based biomarkers of human papillomavirus-associated cancers: A systematic review and meta-analysis.

BACKGROUND: Despite the significant societal burden of human papillomavirus (HPV)-associated cancers, clinical screening interventions for HPV-associated noncervical cancers are not available. Blood-based biomarkers may help close this gap in care. METHODS: Five databases were searched, 5687 articles were identified, and 3631 unique candidate titles and abstracts were independently reviewed by 2 authors; 702 articles underwent a full-text review. Eligibility criteria included the assessment of a blood-based biomarker within a cohort or case-control study. RESULTS: One hundred thirty-seven studies were included. Among all biomarkers assessed, HPV-16 E seropositivity and circulating HPV DNA were most significantly correlated with HPV-associated cancers in comparison with cancer-free controls. In most scenarios, HPV-16 E6 seropositivity varied nonsignificantly according to tumor type, specimen collection timing, and anatomic site (crude odds ratio [cOR] for p16+ or HPV+ oropharyngeal cancer [OPC], 133.10; 95% confidence interval [CI], 59.40-298.21; cOR for HPV-unspecified OPC, 25.41; 95% CI, 8.71-74.06; cOR for prediagnostic HPV-unspecified OPC, 59.00; 95% CI, 15.39-226.25; cOR for HPV-unspecified cervical cancer, 12.05; 95% CI, 3.23-44.97; cOR for HPV-unspecified anal cancer, 73.60; 95% CI, 19.68-275.33; cOR for HPV-unspecified penile cancer, 16.25; 95% CI, 2.83-93.48). Circulating HPV-16 DNA was a valid biomarker for cervical cancer (cOR, 15.72; 95% CI, 3.41-72.57). In 3 cervical cancer case-control studies, cases exhibited unique microRNA expression profiles in comparison with controls. Other assessed biomarker candidates were not valid. CONCLUSIONS: HPV-16 E6 antibodies and circulating HPV-16 DNA are the most robustly analyzed and most promising blood-based biomarkers for HPV-associated cancers to date. Comparative validity analyses are warranted. Variations in tumor type-specific, high-risk HPV DNA prevalence according to anatomic site and world region highlight the need for biomarkers targeting more high-risk HPV types. Further investigation of blood-based microRNA expression profiling appears indicated.

High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck: A Clinical Review.

BACKGROUND: Given the rapidly evolving nature of the field, the current state of "high-risk" head and neck cutaneous squamous cell carcinoma (HNcSCC) is poorly characterized. METHODS: Narrative review of the epidemiology, diagnosis, workup, risk stratification, staging and treatment of high-risk HNcSCC. RESULTS: Clinical and pathologic risk factors for adverse HNcSCC outcomes are nuanced (e.g., immunosuppression and perineural invasion). Frequent changes in adverse prognosticators have outpaced population-based registries and the variables they track, restricting our understanding of the epidemiology of HNcSCC and inhibiting control of the disease. Current heterogeneous staging and risk stratification systems are largely derived from institutional data, compromising their external validity. In the absence of staging system consensus, tumor designations such as "high risk" and "advanced" are variably used and insufficiently precise to guide management. Evidence guiding treatment of high-risk HNcSCC with curative intent is also suboptimal. For patients with incurable disease, an array of trials are evaluating the impact of immunotherapy, targeted biologic therapy, and other novel agents. CONCLUSION: Population-based registries that broadly track updated, nuanced, adverse clinicopathologic risk factors, and outcomes are needed to guide development of improved staging systems. Design and development of randomized controlled trials (RCTs) in advanced-stage HNcSCC populations are needed to evaluate (1) observation, sentinel lymph node biopsy, or elective neck dissection for management of the cN0 neck, (2) indications for surgery plus adjuvant radiation versus adjuvant chemoradiation, and (3) the role of immunotherapy in treatment with curative intent. Considering these knowledge gaps, the authors explore a potential high-risk HNcSCC treatment framework.

Submental flap practice patterns and perceived outcomes: A survey of 212 AHNS surgeons.

OBJECTIVES: To describe American Head and Neck Society (AHNS) surgeon submental flap (SMF) practice patterns and to evaluate variables associated with SMF complications. METHODS: The design is a cross-sectional study. An online survey was distributed to 782 AHNS surgeons between 11/11/16 and 12/31/16. Surgeon demographics, training, practice patterns and techniques were characterized and evaluated for associations with frequency of SMF complications. RESULTS: Among 212 AHNS surgeons, 108 (50.9%) reported performing SMFs, of whom 86 provided complete responses. Most surgeons who performed the SMF routinely reconstructed oral cavity defects with the flap (86.1%, n = 74). Thirty-seven surgeons (43.0%) experienced "very few" complications with the SMF. Surgeons who practiced in the United States versus internationally (p = 0.003), performed more total career SMFs (p = 0.02), and routinely reconstructed parotid and oropharyngeal defects (p = 0.04 and p < 0.001) with SMFs were more frequently perceived to have "very few" complications. SMF surgeons reported more perceived complications with the SMF compared to pectoralis major (p = 0.001) and radial forearm free flaps (p = 0.01). However, similar perceived complications were reported between all three flaps when surgeons performed >30 SMF. Among 94 surgeons not performing SMFs, 71.3% had interest in a SMF training course. CONCLUSIONS: Practice patterns of surgeons performing SMFs are diverse, although most use the flap for oral cavity reconstruction. While 43% of surgeons performing the SMF reported "very few" complications, overall complication rates with the SMF were higher compared to other flaps, potentially due to limited experience with the SMF. Increased training opportunities in SMF harvest and inset are indicated.

Successful facial artery pseudoaneurysm coiling and pedicle preservation following free tissue transfer.

Patients undergoing free tissue reconstruction are at risk for development of an anastomotic pseudoaneurysm, which may present as delayed neck hemorrhage or a pulsatile neck mass. Diagnosis may be achieved by noninvasive imaging, angiography, and exploration. Management strategies for head and neck pseudoaneurysms have included open vessel ligation, open direct vessel repair, endovascular parent vessel embolization, and, most recently, endovascular pseudoaneurysm embolization. In patients with anastomotic pseudoaneurysms where adequate flap inosculation is doubted, endovascular pseudoaneurysm embolization with pedicle preservation may be an appropriate primary treatment approach. We discuss the successful endovascular coiling of an external carotid artery branch anastomotic pseudoaneurysm in a patient one month after free tissue reconstruction of a total laryngopharyngectomy and partial glossectomy defect.

Therapeutic Vaccination for HPV-Mediated Cancers.

Purpose of Review: The goal of this narrative review is to educate clinicians regarding the foundational concepts, efficacy, and future directions of therapeutic vaccines for human papillomavirus (HPV)-mediated cancers. Recent Findings: Therapeutic HPV vaccines deliver tumor antigens to stimulate an immune response to eliminate tumor cells. Vaccine antigen delivery platforms are diverse and include DNA, RNA, peptides, proteins, viral vectors, microbial vectors, and antigen-presenting cells. Randomized, controlled trials have demonstrated that therapeutic HPV vaccines are efficacious in patients with cervical intraepithelial neoplasia. In patients with HPV-mediated malignancies, evidence of efficacy is limited. However, numerous ongoing studies evaluating updated therapeutic HPV vaccines in combination with immune checkpoint inhibition and other therapies exhibit significant promise. Summary: Therapeutic vaccines for HPV-mediated malignancies retain a strong biological rationale, despite their limited efficacy to date. Investigators anticipate they will be most effectively used in combination with other regimens, such as immune checkpoint inhibition.

Stepped Behavioral and Biological Screening for Oral Oncogenic HPV DNA in Middle-aged and Elderly Adults: A Feasibility Study.

Novel preventive interventions are needed to address the rising incidence of human papillomavirus (HPV)-mediated oropharyngeal cancer (HPV+ OPC). This pilot study evaluated the feasibility of a stepped, behavioral and biological screening program for oral oncogenic HPV infection, an intermediate HPV+ OPC outcome.This was a cross-sectional, feasibility study. Eligible 45-74 years old adults identified from three clinical research registries were administered a behavioral risk survey (step 1). Participant tobacco use and sexual behavior history were translated into a quantifiable risk of oral oncogenic HPV DNA, according to prior National Health and Nutrition Examination Survey analyses. Females with >2% risk and males with >7% risk were offered biological screening for oral oncogenic HPV DNA (step 2) via an oral rinse and gargle specimen.A total of 292 individuals were contacted, but only 144 (49%) were reached. Among these, 56 individuals (19%) were uninterested and 18 (13%) were ineligible. Seventy individuals began the survey and 66 completed it (step 1), among whom 46 were classified as low-risk. Among the remaining 20 participants classified as high-risk for an oral oncogenic HPV infection, 5% were current smokers and the median participant had performed oral sex on 10 unique partners. During step 2 (biological screening), 45% (9/20) completed testing, all of whom tested negative for oral oncogenic HPV DNA.In this pilot of a stepped, oral oncogenic HPV screening program, enrollment and study completion were suboptimal. These barriers to screening should be characterized and addressed before reevaluating the feasibility of this program. PREVENTION RELEVANCE: Novel preventive interventions are needed to address the rising incidence of HPV+ OPC. In this feasibility study, we characterized barriers to a two-step, behavioral and biological screening program for oral oncogenic HPV infection, an intermediate outcome for HPV+ OPC.

Adherence to the American Cancer Society Head and Neck Cancer Survivorship Care Guideline According to Chart Review: A Nested Retrospective Cohort Pilot Study.

OBJECTIVES: The purpose of this study was to explore adherence to the American Cancer Society (ACS) Head and Neck Cancer (HNC) Survivorship Care Guideline and their outlined 33 recommendations among posttreatment HNC survivors. METHODS: A bi-institutional, retrospective, nested cohort study of mucosal or salivary gland HNC survivors diagnosed in 2018 was designed. Guideline adherence was assessed via retrospective chart review between 0 and 13 months after completion of oncologic treatment according to 4 categories: (1) problem assessed, (2) problem diagnosed, (3) management offered; (4) problem treated. Adherence was defined as meeting a recommendation subcategory at least once over the 13-month period. RESULTS: Among 60 randomly selected HNC survivors, a total of 38 were included in the final cohort after exclusion of individuals with ineligible cancers and those who died or were lost to follow-up over the study period. Approximately 95% of HNC survivors were assessed for HNC recurrence and screened for lung cancer. Certain common problems such as xerostomia, dysphagia, and hypothyroidism were screened for and managed in ≥70% of eligible survivors. Conversely, screening for other second primary cancers and assessment of a majority of other physical and psychosocial harms occurred in <70% of survivors, and in many cases none to a slim minority of survivors (eg, sleep apnea and sleep disturbance, body and self-image concerns). Only 5% of survivors received a survivorship care plan. CONCLUSION: Overall adherence to the ACS HNC Survivorship Care Guideline in early posttreatment survivors was suboptimal. Interventions are needed to better implement and operationalize these guideline recommendations.

Unmet Needs and Receipt of Supportive Care Services in Head and Neck Cancer Patients Prior to Oncologic Treatment: A Prospective, Cross-Sectional Pilot Study.

OBJECTIVE: To characterize the supportive care (SC) needs and receipt of SC services among head and neck cancer (HNC) patients prior to oncologic treatment and to explore the influence of social determinants of health on these outcomes. MATERIALS AND METHODS: Newly diagnosed HNC patients were surveyed via telephone prior to oncologic treatment between 10/2019 and 1/2021 using a prospective, cross-sectional, bi-institutional, pilot study design. The primary study outcome was unmet SC needs (Supportive Care Needs Survey-Short Form34 [SCNS-SF34]). Hospital type (university- vs county safety-net) was explored as an exposure. Descriptive statistics were performed using STATA16 (College Station, TX). RESULTS: Among 158 potentially eligible patients, 129 were successfully contacted, 78 met the study criteria, and 50 completed the survey. The mean age was 61, 58% exhibited clinical stage III-IV disease, and 68% and 32% were treated at the university and county safety-net hospital, respectively. Patients were surveyed a median of 20 days after their first oncology visit and 17 days prior to initiation of oncology treatment. They had a median of 24 total needs (11 were met and 13 were unmet) and preferred to see a median of 4 SC services but received care from none. County safety-net patients had comparatively more unmet needs than university patients (14.5 vs 11.5, P = .04). CONCLUSION: Pretreatment HNC patients at a bi-institutional academic medical center report a high number of unmet SC needs with corollary poor receipt of available SC services. Novel interventions to address this significant gap in care are needed.

Supportive Care Needs Among Head and Neck Cancer Patients Prior to Oncologic Treatment: A Prospective, Nested Cross-Sectional Qualitative Analysis.

OBJECTIVES: To qualitatively characterize pretreatment head and neck cancer (HNC) patients' supportive care (SC) needs, attitudes toward SC, and barriers to SC utilization. MATERIALS AND METHODS: A prospective, nested, bi-institutional, cross-sectional pilot study design was employed. Participants were sub-selected from a representative sample of 50 patients newly diagnosed with mucosal or salivary gland HNC or sarcoma of the head and neck. Eligibility criteria included reporting ≥2 unmet needs (according to the Supportive Care Needs Survey-Short Form 34) or clinically-significant distress (National Comprehensive Cancer Network Distress Thermometer score ≥4). Semi-structured interviews were performed prior to initiation of oncologic treatment. Audio-recorded interviews were transcribed and thematically analyzed using NVivo 12.0 (QSR Australia). Thematic findings and representative quotes were interpreted by the entire research team. RESULTS: Twenty-seven patients were interviewed. One-third were treated at the county safety-net hospital and the remainder were treated at the university health system. An equal proportion of patients presented with oral cavity, oropharyngeal, and laryngeal or other tumors. Two significant findings were identified on semi-structured interviews. First, patients did not perceive the relevance of SC prior to treatment. Second, anxiety surrounding the HNC diagnosis and impending treatment dominated in the pretreatment phase. CONCLUSION: Improved HNC patient education about the relevance and importance of SC in the pretreatment setting is needed. Integration of social work or psychological services in HNC clinics is warranted to address patients' cancer-related worry-a discrete, dominant pretreatment SC need.

Data envelopment analysis to evaluate the efficiency of tobacco treatment programs in the NCI Moonshot Cancer Center Cessation Initiative.

BACKGROUND: The Cancer Center Cessation Initiative (C3I) is a National Cancer Institute (NCI) Cancer Moonshot Program that supports NCI-designated cancer centers developing tobacco treatment programs for oncology patients who smoke. C3I-funded centers implement evidence-based programs that offer various smoking cessation treatment components (e.g., counseling, Quitline referrals, access to medications). While evaluation of implementation outcomes in C3I is guided by evaluation of reach and effectiveness (via RE-AIM), little is known about technical efficiency-i.e., how inputs (e.g., program costs, staff time) influence implementation outcomes (e.g., reach, effectiveness). This study demonstrates the application of data envelopment analysis (DEA) as an implementation science tool to evaluate technical efficiency of C3I programs and advance prioritization of implementation resources. METHODS: DEA is a linear programming technique widely used in economics and engineering for assessing relative performance of production units. Using data from 16 C3I-funded centers reported in 2020, we applied input-oriented DEA to model technical efficiency (i.e., proportion of observed outcomes to benchmarked outcomes for given input levels). The primary models used the constant returns-to-scale specification and featured cost-per-participant, total full-time equivalent (FTE) effort, and tobacco treatment specialist effort as model inputs and reach and effectiveness (quit rates) as outcomes. RESULTS: In the DEA model featuring cost-per-participant (input) and reach/effectiveness (outcomes), average constant returns-to-scale technical efficiency was 25.66 (SD = 24.56). When stratified by program characteristics, technical efficiency was higher among programs in cohort 1 (M = 29.15, SD = 28.65, n = 11) vs. cohort 2 (M = 17.99, SD = 10.16, n = 5), with point-of-care (M = 33.90, SD = 28.63, n = 9) vs. no point-of-care services (M = 15.59, SD = 14.31, n = 7), larger (M = 33.63, SD = 30.38, n = 8) vs. smaller center size (M = 17.70, SD = 15.00, n = 8), and higher (M = 29.65, SD = 30.99, n = 8) vs. lower smoking prevalence (M = 21.67, SD = 17.21, n = 8). CONCLUSION: Most C3I programs assessed were technically inefficient relative to the most efficient center benchmark and may be improved by optimizing the use of inputs (e.g., cost-per-participant) relative to program outcomes (e.g., reach, effectiveness). This study demonstrates the appropriateness and feasibility of using DEA to evaluate the relative performance of evidence-based programs.

Is 2045 the best we can do? Mitigating the HPV-related oropharyngeal cancer epidemic.

INTRODUCTION: Oropharyngeal cancer (OPC) will be among the most common cancers in men by 2045 due to a rapid rise in human papillomavirus (HPV)-related OPC. Those who survive their cancer often suffer life-long treatment effects and early death. HPV vaccination could prevent virtually all HPV-related cancers but is not an effective preventive strategy for those already exposed. Without a dramatic increase in vaccine uptake in the U.S., HPV vaccination will have a negligible effect on OPC incidence through 2045 and no substantial impact until 2060. Additionally, targeted screening for earlier diagnosis may soon be feasible for those inadequately protected by vaccination. AREAS COVERED: PubMed search for English-language articles related to incidence, screening, and prevention of HPV-related malignancies, focused on OPC in the U.S. EXPERT OPINION: HPV-related OPC incidence will continue to increase for the foreseeable future with prophylactic vaccination offering no substantial public health impact for decades. Consequently, we must rapidly increase vaccination rates and develop screening methods to identify high-risk individuals. Such individuals would be eligible for potential preventive treatments and screening to diagnose early-stage HPV-related OPC allowing less morbid treatments. These methods will bridge the population into an era of decreasing incidence after vaccination takes effect.

Survival and disease progression following solitary locoregional recurrence after head and neck radiotherapy.

PURPOSE: The management of solitary locoregional recurrence (sLRR) of head and neck squamous cell carcinoma (HNSCC) previously treated with radiotherapy (RT) is challenging. We aimed to identify characteristics associated with improved outcome. METHODS: We identified patients treated with non-sinus, mucosal HNSCC who initially received IMRT. We characterized overall survival (OS) and locoregional control (LRC). Multivariable analysis (MVA) on survival and patterns-of-failure were performed using Cox and Fine-Gray competing risks analysis. RESULTS: We identified 90 patients with available follow-up. In total, 67 (74%) patients received curative-intent salvage, while 23 (26%) received palliative care. On MVA, significantly improved OS and LRC were associated with lower initial N-classification and use of salvage total laryngectomy (TL) or neck dissection (ND). CONCLUSION: A nontrivial number of patients with sLRR cannot undergo salvage. Among patients treated with curative intent, TL or ND were clearly associated with improved OS and LRC.

Pilot Study of a Wearable Activity Monitor During Head and Neck Radiotherapy to Predict Clinical Outcomes.

PURPOSE: Given the established associations between performance status and survival in a variety of cancers, there is significant interest in using a biometric wearable device (WD) to predict outcomes in the oncology population. In this pilot study, we investigated the ability of a WD to predict meaningful clinical end points in patients undergoing head and neck radiotherapy. METHODS: Patients receiving head and neck definitive chemoradiotherapy or postoperative radiotherapy/chemoradiotherapy were enrolled in this pilot study, designed to show 90% compliance with using the device. Individuals were asked to wear the WD for 23 hours a day, and hospital admissions, pain medication usage, and FACT-G quality-of-life (QoL) score were prospectively recorded. RESULTS: Fifty-one patients were enrolled and started using the WD, but eight patients stopped wearing it, resulting in a compliance probability of only 84%. There were 15 hospital admissions, 13 of which were planned for feeding tube placement. There was no step count threshold that predicted the need for admission or more pain medications. However, among the 25 patients with a significant reduction in FACT-G score, the average reductions in daily steps during the week and weekend before the decline were 988 (P = .005) and 1,311 (P = .018), respectively, and the odds of a QoL reduction were more than 4-fold higher among patients experiencing a week-to-week reduction of at least 1,000 daily steps. There was no association between heart rate and any end point. CONCLUSION: Although not meeting the compliance goal, the majority of patients did use the WD. The WD signal could not identify patients requiring hospitalization or significantly more pain medication, but the finding of reduced step counts before a significant reduction in QoL is provocative.