Development and validation of a novel TNM staging N-classification of oral cavity squamous cell carcinoma.

BACKGROUND: For oral cavity squamous cell carcinoma (OSCC), extent of extranodal extension (ENE) (minor, ≤2 mm; major, >2 mm) is differentially prognostic, whereas limitations exist with the 8th edition of American Joint Committee on Cancer/International Union Against Cancer TNM N-classification (TNM-8-N). METHODS: Resected OSCC patients at four centers were included and extent of ENE was recorded. Thresholds for optimal overall survival (OS) discrimination of lymph node (LN) features were established. After dividing into training and validation sets, two new N-classifications were created using 1) recursive partitioning analysis (RPA), and 2) adjusted hazard ratios (aHRs) and were ranked against TNM-8-N and two published proposals. RESULTS: A total of 1460 patients were included (pN0: 696; pN+: 764). Of the pN+ cases, 135 (18%) had bilateral/contralateral LNs; 126 (17%) and 244 (32%) had minor and major ENE, and two (0.3%) had LN(s) >6 cm without ENE (N3a). LN number (1 and >1 vs. 0: aHRs, 1.92 [95% confidence interval (CI), 1.44-2.55] and 3.21 [95% CI, 2.44-4.22]), size (>3 vs. ≤3 cm: aHR, 1.88 [95% CI, 1.44-2.45]), and ENE extent (major vs. minor: aHR, 1.40 [95% CI, 1.05-1.87]) were associated with OS, whereas presence of contralateral LNs was not (aHR, 1.05 [95% CI, 0.81-1.36]). The aHR proposal provided optimal performance with these changes to TNM-8-N: 1) stratification of ENE extent, 2) elimination of N2c and 6-cm threshold, and 3) stratification of N2b by 3 cm threshold. CONCLUSION: A new N-classification improved staging performance compared to TNM-8-N, by stratifying by ENE extent, eliminating the old N2c category and the 6 cm threshold, and by stratifying multiple nodes by size.

Bayesian hierarchical profile regression for binary covariates.

Dysphagia, a common result of other medical conditions, is caused by malfunctions in swallowing physiology resulting in difficulty eating and drinking. The Modified Barium Swallow Study (MBSS), the most commonly used diagnostic tool for evaluating dysphagia, can be assessed using the Modified Barium Swallow Impairment Profile (MBSImP™). The MBSImP assessment tool consists of a hierarchical grouped data structure with multiple domains, a set of components within each domain which characterize specific swallowing physiologies, and a set of tasks scored on a discrete scale within each component. We lack sophisticated approaches to extract patterns of physiologic swallowing impairment from the MBSImP task scores within a component while still recognizing the nested structure of components within a domain. We propose a Bayesian hierarchical profile regression model, which uses a Bayesian profile regression model in conjunction with a hierarchical Dirichlet process mixture model to (1) cluster subjects into impairment profile patterns while respecting the hierarchical grouped data structure of the MBSImP, and (2) simultaneously determine associations between latent profile cluster membership for all components and the outcome of dysphagia severity. We apply our approach to a cohort of patients referred for an MBSS and assessed using the MBSImP. Our research results can be used to inform appropriate intervention strategies, and provide tools for clinicians to make better multidimensional management and treatment decisions for patients with dysphagia.

Tobacco use and cancer-related symptom burden: Analysis of the US Population Assessment of Tobacco and Health Study.

BACKGROUND: Understanding the relationship between tobacco use and symptom burden may inform tobacco treatment interventions tailored to the needs of individuals with cancer. METHODS: The study included 1409 adult cancer survivors from Wave 5 of the US Food and Drug Administration Population Assessment of Tobacco and Health (PATH) Study. A multivariate analysis of variance controlling for age, sex, and race/ethnicity assessed the association of cigarette smoking and vaping on cancer-related symptom burden (fatigue, pain, emotional problems) and quality of life (QoL). Generalized linear mixed models controlling for the same factors were used to assess associations among symptom burden, QoL, and quit-smoking intentions, quit-smoking likelihood, and past 12-month smoking quit attempts. RESULTS: Weighted rates of current cigarette smoking and vaping were 14.21% and 2.88%, respectively. Current smoking was associated with greater fatigue (p < .0001; partial η 2  = .02), pain (p < .0001; partial η 2  = .08), emotional problems (p < .0001; partial η 2  = .02), and worse QoL (p < .0001; partial η 2  = .08). Current vaping was associated with greater fatigue (p = .001; partial η 2  = .008), pain (p = .009; partial η 2  = .005), and emotional problems (p = .04; partial η 2  = .003), but not worse QoL (p = .17). Higher cancer symptom burden was not associated with reduced interest in quitting, likelihood of quitting, or odds of past year quit attempts (p > .05 for each). CONCLUSIONS: Among adults with cancer, current smoking and vaping were associated with greater symptom burden. Survivors' interest in and intentions to quit smoking were not related to symptom burden. Future research should examine the role of tobacco cessation in improving symptom burden and QoL.

A Survey of the National Comprehensive Cancer Network on Approaches Toward Addressing Patients' Transportation Insecurity.

BACKGROUND: Addressing patients' social determinants of health is a national priority for cancer treatment centers. Transportation insecurity is one major challenge for patients undergoing active cancer treatment, and missing treatments can result in worse cancer treatment outcomes, including worse morbidity and mortality. How cancer treatment centers are addressing transportation insecurity is understudied. METHODS: In January and February 2022, the NCCN Best Practices Committee conducted a survey of NCCN's 31 Member Institutions (currently 32 member institutions as of April 2022) to assess how centers were addressing patient transportation insecurity: how they screen for transportation insecurity, coordinate transportation, and fund transportation initiatives, and their plans to address transportation insecurity in the future. RESULTS: A total of 25 of 31 (81%) NCCN Member Institutions responded to the survey, of which 24 (96%) reported supporting the transportation needs of their patients through screening, coordinating, and/or funding transportation. Patients' transportation needs were most often identified by social workers (96%), clinicians (83%), or patients self-declaring their needs (79%). Few centers (33%) used routine screening approaches (eg, universal screening of social risk factors) to systematically identify transportation needs, and 54% used the support of technology platforms or a vendor to coordinate transportation. Transportation was predominantly funded via some combination of philanthropy (88%), grants (63%), internal dollars (63%), and reimbursement from insurance companies (58%). Over the next 12 months, many centers were either going to continue their current transportation programs in their current state (60%) or expand existing programs (32%). CONCLUSIONS: Many NCCN Member Institutions are addressing the transportation needs of their patients. Current efforts are heterogeneous. Few centers have systematic, routine screening approaches, and funding relies on philanthropy more so than institutional dollars or reimbursement from insurers. Opportunities exist to establish more structured, scalable, and sustainable programs for patients' transportation needs.

Patient Navigation for Timely, Guideline-Adherent Adjuvant Therapy for Head and Neck Cancer: A National Landscape Analysis.

BACKGROUND: Aligned with the NCCN Clinical Practice Guidelines in Oncology for Head and Neck Cancers, in November 2021 the Commission on Cancer approved initiation of postoperative radiation therapy (PORT) within 6 weeks of surgery for head and neck cancer (HNC) as its first and only HNC quality metric. Unfortunately, >50% of patients do not commence PORT within 6 weeks, and delays disproportionately burden racial and ethnic minority groups. Although patient navigation (PN) is a potential strategy to improve the delivery of timely, equitable, guideline-adherent PORT, the national landscape of PN for this aspect of care is unknown. MATERIALS AND METHODS: From September through November 2022, we conducted a survey of health care organizations that participate in the American Cancer Society National Navigation Roundtable to understand the scope of PN for delivering timely, guideline-adherent PORT for patients with HNC. RESULTS: Of the 94 institutions that completed the survey, 89.4% (n=84) reported that at least part of their practice was dedicated to navigating patients with HNC. Sixty-eight percent of the institutions who reported navigating patients with HNC along the continuum (56/83) reported helping them begin PORT. One-third of HNC navigators (32.5%; 27/83) reported tracking the metric for time-to-PORT at their facility. When estimating the timeframe in which the NCCN and Commission on Cancer guidelines recommend commencing PORT, 44.0% (37/84) of HNC navigators correctly stated ≤6 weeks; 71.4% (60/84) reported that they did not know the frequency of delays starting PORT among patients with HNC nationally, and 63.1% (53/84) did not know the frequency of delays at their institution. CONCLUSIONS: In this national landscape survey, we identified that PN is already widely used in clinical practice to help patients with HNC start timely, guideline-adherent PORT. To enhance and scale PN within this area and improve the quality and equity of HNC care delivery, organizations could focus on providing better education and support for their navigators as well as specialization in HNC.

Mechanism underlying a brief cognitive behavioral treatment for head and neck cancer survivors with body image distress.

PURPOSE: Body image distress (BID) among head and neck cancer (HNC) survivors is a debilitating toxicity associated with depression, anxiety, stigma, and poor quality of life. BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment) is a brief cognitive behavioral therapy (CBT) that reduces BID for these patients. This study examines the mechanism underlying BRIGHT. METHODS: In this randomized clinical trial, HNC survivors with clinically significant BID were randomized to receive five weekly psychologist-led video tele-CBT sessions (BRIGHT) or dose-and delivery matched survivorship education (attention control [AC]). Body image coping strategies, the hypothesized mediators, were assessed using the Body Image Coping Skills Inventory (BICSI). HNC-related BID was measured with the Inventory to Measure and Assess imaGe disturbancE-Head and Neck (IMAGE-HN). Causal mediation analyses were used to estimate the mediated effects of changes in BICSI scores on changes in IMAGE-HN scores. RESULTS: Among 44 HNC survivors with BID allocated to BRIGHT (n = 20) or AC (n = 24), mediation analyses showed that BRIGHT decreased avoidant body image coping (mean change in BICSI-Avoidance scale score) from baseline to 1-month post-intervention relative to AC (p = 0.039). Decreases in BICSI-Avoidance scores from baseline to 1-month resulted in decreases in IMAGE-HN scores from baseline to 3 months (p = 0.009). The effect of BRIGHT on IMAGE-HN scores at 3 months was partially mediated by a decrease in BICSI-Avoidance scores (p = 0.039). CONCLUSIONS: This randomized trial provides preliminary evidence that BRIGHT reduces BID among HNC survivors by decreasing avoidant body image coping. Further research is necessary to confirm these results and enhance the development of interventions targeting relevant pathways to reduce BID among HNC survivors. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03831100 .

Behavioral Activation-Based Digital Smoking Cessation Intervention for Individuals With Depressive Symptoms: Randomized Clinical Trial.

BACKGROUND: Depression is common among adults who smoke cigarettes. Existing depression-specific cessation interventions have limited reach and are unlikely to improve smoking prevalence rates among this large subgroup of smokers. OBJECTIVE: This study aimed to determine whether a mobile app-based intervention tailored for depression paired with a mailed sample of nicotine replacement therapy (NRT) is efficacious for treating depression and promoting smoking cessation. METHODS: A 2-arm nationwide remote randomized clinical trial was conducted in the United States. Adults (N=150) with elevated depressive symptoms (Patient Health Questionnaire-8≥10) who smoked were enrolled. The mobile app ("Goal2Quit") provided behavioral strategies for treating depression and quitting smoking based on Behavioral Activation Treatment for Depression. Goal2Quit participants also received a 2-week sample of combination NRT. Treatment as usual participants received a self-help booklet for quitting smoking that was not tailored for depression. Primary end points included Goal2Quit usability, change in depression (Beck Depression Inventory-II) across 12 weeks, and smoking cessation including reduction in cigarettes per day, incidence of 24-hour quit attempts, floating abstinence, and 7-day point prevalence abstinence (PPA). RESULTS: In total, 150 participants were enrolled between June 25, 2020, and February 23, 2022, of which 80 were female (53.3%) and the mean age was 38.4 (SD 10.3) years. At baseline, participants on average reported moderate depressive symptoms and smoked a mean of 14.7 (SD 7.5) cigarettes per day. Goal2Quit usability was strong with a mean usability rating on the System Usability Scale of 78.5 (SD 16.9), with 70% scoring above the ≥68 cutoff for above-average usability. Retention data for app use were generally strong immediately following trial enrollment and declined in subsequent weeks. Those who received Goal2Quit and the NRT sample reported lower mean depressive symptoms over the trial duration as compared to treatment as usual (difference of mean 3.72, SE 1.37 points less; P=.01). Across time points, all cessation outcomes favored Goal2Quit. Regarding abstinence, Goal2Quit participants reported significantly higher rates of 7-day PPA at weeks 4 (11% vs 0%; P=.02), 8 (7-day PPA: 12% vs 0%; P=.02), and 12 (16% vs 2%; P=.02). CONCLUSIONS: A mobile app intervention tailored for depression paired with a sample of NRT was effective for depression treatment and smoking cessation. Findings support the utility of this intervention approach for addressing the currently unmet public health treatment need for tailored, scalable depression-specific cessation treatments. TRIAL REGISTRATION: ClinicalTrials.gov NCT03837379; https://clinicaltrials.gov/ct2/show/NCT03837379.

Free tissue reconstruction in the "vessel-depleted" neck: A multi-institutional cohort study.

OBJECTIVES: Much of the literature on free tissue reconstruction in the "vessel-depleted" neck is focused on identification of vessels outside the pretreated field and data on free flap outcomes when infield microvascular anastomosis is performed remain scarce. We aim to report on free flap outcomes and recipient vessel choice in a large cohort of patients with prior radiation and neck dissection (RTND) to the ipsilateral side of vessel anastomosis. METHODS: A retrospective review was performed including patients who received head and neck free tissue transfer following prior RTND to the ipsilateral side of vessel anastomosis. Pretreatment data, free flap type, defect site, and recipient vessel choice were reported. Recipient vessel choice was stratified according to neck dissection level and prior free flap. Primary outcome was free flap survival (total failure, partial failure, success) within 30 days after surgery. RESULTS: This study included 72 free flap cases in 68 patients. Free flap success was 94.4%; one case (1.4%) resulted in total flap loss and three cases (4%) had partial flap loss. The facial (35%), external carotid (ECA) (25%), and superior thyroid arteries (16%) were the most common recipient arteries. The external jugular (EJV) (38%), facial (30%), and internal jugular veins (IJV) (15%) were the most common recipient veins. The superior thyroid artery was used less frequently with a prior level 2-3/4 neck dissection compared to a prior level 1-3/4 neck dissection (6% vs. 17%, p = 0.83). The facial artery (7% vs. 67%, p < 0.01) and vein (13% vs. 46%, p = 0.04) were used less frequently when a prior free flap with ipsilateral anastomosis was performed. The superior thyroid, ECA, IJV, and EJV were more commonly used in this subgroup. CONCLUSION: Free tissue transfer with infield microvascular anastomosis in a neck with prior RTND can be safely done with comparable outcomes to surgically naïve, non-irradiated necks.

The effect of reconstruction on positive margin rates in oral cancer: Using length of stay as a proxy measure for flap reconstruction in a national database.

PURPOSE: Planned flap reconstruction, allowing aggressive resections of oral cavity squamous cell carcinoma (OCSCC), may decrease positive surgical margins. The purpose of this study was to determine if length of stay (LOS), as a proxy measure for flap reconstruction, is associated with positive margin rates in OCSCC. MATERIALS AND METHODS: Data from the National Cancer Database was retrospectively collected for patients undergoing surgery for previously untreated clinical T1-3 OCSCC. Post-operative LOS was dichotomized between ≤4 and >4 days as a proxy measure for whether patients may have received flap reconstruction. Patients with LOS >4 days represent a diverse group, but those with a LOS ≤4 days are less likely to have undergone an oral cavity flap reconstruction. RESULTS: 10,107 patients were included, of which 5290 (52%) were clinical T1 and 4852 (48%) were clinical T2-3. 771 (8%) patients had a positive surgical margin. On multivariable logistic regression analysis, LOS ≤4 days was significantly associated with a positive margin resection in patients with clinical T2-3 tumors (OR 1.68, 95%CI 1.37-2.06) compared to patients with LOS >4 days. LOS was not associated with surgical margin status in patients with clinical T1 disease (OR 0.76, 95%CI 0.55-1.06). Patients with positive margin resections demonstrated worse overall survival (cT1: OR 1.35, 95%CI 1.06-1.72; cT2-3: OR 1.52, 95%CI 1.33-1.74). CONCLUSIONS: LOS >4 days after oral cavity cancer resection was significantly associated with negative surgical margins in clinical T2-3 oral cavity cancer, suggesting the possibility that patients undergoing flap reconstruction after resection have fewer positive surgical margins.

Development and validation of a Surgical Prioritization and Ranking Tool and Navigation Aid for Head and Neck Cancer (SPARTAN-HN) in a scarce resource setting: Response to the COVID-19 pandemic.

BACKGROUND: In the wake of the coronavirus disease 2019 (COVID-19) pandemic, access to surgical care for patients with head and neck cancer (HNC) is limited and unpredictable. Determining which patients should be prioritized is inherently subjective and difficult to assess. The authors have proposed an algorithm to fairly and consistently triage patients and mitigate the risk of adverse outcomes. METHODS: Two separate expert panels, a consensus panel (11 participants) and a validation panel (15 participants), were constructed among international HNC surgeons. Using a modified Delphi process and RAND Corporation/University of California at Los Angeles methodology with 4 consensus rounds and 2 meetings, groupings of high-priority, intermediate-priority, and low-priority indications for surgery were established and subdivided. A point-based scoring algorithm was developed, the Surgical Prioritization and Ranking Tool and Navigation Aid for Head and Neck Cancer (SPARTAN-HN). Agreement was measured during consensus and for algorithm scoring using the Krippendorff alpha. Rankings from the algorithm were compared with expert rankings of 12 case vignettes using the Spearman rank correlation coefficient. RESULTS: A total of 62 indications for surgical priority were rated. Weights for each indication ranged from -4 to +4 (scale range; -17 to 20). The response rate for the validation exercise was 100%. The SPARTAN-HN demonstrated excellent agreement and correlation with expert rankings (Krippendorff alpha, .91 [95% CI, 0.88-0.93]; and rho, 0.81 [95% CI, 0.45-0.95]). CONCLUSIONS: The SPARTAN-HN surgical prioritization algorithm consistently stratifies patients requiring HNC surgical care in the COVID-19 era. Formal evaluation and implementation are required. LAY SUMMARY: Many countries have enacted strict rules regarding the use of hospital resources during the coronavirus disease 2019 (COVID-19) pandemic. Facing delays in surgery, patients may experience worse functional outcomes, stage migration, and eventual inoperability. Treatment prioritization tools have shown benefit in helping to triage patients equitably with minimal provider cognitive burden. The current study sought to develop what to the authors' knowledge is the first cancer-specific surgical prioritization tool for use in the COVID-19 era, the Surgical Prioritization and Ranking Tool and Navigation Aid for Head and Neck Cancer (SPARTAN-HN). This algorithm consistently stratifies patients requiring head and neck cancer surgery in the COVID-19 era and provides evidence for the initial uptake of the SPARTAN-HN.

Evaluation of a novel telemedicine-based intervention to manage body image disturbance in head and neck cancer survivors.

OBJECTIVES: The study aimed to evaluate the feasibility, acceptability, and preliminary clinical impact of BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment), a novel telemedicine-based cognitive-behavioral intervention to manage body image disturbance (BID) in head and neck cancer (HNC) survivors. METHODS: Head and neck cancer survivors with BID were enrolled into a single-arm pilot trial. Participants completed study measures at baseline, 1- and 3-months post-BRIGHT to assess its acceptability and clinical impact. Participants completed semi-structured interviews to evaluate the feasibility and acceptability of BRIGHT and refine the intervention. RESULTS: Ten HNC survivors with BID were enrolled into the trial of tablet-based BRIGHT. BRIGHT was feasible, as judged by low dropout (n = 1), high session completion rates (100%; 45/45) and low rates of technical issues with the tablet-based delivery (11% minor; 0% major). Ninety percent of participants were highly likely to recommend BRIGHT, reflecting its acceptability. BRIGHT was associated with a 34.5% reduction in mean Body Image Scale scores at 1-month post-BRIGHT (mean difference from baseline = 4.56; 95% CI 1.55, 7.56), an effect that was durable at 3-months post-BRIGHT (mean decrease from baseline = 3.56; 95% CI 1.15-5.96). Program evaluation revealed high levels of satisfaction with BRIGHT, particularly the delivery platform. During the qualitative evaluation, participants highlighted that BRIGHT improved image-related coping behavior. CONCLUSIONS: BRIGHT is feasible, acceptable to HNC survivors, and has significant potential as a novel approach to manage BID in HNC survivors. Additional research is necessary to refine BRIGHT and evaluate its clinical efficacy and scalability.

Intermediate-grade carcinoma of the parotid and the impact of adjuvant radiation.

PURPOSE: To determine the influence of adjuvant radiotherapy on survival in surgically-managed early stage intermediate-grade mucoepidermoid and acinic cell carcinoma of the parotid. MATERIALS AND METHODS: The National Cancer Database was reviewed between 2004 and 2015 to identify patients with intermediate-grade, early T-stage, node-negative parotid carcinoma who underwent parotidectomy ± radiotherapy. RESULTS: There were 744 patients identified of which 81% had mucoepidermoid carcinoma and 19% had acinic cell carcinoma. Positive surgical margins were identified in 21% and adjuvant radiotherapy was administered in 38% of cases. Of the 159 patients with positive margins, 113 (71%) received adjuvant radiotherapy. Of the 585 patients with negative margins, 173 (30%) underwent adjuvant radiotherapy. In multivariable analysis, age (over 52 years: HR 5.19, 95%CI 2.33-11.57), insurance status (private insurance: HR 0.24 95%CI 0.13-0.43), and extent of parotidectomy (total parotidectomy: HR 2.02 95%CI 1.23-3.31) were significantly associated with overall survival, while adjuvant radiotherapy was not a significant predictive factor (HR 0.81, 95%CI 0.49-1.36). In patients with positive margin resections, however, adjuvant radiation was an independent predictor of improved survival when adjusted for age, insurance status, and extent of parotidectomy (HR 0.34, 95%CI 0.13-0.88). Conversely, in patients with negative margin resections, adjuvant radiation did not influence survival outcomes when adjusted for these covariates (HR 1.02, 95%CI 0.53-1.93). CONCLUSIONS AND RELEVANCE: In patients with early stage intermediate-grade parotid carcinoma, adjuvant radiotherapy significantly and independently improves survival in those with post-operative positive margins. Adjuvant therapy, however, does not appear to improve survival outcomes in those with negative margin resections.

Racial and Ethnic Disparities in Travel for Head and Neck Cancer Treatment and the Impact of Travel Distance on Survival.

BACKGROUND: Patients who travel a long distance (≥50 miles) for cancer care have improved outcomes. However, to the authors' knowledge, the prevalence of long travel distances for treatment by patients with head and neck squamous cell carcinoma (HNSCC), and the effect of travel distance on overall survival (OS), remains unknown. METHODS: The authors used the National Cancer Data base from 2004 through 2013 to identify patients with HNSCC undergoing definitive treatment. Travel distance for treatment was categorized as short (<12.5 miles), intermediate (12.5-49.9 miles), and long (50-249.9 miles). The primary outcome, OS, was evaluated using Cox shared-frailty modeling. A secondary outcome, factors associated with intermediate and long travel distances, was evaluated using multivariable hierarchical logistic regression. RESULTS: Among 118,000 patients with HNSCC, 62,753 (53.2%), 40,644 (34.4%), and 14,603 (12.4%) patients, respectively, traveled short, intermediate, and long distances for treatment. After adjusting for relevant covariates, long travel distance was associated with treatment at academic and high-volume centers. Patients of black race, of Hispanic ethnicity, with Medicaid insurance, and who were treated with nonsurgical treatment were less likely to travel long distances for treatment (P<.001). Traveling a long distance for treatment was associated with improved OS on multivariable analysis (adjusted hazard ratio, 0.93; 95% confidence interval, 0.89-0.96) compared with a short distance. CONCLUSIONS: Traveling a long distance for HNSCC treatment is associated with improved survival, especially for patients receiving nonsurgical management. Racial and ethnic disparities in travel for HNSCC treatment exist. As regionalization of care continues, future work should identify and address reasons for racial and ethnic disparities in travel that may prevent access to care at high-volume facilities. Cancer 2018;000:000-000. © 2018 American Cancer Society.

Adherence to National Comprehensive Cancer Network guidelines for time to initiation of postoperative radiation therapy for patients with head and neck cancer.

BACKGROUND: Adherence to evidence-based treatment guidelines has been proposed as a measure of cancer care quality. The objective of this study was to determine the rate and predictors of care that does not adhere to National Comprehensive Cancer Network guidelines regarding commencing postoperative radiation therapy (PORT) within 6 weeks of surgery for patients with head and neck squamous cell carcinoma (HNSCC). METHODS: The National Cancer Data Base was reviewed from 2006 to 2014, and patients with HNSCC who underwent curative-intent surgery followed by PORT were identified. Multivariable logistic regression analysis was used to determine the factors associated with nonadherence to guidelines regarding the timing of initiating PORT. RESULTS: In total, 47,273 patients were included in the study. 55.7% of patients (26,340/47,273) failed to commence PORT within 6 week of surgery. The percentage of patients who failed to initiate PORT within 6 week of surgery increased over time. On multivariable analysis, the factors associated with failure to initiate timely, guideline-adherent PORT included black race, public insurance [Medicare, Medicaid] or uninsured status, lower levels of education, increased severity of comorbidity, increased postoperative length of stay, 30-day unplanned hospital readmission, treatment at an academic medical center, and the receipt of surgery and PORT at different facilities. CONCLUSIONS: Over 50% of patients with HNSCC who undergo surgery and PORT receive care that does not adhere to National Comprehensive Cancer Network guidelines with regard to initiating PORT within 6 weeks of surgery. Sociodemographic, oncologic, treatment, and hospital factors are all associated with failure to receive guideline-directed care and should be explored in future studies. Cancer 2017;123:2651-60. © 2017 American Cancer Society.

Effect of postoperative radiotherapy on survival for surgically managed pT3N0 and pT4aN0 laryngeal cancer: Analysis of the National Cancer Data Base.

BACKGROUND: The current study was conducted to determine the effect of postoperative radiotherapy (PORT) on overall survival in patients with surgically managed pT3-T4aN0 laryngeal squamous cell carcinoma (SCC). METHODS: A review of the National Cancer Data Base from 2004 through 2013 was performed. Patients with surgically managed pT3-4aN0 laryngeal SCC with negative surgical margins were included. Univariable and multivariable Cox regression analyses were used to determine factors associated with survival. RESULTS: A total of 1460 patients were included, 46.2% of whom had pT3N0 disease (674 patients) and 53.8% of whom had pT4aN0 disease (786 patients). Approximately 72.0% of the patients with pT3N0 disease (485 patients) and 50.1% of the patients with pT4aN0 disease (394 patients) received PORT. PORT was not found to be associated with improved overall survival on univariable analysis for patients with pT3N0 disease (hazard ratio [HR], 0.84; 95% confidence interval [95% CI], 0.62-1.14), but was for patients with pT4aN0 disease (HR, 0.57; 95% CI, 0.45-0.71). For patients with pT3N0 SCC of the larynx, in a multivariable Cox regression analysis adjusting for age >65 years, severity of comorbidities, larynx subsite, extent of laryngectomy, and number of lymph nodes removed, PORT was not found to be associated with improved survival (adjusted HR, 0.88; 95% CI, 0.64-1.21). For patients with pT4aN0 disease, the administration of PORT was associated with improved survival on multivariable analysis adjusting for age >65 years, severity of comorbidities, larynx subsite, number of lymph nodes removed, and type of hospital (adjusted HR, 0.58; 95% CI, 0.46-0.73). CONCLUSIONS: For patients with surgically managed pT3N0 laryngeal SCC with negative margins, PORT does not appear to be associated with improved survival. Despite a survival benefit, nearly 50% of patients with pT4aN0 laryngeal SCC and negative surgical margins do not receive standard-of-care PORT. Cancer 2017;123:2248-2257. © 2017 American Cancer Society.

Effect of time to initiation of postoperative radiation therapy on survival in surgically managed head and neck cancer.

BACKGROUND: The objective of this study was to determine the effects of National Comprehensive Cancer Network (NCCN) guideline-adherent initiation of postoperative radiation therapy (PORT) and different time-to-PORT intervals on the overall survival (OS) of patients with head and neck squamous cell carcinoma (HNSCC). METHODS: The National Cancer Data Base was reviewed for the period of 2006-2014, and patients with HNSCC undergoing surgery and PORT were identified. Kaplan-Meier survival estimates, Cox regression analysis, and propensity score matching were used to determine the effects of initiating PORT within 6 weeks of surgery and different time-to-PORT intervals on survival. RESULTS: This study included 41,291 patients. After adjustments for covariates, starting PORT >6 weeks postoperatively was associated with decreased OS (adjusted hazard ratio [aHR], 1.13; 99% confidence interval [CI], 1.08-1.19). This finding remained in the propensity score-matched subset (hazard ratio, 1.21; 99% CI, 1.15-1.28). In comparison with starting PORT 5 to 6 weeks postoperatively, initiating PORT earlier was not associated with improved survival (aHR for ≤ 4 weeks, 0.93; 99% CI, 0.85-1.02; aHR for 4-5 weeks, 0.92; 99% CI, 0.84-1.01). Increasing durations of delay beyond 7 weeks were associated with small, progressive survival decrements (aHR, 1.09, 1.10, and 1.12 for 7-8, 8-10, and >10 weeks, respectively). CONCLUSIONS: Nonadherence to NCCN guidelines for initiating PORT within 6 weeks of surgery was associated with decreased survival. There was no survival benefit to initiating PORT earlier within the recommended 6-week timeframe. Increasing durations of delay beyond 7 weeks were associated with small, progressive survival decrements. Cancer 2017;123:4841-50. © 2017 American Cancer Society.

Acellular dermal graft pharyngeal repair augmentation after laryngectomy.

PURPOSE: Pharyngocutaneous fistula (PCF) after laryngectomy continues to be a serious complication, especially after radiation. Recruitment of non-radiated tissue into the surgical defect may decrease the risk of fistula. These techniques however have significant morbidity and increases operative time. We hypothesized that using acellular dermal graft to reinforce the pharyngeal closure could decrease the risk of fistula, without the added morbidity of a vascularized flap. METHODS: We performed a retrospective chart review of all patients that underwent a laryngectomy between 2005 and 2015 at an acedemic tertiary referral center. Patients who underwent primary pharyngeal closure with Alloderm® reinforcement without any other flap reconstruction were identified. Basic demographics, previous treatment, operative technique and fistula were extracted from the medical records. The primary outcome was PCF rate. The time to closure, margin status and disease recurrence was also evaluated. RESULTS: Among 16 patients with AlloDerm® augmentation, eight had primary laryngectomy and eight had salvage laryngectomy. A total of three in the salvage laryngectomy with prior history of radiation developed PCF. The fistula closed in all three cases with conservative treatment. There was no PCF in the primary laryngectomy group without prior history of radiation. CONCLUSION: The rate of PCF among the salvage laryngectomy group with previous radiation did not differ from historical data. AlloDerm® can however, provide a simple alternative for repair in radiation patients where flap cannot be performed for pharyngeal reconstruction. In non-radiated patients, AlloDerm® augmentation may have a protective effect on fistula formation.

Prognosis and patterns of failure for the extubation of patients who remain intubated after head and neck surgery.

OBJECTIVE: This study aimed to analyze the rate of failure, patterns of failure, and prognostic factors for patients who remain intubated after head and neck surgery and then undergo delayed extubation. METHODS: Retrospective chart review of all otolaryngology patients who remained intubated after head and neck surgery and then underwent delayed extubation between 2006 and 2013. The incidence and patterns of extubation failure were analyzed. Univariable logistic regression analysis was performed to identify risk factors for postextubation failure. RESULTS: Fifteen of the 129 patients (12%) who remained intubated after head and neck surgery and underwent delayed extubation subsequently failed and required either repeat intubation or an emergency surgical airway. The most common reasons for failure were hemorrhage (47%) and upper airway edema (33%). Failure typically occurred within 6 hours of extubation. Twenty-seven percent of the patients who failed extubation (4/15) required an emergency surgical airway. On univariable logistic regression analysis, ligation of a major neck vessel predicted extubation failure (odds ratio=5.20; 95% confidence interval, 1.48-18.23). CONCLUSION: Postextubation failure in carefully selected patients undergoing delayed extubation after head and neck surgery is infrequent and most commonly due to postoperative bleeding. Prospective data are required to facilitate safe and quality care for these patients.

Factors associated with parental human papillomavirus vaccination intentions among adolescents from socioeconomically advantaged versus deprived households: a nationwide, cross-sectional survey.

Background: In the USA, HPV vaccine coverage is substantially lower among adolescents from high-income households compared to their low-income counterparts. We examined and compared the factors associated with parental HPV vaccination intentions between socioeconomically divergent groups. Methods: Data from unvaccinated and not fully HPV-vaccinated adolescents from the 2017-2021 National Immunization Survey (NIS)-Teen were analyzed. Socioeconomically advantaged vs. deprived groups were identified based on dichotomized income (material capital) and education (social capital). Parental intent to initiate and complete the HPV vaccine series was compared using bivariable analysis and the factors associated with lacking intent were identified. Findings: The 2017-2021 NIS-Teen included a total of 212,643 participants; the final analytical sample consisted of 105,958 adolescents (an estimated 10.3 million adolescents) who were unvaccinated or not fully vaccinated. In the advantaged group, 64.7% of parents of unvaccinated adolescents (equating to 2.4 million US adolescents) had no intention to initiate the HPV vaccine compared to 40.9% of parents in the deprived group (equating to 0.2 million adolescents) (P < 0.0001; S > 13.29). The most frequent reason for lacking intent in the advantaged group was 'safety concerns' (25.5%). In the deprived group, 'lack of knowledge', 'not recommended', and 'not needed' were common reasons (nearly 15% each). Lack of intent to complete the HPV vaccine series was higher in the advantaged group (43.9%; 1.1 million adolescents) compared to the deprived group (25.2%; 0.08 million adolescents) (P < 0.0001; S > 13.29). More than half in the advantaged group (58.4%) and over a third (37.1%) in the deprived group cited 'already up to date' as the main reason for not completing the HPV vaccine series. Interpretation: Lack of intent to initiate and complete the HPV vaccination series, particularly among socioeconomically advantaged parents is a significant barrier to achieving the national goal in the USA. Funding: The US National Institute on Minority Health and Health Disparities, the National Center for Advancing Translational Sciences, MUSC Hollings Cancer Center Seed funding, and the US National Cancer Institutes.

Interventions addressing health-related social needs among patients with cancer.

Health-related social needs are prevalent among cancer patients; associated with substantial negative health consequences; and drive pervasive inequities in cancer incidence, severity, treatment choices and decisions, and outcomes. To address the lack of clinical trial evidence to guide health-related social needs interventions among cancer patients, the National Cancer Institute Cancer Care Delivery Research Steering Committee convened experts to participate in a clinical trials planning meeting with the goal of designing studies to screen for and address health-related social needs among cancer patients. In this commentary, we discuss the rationale for, and challenges of, designing and testing health-related social needs interventions in alignment with the National Academy of Sciences, Engineering, and Medicine 5As framework. Evidence for food, housing, utilities, interpersonal safety, and transportation health-related social needs interventions is analyzed. Evidence regarding health-related social needs and delivery of health-related social needs interventions differs in maturity and applicability to cancer context, with transportation problems having the most maturity and interpersonal safety the least. We offer practical recommendations for health-related social needs interventions among cancer patients and the caregivers, families, and friends who support their health-related social needs. Cross-cutting (ie, health-related social needs agnostic) recommendations include leveraging navigation (eg, people, technology) to identify, refer, and deliver health-related social needs interventions; addressing health-related social needs through multilevel interventions; and recognizing that health-related social needs are states, not traits, that fluctuate over time. Health-related social needs-specific interventions are recommended, and pros and cons of addressing more than one health-related social needs concurrently are characterized. Considerations for collaborating with community partners are highlighted. The need for careful planning, strong partners, and funding is stressed. Finally, we outline a future research agenda to address evidence gaps.