Neighborhood-Level Disadvantage and Delayed Adjuvant Therapy in Head and Neck Cancer.

Importance: For patients with head and neck squamous cell carcinoma (HNSCC), initiation of postoperative radiation therapy (PORT) within 6 weeks of surgery is recommended by the National Comprehensive Cancer Network Guidelines and the Commission on Cancer. Although individual-level measures of socioeconomic status are associated with receipt of timely, guideline-adherent PORT, the role of neighborhood-level disadvantage has not been examined. Objective: To characterize the association of neighborhood-level disadvantage with delays in receiving PORT. Design, Setting, and Participants: This retrospective cohort study included 681 adult patients with HNSCC undergoing curative-intent surgery and PORT from 2018 to 2020 at 4 US academic medical centers. The data were analyzed between June 21, 2023, and March 5, 2024. Main Outcome Measures and Measures: The primary outcome was delay in initiating guideline-adherent PORT (ie, >6 weeks after surgery). Time-to-PORT (TTP) was a secondary outcome. Census block-level Area Deprivation Index (ADI) scores were calculated and reported as national percentiles (0-100); higher scores indicate greater deprivation. The association of ADI scores with PORT delay was assessed using multivariable logistic regression adjusted for demographic, clinical, and institutional characteristics. PORT initiation across ADI score population quartiles was evaluated with cumulative incidence plots and Cox models. Results: Among 681 patients with HNSCC undergoing surgery and PORT (mean [SD] age, 61.5 [11.2] years; 487 [71.5%] men, 194 [29.5%] women) the PORT delay rate was 60.8% (414/681) and median (IQR) TTP was 46 (40-56) days. The median (IQR) ADI score was 62.0 (44.0-83.0). Each 25-point increase in ADI score was associated with a corresponding 32% increase in the adjusted odds ratio (aOR) of PORT delay (aOR, 1.32; 95% CI, 1.07-1.63) on multivariable regression adjusted for institution, age, race and ethnicity, insurance, comorbidity, cancer subsite, stage, postoperative complications, care fragmentation, travel distance, and rurality. Increasing ADI score population quartiles were associated with increasing TTP (hazard ratio of PORT initiation, 0.71; 95% CI, 0.53-0.96; 0.59; 95% CI, 0.44-0.77; and 0.54; 95% CI, 0.41-0.72; for ADI quartiles 2, 3, and 4 vs ADI quartile 1, respectively). Conclusions and Relevance: Increasing neighborhood-level disadvantage was independently associated with a greater likelihood of PORT delay and longer TTP in a dose-dependent manner. These findings indicate a critical need for the development of multilevel strategies to improve the equitable delivery of timely, guideline-adherent PORT.

Delays Starting Postoperative Radiotherapy Among Head and Neck Cancer Patients: A Systematic Review and Meta-analysis.

OBJECTIVE: Initiating postoperative radiotherapy (PORT) within 6 weeks (42 days) of surgery is the first and only Commission on Cancer (CoC) approved quality metric for head and neck squamous cell carcinoma (HNSCC). No study has systematically reviewed nor synthesized the literature to establish national benchmarks for delays in starting PORT. DATA SOURCES: Following Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, we performed a systematic review of PubMed, Scopus, and CINAHL. REVIEW METHODS: Studies that described time-to-PORT or PORT delays in patients with HNSCC treated in the United States after 2003 were included. Meta-analysis of proportions and continuous measures was performed on nonoverlapping datasets to examine the pooled frequency of PORT delays and time-to-PORT. RESULTS: Thirty-six studies were included in the systematic review and 14 in the meta-analysis. Most studies utilized single-institution (n = 17; 47.2%) or cancer registry (n = 16; 44.4%) data. Twenty-five studies (69.4%) defined PORT delay as >6 weeks after surgery (the definition utilized by the CoC and National Comprehensive Cancer Network Guidelines), whereas 4 (11.1%) defined PORT delay as a time interval other than >6 weeks, and 7 (19.4%) characterized time-to-PORT without defining delay. Meta-analysis revealed that 48.6% (95% confidence interval [CI], 41.4-55.9) of patients started PORT > 6 weeks after surgery. Median and mean time-to-PORT were 45.8 (95% CI, 42.4-51.4 days) and 47.4 days (95% CI, 43.4-51.4 days), respectively. CONCLUSION: Delays in initiating guideline-adherent PORT occur in approximately half of patients with HNSCC. These meta-analytic data can be used to set national benchmarks and assess progress in reducing delays.

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.

Development and Evaluation of a Navigation-Based, Multilevel Intervention to Improve the Delivery of Timely, Guideline-Adherent Adjuvant Therapy for Patients With Head and Neck Cancer.

PURPOSE: More than half of patients with head and neck squamous cell carcinoma (HNSCC) experience a delay initiating guideline-adherent postoperative radiation therapy (PORT), contributing to excess mortality and racial disparities in survival. However, interventions to improve the delivery of timely, equitable PORT among patients with HNSCC are lacking. This study (1) describes the development of NDURE (Navigation for Disparities and Untimely Radiation thErapy), a navigation-based multilevel intervention (MLI) to improve guideline-adherent PORT and (2) evaluates its feasibility, acceptability, and preliminary efficacy. METHODS: NDURE was developed using the six steps of intervention mapping (IM). Subsequently, NDURE was evaluated by enrolling consecutive patients with locally advanced HNSCC undergoing surgery and PORT (n = 15) into a single-arm clinical trial with a mixed-methods approach to process evaluation. RESULTS: NDURE is a navigation-based MLI targeting barriers to timely, guideline-adherent PORT at the patient, healthcare team, and organizational levels. NDURE is delivered via three in-person navigation sessions anchored to case identification and surgical care transitions. Intervention components include the following: (1) patient education, (2) travel support, (3) a standardized process for initiating the discussion of expectations for PORT, (4) PORT care plans, (5) referral tracking and follow-up, and (6) organizational restructuring. NDURE was feasible, as judged by accrual (88% of eligible patients [100% Blacks] enrolled) and dropout (n = 0). One hundred percent of patients reported moderate or strong agreement that NDURE helped solve challenges starting PORT; 86% were highly likely to recommend NDURE. The rate of timely, guideline-adherent PORT was 86% overall and 100% for Black patients. CONCLUSION: NDURE is a navigation-based MLI that is feasible, is acceptable, and has the potential to improve the timely, equitable, guideline-adherent PORT.

Oral Intubation Attempts in Patients With a Laryngectomy: A Significant Safety Threat.

It is impossible to secure the airway of a patient with "neck-only" breathing transorally or transnasally. Surgical removal of the larynx (laryngectomy) or tracheal rerouting (tracheoesophageal diversion or laryngotracheal separation) creates anatomic discontinuity. Misguided attempts at oral intubation of neck breathers may cause hypoxic brain injury or death. We present national data from the American Academy of Otolaryngology-Head and Neck Surgery, the American Head and Neck Society, and the United Kingdom's National Reporting and Learning Service. Over half of US otolaryngologist respondents reported instances of attempted oral intubations among patients with laryngectomy, with a mortality rate of 26%. UK audits similarly revealed numerous resuscitation efforts where misunderstanding of neck breather status led to harm or death. Such data underscore the critical importance of staff education, patient engagement, effective signage, and systems-based best practices to reliably clarify neck breather status and provide necessary resources for safe patient airway management.

Adverse events in facial plastic surgery: Data-driven insights into systems, standards, and self-assessment.

PURPOSE: Complications in facial plastic surgery can lead to pain, suffering, and permanent harm. Yet, the etiology and outcomes of adverse events are understudied. This study aims to determine the etiology and outcomes of adverse events reported in aesthetic facial plastic surgery and identify quality improvement opportunities. MATERIAL AND METHODS: A cross-sectional survey analysis was conducted using an anonymous 22-item questionnaire distributed to members of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) and American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS). Participants were queried on demographics, practice type, and adverse events related to aesthetic facial surgeries. RESULTS: Two hundred fifty-three individuals participated; nearly half of respondents (49.0%) held membership in both AAO-HNS and AAFPRS. Of these, 40.8% of respondents reported at least one adverse event within the past 12 months of practice. A total of 194 adverse events were reported, most commonly related to facelift (n = 59/194, 30.4%), rhinoplasty (n = 55/194, 28.4%), and injection procedures (n = 38/194, 19.6%), with hematoma or seroma being the most commonly described. Most adverse events were self-limited, but approximately 68% resulted in further procedures. Surgeon error or poor judgement (n = 42) and patient non-adherence (n = 18) were the most commonly ascribed reasons for adverse events; 37.1% of participants reported a change in clinical practice after the incident. CONCLUSIONS: Adverse events were not infrequent in facial plastic surgery. Understanding these adverse events can provide impetus for tracking outcomes, standardization, and engagement with lifelong learning, self-assessment, and evaluation of practice performance.

Intraoperative Sentinel Events in the Era of Surgical Safety Checklists: Results of a National Survey.

OBJECTIVE: Despite the implementation of advanced health care safety systems including checklists, preventable perioperative sentinel events continue to occur and cause patient harm, disability, and death. We report on findings relating to otolaryngology practices with surgical safety checklists, the scope of intraoperative sentinel events, and institutional and personal response to these events. STUDY DESIGN: Survey study. SETTING: Anonymous online survey of otolaryngologists. METHODS: Members of the American Academy of Otolaryngology-Head and Neck Surgery were asked about intraoperative sentinel events, surgical safety checklist practices, fire safety, and the response to patient safety events. RESULTS: In total, 543 otolaryngologists responded to the survey (response rate 4.9% = 543/11,188). The use of surgical safety checklists was reported by 511 (98.6%) respondents. At least 1 patient safety event in the past 10 years was reported by 131 (25.2%) respondents; medication errors were the most commonly reported (66 [12.7%] respondents). Wrong site/patient/procedure events were reported by 38 (7.3%) respondents, retained surgical items by 33 (6.4%), and operating room fire by 18 (3.5%). Although 414 (79.9%) respondents felt that time-outs before the case have been the single most impactful checklist component to prevent serious patient safety events, several respondents also voiced frustrations with the administrative burden. CONCLUSION: Surgical safety checklists are widely used in otolaryngology and are generally acknowledged as the most effective intervention to reduce patient safety events; nonetheless, intraoperative sentinel events do continue to occur. Understanding the scope, causes, and response to these events may help to prioritize resources to guide quality improvement initiatives in surgical safety practices.

Barriers to the Delivery of Timely, Guideline-Adherent Adjuvant Therapy Among Patients With Head and Neck Cancer.

PURPOSE: Delays initiating guideline-adherent postoperative radiation therapy (PORT) in head and neck squamous cell carcinoma (HNSCC) are common, contribute to excess mortality, and are a modifiable target for improving survival. However, the barriers that prevent the delivery of timely, guideline-adherent PORT remain unknown. This study aims to identify the multilevel barriers to timely, guideline-adherent PORT and organize them into a conceptual model. MATERIALS AND METHODS: Semi-structured interviews with key informants were conducted with a purposive sample of patients with HNSCC and oncology providers across diverse practice settings until thematic saturation (n = 45). Thematic analysis was performed to identify the themes that explain barriers to timely PORT and to develop a conceptual model. RESULTS: In all, 27 patients with HNSCC undergoing surgery and PORT were included, of whom 41% were African American, and 37% had surgery and PORT at different facilities. Eighteen clinicians representing a diverse mix of provider types from 7 oncology practices participated in key informant interviews. Five key themes representing barriers to timely PORT were identified across 5 health care delivery levels: (1) inadequate education about timely PORT, (2) postsurgical sequelae that interrupt the tight treatment timeline (both intrapersonal level), (3) insufficient coordination and communication during care transitions (interpersonal and health care team levels), (4) fragmentation of care across health care organizations (organizational level), and (5) travel burden for socioeconomically disadvantaged patients (community level). CONCLUSION: This study provides a novel description of the multilevel barriers that contribute to delayed PORT. Interventions targeting these multilevel barriers could improve the delivery of timely, guideline-adherent PORT and decrease mortality for patients with HNSCC.

Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial.

PURPOSE: Pembrolizumab improved survival in patients with recurrent or metastatic head and neck squamous-cell carcinoma (HNSCC). The aims of this study were to determine if pembrolizumab would be safe, result in pathologic tumor response (pTR), and lower the relapse rate in patients with resectable human papillomavirus (HPV)-unrelated HNSCC. PATIENTS AND METHODS: Neoadjuvant pembrolizumab (200 mg) was administered and followed 2 to 3 weeks later by surgical tumor ablation. Postoperative (chemo)radiation was planned. Patients with high-risk pathology (positive margins and/or extranodal extension) received adjuvant pembrolizumab. pTR was quantified as the proportion of the resection bed with tumor necrosis, keratinous debris, and giant cells/histiocytes: pTR-0 (<10%), pTR-1 (10%-49%), and pTR-2 (≥50%). Coprimary endpoints were pTR-2 among all patients and 1-year relapse rate in patients with high-risk pathology (historical: 35%). Correlations of baseline PD-L1 and T-cell infiltration with pTR were assessed. Tumor clonal dynamics were evaluated (ClinicalTrials.gov NCT02296684). RESULTS: Thirty-six patients enrolled. After neoadjuvant pembrolizumab, serious (grades 3-4) adverse events and unexpected surgical delays/complications did not occur. pTR-2 occurred in eight patients (22%), and pTR-1 in eight other patients (22%). One-year relapse rate among 18 patients with high-risk pathology was 16.7% (95% confidence interval, 3.6%-41.4%). pTR ≥10% correlated with baseline tumor PD-L1, immune infiltrate, and IFNγ activity. Matched samples showed upregulation of inhibitory checkpoints in patients with pTR-0 and confirmed clonal loss in some patients. CONCLUSIONS: Among patients with locally advanced, HPV-unrelated HNSCC, pembrolizumab was safe, and any pathologic response was observed in 44% of patients with 0% pathologic complete responses. The 1-year relapse rate in patients with high-risk pathology was lower than historical.

Development and Validation of Nomograms for Predicting Delayed Postoperative Radiotherapy Initiation in Head and Neck Squamous Cell Carcinoma.

Importance: The standard of care for initiation of postoperative radiotherapy (PORT) in head and neck squamous cell carcinoma (HNSCC) is within 6 weeks of surgical treatment. Delays in guideline-adherent PORT initiation are common, associated with mortality, and a measure of quality care, but patient-specific tools to estimate the risk of these delays are lacking. Objective: To develop and validate 2 nomograms (that use presurgical and postsurgical data) for predicting delayed PORT initiation. Design, Setting, and Participants: This cohort study obtained patient data from January 1, 2004, to December 31, 2015, from the National Cancer Database. Adults aged 18 years or older with a newly diagnosed HNSCC who underwent surgical treatment and PORT at a Commission on Cancer-accredited facility were included. Data analysis was conducted from June 2, 2019, to January 29, 2020. Exposures: Surgical treatment and PORT. Main Outcomes and Measures: The primary outcome measure was PORT initiation more than 6 weeks after the surgical intervention. Multivariable logistic regression models were created in a random selection of 80% of the sample (derivation cohort) and were internally validated with bootstrapping, assessed for discrimination by calibration plots and the concordance (C) index, and externally validated in the remaining 20% of the sample (validation cohort). Results: The study included 60 766 adults with HNSCC who were grouped into derivation and validation cohorts. The derivation cohort comprised 48 625 patients (mean [SD] age, 59.59 [11.3] years; 36 825 men [75.7%]) selected randomly from the full sample, whereas 12 151 patients (mean [SD] age, 59.63 [11.2] years; 9266 men [76.3%]) composed the validation cohort. The rate of PORT delay was 55.8% (n=27140) in the derivation cohort and 56.7% (n=6900) in the validation cohort. Both nomograms created to predict the risk of PORT initiation delay used variables, including race/ethnicity, insurance type, tumor site, and facility type. The nomogram based on presurgical variables included clinical stage and severity of comorbidity, whereas the nomogram with postsurgical variables included US region, length of stay, and care fragmentation between surgical and radiotherapy facilities. For the presurgical nomogram, the concordance indices were 0.670 (95% CI, 0.664-0.676) in the derivation cohort and 0.674 (95% CI, 0.662-0.685) in the validation cohort. For the nomogram with postsurgical variables, the concordance indices were 0.691 (95% CI, 0.686-0.696) in the derivation cohort and 0.694 (95% CI, 0.685-0.704) in the validation cohort. Conclusions and Relevance: This study found that a nomogram developed with presurgical data to generate personalized estimates of PORT initiation delay may improve pretreatment counseling and the delivery of interventions to patients at high risk for such a delay. A nomogram including postsurgical data can drive institutional quality improvement initiatives and enhance risk-adjusted comparisons of delay rates across facilities.

Eliminating Postoperative Radiation to the Pathologically Node-Negative Neck: Long-Term Results of a Prospective Phase II Study.

PURPOSE: The volume treated with postoperative radiation therapy (PORT) is a mediator of toxicity, and reduced volumes result in improved quality of life (QOL). In this phase II trial, treatment volumes were reduced by omitting PORT to the pathologically negative (PN0) neck in patients with primary head and neck squamous cell carcinoma. METHODS: Patients with head and neck squamous cell carcinoma who underwent surgical resection and neck dissection with a PN0 neck and high-risk features mandating PORT to the primary and/or involved neck were eligible. The primary end point was greater than 90% disease control in the unirradiated neck. QOL was evaluated using the MD Anderson Dysphagia Inventory and the University of Michigan patient-reported xerostomia questionnaire. RESULTS: Seventy-three patients were enrolled, and 72 were evaluable. Median age was 56 years (range, 31 to 81 years); 58 patients were male, and 47 (65%) had a smoking history. Sites included oral cavity (n = 14), oropharynx (n = 37), hypopharynx (n = 4), larynx (n = 16), and unknown primary tumor (n = 1). According to the American Joint Committee on Cancer Staging Manual (7th edition), 67 patients (93%) had stage III/IV disease, and 71% of tumors involved or crossed midline. No patient had contralateral neck PORT. In 17 patients (24%), only the primary site was treated. At a median follow-up of 53 months, two patients experienced treatment failure of the PN0 unirradiated neck; they also experienced treatment failure locally. Unirradiated neck control was 97% (95% CI, 93.4% to 100.0%). Five-year rates of local control, regional control, progression-free survival, and overall survival were 84%, 93%, 60%, and 64%, respectively. QOL measures were not significantly different from baseline at 12 and 24 months post-PORT (P > .05). CONCLUSION: Eliminating PORT to the PN0 neck resulted in excellent control rates in the unirradiated neck without long-term adverse effects on global QOL.

Multicenter Trial of [18F]fluorodeoxyglucose Positron Emission Tomography/Computed Tomography Staging of Head and Neck Cancer and Negative Predictive Value and Surgical Impact in the N0 Neck: Results From ACRIN 6685.

PURPOSE: The objective of this study was to determine the negative predictive value (NPV) of positron emission tomography (PET)/computed tomography (CT) for the clinically N0 neck on the basis of neck dissection. METHODS: Participants with newly diagnosed, first-time, head and neck squamous cell carcinoma (HNSCC) and at least one clinically N0 neck side for which dissection was planned were included. A total of 287 participants were prospectively enrolled from 23 American College of Radiology Imaging Network-qualified institutions. PET/CT was compared with findings at neck dissection. RESULTS: PET/CT scans and pathology findings were available for 270 N0 neck sides from 212 participants. For visual assessment, the NPV specific to the clinical-N0 sides was 0.868 (95% CI, 0.803 to 0.925). For dichotomized maximum standardized uptake value, the NPVs specific to the nodal basins were 0.940 (95% CI, 0.928 to 0.952) and 0.937 (95% CI, 0.925 to 0.949) at prespecified cutoffs of 2.5 and 3.5, respectively. The optimal cutoff maximum standardized uptake value was determined to be 1.8, with an NPV of 0.942 (95% CI, 0.930 to 0.953). The PET/CT-informed surgical treatment plan was changed in 51 of 237 participants (22%) compared with the PET/CT-blinded surgical plan. In 34 participants (14%), this led to planned dissection of additional nodal levels. In 12 participants (5%), this led to fewer planned dissected nodal levels. Negative PET/CT scans in N0 necks was true negative in 87% and false negative in 13%. CONCLUSION: [18F]fluorodeoxyglucose-PET/CT has high NPV for the N0 neck in T2 to T4 HNSCC. The surgical treatment plans on the basis of PET/CT findings may be changed in approximately 22% of this group. These findings suggest that [18F]fluorodeoxyglucose-PET/CT may assist the clinician in deciding on the best therapy for the clinically N0 neck in HNSCC. Well-designed clinical trials should be performed to test the outcome of omitting neck dissection by using PET/CT.

Association of Disease Recurrence With Survival Outcomes in Patients With Cutaneous Squamous Cell Carcinoma of the Head and Neck Treated With Multimodality Therapy.

Importance: It has previously been demonstrated that immunosuppressed patients with cutaneous squamous cell cancer of the head and neck (cSCC-HN) treated with surgery and postoperative radiotherapy have significantly inferior disease-related outcomes compared with immunocompetent patients, but data on outcomes after disease recurrence are limited. Objectives: To report survival outcomes in patients with cSCC-HN after disease recurrence after surgery and postoperative radiotherapy and to investigate the association of immune status with disease-related outcomes. Design, Setting, and Participants: A multi-institutional study of 205 patients treated at the Cleveland Clinic, Washington University in St Louis, and the University of California, San Francisco, in which patients who underwent surgical resection and postoperative radiotherapy for primary or recurrent stage I to IV (nonmetastatic) cSCC-HN between January 1, 1995, and December 31, 2014, were identified. Patients with any disease recurrence, defined as local, regional, and/or distant failure, were included. Patients were categorized as immunosuppressed if they received a diagnosis of chronic hematologic malignant neoplasm or HIV or AIDS, or were treated with immunosuppressive therapy for organ transplantation 6 months or more before diagnosis. Statistical analysis was conducted from January 1, 1995, to December 31, 2015. Main Outcomes and Measures: Overall survival calculated using the Kaplan-Meier method and compared using the log-rank test. Results: Of the 205 patients in the original cohort, 72 patients (63 men and 9 women; median age, 71 years [range, 43-91 years]) developed disease recurrence after surgery and postoperative radiotherapy. Forty patients (55.6%) were immunosuppressed, and 32 patients (44.4%) were immunocompetent. Locoregional recurrence was the most common first pattern of failure for both groups (31 immunosuppressed patients [77.5%]; 21 immunocompetent patients [65.6%]). After any recurrence, 1-year overall survival was 43.2% (95% CI, 30.9%-55.4%), and median survival was 8.4 months. For patients for whom information on salvage treatment was available (n = 45), those not amenable to surgical salvage had significantly poorer median cumulative incidence of survival compared with those who were amenable to surgical salvage (4.7 months; 95% CI, 3.7-7.0 months vs 26.1 months; 95% CI, 6.6 months to not reached; P = .01), regardless of their immune status. Conclusions and Relevance: Results of this study suggest that patients with cSCC-HN who experience disease recurrence after definitive treatment with surgery and postoperative radiotherapy have poor survival, irrespective of immune status. Survival rates are low for patients with recurrent disease that is not amenable to surgical salvage. The low rate of successful salvage underscores the importance of intensifying upfront treatment to prevent recurrence.

Association of Treatment Delays With Survival for Patients With Head and Neck Cancer: A Systematic Review.

Importance: Delays in the delivery of care for head and neck cancer (HNC) are a key driver of poor oncologic outcomes and thus represent an important therapeutic target. Objective: To synthesize information about the association between delays in the delivery of care for HNC and oncologic outcomes. Evidence Review: A systematic review of the English-language literature in PubMed/MEDLINE and Scopus published between January 1, 2007, and February 28, 2018, was performed to identify articles addressing the association between treatment delays and oncologic outcomes for patients with HNC. Articles that were included (1) addressed cancer of the oral cavity, oropharynx, hypopharynx, or larynx; (2) discussed patients treated in 2004 or later; (3) analyzed time of diagnosis to treatment initiation (DTI), time from surgery to the initiation of postoperative radiotherapy, and/or treatment package time (TPT; the time from surgery through the completion of postoperative radiotherapy); (4) included a clear definition of treatment delay; and (5) analyzed the association between the treatment time interval and an oncologic outcome measure. Quality assessment was performed using the Institute of Health Economics Quality Appraisal Checklist for Case Series Studies. Findings: A total of 18 studies met inclusion criteria and formed the basis of the systematic review. Nine studies used the National Cancer Database and 6 studies were single-institution retrospective reviews. Of the 13 studies assessing DTI, 9 found an association between longer DTI and poorer overall survival; proposed DTI delay thresholds ranged from more than 20 days to 120 days or more. Four of the 5 studies assessing time from surgery to the initiation of postoperative radiotherapy (and all 4 studies assessing guideline-adherent time to postoperative radiotherapy) found an association between a timely progression from surgery to the initiation of postoperative radiotherapy and improved overall or recurrence-free survival. Of the 5 studies examining TPT, 4 found that prolonged TPT correlated with poorer overall survival; proposed thresholds for prolonged TPT ranged from 77 days or more to more than 100 days. Conclusions and Relevance: Timely care regarding initiation of treatment, postoperative radiotherapy, and TPT is associated with survival for patients with HNC, although significant heterogeneity exists for defining delayed DTI and TPT. Further research is required to standardize optimal time goals, identify barriers to timely care for each interval, and design interventions to minimize delays.

Rethinking Morbidity and Mortality Conference.

This article will discuss the importance of an effective morbidity and mortality (M&M) conference toward supporting a proactive and preventative approach to patient safety and quality improvement (PSQI). Key characteristics will be discussed that enhance this process for being a mechanism for driving positive PSQI culture change that permeates the department. The focus of this article will be on how to approach the structure and process of this conference for maximal benefit.

Predictors of acute throat or esophageal patient reported pain during radiation therapy for head and neck cancer.

BACKGROUND AND PURPOSE: Acute pain during weekly radiotherapy (RT) to the head and neck is not well characterized. We studied dose-volume metrics and clinical variables that are plausibly associated with throat or esophageal pain as measured with a weekly questionnaire during RT. MATERIALS AND METHODS: We prospectively collected weekly patient-reported outcomes from 122 head and neck cancer patients during RT. The pain score for each question consisted of a four-level scale: none (0), mild (1), moderate (2), and severe (3). Univariate and multivariate ordinal logistic regression analyses were performed to investigate associations between both esophageal and throat pain and clinical as well as dosimetric variables. RESULTS: In multivariate analysis, age was significantly associated with both types of pain, leading to odds ratio (OR) = 0.95 (p = 0.008) and OR = 0.95 (p = 0.007) for esophageal and throat pain, respectively. For throat pain, sex (OR = 4.12; p = 0.010), with females at higher risk, and fractional organ at risk (OAR) mean dose (OR = 3.30; p = 0.014) were significantly associated with throat pain. CONCLUSIONS: A fractional OAR mean dose of 1.1 Gy seems a reasonable cutoff for separating no or mild pain from moderate to severe esophageal and throat pain. Younger patients who received RT experienced more esophageal and throat pain. Females experienced more throat pain, but not esophageal pain.

Pretreatment metabolic tumor volume as a prognostic factor in HPV-associated oropharyngeal cancer in the context of AJCC 8th edition staging.

BACKGROUND: This study evaluates the prognostic significance of 18 F-fluorodeoxyglucose-positron emission tomography ([F-18]FDG-PET)-derived metabolic tumor volume (MTV) in human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinomas (OPSCCs) in the context of AJCC 8th edition staging. METHODS: We performed a retrospective study of HPV-associated OPSCCs treated with postoperative or definitive radiation. The prognostic significance of pretreatment MTV for freedom from recurrence (FFR), freedom from distant metastasis (FFDM), and overall survival (OS) was determined using Kaplan-Meier analysis. Multivariate analysis (MVA) was performed using Cox regression. RESULTS: In this 153-patient cohort, stratifying by the optimum MTV (24 cm3 ) was prognostic for FFR (P = .0002), FFDM (P = .001), and OS (P < .0001). Metabolic tumor volume (MTV) was prognostic of FFR in AJCC 8th edition stage I/II (P = .03), and stage III patients (P = .04). On multivariate analysis only MTV was a significant factor for OS. CONCLUSION: Metabolic tumor volume (MTV) is a significant prognostic factor in HPV-associated OPSCCs, independent of AJCC 8th edition stage.

Effect of Perioperative Gabapentin Use on Postsurgical Pain in Patients Undergoing Head and Neck Mucosal Surgery: A Randomized Clinical Trial.

Importance: Effective postoperative pain management increases patient satisfaction, reduces cost, reduces morbidity, and shortens hospitalizations. Previous studies investigating multimodal pain therapy in otolaryngology patients focused on homogenous patient groups with short postoperative follow-up times. Objective: To investigate the effect of perioperative gabapentin treatment on postsurgical pain in patients undergoing head and neck mucosal surgery. Design, Setting, and Participants: Adults undergoing head and neck mucosal surgery from July 25, 2016, through June 19, 2017, were included in this double-blinded, placebo-controlled randomized clinical trial and randomized to receive gabapentin, 300 mg twice daily, or placebo before surgery and up to 72 hours after surgery. Main Outcomes and Measures: Primary outcome was hourly narcotic use calculated in morphine equivalents. Secondary outcomes included subjective visual analog scale pain scores captured for resting, coughing, and swallowing using a 0- to 100-mm scale (a 100-mm line anchored with no pain on the left end and worst possible pain on the right end). A change of 10 mm or more was deemed to be clinically meaningful. Additional secondary outcome measures included degree of pain control, patient satisfaction, and adverse effects. Results: Of the 110 patients randomized to receive gabapentin or placebo, 11 and 10 withdrew from each group, respectively. Ninety patients were then analyzed: 44 in the gabapentin group (mean [SD] age, 61.1 [10.0] years; 33 [75%] male; 40 [91%] white) and 46 in the placebo group (mean [SD] age, 60.9 [11.3] years; 35 [78%] male; 43 [94%] white). Both groups had similar self-reported levels of preoperative pain and narcotic effectiveness. A median difference of 0.26 mg/h of morphine (95% CI, -0.27 to 0.94 mg/h) was found between groups. After controlling for comorbidity and self-reported baseline pain levels, mixed model analysis found the difference in marginal means of visual analog scale scores between groups to be lower in the gabapentin group compared with the placebo group for all categories (rest difference, 7.9 mm; 95% CI, -0.4 to 16.2 mm; cough difference, 8.9 mm; 95% CI, -0.5 to 18.3 mm; swallow difference, 9.4 mm; 95% CI, -1.2 to 20.0 mm). More patients in the gabapentin group reported that pain was always well controlled than in the placebo group (difference, 9.2%; 95% CI, -21% to 3%). Gabapentin and placebo groups reported similar levels of satisfaction with pain control (difference, 2%; 95% CI, -11% to 15%). There was no clinically meaningful difference in reported nausea between the 2 groups (difference, 6%; 95% CI, -14% to 26%). Conclusion and Relevance: Perioperative gabapentin given 300 mg twice daily did not result in reduced narcotic use, but results were compatible with clinically meaningful reductions in pain scores. Satisfaction with pain control and adverse effects were similar between groups. Trial Registration: ClinicalTrials.gov Identifier: NCT02926573.