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OBJECTIVES: To analyze charges, complications, survival, and functional outcomes for definitive surgery of mandibular osteoradionecrosis (ORN). MATERIALS AND METHODS: Retrospective analysis of 76 patients who underwent segmental mandibulectomy with reconstruction from 2000 to 2009. RESULTS: Complications occurred in 49 (65%) patients and were associated with preoperative drainage (odds ratio [OR] 4.40, 95% confidence interval [CI] 1.01–19.27). The adjusted median charge was $343 000, and higher charges were associated with double flap reconstruction (OR 8.15, 95% CI 2.19–30.29) and smoking (OR 5.91, 95% CI 1.69–20.72). Improved swallow was associated with age

Purpose:In oropharyngeal squamous cell carcinoma (OPC), high CD8+ tumor-infiltrating lymphocyte (CD8+TIL) density confers improved prognosis. We compared neoadjuvant durvalumab (PD-L1 inhibitor) with durvalumab + tremelimumab (CTLA-4 inhibitor) in terms of impact on CD8+TIL density, safety, and efficacy in patients with OPC.Patients and Methods:Patients with newly diagnosed stage II–IVA OPC or locoregionally recurrent OPC amenable to resection were included. Patients were randomized to two cycles of durvalumab or durvalumab + tremelimumab before surgery. The primary endpoint was change between baseline and resection specimen in CD8+TIL density between arms. Secondary endpoints included safety, response rate per RECIST, major pathologic response (MPR; ≤10% viable tumor cells) rate, and patient-reported outcomes.Results:Of 28 eligible patients (14/arm), 20 (71%) had newly diagnosed OPC, and 24 (86%) were p16-positive. The posttreatment to pretreatment median CD8+TIL density ratio was 1.31 for durvalumab and 1.15 for combination treatment (P = 0.97; 95% CI: −1.07–2.28). In each group, 6 patients (43%, 95% CI: 17.66–71.14) had a response. Eight patients (29%) had a MPR at the primary tumor and/or nodal metastases. Neither baseline CD8+TIL density nor PD-L1 expression level correlated with overall response, but a trend toward greater CD8+TIL change in patients with a MPR was seen (P = 0.059; 95% CI: −0.33–3.46). Four patients (14%) had grade ≥3 adverse events. At median follow-up time of 15.79 months, all patients were alive, and one had an additional recurrence.Conclusions:Durvalumab + tremelimumab did not increase CD8+TIL density more than durvalumab alone did. The observed safety and activity support further investigation of neoadjuvant checkpoint inhibitor for OPC.

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Background Postoperative complications are an independent predictor of poor survival across several tumors. However, there is limited literature on the association between postoperative morbidity and long-term survival following total laryngectomy (TL) for cancer. Methods We conducted a retrospective review of all TL patients at a single institution from 2008 to 2013. Demographic and clinical data were collected and analyzed, including postsurgical outcomes, which were classified using the Clavien-Dindo system. Multivariable Cox regression analyses were performed to identify factors associated with overall survival (OS) and disease-free survival (DFS). Results A total of 362 patients were identified. The mean age was 64 years, and the majority of patients were male (81%). The median follow-up interval was 21 months. Fifty-seven percent of patients had received preoperative radiation, and 40% had received preoperative chemotherapy. Fifty-seven percent of patients underwent salvage TL, and 60% underwent advanced reconstruction (45% free flap and 15% pedicled flap). A total of 136 patients (37.6%) developed postoperative complications, 92 (25.4%) of which were major. Multivariable modeling demonstrated that postoperative complications independently predicted shorter OS (hazard ratio [HR], 1.50; 95% CI, 1.16-1.96; P = .002) and DFS (HR, 1.36; 95% CI, 1.05-1.76; P = .021). Other independent negative predictors of OS and DFS included positive lymph node status, preoperative chemotherapy, comorbidity grade, and delayed adjuvant therapy. Severity of complication and reason for TL (salvage vs primary) were not shown to be predictive of OS or DFS. Conclusion Postoperative complications are associated with worse long-term OS and DFS relative to uncomplicated cases. Patient optimization and timely management of postoperative complications may play a critical role in long-term survival.

Purpose: In oropharyngeal squamous cell carcinoma (OPC), high CD8+ tumor-infiltrating lymphocyte (CD8+TIL) density confers improved prognosis. We compared neoadjuvant durvalumab (PD-L1 inhibitor) with durvalumab + tremelimumab (CTLA-4 inhibitor) in terms of impact on CD8+TIL density, safety, and efficacy in patients with OPC. Patients and Methods: Patients with newly diagnosed stage II–IVA OPC or locoregionally recurrent OPC amenable to resection were included. Patients were randomized to two cycles of durvalumab or durvalumab + tremelimumab before surgery. The primary endpoint was change between baseline and resection specimen in CD8+TIL density between arms. Secondary endpoints included safety, response rate per RECIST, major pathologic response (MPR; ≤10% viable tumor cells) rate, and patient-reported outcomes. Results: Of 28 eligible patients (14/arm), 20 (71%) had newly diagnosed OPC, and 24 (86%) were p16-positive. The posttreatment to pretreatment median CD8+TIL density ratio was 1.31 for durvalumab and 1.15 for combination treatment (P = 0.97; 95% CI: −1.07–2.28). In each group, 6 patients (43%, 95% CI: 17.66–71.14) had a response. Eight patients (29%) had a MPR at the primary tumor and/or nodal metastases. Neither baseline CD8+TIL density nor PD-L1 expression level correlated with overall response, but a trend toward greater CD8+TIL change in patients with a MPR was seen (P = 0.059; 95% CI: −0.33–3.46). Four patients (14%) had grade ≥3 adverse events. At median follow-up time of 15.79 months, all patients were alive, and one had an additional recurrence. Conclusions: Durvalumab + tremelimumab did not increase CD8+TIL density more than durvalumab alone did. The observed safety and activity support further investigation of neoadjuvant checkpoint inhibitor for OPC.

Author(s): MD Anderson Head and Neck Surgery Treatment Guidelines Consortium; Consortium members; Maniakas, Anastasios; Jozaghi, Yelda; Zafereo, Mark E; Sturgis, Erich M; Su, Shirley Y; Gillenwater, Ann M; Gidley, Paul W; Lewis, Carol M; Diaz, Eduardo; Goepfert, Ryan P; Kupferman, Michael E; Gross, Neil D; Hessel, Amy C; Pytynia, Kristen B; Nader, Marc-Elie; Wang, Jennifer R; Lango, Miriam N; Kiong, Kimberley L; Guo, Theresa; Zhao, Xiao; Yao, Christopher MKL; Appelbaum, Eric; Alpard, Jennifer; Garcia, Jose A; Terry, Shawn; Flynn, Jill E; Bauer, Sarah; Fournier, Danielle; Burgess, Courtlyn G; Wideman, Cayla; Johnston, Matthew; You, Chenxi; De Luna, Rolando; Joseph, Liza; Diersing, Julia; Prescott, Kaitlin; Heiberger, Katherine; Mugartegui, Lilian; Rodriguez, Jessica; Zendehdel, Sara; Sellers, Justin; Friddell, Rebekah A; Thomas, Ajay; Khanjae, Sonam J; Schwarzlose, Katherine B; Chambers, Mark S; Hofstede, Theresa M; Cardoso, Richard C; Wesson, Ruth Aponte; Won, Alex; Otun, Adegbenga O; Gombos, Dan S; Al-Zubidi, Nagham; Hutcheson, Katherine A; Gunn, G Brandon; Rosenthal, David I; Gillison, Maura L; Ferrarotto, Renata; Weber, Randal S; Hanna, Ehab Y; Myers, Jeffrey N; Lai, Stephen Y | Abstract: BackgroundCOVID-19 pandemic has strained human and material resources around the world. Practices in surgical oncology had to change in response to these resource limitations, triaging based on acuity, expected oncologic outcomes, availability of supportive resources, and safety of health care personnel.MethodsThe MD Anderson Head and Neck Surgery Treatment Guidelines Consortium devised the following to provide guidance on triaging head and neck cancer (HNC) surgeries based on multidisciplinary consensus. HNC subsites considered included aerodigestive tract mucosa, sinonasal, salivary, endocrine, cutaneous, and ocular.RecommendationsEach subsite is presented separately with disease-specific recommendations. Options for alternative treatment modalities are provided if surgical treatment needs to be deferred.ConclusionThese guidelines are intended to help clinicians caring for patients with HNC appropriately allocate resources during a health care crisis, such as the COVID-19 pandemic. We continue to advocate for individual consideration of cases in a multidisciplinary fashion based on individual patient circumstances and resource availability.

Background Tumor-induced osteomalacia is a rare paraneoplastic syndrome in which patients develop hypophosphatemia and osteomalacia. Methods and results Here, we report a unique case of a 42-year-old man who presented to our institution with a 1-year history of pain in his ribs, hips, lower back, and feet. Radiologic examination revealed a decrease in bone density and multiple insufficiency fractures. Laboratory evaluation revealed hypophosphatemia, low serum 1,25 dihydroxy vitamin D3 , and elevated fibroblast growth factor 23 (FGF23). A positron emission tomography/CT scan showed increased uptake in the right mandibular third molar region. Panoramic radiography and CT scanning showed a lytic expansile bone lesion. A mandibular bone biopsy revealed a mixed connective tissue tumor. A right segmental mandibulectomy was performed, followed by microvascular reconstruction. The resection was confirmed by normalization of serum phosphate and FGF23. Conclusion Successful management of this condition was achieved, with complete surgical resection of the tumor and reconstructive surgery.

Background The current study was performed to assess the efficacy of surveillance imaging in patients with head and neck cancer (HNC) who are treated definitively with radiotherapy. Methods Eligible patients included those with a demonstrable disease-free interval (≥1 follow-up imaging procedure without evidence of disease and a subsequent visit/imaging procedure) who underwent treatment of HNC from 2000 through 2010. Results A total of 1508 patients were included. The median overall survival was 99 months, with a median imaging follow-up period of 59 months. Of the 1508 patients, 190 patients (12.6%) experienced disease recurrence (107 patients had locoregional and 83 had distant disease recurrence). A total of 119 patients (62.6%) in the group with disease recurrence were symptomatic and/or had an adverse clinical finding associated with the recurrence. Approximately 80% of patients with locoregional disease recurrences presented with a clinical finding, whereas 60% of distant disease recurrences were detected by imaging in asymptomatic patients. Despite the earlier detection of disease recurrence via imaging, those patients in the group of patients with clinically detected disease recurrence were significantly more likely to undergo salvage therapy compared with those whose recurrence was detected on imaging (odds ratio, 0.35). There was no difference in overall survival noted between those patients with disease recurrences that were detected clinically or with imaging alone. Approximately 70% of disease recurrences occurred within the first 2 years. In those patients who developed disease recurrence after 2 years, the median time to recurrence was 51 months. After 2 years, the average number of imaging procedures per patient for the detection of a salvageable recurrence for the imaging-detected group was 1539. Conclusions Surveillance imaging in asymptomatic patients with HNC who are treated definitively with radiotherapy without clinically suspicious findings beyond 2 years has a low yield and a high cost. Physicians ordering these studies must use judicious consideration and discretion.

Author(s): Guo, Theresa; Kiong, Kimberley L; Yao, Christopher MKL; Windon, Melina; Zebda, Denna; Jozaghi, Yelda; Zhao, Xiao; Hessel, Amy C; Hanna, Ehab Y | Abstract: BackgroundThe COVID-19 pandemic has reduced clinical volume with a negative impact on trainee education.MethodsSurvey study of Otolaryngology trainees in North America, during the COVID-19 pandemic in April 2020.ResultsOf 216 respondents who accessed the survey, 175 (83%) completed the survey. Respondents reported a universal decrease in clinical activities (98.3%). Among participants who felt their program utilized technology well, there were significantly decreased concerns to receiving adequate educational knowledge (29.6% vs 65.2%, P = .003). However, 68% of trainees still expressed concern in ability to receive adequate surgical training. In addition, 54.7% of senior trainees felt that the pandemic had a negative impact on their ability to secure a job or fellowship after training.ConclusionsTrainees universally felt a negative impact due to the COVID-19 pandemic. Use of technology was able to alleviate some concerns in gaining adequate educational knowledge, but decreased surgical training remained the most prevalent concern.

BACKGROUND: The COVID-19 pandemic has significantly impacted medical training. Here we assess its effect on head and neck surgical education. METHODS: Surveys were sent to current accredited program directors and trainees to assess the impact of COVID-19 on the fellow's experience and employment search. Current fellows' operative logs were compared with those of the 2018 to 2019 graduates. RESULTS: Despite reduction in operative volume, 82% of current American Head and Neck Society fellows have reached the number of major surgical operations to support certification. When surveyed, 86% of program directors deemed their fellow ready to enter practice. The majority of fellows felt prepared to practice ablative (96%), and microvascular surgery (73%), and 57% have secured employment to follow graduation. Five (10%) had a pending job position put on hold due to the pandemic. CONCLUSIONS: Despite the impact of the COVID-19 pandemic, current accredited trainees remain well-positioned to obtain proficiency and enter the work-force.

Preclinical studies suggest that treatment with neoadjuvant immune checkpoint blockade is associated with enhanced survival and antigen-specific T cell responses over adjuvant treatment1; however, optimal regimens have not been defined. Herein, we report results from a randomized phase II study of neoadjuvant nivolumab versus combined ipilimumab with nivolumab in 23 patients with high-risk resectable melanoma (NCT02519322). RECIST overall response rates (ORR), pathologic complete response rates (pCR), treatment-related adverse events (trAEs), and immune correlates of response were assessed. Treatment with combined ipilimumab and nivolumab yielded high response rates (RECIST ORR 73%, pCR 45%) but substantial toxicity (73% grade 3 trAEs), whereas treatment with nivolumab monotherapy yielded modest responses (ORR 25%, pCR 25%) and low toxicity (8% grade 3 trAEs). Immune correlates of response were identified, demonstrating higher lymphoid infiltrates in responders to both therapies and a more clonal and diverse T cell infiltrate in responders to nivolumab monotherapy. These results are the first to describe the feasibility of neoadjuvant immune checkpoint blockade in melanoma and emphasize the need for additional studies to optimize treatment regimens and to validate putative biomarkers.

Key Clinical Message This study highlights gamma knife stereotactic radiosurgery (GK‐SRS) as boost therapy in a patient with adenoid cystic carcinoma of the parotid involving the skull base and invasion of the facial nerve. Using GK‐SRS, dose to the brainstem and temporal lobe were reduced when compared to less conformal radiotherapy techniques.

Background Functional outcomes after treatment for oropharyngeal squamous cell carcinoma (SCC) are increasingly prioritized. The purpose of this study was to investigate the incidence of gastrostomy tube placement and weight loss in patients with oropharyngeal SCC who may be eligible for either transoral robotic surgery (TORS) or nonsurgical management. Methods We conducted a retrospective review of previously untreated T1 to T2 and N0 to N2b oropharyngeal SCC to determine the rates of gastrostomy tube placement and weight loss according to Common Terminology Criteria for Adverse Events (CTCAE) criteria. Multivariate regression models were fit to compare these end points between groups. Results Two hundred twenty-three patients were included, comprised of 66 patients who underwent TORS and 157 patients who underwent (chemo)radiation. Thirty-two (48.5%) of the TORS patients received adjuvant radiation. On multivariate analysis, patients treated nonsurgically were 10.6 times and 8.1 times more likely to receive a gastrostomy tube and experience greater than CTCAE grade 1 weight loss, respectively. Conclusion In selected patients with oropharyngeal SCC, TORS may help avoid critical weight loss and gastrostomy tube placement in the acute treatment period.

Objectives To investigate the impact of 3-Diminsional (3D) tumor volume (TV) and extent of involvement of primary tumor on treatment outcomes in a large uniform cohort of T3 laryngeal carcinoma patients treated with nonsurgical laryngeal preservation strategies. Materials and Methods The pretreatment contrast-enhanced computed tomography images of 90 patients with T3 laryngeal carcinoma were reviewed. Primary gross tumor volume (GTVp) was delineated to calculate the 3D TV and define the extent of invasion. Cartilage and soft tissue involvement was coded. The extent of invasion was dichotomized into non/limited invasion versus multiple invasion extension (MIE), and was subsequently correlated with survival outcomes. Results The median TV was 6.6 cm3. Sixty-five patients had non/limited invasion, and 25 had MIE. Median follow-up for surviving patients was 52 months. The 5-year local control and overall survival rates for the whole cohort were 88% and 68%, respectively. There was no correlation between TV and survival outcomes. However, patients with non/limited invasion had better 5-year local control (LC) than those with MIE (95% vs 72%, p = .009) but did not have a significantly higher rate of overall survival (OS) (74% vs 67%, p = .327). In multivariate correlates of LC, MIE maintained statistical significance whereas baseline airway status showed a statistically significance trend with poor LC (p = .0087 and 0.06, respectively). Baseline good performance status was an independent predictor of improved OS (p = .03) in multivariate analysis. Conclusion The extent of primary tumor invasion is an independent prognostic factor of LC of the disease after definitive radiotherapy in T3 larynx cancer.

Background The purpose of this study was to determine the impact of CT-determined pretreatment primary tumor volume on survival and disease control in T4a laryngeal squamous cell carcinoma (SCC). Methods We retrospectively reviewed 124 patients with T4a laryngeal cancer from 2000-2011. Tumor volume measurements were collected and correlated with outcomes. Results Five-year overall survival (OS) for patients with tumor volume ≥21 cm3 treated with larynx preservation (n = 26 of 41) was significantly inferior compared to

Background Transoral endoscopic head and neck surgery (eHNS), including transoral laser microsurgery (TLM) and transoral robotic surgery (TORS), provides access to subsites in the head and neck that have traditionally been difficult to approach. Minor salivary gland tumors, while relatively uncommon, are frequently malignant and can occur at sites in the oropharynx accessible by transoral eHNS. Presented here is the largest review to date of patients with minor salivary gland tumors of the oropharynx managed with transoral eHNS as primary or salvage therapy. Methods A retrospective chart review was performed, including data from 20 patients with minor salivary gland tumors of the oropharynx managed with transoral eHNS at 2 tertiary, academic medical centers. Details of tumor pathology, margin analysis, adjuvant therapy, and an assessment of oncologic outcome were included. Results The base of tongue was the most common tumor site (75%). Adenoid cystic carcinoma (ACC) accounted for most cases (35%), and negative margins were obtained in most (95%) through an endoscopic-only approach. Overall, 50% of patients received post-operative radiation therapy. Postoperative complications were limited, with one patient (5%) returning to the OR for control of post-operative oropharyngeal bleeding. On average follow-up of 36 months, 90% of patients were alive with no evidence of recurrence. Conclusion In this experience, transoral eHNS provided a safe and consistent surgical approach to management of minor salivary gland malignancies, with low complication rates and good locoregional control. Thus, transoral eHNS may play a valuable role in the multi-disciplinary management of these malignancies. Trial registration number None/not applicable Electronic supplementary material The online version of this article (doi:10.1186/s41199-017-0024-2) contains supplementary material, which is available to authorized users.

PURPOSE: In oropharyngeal squamous cell carcinoma (OPC), high CD8-positive tumor-infiltrating lymphocytes (CD8(+)TIL) density confers improved prognosis. We compared neoadjuvant durvalumab (PD-L1 inhibitor) with durvalumab plus tremelimumab (CTLA-4 inhibitor) in terms of impact on CD8(+)TIL density, safety, and efficacy in OPC patients. PATIENTS AND METHODS: Patients with newly diagnosed stage II-IVA OPC or locoregionally-recurrent OPC amenable to resection were included. Patients were randomized to two cycles of durvalumab or durvalumab plus tremelimumab before surgery. The primary endpoint was change between baseline and resection specimen in CD8(+)TIL density between arms. Secondary endpoints included safety, response rate per RECIST, major pathologic response (MPR; ≤10% viable tumor cells) rate, and patient-reported outcomes. RESULTS: Of 28 eligible patients (14 per arm), 20 (71%) had newly diagnosed OPC, and 24 (86%) were p16-positive. The posttreatment to pretreatment median CD8(+)TIL density ratio was 1.31 for durvalumab and 1.15 for combination treatment (P=.97, 95%CI:(−1.07,2.28)). In each group, 6 patients (43%, 95%CI:(17.66,71.14)) had a response. Eight patients (29%) had a MPR at the primary tumor and/or nodal metastases. Neither baseline CD8(+)TIL density nor PD-L1 expression level correlated with overall response, but a trend toward greater CD8(+)TIL change in patients with a MPR was seen (P=.059, 95%CI:(−0.33,3.46)). Four patients (14%) had grade ≥3 adverse events. At median follow-up time of 15.79 months, all patients were alive, and one had an additional recurrence. CONCLUSIONS: Durvalumab plus tremelimumab did not increase CD8(+)TIL density more than durvalumab alone did. The observed safety and activity support further investigation of neoadjuvant checkpoint inhibitor for OPC. Clinicaltrials.gov identifier NCT03144778

OBJECTIVES 1) Identify causes of increased patient wait times in a high-volume outpatient cancer clinic; and 2) use quality improvement tools to implement changes to reduce patient wait times. METHODS Baseline patient wait times for 10 faculty members in the Department of Head and Neck Surgery at the University of Texas MD Anderson Cancer Center (Houston, TX) outpatient head and neck cancer clinic were calculated. Patient workflow and scheduling processes were recorded and analyzed. The faculty with the lowest patient wait times was interviewed, and best practices were identified. Two physicians piloted interventions. Clinic templates were standardized and load-leveled, and the total patients scheduled per hour was based on the physician's calculated capacity per hour. Paired t tests were used to analyze data, and P values

Background We evaluated the impact of radiation, reconstruction, and timing of tracheoesophageal puncture (TEP) on complications and speech outcomes. Methods Retrospective review identified 145 patients who underwent TEP between 2003 and 2007. Results Ninety-nine patients (68%) had primary and 46 (32%) had secondary TEP, with complications occurring in 65% and 61%, respectively (p = .96). Twenty-nine patients (20%) had major complications (18 primary and 11 secondary; p = .42). Ninety-four patients (65%) had pre-TEP radiation, 39 (27%) post-TEP radiation, and 12 (8%) no radiation. With patients grouped by TEP timing and radiation history, there was no difference in complications, fluency, or TEP use. With mean 4.7-year follow-up, 82% primary and 85% secondary used TEP for primary communication (p = .66). Free-flap patients used TEP more commonly for primary communication after secondary versus primary TEP (90% vs 50%; p = .02). Conclusion Primary and secondary tracheoesophageal speakers experience similar high rates of complications. Extent of pharyngeal reconstruction, rather than radiation, may be more important in selection of TEP timing. © 2016 Wiley Periodicals, Inc. Head Neck 38: 1765–1771, 2016

6578 Background: Given the expected excellent prognosis of low-risk oropharyngeal squamous cell carcinoma (OPSCC), consideration of long-term toxicity and functional outcomes has become increasingly important. Activity monitors (e.g. FITBIT) are imperfect but have been shown to have reasonable validity in healthy adults. Here we aimed to test the feasibility of using medical grade longitudinal digital activity monitoring to better define objective functional outcomes after treatment of low-risk OPSCC. Methods: This prospective, observational parallel cohort study included patients with previously untreated stage I-III (AJCC 7) OPSCC eligible for standard of care single-modality treatment with either Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS). Objective Actigraph accelerometer data (Actigraph, Pensacola, FL) were collected continuously for 1 week at baseline, 3, 6 and 12 months after treatment along with subjective patient-reported outcome (PRO) measures. Results: Forty-four patients (34M, 10F) enrolled with median age 59 years (range: 42-78). Baseline, 3 and 6 month activity data were available for 40 patients (91%): 16 IMPT and 24 TORS. There was a significant decrease in mean percent of day performing moderate to vigorous physical activity (MVPA) (-0.78, 0.021) mean number of steps/minute (-1.1, p = 0.035), and mean kcals/day (-115.9, p < 0.001) from baseline to 3 months after treatment for the overall cohort. A significant decrease in mean kcals/day (-82.2, p = 0.004) persisted for the overall cohort at 6 months with no significant difference between groups. Conclusions: Longitudinal digital activity monitoring is feasible before and after treatment of low-risk OPSCC. This approach may offer objective functional endpoints for future de-escalation trials. Similar short-term decreases in objective activity measurements were observed after IMPT and TORS. Long-term (12 month) activity data and correlations to subjective PRO measures will be available at the time of presentation. Clinical trial information: 02663583 .

Purpose To explore treatment-related changes in symptom burden and quality of life (QOL) in oropharyngeal squamous cell cancer (OPSCC) patients treated surgically and non-surgically. Patients and Methods Eighty-six patients with human papillomavirus–associated OPSCC treated at the Head and Neck Center at The University of Texas MD Anderson Cancer Center were recruited to a prospective registry study between 2014 and 2016 and completed the core, head and neck-specific, and symptom interference sections of the MD Anderson symptom inventory (MDASI) multi-symptom questionnaire and the EQ-5D health status assessment as a measure of QOL at four time points. Results Longitudinal improvements from post-treatment nadir were observed across all groups. For patients treated with single modality, symptom interference, but not core and head and neck specific, MDASI scores were significantly better at 6 months in patients treated with surgery than radiation (P = 0.04). For patients treated with multiple modalities, scores for each of the three domains (i.e., core, head and neck -specific, and interference MDASI) were significantly better in the surgical group than the nonsurgical group at treatment completion (P = 0.0003, P = 0.0006 and P = 0.02) and 6 weeks (P = 0.001, P = 0.05 and P = 0.04), but not 6 months (P = 0.11, P = 0.16 and P = 0.040). No significant differences in EQ5D health status were observed between groups at any time point, reflecting similar overall QOL in all groups. Conclusion Symptom burden and QOL improves after treatment in OPSCC survivors over time regardless of whether primary surgical or nonsurgical treatment is used, although acute symptom profiles may differ.

Background Primary extradural meningiomas (PEMs) are rare, particularly those involving the paraspinal cervical area, so little is known about them. We identified a new case and compared it with 10 previous cases, addressed the diagnostic challenges, and highlighted the clinical and pathologic characteristics. Methods We conducted a case report and literature review of PEM cases reported since 1976. Results A 59-year-old man presented with right neck stiffness and discomfort that was present over the last several months, which is consistent with other cases. CT scan and MRI revealed a paraspinal cervical mass. Fine-needle aspiration (FNA) and core biopsy revealed spindle cells with whorling consistent with meningioma. The patient underwent complete en bloc resection of the tumor. The PEM was histologically benign. Conclusion Cervical PEMs should be considered in the differential diagnosis of a deep neck mass. These tumors are typically benign and are surgically resected. © 2014 Wiley Periodicals, Inc. Head Neck 37: E92–E95, 2015

Background We have established an evaluation system for measuring physician performance. We aimed to determine whether initial evaluation with surgeon feedback improved subsequent performance.

Purpose: Despite growing interest in bundled payments to reduce the costs of care, this payment method remains largely untested in cancer. This 3-year pilot tested the feasibility of a 1-year bundled payment for the multidisciplinary treatment of head and neck cancers. Methods: Four prospective treatment-based bundles were developed for patients with selected head and neck cancers. These risk-adjusted bundles covered 1 year of care that began with primary cancer treatment. Manual processes were developed for patient identification, enrollment, billing, and payment. Patients were prospectively identified and enrolled, and bundled payments were made at treatment start. Operational metrics tracked incremental effort for pilot processes and average payment cycle time compared with fee-for-service (FFS) payments. Results: This pilot confirmed the feasibility of a 1-year prospective bundled payment for head and neck cancers. Between November 2014 and October 2016, 88 patients were enrolled successfully with prospective bundled payments. Through September 2017, 94% of patients completed the pilot with 6% still enrolled. Manual pilot processes required more effort than anticipated; claims processing was the most time-consuming activity. The production of a bundle bill took an additional 15 minutes versus FFS billing. The average payment cycle time was 37 days (range, 15 to 141 days) compared with a 15-day average under FFS. Conclusion: Prospective bundled payments were successfully implemented in this pilot. Additional pilots should study this payment method in higher-volume cancers. Robust systems are needed to automate patient identification, enrollment, billing, and payment along with policies that reduce administrative burden and allow for the introduction of novel cancer therapies.

Background. Sleep disturbance is a prominent complaint of cancer patients. Most studies have focused on insomnia and cancer-related fatigue. Obstructive sleep apnea (OSA) has been reported in small studies and case reports. Methods. In a retrospective review of patients who underwent formal sleep evaluation and polysomnography (PSG) from 2006 to 2011, 56 patients with tumors in the head and neck region were identified. Clinical characteristics, sleep-related history, and PSG data were reviewed. Results. Most patients had active cancer (80%), and the majority had squamous pathology (68%). Prominent symptoms included daytime fatigue (93%), daytime sleepiness (89%), and snoring (82%). Comorbid conditions primarily included hypertension (46%) and hypothyroidism (34%). Significant sleep-related breathing disorder was noted in 93% of patients, and 84% met clinical criteria for OSA. A male predominance (77%) was noted, and patients were not obese (body mass index Conclusion. Sleep-related breathing disorder was common in patients with tumors in the head and neck region referred for evaluation of sleep disruption, and most met clinical criteria for OSA. Daytime fatigue and sleepiness were the most common complaints. OSA was prevalent in male patients, and most with OSA were not obese. Architectural distortion from the malignancy and/or treatment may predispose these patients to OSA by altering anatomic and neural factors. A heightened clinical suspicion for sleep-related breathing disorder and referral to a sleep specialist would be beneficial for patients with these complaints.

BACKGROUND The goal of the current study was to assess the rates of recurrence in the neck for patients with lymph node-positive human papillomavirus-associated cancer of the oropharynx who were treated with definitive radiotherapy (with or without chemotherapy). METHODS This is a single-institution retrospective study. Methodology included database search, and statistical testing including frequency analysis, Kaplan-Meier tests, and comparative tests including chi-square, logistic regression, and log-rank. RESULTS The cohort consisted of 401 patients with lymph node-positive disease who underwent radiotherapy between January 2006 and June 2012. A total of 388 patients had computed tomography restaging, and 251 had positron emission tomography and/or ultrasound as a component of their postradiation staging. Eighty patients (20%) underwent neck dissection, and 21 patients (26%) had a positive specimen. The rate of neck dissection increased with increasing lymph node stage, and was lower in patients who had positron emission tomography scans or ultrasound in addition to computed tomography restaging. The median follow-up was 30 months. The 2-year actuarial neck recurrence rate was 7% and 5%, respectively, in all patients and those with local control. Lymph node recurrence rates were greater in current smokers (P = .008). There was no difference in lymph node recurrence rates noted between patients who did and those who did not undergo a neck dissection (P = .4) CONCLUSIONS A treatment strategy of (chemo)radiation with neck dissection performed based on response resulted in high rates of regional disease control in patients with human papillomavirus-associated oropharyngeal cancer. Cancer 2014;120:3082–3088. © 2014 American Cancer Society.

Importance A major goal of primary transoral robotic surgery (TORS) for oropharyngeal cancer is to optimize swallowing outcomes by personalized treatment based on pathologic staging. However, swallowing outcomes after TORS are uncertain, as are the outcomes compared with nonsurgical options. Objectives To estimate rates of acute dysphagia and recovery after TORS and to compare swallowing outcomes by primary treatment modality (TORS or radiotherapy). Design, Setting, and Participants This case series study was a secondary analysis of prospective registry data from 257 patients enrolled from March 1, 2015, to February 28, 2018, at a single academic institution who, according to theAJCC Staging Manual, 7th edition TNM classification, had low- to intermediate-risk human papillomavirus–related oropharyngeal squamous cell carcinoma possibly resectable by TORS. Exposure Patients were stratified by primary treatment (75 underwent TORS and 182 received radiotherapy). Main Outcomes and Measures Modified barium swallow (MBS) studies graded per Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) and the MD Anderson Symptom Inventory–Head and Neck Module (MDASI-HN) questionnaires were administered at standard intervals. Prevalence and severity of dysphagia were estimated per DIGEST before and after TORS and 3 to 6 months after treatment. Moderate-severe dysphagia (DIGEST grade ≥2) was assessed using logistic regression and compared by primary treatment group. The MDASI swallowing symptom severity item scores during and after radiotherapy were compared using generalized estimating equations by treatment status at the start of radiotherapy, after induction, and after TORS. Results A total of 257 patients (mean [SD] age, 59.54 [9.07] years; 222 [86.4%] male) were included in the study. Dysphagia severity (per DIGEST) was significantly worse after TORS (r = −0.63; 95% CI, −0.78 to −0.44): 17 patients (22.7%; 95% CI, 13.8%-33.8%) had moderate-severe (DIGEST grade ≥2) acute post-TORS dysphagia significantly associated with primary tumor volume (odds ratio, 1.43; 95% CI, 1.11-1.84). DIGEST improved by 3 to 6 months but remained worse than that at baseline; at 3 to 6 months, the number of patients with DIGEST grade 2 or higher dysphagia was 5 (6.7%; 95% CI, 2.2%-14.9%) after primary TORS and 29 (15.9%; 95% CI, 10.9%-22.1%) after radiotherapy. At the start of radiotherapy, MDASI swallowing symptom severity item scores were significantly worse in the post-TORS group compared with postinduction (mean [SD] change, 2.6 [1.1]) and treatment-naive (mean [SD] change, 1.7 [0.3]) patients. This result inverted at radiotherapy end, and all groups converged at 3 to 6 months. Conclusions and Relevance Subacute swallowing outcomes were similar regardless of primary treatment modality among patients with low- to intermediate-risk oropharyngeal squamous cell carcinoma.

6008 Background: Anti-PD-1/PD-L1 are active in metastatic oropharynx squamous cell carcinoma (OPC). Durvalumab (durva) and tremelimumab (tremi) target respectively PD-L1 and CTLA-4, which in combination may be synergistic. Here we report the safety and interim results of durva vs. durva+tremi prior to surgery in a window of opportunity trial in OPC. Methods: Pts were randomized 1:1 to durva 1500 mg or durva 1500 mg + tremi 75 mg IV Q4W x 2 cycles. The primary objective was to quantify pre- and post-treatment differences in CD8+ tumor infiltrating lymphocytes for the two arms. Secondary objectives included safety, toxicity, ORR by RECIST, fraction of patients undergoing surgery at 8 wks, and percentage viable tumor cells in the surgical specimen. Serial pre- and post-treatment blood and tumor specimens were collected for ongoing correlative analyses. Results: 28 pts enrolled: median age 64y, 27 (96%) male, 19 (68%) newly diagnosed, most (63%) at stage IVA (AJCC 7th Ed), 9 (32%) had locoregional recurrence, 24 (86%) p16 positive, and 22 (79%) had ≤ 10 PPY smoking history. Median follow-up was 7.6 months. The most common AEs were fatigue (36%), leukopenia/lymphopenia (25%), transaminitis (25%), and rash (21%). Grade 3 AEs occurred in 4 (14%) pts: 2 elevated lipase, 1 diarrhea, and 1 hepatitis, all were manageable. There were no grade >3 AEs. ORR was 43%: 50% had SD (including 29% tumor shrinkage in 1 pt). Treatment effect in the surgical specimen was observed in 19 (79%) of 24 evaluable pts; 2 pts had major pathologic response (≤ 10% viable tumor) at the primary site. Efficacy was equivalent in both arms. The 2 pts with PD and 1 pt with SD were switched to chemotherapy after durva +/- tremi before resection; interestingly, each achieved a pCR in the primary. Most pts (57%) didn’t receive radiotherapy after surgery. There was a statistically significant association between ORR and treatment effect (p=0.014). The median percentage of viable tumor in the primary was 37.5% in pts with PR, and 82.5% in SD (p=0.003). Conclusions: Durva +/- tremi prior to surgery was well tolerated in OPC pts. Activity is encouraging with treatment effect seen in 79% of pts. The primary endpoint and complete efficacy data will be presented. Clinical trial information: NCT03144778.

BACKGROUND The purpose of this study was to describe the 30-day incidence of complications after total laryngectomy (TL) in a high-volume institution and their impact on the hospital length of stay (LOS) and readmission rates. METHODS A retrospective cohort study of all patients who underwent TL at The University of Texas MD Anderson Cancer Center from January 1, 2010 through June 30, 2013 was conducted. The patient demographics, treatment history, LOS, and 30-day post-TL complications and readmissions were extracted from the medical record. Univariate associations were analyzed, and stepwise backward selection methods were used to fit multivariate models. RESULTS Two hundred forty-five patients were included. Complications occurred in 83 patients (33.9%) and included 3 deaths (1.2%). Wound complications occurred in 53 patients (21.6%), and 34 were pharyngocutaneous fistulas (PCFs; 13.9% overall). Thirty-four patients (13.9%) were readmitted within 30 days. A multivariate analysis revealed the following: wound complications were associated with former (odds ratio [OR], 5.1; P = .03) and current smokers (OR, 5.8; P = .02), PCFs were associated with prior wide-field radiation (OR, 3.1; P = .01) but not prior narrow-field (larynx-only) radiation (OR, 1.4; P = .61), LOS was associated with the type of flap (P = .002) and postoperative hematomas (P = .05), and readmissions were associated with preoperative hypoalbuminemia (P = .003) and postoperative wound complications (P

We evaluated the impact of radiation, reconstruction, and timing of tracheoesophageal puncture (TEP) on complications and speech outcomes.Retrospective review identified 145 patients who underwent TEP between 2003 and 2007.Ninety-nine patients (68%) had primary and 46 (32%) had secondary TEP, with complications occurring in 65% and 61%, respectively (p = .96). Twenty-nine patients (20%) had major complications (18 primary and 11 secondary; p = .42). Ninety-four patients (65%) had pre-TEP radiation, 39 (27%) post-TEP radiation, and 12 (8%) no radiation. With patients grouped by TEP timing and radiation history, there was no difference in complications, fluency, or TEP use. With mean 4.7-year follow-up, 82% primary and 85% secondary used TEP for primary communication (p = .66). Free-flap patients used TEP more commonly for primary communication after secondary versus primary TEP (90% vs 50%; p = .02).Primary and secondary tracheoesophageal speakers experience similar high rates of complications. Extent of pharyngeal reconstruction, rather than radiation, may be more important in selection of TEP timing. © 2016 Wiley Periodicals, Inc. Head Neck 38: 1765-1771, 2016.

A case of a 55-year-old woman with iatrogenic vocal cord trauma and sleep-related symptoms is reported. In particular, this case highlights sleep-disordered breathing as a delayed complication after iatrogenic vocal cord trauma. The patient developed acute stridor from a contralateral vocal cord hematoma following vocal fold injection for right vocal cord paralysis. Acute respiratory symptoms resolved with oxygen, steroids, and nebulized therapy, but nocturnal symptoms persisted and polysomnography revealed sleep-related hypoventilation and mild obstructive sleep apnea. Positive pressure therapy was successfully used to ameliorate her symptoms and treat sleep-disordered breathing until her hematoma resolved. In addition to the typically acute respiratory symptoms that may result from vocal cord dysfunction, sleep-disordered breathing may also present as a significant subacute or chronic problem. Management of the acute respiratory symptoms is relatively well established, but clinicians should be alert for more subtle nocturnal symptoms that may require further study with polysomnography.

In the version of this article originally published, there was an error in Fig. 1. In the neoadjuvant phase column, the n values for arms A and B were both reported to be 20. The n values for arms A and B were actually 12 and 11, respectively. Also, the URL underlying the accession code in the data availability section was incorrect. The URL was originally https://www.ebi.ac.uk/ega/studies/EGAS00001002698. It should have been https://www.ebi.ac.uk/ega/studies/EGAS00001003178. The errors have been corrected in the print, HTML and PDF versions of this article.

BACKGROUND: The objective of this study was to identify measurable parameters that provide quality data for assessing how well cancer care adheres to accepted treatment guidelines and is delivered to any given patient with oral tongue cancer. METHODS: A retrospective chart review included 116 patients treated for T1-T2/N0-N1 squamous cell carcinoma (SCC) of the oral tongue between 1998 and 2003. A set of quality measures considered critical for outcome included: 1) accurate TNM staging at presentation, 2) documentation of margin status, 3) appropriate referral for adjuvant radiation therapy, and 4) neck dissection for depth of invasion >4 mm. In addition, 26 clinical endpoints involving pretreatment assessment, staging, treatment, surveillance, and symptom control were analyzed. RESULTS: Patients comprised 73 men and 43 women (median age, 57 years). Forty-one (35.3%) patients presented with stage I disease, 61 (52.6%) with stage II, and 14 (12.1%) with stage III. The overall 5-year survival rate for all patients was 68.6%. There was a 90.5% compliance with TNM staging at presentation, 99.1% for documentation of margin status, 98.2% for adequate referral to radiation therapy, and 88.7% for appropriate neck dissection based on depth of invasion. Compliance with clinical endpoints was variable and ranged from 100% for endpoints related to radiation therapy to

We report a locally aggressive collagenous myofibroblastic neoplasm of the mandible in an 18-year-old male. Clinically, the lesion presented with rapid growth and irregular mandibular bone destruction. Grossly, the tumor was 10 cm in greatest dimension, light-tan, firm, and involving the posterior one-thirds of the body and inferior half of the left mandibular ramus. Histologically, the lesion was composed of a loose spindle cell proliferation interspersed with periodic dense bands of collagen. The spindle cells reacted positively to smooth muscle actin, calponin, and focally to desmin and were negative for S-100, pan-cytokeratin, CD99, CD34 and caldesmon, supporting myofibroblastic derivation. At our 4 year follow-up, the patient remained free of local recurrence and surgery related complications. The clinicopathologic findings and the differential diagnosis of this lesion is presented and discussed.

Merkel cell carcinoma (MCC) is an uncommon primarily dermal malignancy of relatively aggressive biologic course. Several presentations in the mucosa of the head and neck region have been reported in the literature, and 3 such patients have recently been seen at our institution. We review this recent experience and present the first reported primary lingual MCC in a 57-year-old caucasian man. We provide a review of oral mucosal MCC and guidelines for histopathologic and immunohistochemical diagnosis. Merkel cell carcinoma should be included in the differential diagnosis of head and neck mucosal lesions, especially if the tumor is submucosal, and MCC may involve the tongue. Mucosal MCC is aggressive, and there is a high risk for local recurrence and regional and distant metastasis. Fulminating courses are often seen. We discuss our treatment policies based on the current literature.

In the original publication [1] the name of author Jeremy M. Aymard was spelled wrong. The original article was updated to rectify this error.

Importance The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) serves the need for continual quality assessment in general surgery. Previously, no parallel mechanism specific to head and neck oncologic surgery existed. Objective To address the need for continual quality assessment in subspecialty surgery by adapting the ACS NSQIP platform for complex head and neck oncologic surgical procedures. Design, Setting, and Participants With an institutional ACS NSQIP team’s guidance, surgeons from the departments of head and neck surgery and plastic and reconstructive surgery developed disease- and procedure-specific preoperative, intraoperative, and postoperative variables specific to head and neck surgery requiring reconstruction. Collection occurred with 100% sampling and standard ACS NSQIP 30-day follow-up. After a pilot period, long-term functional outcomes were added to this platform. A total of 312 patients underwent head and neck surgery requiring reconstruction at an academic medical center between August 1, 2012, and June 30, 2013. Exposures Development of a specialty-specific head and neck surgery ACS NSQIP platform. Main Outcomes and Measures The feasibility of adapting the ACS NSQIP platform to capture complex head and neck surgery metrics in all patients. Results Head and neck surgery–specific preoperative, intraoperative, and postoperative variables were added to the ACS NSQIP platform and evaluated in 312 patients (201 [64.4%] male). Only 42 patients (13.5%) had no preoperative risk factors, and 136 (43.6%) had 3 or more risk factors. The mean (SD) duration of operation was 9.4 (3.0) hours (range, 1.7-19.3 hours). The mean (SD) postoperative length of stay was 7.9 (4.7) days (range, 1-40 days), 58 patients (18.6%) had an unplanned return to the operating room, 23 patients (7.4%) were readmitted within 30 days, and 3 patients (1.0%) died within 30 days. More than half of the patients (160 [51.3%]) did not experience a postoperative occurrence. Conclusions and Relevance To our knowledge, this is the first comprehensive complex oncologic surgery outcomes platform derived from ACS NSQIP methods. The initial pilot demonstrates the ability to systematically capture head and neck surgery–specific variables with complete sampling. With multi-institutional expansion, increased accrual, and long-term patient-reported outcomes, we hope to set risk-adjusted benchmarks that may underpin quality improvement efforts in complex head and neck surgery.

11 Background: Value, defined as outcomes relative to costs, cannot be improved without rigorous long-term measurement. To assess value within a bundled payment pilot for head and neck cancer, we aim to generate timely, patient-centered outcomes and robust, near-real time financial tracking (Porter and Teisberg, Redefining health care. Creating value-based competition on results; Harvard Business School Press, 2006). Methods: Clinical and quality experts created an outcome measure set for head and neck cancer, using a three-tiered outcomes hierarchy from Michael Porter of Harvard Business School as a framework. Process measures were identified to evaluate compliance with standards of care. Data sources were verified and patient-reported outcomes were collected via a patient portal. A REDCap database was created to aggregate all longitudinal outcomes. The project managers and financial leaders identified key financial metrics to be tracked for enrolled patients. Outcomes and financial data were built into a dashboard to deliver timely, actionable information on value. Patients will be tracked for 2 years post-treatment completion. Results: 22 outcome measures and 6 process measures are being collected for all enrolled patients. Financial indicators, such as cumulative costs and fee-for-service payment vs. bundled payment, are being tracked for each patient. Currently, most outcomes and financial data are extracted manually. Implementation of a new electronic health record (EHR) should alleviate much of this administrative burden (Table). Conclusions: The project demonstrates the feasibility of value measurement for bundled payment. With provider and patient input, the outcome measures direct attention to what is important to patients and is actionable by clinicians. Additionally, near real-time financial tracking offers insights into the financial implications of this alternative payment model for cancer care. With automation via the EHR, this value measurement methodology can be scaled for other disease sites and additional payers. [Table: see text]

these cases included nerves innervating the involved skin dermatome but not SBG. Seventy-three percent of observed patients and 31% of irradiated patients with MEPNI recurred. Two years RFS in nerves (94% vs 25% respectively; hazard ratio [HR] 0.06, 95% confidence interval [CI] 0.006-0.5, PZ.01) and DFS (73% vs 40%, HR 0.32, 95% CI 0.1-0.99, PZ.05) rates were significantly higher in the treated MEPNI pts compared with the observed. Twenty-seven of 37 patients (73%) diagnosed with MFPNI were observed; the rest were treated with RT. Patients with MFPNI had a low rate of neural and overall failure, and there was no significant benefit to irradiation in these patients. Conclusion: Our study demonstrates the patterns of failure and the role of RT for patients with HNCSCC, GCNI, MEPNI. Awareness of these patterns and knowledge of the cranial nerves anatomy should serve as guidelines for target volume delineation. In patients with MEPNI, RT is associated with fewer gross perineural recurrences and better DFS, compared with the observation strategy. Author Disclosure: E. Sapir: None. A.A. Tolpadi: None. S. Samuels: None. M. Ibrahim: None. E. Elalfy: None. J.B. McHugh: None. A. Eisbruch: None.