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Patient characteristics of control group

Comparison of clinical to pathologic stage migration between patients enrolled in 1 of 4 window trials compared to a second control group

Representativeness of study participants

Purpose:Neoadjuvant targeted therapy provides a brief, preoperative window of opportunity that can be exploited to individualize cancer care based on treatment response. We investigated whether response to neoadjuvant therapy during the preoperative window confers survival benefit in patients with operable head and neck squamous cell carcinoma (HNSCC).Patients and Methods:A pooled analysis of treatment-naïve patients with operable HNSCC enrolled in one of three clinical trials from 2009 to 2020 (NCT00779389, NCT01218048, NCT02473731). Neoadjuvant regimens consisted of EGFR inhibitors (n = 83) or anti-ErbB3 antibody therapy (n = 9) within 28 days of surgery. Clinical to pathologic stage migration was compared with disease-free survival (DFS) and overall survival (OS) while adjusting for confounding factors using multivariable Cox regression. Circulating tumor markers validated in other solid tumor models were analyzed.Results:92 of 118 patients were analyzed; all patients underwent surgery following neoadjuvant therapy. Clinical to pathologic downstaging was more frequent in patients undergoing neoadjuvant targeted therapy compared with control cohort (P = 0.048). Patients with pathologic downstage migration had the highest OS [89.5%; 95% confidence interval (CI), 75.7–100] compared with those with no stage change (58%; 95% CI, 46.2–69.8) or upstage (40%; 95% CI, 9.6–70.4; P = 0.003). Downstage migration remained a positive prognostic factor for OS (HR, 0.22; 95% CI, 0.05–0.90) while adjusting for measured confounders. Downstage migration correlated with decreased circulating tumor markers, SOX17 and TAC1 (P = 0.0078).Conclusions:Brief neoadjuvant therapy achieved pathologic downstaging in a subset of patients and was associated with significantly better DFS and OS as well as decreased circulating methylated SOX17 and TAC1.

CONSORT diagram of patients included neoadjuvant targeted therapy trials

Detection of methylated DNA in plasma of HNSCC patients

Comparison of clinical to pathologic stage migration between patients enrolled in 1 of 4 window trials compared to a control group

We ascertain the role of a low cervical paraspinal skeletal muscle index (CPSMI) as a biomarker for poor treatment tolerance in patients with operable mucosal head and neck squamous cell carcinoma (HNSCC).A prospective cohort of patients with operable HNSCC requiring microvascular reconstruction was evaluated. Low CPSMI was calculated using preoperative CT neck imaging. Poor treatment tolerance, a composite measure of incomplete therapy or severe morbidity/mortality during treatment, was the primary outcome.One hundred and twenty-seven patients underwent extirpative surgery with a mean age was 60.5. Poor treatment tolerance occurred in 71 (56%) patients with 21 not completing recommended adjuvant therapy and 66 having severe treatment-related morbidity. A low CPSMI was independently associated with poor treatment tolerance (OR 2.49, 95%CI 1.10-5.93) and delay to adjuvant therapy (OR 4.48, 95%CI 1.07-27.6) after adjusting for multiple confounders.Low CPSMI was independently associated with poor treatment tolerance in patients with operable HNSCC.

Sarcopenia is increasingly being recognized as a negative prognostic factor in patients with head and neck cancer (HNC). We associate a sarcopenia biomarker measured radiographically from computed tomography (CT) of the neck to postoperative adverse events in patients with operable HNC.A prospective cohort of treatment-naïve HNC patients undergoing surgery with microvascular reconstruction was performed. Cervical paraspinal skeletal muscle index (CPSMI) was calculated using preoperative CT neck imaging and adjusted for height and sex. Postoperative adverse events, including Clavien-Dindo Grade 3+ complications and fistula, were recorded within 30-days of the index surgery. Multivariate logistic regression was used to evaluate the association between CPSMI and postoperative complications. The modified frailty index (mFI) and Risk Assessment Index (RAI) were compared with CPSMI outcomes.A total of 127 patients with mucosal HNC were included in the study. The mean age was 60.5 years, and 87 (68.5%) patients were male. Sixty Clavien-Dindo grade 3+ events occurred; 17 patients developed an oro/pharyngocutaneous fistula. Low CPSMI was independently associated with Clavien-Dindo Grade 3+ events (OR 2.80, 95% CI of 1.18-6.99) and fistula (OR of 6.10, 95% CI of 1.53-24.3) when adjusted for multiple factors. CPSMI outperformed the mFI and RAI frailty indices to predict postoperative adverse events (p .05).Low CPSMI is independently associated with postoperative adverse events and outperforms current frailty indices inoperable HNC with microvascular reconstruction.

Background This study aims to develop and validate, a clinically useful modified index of fragility (mIFG) to identify patients at risk of fragility and to predict postoperative adverse events. Method An observational study was performed using the American College of Surgeons National Surgical Quality Improvement Program database, from 2006 to 2018. All patients undergoing nonemergency head and neck cancer surgery were included. A seven-item index (mIFG) was developed using variables associated with frailty, cachexia, and sarcopenia, drawn from the literature (weight loss, low body mass index, dyspnea, diabetes, serum albumin, hematocrit, and creatinine). Multivariable logistic regression was used to model the association between mIFG, postoperative adverse events and death. A validation cohort was then used to ascertain the diagnostic accuracy of the mIFG. Results A total of 23,438 cases were included (16,407 in the derivation group and 7031 in the validation group). There was a total of 4273 postoperative major adverse events (AE) and deaths, 1023 postoperative pulmonary complications and 1721 wound complications. Using the derivation cohort, the 7-item mIFG was independently associated with death, major AEs, pulmonary and wound complications, when controlling for significant covariates. The mIFG predicted death and major adverse events using the validation cohort with an accuracy of 0.70 (95% CI: 0.63–0.76) and 0.64 (95% CI: 0.63–0.66), respectively. The mIFG outperformed the modified Frailty index. Conclusion The modified index of fragility is a reliable and easily accessible tool to predict risk of postoperative adverse events and death in patients undergoing head and neck cancer surgery. Graphical Abstract

Objective: Major postoperative adverse events (MPAEs) following head and neck surgery are not infrequent and lead to significant morbidity. The objective of this study was to ascertain which factors are most predictive of MPAEs in patients undergoing head and neck surgery. Methods: A cohort study was carried out based on data from patients registered in the National Surgical Quality Improvement Program (NSQIP) from 2006 to 2018. All patients undergoing non-ambulatory head and neck surgery based on Current Procedural Terminology codes were included. Perioperative factors were evaluated to predict MPAEs within 30-days of surgery. Age was classified as both a continuous and categorical variable. Retained factors were classified by attributable fraction and C-statistic. Multivariate regression and supervised machine learning models were used to quantify the contribution of age as a predictor of MPAEs. Results: A total of 43 701 operations were analyzed with 5106 (11.7%) MPAEs. The results of supervised machine learning indicated that prolonged surgeries, anemia, free tissue transfer, weight loss, wound classification, hypoalbuminemia, wound infection, tracheotomy (concurrent with index head and neck surgery), American Society of Anesthesia (ASA) class, and sex as most predictive of MPAEs. On multivariate regression, ASA class (21.3%), hypertension on medication (15.8%), prolonged operative time (15.3%), sex (13.1%), preoperative anemia (12.8%), and free tissue transfer (9%) had the largest attributable fractions associated with MPAEs. Age was independently associated with MPAEs with an attributable fraction ranging from 0.6% to 4.3% with poor predictive ability (C-statistic 0.60). Conclusion: Surgical, comorbid, and frailty-related factors were most predictive of short-term MPAEs following head and neck surgery. Age alone contributed a small attributable fraction and poor prediction of MPAEs. Level of evidence: 3

Background: Endoscopic percutaneous tracheostomy (PT) is a safe technique that is performed frequently by otolaryngologists and intensivists. New challenges have been identified in order to maintain the safety of this procedure during the COVID-19 pandemic. A novel approach, using a modified demistifier canopy, was developed during the first wave of the pandemic and implemented for 17 consecutive percutaneous tracheostomies in order to enhance procedural safety. Methods: A protocol was developed after performing a literature review of tracheostomy in COVID-19 patients. A multidisciplinary tracheostomy team was established, including the departments of otolaryngology, critical care, and respiratory therapy. Simulation was performed prior to each PT, and postoperative debriefings were done. Results: A protocol and technical description of PT using a modified demistifier canopy covering was written and video documented. Data were collected on 17 patients who underwent this procedure safely in our tertiary care hospital. There were no procedure-related complications, and no evidence of COVID-19 transmission to any member of the health care team during the study period. Conclusion: As patients continue to recover from COVID-19, their need for tracheostomy will increase. The technique described provides a safe, multidisciplinary method of performing PT in COVID-19 patients.

Objective The purpose of this study was to evaluate the quality of evidence of rhinology and rhinologic skull base surgery (RSBS) research and its evolution over the past decade. Study Design Review article. Setting We reviewed articles from 2007 to 2019 in 4 leading peer-reviewed otolaryngology journals and 3 rhinology-specific journals. Methods The articles were reviewed and levels of evidence were assigned using the Oxford Centre for Evidence-Based Medicine 2011 guidelines. High quality was defined as level of evidence 1 or 2. Results In total, 1835 articles were reviewed in this study spanning a 13-year period. Overall, the absolute number of RSBS publications increased significantly 22.6% per year, from 108 articles in 2007 to 481 in 2019 (P < .001; 95% CI, 7.9-37.2). In 2007, only 13 articles, or 15%, were high quality, and this grew to 146 articles, or 39%, in 2019. A 14.0% per year exponential increase in the number of high-quality publications was found to be statistically significant (P < .001; 95% CI, 7.2, 20.7). Overall, high-quality publications represented just 25.8% of RSBS articles overall. There was no significant difference in quality between rhinology-specific journals and general otolaryngology journals (χ2 = 3.1, P = .077). Conclusion The number of overall publications and of high-quality RSBS publications has significantly increased over the past decade. However, the proportion of high-quality studies continues to represent a minority of total RSBS research.

BACKGROUND Neoadjuvant chemotherapy followed by surgery (NAC + S), a paradigm based on systemic escalation coupled with surgery-based de-escalation, is under investigation for treatment of HPV-associated oropharynx cancer (OPC). METHODS Prospective cohort of patients with non-metastatic, p16 positive OPC enrolled in a clinical trial of NAC + S was compared to a historic cohort of patients undergoing concurrent chemoradiation (CCRT) to compare disease-free survival (DFS). RESULTS Fifty-five patients were treated with NAC + S and 142 with CCRT. Stage-matched patients undergoing CCRT had higher frequency of smoking and alcohol consumption. 5-year DFS in the NAC + S group was 96.1% (95% CI 90.8-100) compared to 67.6% (95% CI 50.7-84.5) for CCRT (P = .01). At 12 months from treatment, 24.5% of patients undergoing CCRT and none of the patients in the NAC + S were feeding tube dependent (P

Purpose: Neoadjuvant targeted therapy provides a brief, preoperative ‘window of opportunity’ that can be exploited to individualize cancer care based on treatment response. We investigated whether response to neoadjuvant therapy during the preoperative window confers survival benefit in patients with operable head and neck squamous cell carcinoma (HNSCC). Patients and Methods: A pooled analysis of treatment naïve patients with operable HNSCC enrolled in one of three clinical trials from 2009-2020 (NCT00779389, NCT01218048, NCT02473731). Neoadjuvant regimens consisted of EGFR inhibitors (n=83) or anti-ErbB3 antibody therapy (n=9) within 28 days of surgery. Clinical to pathologic stage migration was compared to disease-free survival (DFS) and overall survival (OS) while adjusting for confounding factors using multivariable Cox regression. Circulating tumor markers validated in other solid tumor models were analyzed. Results: 92 of 118 patients were analyzed; all patients underwent surgery following neoadjuvant therapy. Clinical to pathologic downstaging was more frequent in patients undergoing neoadjuvant targeted therapy compared to a historic cohort without neoadjuvant therapy (P=0.048). Patients with pathologic downstage migration had the highest OS (89.5%, 95% CI 75.7-100) compared to those with no stage change (58%, 95% CI 46.2-69.8) or upstage (40%, 95% CI 9.6-70.4, P=0.003). On multivariable analysis, downstage migration remained a positive prognostic factor for OS (hazard ratio 0.22, 95% CI 0.05-0.90) while adjusting for measured confounders. Downstage migration correlated with decreased circulating tumor markers, SOX17 and TAC1 (P=0.0078). Conclusion: Brief neoadjuvant therapy achieved pathologic downstaging in a subset of patients and was associated with significantly better DFS and OS as well as decreased circulating methylated SOX17 and TAC1. Citation Format: Marco Antonio Mascarella, Tolani Olonisakin, Purva Rumde, Varun Vendra, Melonie Nance, Seungwon Kim, Mark Kubik, Shaum Sridharan, Robert Ferris, Moon Fenton, Daniel Clayburgh, James Ohr, Malabika Sen, Sonali Joyce, James Herman, Jennifer Grandis, Dan Zandberg, Umamaheswar Duvvuri. Response to neoadjuvant targeted therapy in operable head and neck cancer confers survival benefit. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 4338.

BACKGROUND We ascertain the association of postoperative infection on survival in patients with locoregionally advanced oral cavity squamous cell carcinoma (OCSCC). METHODS A retrospective study of patients with stage III/IVA OCSCC undergoing curative-intent surgery was performed. Postoperative infection was considered within 30 days after surgery. Kaplan-Meier survival curves were used to compare overall survival (OS) in patients with postoperative infection. Cox regression and propensity-score matching were used to adjust for confounders. RESULTS Fifty-four of 114 patients had a postoperative infection. The 5-year OS in patients with a postoperative infection (24.1%) was lower than those without (65.2%; P

Purpose:Neoadjuvant targeted therapy provides a brief, preoperative window of opportunity that can be exploited to individualize cancer care based on treatment response. We investigated whether response to neoadjuvant therapy during the preoperative window confers survival benefit in patients with operable head and neck squamous cell carcinoma (HNSCC).Patients and Methods:A pooled analysis of treatment-naïve patients with operable HNSCC enrolled in one of three clinical trials from 2009 to 2020 (NCT00779389, NCT01218048, NCT02473731). Neoadjuvant regimens consisted of EGFR inhibitors (n = 83) or anti-ErbB3 antibody therapy (n = 9) within 28 days of surgery. Clinical to pathologic stage migration was compared with disease-free survival (DFS) and overall survival (OS) while adjusting for confounding factors using multivariable Cox regression. Circulating tumor markers validated in other solid tumor models were analyzed.Results:92 of 118 patients were analyzed; all patients underwent surgery following neoadjuvant therapy. Clinical to pathologic downstaging was more frequent in patients undergoing neoadjuvant targeted therapy compared with control cohort (P = 0.048). Patients with pathologic downstage migration had the highest OS [89.5%; 95% confidence interval (CI), 75.7–100] compared with those with no stage change (58%; 95% CI, 46.2–69.8) or upstage (40%; 95% CI, 9.6–70.4; P = 0.003). Downstage migration remained a positive prognostic factor for OS (HR, 0.22; 95% CI, 0.05–0.90) while adjusting for measured confounders. Downstage migration correlated with decreased circulating tumor markers, SOX17 and TAC1 (P = 0.0078).Conclusions:Brief neoadjuvant therapy achieved pathologic downstaging in a subset of patients and was associated with significantly better DFS and OS as well as decreased circulating methylated SOX17 and TAC1.

OBJECTIVES The aim of this study was to ascertain the relationship between Bethesda category and molecular mutation of thyroid nodules in patients undergoing thyroidectomy. DESIGN A retrospective cohort of patients who underwent thyroidectomy following needle biopsy and molecular profile testing was performed. SETTING Two tertiary care academic hospitals. PARTICIPANTS Consecutive patients with a dominant thyroid nodule who underwent both USFNA and molecular profile testing followed by thyroidectomy were included in the study. MAIN OUTCOME AND MEASURES The main outcome was postoperative diagnosis of thyroid cancer and aggressivity of disease based on histopathological variants, nodal metastasis or extra-thyroidal extension. Associations between Bethesda category, molecular mutation and postoperative pathology was assessed using descriptive analysis and chi-square testing. RESULTS Four hundred fifty-one patients were included. 95.9% (93/97) of patients with a BRAFV600E mutation had a Bethesda category V or VI (p

Objective: Examine the association of Graves’ disease with the development of postoperative neck hematoma. Design: A cohort of patients participating in the Thyroid Procedure-Targeted Database of the National Surgical Quality Improvement Program from January 1, 2016 to December 31, 2018. Setting: A North American surgical cohort study. Methods: 17 906 patients who underwent thyroidectomy were included. Propensity score matching was performed to adjust for differences in baseline covariates. Multivariate logistic regression was used to ascertain the association between thyroidectomy for Graves’ disease and risk of postoperative adverse events within 30 days of surgery. The primary outcome was postoperative hematoma. Secondary outcomes were postoperative hypocalcemia and recurrent laryngeal nerve injury. Results: One-to-three propensity score matching yielded 1207 patients with mean age (SD) of 42.6 (14.9) years and 1017 (84.3%) female in the group with Graves’ disease and 3621 patients with mean age (SD) of 46.7 (15.0%) years and 2998 (82.8%) female in the group with indications other than Graves’ disease for thyroidectomy. The cumulative 30-day incidence of postoperative hematoma was 3.1% (38/1207) in the Graves’ disease group and 1.9% (70/3621) in other patients. The matched cohort showed that Graves’ disease was associated with higher odds of postoperative hematoma (OR 1.65, 95% CI 1.10-2.46) and hypocalcemia (OR 2.04, 95% CI 1.66-2.50) compared with other indications for thyroid surgery. There was no difference in recurrent laryngeal nerve injury among the 2 groups. Conclusions: Patients with Graves’ disease undergoing thyroidectomy are more likely to suffer from postoperative hematoma and hypocalcemia compared to patients undergoing surgery for other indications.

Background A longitudinal curriculum was developed in conjunction with anesthesiologists, otolaryngologists, emergency physicians and experts in medical simulation and education. Methods Residents participated in four different simulation-based training modules using animal models, cadavers, task trainers, and crisis scenarios using high fidelity manikins. Scenarios were based on various clinical settings (i.e. emergency room, operating room) and were followed by video-assisted structured debriefings. Participants completed both a self-assessment questionnaire and an exit survey using five-point Likert scales. Results 31 otolaryngology residents participated in the curriculum. Residents reported simulation training significantly improved technical skills such as tracheostomy, cricothyroidotomy and pediatric intubation (p 90% (28/31) of participants found the modules of the curriculum to be useful and would recommend them to others. Conclusion A longitudinal simulation-based medical curriculum can be an effective method to teach airway management and teamwork skills to otolaryngology residents.

BACKGROUND Hematologic markers, such as the neutrophil-to-lymphocyte ratio (NLR), characterize the inflammatory response to cancer and are associated with poorer survival in various malignancies. We evaluate the effect of pretreatment NLR on overall survival (OS) in patients with head and neck squamous cell carcinoma (HNSCC). METHODS Using multiple databases, a systematic search for articles evaluating the effect of NLR on OS in patients with HNSCC was performed. An inverse variation, random-effects model was used to analyze the data. RESULTS A total of 24 of 241 articles, including 6479 patients, were analyzed. The combined hazard ratio for OS in patients with an elevated NLR (range 2.04-5) was 1.78 (confidence interval [CI] 1.53-2.07; P

PURPOSE Direct assessment of trainee performance across time is a core tenet of competency-based medical education. Unlike variability of psychomotor skills across levels of expertise, performance variability exhibited by a particular trainee across time remains unexplored. The goal of this study was to document the consistency of individual surgeons' technical skill performance. METHOD A secondary analysis of assessment data (collected in 2010-2012, originally published in 2015) generated by a prospective cohort of participants at Montreal Children's Hospital with differing levels of expertise was conducted in 2017. Trained raters scored blinded recordings of a myringotomy and tube insertion performed 4 times by junior and senior residents and attending surgeons over a 6-month period using a previously reported assessment tool. Descriptive exploratory analyses and univariate comparison of standard deviations (SDs) were conducted to document variability within individuals across time and across training levels. RESULTS Thirty-six assessments from 9 participants were analyzed. The SD of scores for junior residents was highly variable (5.8 out of a scale of 30 compared with 1.8 for both senior residents and attendings [F(2,19) = 5.68, P < 0.05]). For a given individual, the range of scores was twice as large for junior residents than for senior residents and attendings. CONCLUSIONS Surgical residents may display highly variable performances across time, and individual variability appears to decrease with increasing expertise. Operative skill variability could be underrepresented in direct observation assessment; emphasis on an adequate amount of repetitive evaluations for junior residents may be needed to support judgments of competence or entrustment.

Inverted papillomas are tumors of the sinonasal tract with a propensity to recur. Raman spectroscopy can potentially identify inverted papillomas from other tissue based on biochemical signatures. A pilot study comparing Raman spectroscopy to histopathology for 3 types of sinonasal tissue was performed. Spectral data of biopsies from patients with normal sinonasal mucosa, chronic rhinosinusitis, and inverted papillomas are compared to histopathology using principal component analysis and linear discriminant analysis after data preprocessing. A total of 18 normal, 15 chronic rhinosinusitis, and 18 inverted papilloma specimens were evaluated. The model distinguished normal sinonasal mucosa, chronic rhinosinusitis, and inverted papilloma tissue with an overall accuracy of 90.2% (95% confidence interval, 0.86-0.94). In conclusion, Raman spectroscopy can distinguish inverted papilloma, normal sinonasal mucosa, and chronically rhinosinusitis tissue with acceptable accuracy.

To determine the effect of current smoking status on 30-day postoperative adverse events in patients undergoing otologic surgery.Retrospective cohort study.Database of the American College of Surgeons National Surgical Quality Improvement Program from 2006 to 2016.Adult patients undergoing middle ear and mastoid surgery were included. Preoperative smoking status was determined, and adverse events within 30 days of surgery were recorded. Descriptive statistics were used to characterize the study sample. Multivariable logistic regression was performed to identify the association between sociodemographic and clinical variables and postoperative adverse events. Population-attributable fractions were then calculated.A total of 10,684 patients who underwent otologic surgery were included, of whom 2036 (19.1%) were smokers. The most commonly performed surgery was tympanoplasty with and without ossicular chain reconstruction, followed by canal wall up tympanomastoidectomy. Adverse events occurred in 221 (2.1%) patients; the most common was superficial wound infections (n = 99, 0.9%). In smokers, the odds ratio for any adverse event was 1.97 (95% CI, 1.42-2.71). The odds ratios (95% CIs) for superficial wound infections, wound dehiscence, and 30-day readmission among smokers were 1.89 (1.32-2.86), 3.92 (1.26-11.60), and 1.84 (1.15-2.87), respectively. The population-attributable fraction for any adverse event in smokers was 15.5%.In patients undergoing otologic surgery, smokers are more likely than nonsmokers to have postoperative adverse events-in particular, wound infections, wound dehiscence, and readmission to hospital.

Background A paradigm shift has led to de-escalation trials for the treatment of HPV-positive oropharynx cancer (OPC). The objective of this study was to assess the ability of tumor volume reduction on imaging to predict pathological response to neoadjuvant chemotherapy in patients with HPV-positive OPC. Methods A prospective observational study of 54 patients with HPV-positive OPC enrolled in a clinical trial of neoadjuvant chemotherapy followed by surgery was performed. Patients underwent three cycles of induction chemotherapy (cisplatin/docetaxel); prechemotherapy and postchemotherapy imaging were obtained. Receiver operating characteristic curves and logistic regression analyses were used. Results The complete pathologic response (pCR) rate at primary and nodal sites were 72% and 57%, respectively. Tumor volume reduction of ≥90% following induction chemotherapy predicted pCR of the primary tumor. Conclusions Neoadjuvant chemotherapy followed by definitive transoral surgery is a new paradigm worthy of further investigation and MRI is a reliable modality to assess preoperative response.

Background Acute invasive fungal infections of the head and neck secondary to tyrosine kinase inhibitors are rare and potentially life-threatening events. Case presentation We report a case of mucormycosis of the thyroid gland in a patient known for chronic lymphocytic leukemia receiving ibrutinib who presented with a rapidly growing thyroid nodule and dysphonia. An acute invasive fungal infection was identified on a core needle biopsy; mucormycosis was confirmed on culture. The patient was successfully treated with surgical debridement and long-term antifungal therapy. Conclusion Patients on ibrutinib may be at risk of acute invasive fungal infections of the head and neck.

Background The personalization of oncologic treatment using radiomic signatures is mounting in nasopharyngeal carcinoma (NPC). We ascertain the predictive ability of 3D volumetric magnetic resonance imaging (MRI) texture features on NPC disease recurrence. Methods A retrospective study of 58 patients with NPC undergoing primary curative-intent treatment was performed. Forty-two image texture features were extracted from pre-treatment MRI in addition to clinical factors. A multivariate logistic regression was used to model the texture features. A receiver operating characteristic curve on 100 bootstrap samples was used to maximize generalizability to out-of-sample data. A Cox proportional model was used to predict disease recurrence in the final model. Results A total of 58 patients were included in the study. MRI texture features predicted disease recurrence with an area under the curve (AUC), sensitivity, and specificity of 0.79, 0.73, and 0.71, respectively. Loco-regional recurrence was predicted with AUC, sensitivity, and specificity of 0.82, 0.73 and 0.74 respectively while prediction for distant metastasis had an AUC, sensitivity, and specificity of 0.92, 0.79 and 0.84, respectively. Texture features on MRI had a hazard ratio of 4.37 (95% confidence interval 1.72–20.2) for disease recurrence when adjusting for age, sex, smoking, and TNM staging. Conclusion Texture features on MRI are independent predictors of NPC recurrence in patients undergoing curative-intent treatment.

6033 Background: Quality oncologic care, including negative surgical margin status, adequate lymph node yield and prompt initiation of adjuvant treatment, impacts disease control and overall survival in patients with mucosal head and neck squamous cell carcinoma (HNSCC). The aim of this study was to ascertain the effect of neoadjuvant systemic therapy given during window trials on oncologic quality metrics in patients with delayed definitive surgery for a HNSCC. Methods: Treatment-naïve patients with HNSCC participating in one of two window of opportunity clinical trials at UPMC from 2009-2019 were included. Neoadjuvant regimens consisted of one dose of cetuximab (n = 33) or anti-ErbB3 antibody (n = 9) within 28 days of surgery. Sociodemographic, clinical and tumor staging were recorded. The primary outcome was overall oncologic quality, as defined as a composite measure of negative margin status, adequate lymph node yield, completion of adjuvant therapy (if indicated) and time to initiation of adjuvant therapy within 6 weeks of surgery. Secondary outcomes were difference in clinical and pathologic stages and overall survival (OS). Results: A total of 42 patients with a mean age of 57.1 (±10.2) years and median follow-up of 58 months were analyzed. 29 patients had clinical stage IVA disease with 43% (18/42) oral cavity, 36% (15/42) larynx/hypopharynx and 21% (9/42) oropharynx primaries. All patients underwent surgery following neoadjuvant systemic therapy. In 30 patients (71%), all oncologic quality markers were achieved. Pathological downstaging occurred in 21% (9/42) of patients with 4 patients no longer meeting criteria for adjuvant treatment and were observed. 3 patients showed pathological upstaging. The 3-year OS were 76% (95% CI of 63.6-88.4), respectively. Patients with a pathologic downstage migration (64.9%, 95% CI of 49.9-79.8) had higher 5-year OS compared to those without (57.8%, 95% CI of 40.1-76.4, P = 0.046). Conclusions: Most patients receiving neoadjuvant systemic therapy on window trials prior to surgery met all oncologic quality markers. Importantly, even with brief window trial therapy pathologic downstaging was achieved and associated with significantly better overall survival.

We developed a high efficiency endocrine operative protocol based on a mathematical programming approach, process reengineering, and value-stream mapping to increase the number of operations completed per day without increasing operating room time at a tertiary-care, academic center.Using this protocol, a case-control study of 72 patients undergoing endocrine operation during high efficiency days were age, sex, and procedure-matched to 72 patients undergoing operation during standard days. The demographic profile, operative times, and perioperative complications were noted.The average number of cases per 8-hour workday in the high efficiency and standard operating rooms were 7 and 5, respectively. Mean procedure times in both groups were similar. The turnaround time (mean ± standard deviation) in the high efficiency group was 8.5 (±2.7) minutes as compared with 15.4 (±4.9) minutes in the standard group (P .001). Transient postoperative hypocalcemia was 6.9% (5/72) and 8.3% (6/72) for the high efficiency and standard groups, respectively (P = .99).In this study, patients undergoing high efficiency endocrine operation had similar procedure times and perioperative complications compared with the standard group. The proposed high efficiency protocol seems to better utilize operative time and decrease the backlog of patients waiting for endocrine operation in a country with a universal national health care program.

Objectives/Hypothesis Despite the transition to competency-based education in surgery, few standardized assessment tools exist in otolaryngology training. In particular, myringotomy and tympanostomy tube insertion (M+T) is a common surgical procedure with few validated assessment tools available. Our objectives were to develop an objective structured assessment of operative skills in M+T and to provide validity evidence for the developed assessment tool within otolaryngology training. Study Design Prospective study involving the evaluation of an assessment tool. Methods Through consultation with a panel of experts in otolaryngology and medical education we developed a Task-Specific Checklist and Global Rating Scale for M+T. Postgraduate year 2 junior residents, postgraduate year 3 senior residents, and attending otolaryngologists were video recorded performing M+T at a tertiary care pediatric hospital. The videos were subsequently reviewed and independently evaluated by three blinded raters from an unaffiliated academic institution. Results The average score of junior residents, senior residents, and attending otolaryngologists using the Task-Specific Checklist was 21.7/30 (±7.1), 26.3/30 (±3.5), and 27.3/30 (±6.2), respectively (P = .04). For the Global Rating Scale, the scores for junior residents, senior residents, and attending surgeons were 27.7/50 (±11.2), 34.5/50 (±9.5), and 45.1/50 (±4.6), respectively (P < .001). The inter-rater and intrarater reliability were both above 0.88. Conclusions The Task-Specific Checklist and Global Rating Scale for M+T appear reliable, with validity evidence supporting their use in otolaryngology training. Level of Evidence NA Laryngoscope, 2015

Patients with cystic fibrosis (CF) frequently present with severe sinonasal disease often requiring radiologic imaging and surgical intervention. Few studies have focused on the relationship between radiologic scoring systems and the need for sinus surgery in this population. The objective of this study is to evaluate the Lund-Mackay (LM) and modified Lund-Mackay (m-LM) scoring systems in predicting the need for sinus surgery or revision surgery in patients with CF.We performed a retrospective chart review of CF patients undergoing computed tomography (CT) sinus imaging at a tertiary care pediatric hospital from 1995 to 2008. Patient scans were scored using both the LM and m-LM systems and compared to the rate of sinus surgery or revision surgery. Receiver-operator characteristics curves (ROC) were used to analyze the radiological scoring systems.A total of 41 children with CF were included in the study. The mean LM score for patients undergoing surgery was 17.3 (±3.1) compared to 11.5 (±6.2) for those treated medically (p0.01). For the m-LM, the mean score of patients undergoing surgery was 20.3 (±3.5) and 13.5 (±7.3) for those medically treated (p0.01). Using a ROC curve with a threshold score of 13 for the LM, the sensitivity was 89.3% (95% CI of 72-98) and specificity of 69.2% (95% CI of 39-91). At an optimal score of 19, the m-LM system produced a sensitivity of 67.7% (95% CI of 48-84) and specificity of 84.6% (95% CI of 55-98).The modified Lund-Mackay score provides a high specificity while the Lund-Mackay score a high sensitivity for CF patients who required sinus surgery. The combination of both radiologic scoring systems can potentially predict the need for surgery in this population.

An array of genetic syndromes has been associated with intra-oral adhesions in neonates. The primary medical issues arise from airway obstruction, feeding difficulties and poor oral development, specifically with cleft palate lateral synechia syndrome (CPLSS). Despite this, a paucity of data exists for the clinical management of intra-oral adhesions in this population. We report the cases of a father and daughter diagnosed with CPLSS who presented with respiratory and feeding difficulties at birth undergoing surgical correction. Early surgical ligation of intra-oral bands allows for a stabilization of the airway, improved feeding and oral development with a good long-term outcome.

IMPORTANCE: Frailty represents a multidimensional syndrome that is increasingly being used to stratify risk in surgical patients. Current frailty risk models are limited among those undergoing thyroid or parathyroid surgery. OBJECTIVE: To develop and compare preoperative risk indices to determine factors associated with short-term major postoperative adverse events in patients undergoing thyroid or parathyroid surgery. DESIGN, SETTING, AND PARTICIPANTS: This cohort study evaluated 154 895 patients in the American College of Surgeons National Surgical Quality Improvement Program who underwent thyroid or parathyroid surgery from January 1, 2007, to December 31, 2016. EXPOSURES: Preoperative frailty-related and surgical factors from a derivation cohort were evaluated using simple and multiple logistic regression. Variables potentially associated with postoperative adverse events were subsequently combined into a personalized preoperative Cervical Endocrine Surgery Risk Index (CESRI) and compared with existing risk models using the validation cohort. MAIN OUTCOMES AND MEASURES: Composite variable of any major postoperative adverse event, including death, within 30 days of surgery. RESULTS: Of the 154 895 operations reviewed, 3318 patients (2.1%; 2296 women and 1022 men; mean [SD] age, 56.1 [15.6] years) experienced a major postoperative adverse event, with 163 deaths (0.1%). Older age (age, ≥80 years: odds ratio [OR], 2.35; 95% CI, 1.74-3.13), inpatient status (OR, 3.55; 95% CI, 3.08-4.11), male sex (OR, 1.49; 95% CI, 1.29-1.71), current tobacco smoking (OR, 1.25; 95% CI, 1.05-1.48), dyspnea (OR, 1.58; 95% CI, 1.29-1.91), recent weight loss (OR, 1.88; 95% CI, 1.23-2.78), functional dependence (OR, 2.77; 95% CI, 2.05-3.69), obesity (OR, 1.33; 95% CI, 1.10-1.60), anemia (OR, 2.14; 95% CI, 1.82-2.52), leukocytosis (OR, 1.73; 95% CI, 1.38-2.14), hypoalbuminemia (OR, 1.87; 95% CI, 1.56-2.23), use of anticoagulation (OR, 2.16; 95% CI, 1.64-2.81), and length of surgery (>4 hours: OR, 2.92; 95% CI, 2.37-3.59) were independently associated with major adverse events or death on multiple regression analysis (C statistic, 0.77; 95% CI, 0.76-0.78). The area under the curve of the CESRI to determine major adverse events, including death, using the validation cohort was 0.63 (95% CI, 0.61-0.64), with a sensitivity of 0.66 (95% CI, 0.64-0.68) and specificity of 0.66 (95% CI, 0.65-0.66). The CESRI outperformed other risk models for determining adverse events (CESRI vs 5-Factor Modified Frailty Index: delta C index, 0.11; 95% CI, 0.09-0.13; CESRI vs American Society of Anesthesiologists Physical Status Classification System: delta C index, 0.05; 95% CI, 0.03-0.07; CESRI vs American College of Surgeons Risk Calculator: delta C index, 0.02; 95% CI, 0.01-0.03; and CESRI vs Head and Neck Surgery Risk Index: delta C index, 0.04; 95% CI, 0.03-0.06). CONCLUSIONS AND RELEVANCE: This study suggests that the CESRI is able to determine major postoperative adverse events in patients undergoing thyroid or parathyroid surgery.

Importance Patients 65 years or older are the most frequent users of operative resources and are also the most vulnerable to postoperative adverse events (AEs). Frailty indices are increasingly being used for preoperative risk stratification within head and neck cancer surgery, but most models lack a multifactorial basis and cannot be directly applied to clinical practice. A practical risk index is needed for clinicians to gauge risk factors preoperatively. Objective To develop a preoperative risk index of short-term major postoperative AEs for patients undergoing head and neck cancer surgery. Design Cohort analysis of patients from multiple medical centers undergoing inpatient ablative or reconstructive head and neck cancer surgery and registered in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) from 2006 to 2016. Exposures Inpatient ablative or reconstructive head and neck cancer surgery. Main Outcomes and Measures Sociodemographic, frailty-related, and surgical factors in the derivation cohort were evaluated using simple and multiple logistic regression. Risk factors were subsequently integrated into a preoperative head and neck surgery risk index (HNSRI) and compared with existing models using the validation cohort. A composite variable of major postoperative AEs was used, including death within 30 days of surgery. Results A total of 43 968 operations were found using the ACS NSQIP database. Of these, 12 569 cases were excluded as non–head and neck cancer or emergency surgery. Of the included 31 399 operations reviewed, the mean (SD) patient age was 56.9 (15.4) years, and 16 994 of the patients were women (54.1%). A total of 4556 (14.5%) patients had a major postoperative AE, and 209 (0.7%) died. Older age, male sex, smoking, anticoagulation, recent weight loss, functional dependence, free-tissue transfer, tracheotomy, duration of surgery, wound classification, anemia, leukocytosis, and hypoalbuminemia were independently associated with major AEs or death on multiple regression analysis (C statistic, 0.83). The area under the curve of the HNSRI to predict major AEs including death using the validation cohort (n = 15 699) was 0.84 (95% CI, 0.83-0.85) with a sensitivity of 80.1% (95% CI, 79.4%-80.8%) and specificity, 72.3% (95% CI, 70.3%-74.2%). The HNSRI outperformed existing risk models for prediction of AEs: delta C index of the HNSRI to the modified frailty index 11, 0.23 (95% CI, 0.22-0.25); the American Society of Anesthesiologists classification, 0.14 (95% CI, 0.13-0.16); and the ACS risk calculator, 0.02 (95% CI, 0.01-0.03). Conclusions and Relevance The proposed HNSRI demonstrated a high sensitivity and specificity for major postoperative AEs and death in the studied population. This risk index can be used to counsel patients awaiting head and neck cancer surgery.

Summary Background In-office laryngeal surgery is taking on a more commonplace role in the treatment of laryngeal disorders. The potassium-titanyl-phosphate (KTP) laser has been a resourceful adjunct to the management of patients with mucosal lesions of the vocal cords. However, a paucity of data exists for its use in postintubation granulomas treated in-office. Clinical Case A 43-year-old female presented with voice hoarseness and found to have a large obstructing postintubation granuloma which was treated by in-office KTP laser and en masse excision. Conclusions We report the successful case of a patient receiving in-office treatment for a large vocal process granuloma using the KTP laser with en masse excision. The combined use of the KTP laser and forceps in-office can be valuable to the surgical management of vocal process granulomas, given their numerous recurrences. New avenues in office-based surgical management of laryngeal disorders can offer accessibility and decreased morbidity to patients.

Background A commonly employed treatment for advanced staged oropharyngeal squamous cell carcinoma (OPSCC) is concurrent radiation and chemotherapy with cisplatin as the gold standard. Carboplatin is reported to have the same radiopotentiation properties and a superior side effect profile; however, its use in head and neck cancer has been limited due to the paucity of data and reported hematologic side effects. In this study, we describe our institution’s experience with carboplatin, paclitaxel and radiation in the treatment of oropharyngeal squamous cell carcinoma over a 10 year period. Methods A retrospective chart review of patients aged 18 to 80 years old with stage III-IV OPSCC treated with weekly carboplatin, paclitaxel and intensity modulated radiotherapy (IMRT) was performed. Data collected included patient demographics, tumor location and stage and survival outcomes. In addition, we noted treatment morbidities according to the Radiation Therapy Oncology Group (RTOG) scoring criteria scale. The data was analyzed using the student’s t-test and analysis of variables. Results Over a 10 year period, 160 patients received chemoradiation with carboplatin and paclitaxel for OPSCC. One-hundred-four and 65 patients were followed for at least 3 and 5 years, respectively. Overall survival for all patients was 81.7 and 70.7 % at 3 and 5 years, respectively. Disease free survival and locoregional recurrence-free survival at 5 years was 64.6 and 89.2 %, respectively. There was no association of survival with stage, regional nodal status or subsite. The most common side effect attributed to treatment was acute dysphagia (75.25 %) followed by odynophagia, xerostomia and hypogeusia. Hospitalizations and non-hospitalization emergency department visits attributed to treatment totalled 33 and 11, respectively. Hematologic toxicities greater than grade II were: 11.9 % neutropenia, 6.3 % anemia, 1.8 % thrombocytopenia. The incidence of febrile neutropenia was 5.0 % (8/160). Conclusion In conclusion, the overall, disease-free and locoregional recurrence-free survival of patients treated with carboplatin and radiotherapy for advanced stage OPSCC parallels what has been described in the literature for cisplatin, with an acceptable side effect profile.

Objective To identify clinico-radiologic factors associated with incomplete anterior cranial fossa (ACF) meningioma resection via an endoscopic endonasal approach. Method Patients undergoing endoscopic endonasal resection of an ACF meningioma were retrospectively accrued from two university-affiliated centers. Demographic profiles and radiologic findings, including tumor dimensions and morphology, anatomic location, and vascular involvement, were stratified according to the extent of resection. Results Twenty-five patients were included in this study. Factors associated with incomplete surgical resection via an endonasal route were: presence of hyperostosis ( P = 0.04), cavernous internal carotid artery involvement ( P = 0.001), maximal dural tail length in the transverse plane ( P = 0.006), and its ratio to the inter-fovea ethmoidalis distance ( P = 0.01). Using a multiple regression analysis, only cavernous internal carotid artery involvement ( P = 0.002) and a large dural tail length to inter-foveal distance ratio ( P = 0.04) were significant predictors of incomplete resection (multiple correlation coefficient = 0.71). The combination of predictive factors to determine the likelihood of complete endoscopic resection produced a scoring system with a sensitivity and specificity of 85.7% (95% confidence interval [CI], 42.1–99.6] and 100% (95% CI, 81.5–100), respectively. Conclusion The use of a simple scoring system outlined in our study can facilitate proper patient selection for endoscopic endonasal resection of ACF meningiomas.

Hypocalcemia following thyroidectomy often prolongs hospital stay and is potentially life-threatening. The objective of this study is to determine whether the season when thyroidectomy is performed is associated with postoperative hypocalcemia.Retrospective case series of patients undergoing thyroid surgery from 2009 to 2015.Tertiary care academic institution in Montreal, Canada.A consecutive sample of 823 patients undergoing thyroidectomy by a single high-volume otolaryngologist for a suspected or confirmed thyroid malignancy. Patient demographics, procedure type, calcium and vitamin D supplementation, and seasonal rate of hypocalcemia postthyroidectomy were calculated and compared.Average seasonal rates of postthyroidectomy hypocalcemia in the winter, spring, summer, and autumn were, respectively, 8.3% (8 of 216), 7.3% (12 of 165), 1.5% (3 of 201), and 3.5% (8 of 228; P.005). Patients operated in the winter were 5.6 times more likely to develop hypocalcemia as compared with those in the summer (P.01; 95% confidence interval: 1.7-18.7). In a multiple regression analysis factoring in season when surgery was performed, procedure type, and preoperative vitamin D/calcium supplementation, surgery occurring in the winter predicted a hypocalcemia event (correlation coefficient [SE]: 0.72 [0.024], P = .026; 0.006 [0.025], P = .81; 0.004 [0.019], P = .82, respectively).In this study, patients undergoing thyroidectomy in the winter months were more likely to develop postoperative hypocalcemia when compared with those operated in the summer. Further studies are needed to understand the role of vitamin D in the observed seasonal difference in hypocalcemia rates.

Despite the transition to competency-based education in surgery, few standardized assessment tools exist in otolaryngology training. In particular, myringotomy and tympanostomy tube insertion (M+T) is a common surgical procedure with few validated assessment tools available. Our objectives were to develop an objective structured assessment of operative skills in M+T and to provide validity evidence for the developed assessment tool within otolaryngology training.Prospective study involving the evaluation of an assessment tool.Through consultation with a panel of experts in otolaryngology and medical education we developed a Task-Specific Checklist and Global Rating Scale for M+T. Postgraduate year 2 junior residents, postgraduate year 3 senior residents, and attending otolaryngologists were video recorded performing M+T at a tertiary care pediatric hospital. The videos were subsequently reviewed and independently evaluated by three blinded raters from an unaffiliated academic institution.The average score of junior residents, senior residents, and attending otolaryngologists using the Task-Specific Checklist was 21.7/30 (±7.1), 26.3/30 (±3.5), and 27.3/30 (±6.2), respectively (P = .04). For the Global Rating Scale, the scores for junior residents, senior residents, and attending surgeons were 27.7/50 (±11.2), 34.5/50 (±9.5), and 45.1/50 (±4.6), respectively (P.001). The inter-rater and intrarater reliability were both above 0.88.The Task-Specific Checklist and Global Rating Scale for M+T appear reliable, with validity evidence supporting their use in otolaryngology training.NA Laryngoscope, 126:2140-2146, 2016.

Objective To identify clinicopathologic factors associated with a reduced intercarotid distance (ICD) and subgroups at risk for internal carotid artery injury during transsphenoidal surgery. Design A retrospective case-control study. Setting This study was conducted at the McGill University Health Centre, a university-affiliated tertiary care center. Participants Patients with a sellar or parasellar tumor and nontumor controls were included in the study. Main Outcome Measures The smallest distance between the internal carotid arteries at the clival, cavernous, and paraclinoid segments on coronal magnetic resonance imaging was measured. Demographic profiles, cephalometric measurements, tumor dimensions, and sphenoid configuration were assessed as potential determinants of the ICD. Results A total of 212 cases and 34 controls were analyzed. Widening of the ICD at the three segments of the internal carotid arteries was found in patients with pituitary macroadenomas (p

Objectives:(1) Review the rate of postoperative hypocalcemia in patients undergoing thyroidectomy in the summer and winter. (2) Identify the association between the season when surgery was completed and the risk of postoperative hypocalcemia.Methods:A retrospective chart review of 436 patients undergoing thyroidectomy at the McGill University Thyroid Cancer Centre from 2006 to 2014 was performed. Patients undergoing total or completion thyroidectomy in the winter months (December to February) and summer months (July to September) were included in the study. Parathyroid hormone (PTH) and serum corrected calcium were recorded according to the McGill post-thyroidectomy protocol. Preoperative PTH and 25-hydroxyvitamin D (25-OHD) were measured. Hypocalcemia was defined as a corrected calcium level