Diffuse large B-cell lymphoma involving osseous sites: utility of response assessment by PET/CT and good longterm outcomes.

Osseous involvement by diffuse large B-cell lymphoma (DLBCL-bone) is a heterogeneous disease. There is limited data regarding response assessment by positron emission tomography with fluorodeoxyglucose, which may demonstrate residual avidity despite a complete response. We analyzed clinical data of patients with newly diagnosed DLBCL and identified all cases with DLBCL-bone. End of treatment scans were reviewed by two independent experts classifying osseous lesions into Deauville (DV) ≤3; DV ≥4, or reactive uptake in the bone marrow (M), site of fracture (F) or surgery (S). We compared outcomes of DLBCL-bone to other extranodal sites (EN) matched on International Prognotic Index features and regimen. Of 1,860 patients with DLBCL (bone 16%; EN 45%; nodal 39%), 41% had localized disease and 59% advanced. Only 9% (n=27) of patients with initial bone involvement had residual fluorodeoxyglucose avidity at the osseous site. In half of these cases, the uptake was attributed to F/S/M, and of the remaining 13, only two were truly refractory (both with persistent disease at other sites). Overall survival and progression-free survival (PFS) were found to be similar for early- stage nodal DLBCL and DLBCL-bone, but inferior in EN-DLBCL. Advanced-stage disease involving the bone had a similar 5-year PFS to nodal disease and EN-DLBCL. After matching for International Prognotic Index and treatment regiments, PFS between bone and other EN sites was similar. Osseous involvement in DLBCL does not portend a worse prognosis. End of treatment DV ≥4 can be expected in 5-10% of cases, but in the absence of other signs of refractory disease, may be followed expectantly.

Otolaryngologic Side Effects After COVID-19 Vaccination.

OBJECTIVES: With widespread vaccination against COVID-19, concerns regarding side effects have been raised. We aim to assess the frequency of otolaryngologic adverse events (AEs) following COVID-19 vaccination as compared with other vaccines in a national database. STUDY DESIGN: Retrospective analysis of national registry. METHODS: The Food and Drug Administration's Vaccine Adverse Event Reporting System (VAERS) database was queried from December 2020 to May 2021 for all COVID-19 vaccination AEs. Complaints were categorized as otolaryngologic and sub stratified into different anatomic components. Reporting odds ratios (ROR) and proportional reporting ratios (PRR) were determined for AEs of clinical significance. RESULTS: The total number of AEs reported from vaccination with the Moderna, Pfizer-BioNTech, and Janssen vaccines equaled 1,280,950. Of these, 62,660 (4.9%) were otolaryngologic in nature, with 32.6% associated with the oropharynx/larynx, 18.3% with the nasal cavity/sinuses, 17.1% with the ears/vestibular system, 10.0% with the oral cavity, and 21.9% miscellaneous. Signal ratios reached significance levels for dysgeusia (n = 2124, PRR: 17.33, ROR: 16.36), ageusia (n = 1376, PRR: 2.81, ROR: 2.81), anosmia (n = 983, PRR: 4.01, ROR: 4.01), rhinorrhea (n = 2203, PRR: 2.99, ROR: 3.00), throat tightness (n = 3666, PRR: 4.99, ROR: 5.00), throat irritation (n = 3313, PRR: 4.51, ROR: 4.52), dysphagia (n = 2538, PRR: 2.07, ROR: 2.07), tinnitus (n = 4377, PRR: 3.97, ROR: 3.98), and vertigo (n = 2887, PRR: 3.93, ROR: 3.93). Signal ratios were not significant for facial paralysis, Bell's palsy, anaphylaxis, sinusitis, hearing disability, and ear pain. CONCLUSIONS: Although several otolaryngologic symptoms were reported, few were found to be clinically significant. Of note, facial paralysis, Bell's palsy, and anaphylaxis did not meet signal thresholds to be determined significant. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:1163-1168, 2024.

US residents experiences with intraoperative nerve monitoring in thyroid and parathyroid surgery.

BACKGROUND: Understanding the patterns of IONM use and training among resident otolaryngologists is essential to ensure that the IONM skills and knowledge gained in residency are optimized for successful future practice of IONM. METHOD: An electronic survey was distributed to US-based OHNS residents. Questions evaluated resident experience, implementation, knowledge and understanding of IONM for endocrine surgeries. RESULTS: One hundred and seven OHNS residents participated, spanning all training levels and US geographic locations. The majority of residents received no didactic teaching on IONM (74.5%) nor had a clear troubleshooting algorithm in the event of a loss of signal (69.8%). The majority of residents were uncertain regarding the advantages/disadvantages of continuous versus intermittent IONM. CONCLUSION: The knowledge gap found in our survey study suggests that greater teaching of IONM principles for endocrine head and neck surgeries in OHNS residency programs would help to ensure successful utilization in future practice.

Impact of Age on Surgical Outcomes Following Mandible Fracture Repair.

OBJECTIVES: Open repair of mandibular fractures are frequently performed surgical procedures. Increasing rates of such fractures are seen in older adults following falls. This study assesses the impact of older age on early complications following mandible fracture repair. STUDY DESIGN: Retrospective analysis of national registry. METHODS: The 2013-2018 National Surgical Quality Improvement Program database was queried for all cases of open mandible fracture repair and cases were categorized into younger (18-40), middle (41-65), and older (>65) age cohorts. Demographics and comorbidities were compared between the age groups. Rates of surgical, medical, and wound complications within 30-days of surgery were determined. Multivariable logistic analyses were performed to assess the relationship between age and complications. RESULTS: Altogether, 1818 cases were included for analysis, of which 1269 (69.8%) were younger, 459 (25.2%) were middle, and 90 (5.0%) were older age. Increased rates of complications were seen in the older groups, including unplanned reoperation, unplanned readmission, wound disruption, and medical complications (p < 0.01). On unadjusted analysis, the older (>65) age group had an increased odds of experiencing a complication compared to the younger (18-40) group (OR: 4.19, p < 0.001). The older age group continued to have a significantly increased odds of medical complications after multivariable adjustment (adjusted OR: 8.64, p < 0.001). CONCLUSIONS: On this analysis of a national database, advanced age was associated with an increased frequency of early postoperative complications following open mandibular fracture repair. Following multivariable adjustment, advanced age continued to be associated with increased odds of postoperative medical complications within 30 days of surgery. LEVEL OF EVIDENCE: 3 Laryngoscope, 133:287-293, 2023.

Relative Value Units and Operative Time in Plastic and Reconstructive Surgery.

BACKGROUND: Work relative value units (wRVUs) are linked to clinical reimbursements and physician compensation in the USA and thus should consider the time of the physician providing care. The primary goal of this study is to assess whether wRVUs appropriately consider operative time in plastic and reconstructive surgery. METHODS: The 2015-2018 National Surgical Quality Improvement Program was queried for the 50 most performed plastic surgery cases with assigned wRVUs and a recorded operative time. Linear regressions were used to assess the relationships between operative time, assigned wRVUs, and wRVUs per hour. The procedures with the highest and lowest assigned wRVUs relative to their operative time were identified. RESULTS: A total of 31,156 cases were included in this analysis. Among the 50 most performed procedures, the median (range) for assigned wRVUs was 10.0 (1.0-42.6), operative time was 61 min (21-441), and wRVUs per hour was 8.7 (2.2-16.2). There was a strong positive linear correlation between assigned wRVUs and median operative time (R2=0.78), with each additional operative hour being associated with an increase of 5.3 wRVUs (p<0.001). The procedures earning the most wRVUs relative to their operative times were breast reconstruction with other techniques and tissue expander placement in breast reconstruction. However, excisional debridements of the muscle/fascia and subcutaneous tissue had the lowest earned wRVUs relative to their operative times. CONCLUSION: Although wRVUs and operative time are correlated in plastic surgery, numerous outliers from this trend exist. This suggests that wRVUs may not be optimally assigned across the range of plastic surgery procedures.

Understanding basal cell adenocarcinoma of the head and neck: Population-based study.

BACKGROUND: Using a population-based database, this study investigates the risk factors, epidemiology, and outcomes of basal cell adenocarcinoma (BCAC) of the head and neck. METHODS: The Surveillance, Epidemiology, and End Results database was analyzed for all patients with BCAC of the head and neck from 1973 to 2015. RESULTS: Three hundred and twenty-two cases of BCAC of the head and neck were identified. Mean age of diagnosis was 64.1 years. 52.5% were male and 77.3% were white. The most common primary site was the parotid gland (71.7%). Most patients underwent surgery alone (51.9%). Five-year disease-specific survival (5Y-DSS) was 95.6%, and 10Y-DSS was 90.3%. Highest survival was seen with surgery alone followed by combined surgery and radiation (10Y-DSS: 93.9% vs. 88.9%, p = 0.001). Age, primary site, T-classification, grade, and treatment type significantly affected survival. CONCLUSIONS: BCAC of the head and neck presents most frequently in the parotid glands. Surgery alone is associated with highest survival.

Single-Port Robotic Radical Cystectomy with Intracorporeal Bowel Diversion: Initial Experience and Review of Surgical Outcomes.

Introduction and Objective: Scant literature is available on surgical outcomes of radical cystectomies on the new single-port (SP) system. This study compares short-term outcomes in patients undergoing radical cystectomy with those undergoing intracorporeal urinary diversion (ICUD) on the multiport (MP) vs SP platform. Methods: This institutional review board approved study used a prospective cystectomy database and nonparametric testing including chi-squared, Mann-Whitney U, and Fisher exact tests to analyze all variables stratified by surgical approach. Results: Thirty-four patients underwent radical cystectomy with ICUD from September 1, 2019, to February 8, 2021. Twenty patients were in the MP cohort, whereas 14 were in the SP group. Table 1 presents the demographics of both groups and shows no statistically significant differences. Intra- and postoperative as well as pathology data are given in Table 2. Patients in the SP group had less narcotic use (MP: 25 morphine milligram equivalent [MME] vs SP: 11.5 MME, p = 0.047) and shorter return of bowel function (MP: 3 days vs SP: 2 days, p = 0.032). Operative times were similar between both groups despite having fewer patients undergoing ileal conduit (MP: 85% vs SP: 50%, p = 0.027) in the SP group. In Table 3, we list the early short-term postoperative follow-up data for each group that showed no significant differences between the two groups with an average follow-up of 4.9 months for MP and 4.4 months for SP. Conclusions: Our initial experience with SP robotic cystectomy and ICUD appears to be safe and an effective alternative to MP cystectomies. A learning curve was involved but the overall transition from MP to SP was smooth. Operative times were similar despite fewer patients undergoing ileal diversion, shorter return of bowel function, and less narcotic use in the SP group. Further studies including longer follow-ups with multi-institutional data are underway.

The impact of diabetes mellitus on medical complication and mortality rates among inpatients with bullous pemphigoid.

BACKGROUND: There is currently limited population-based data on the effect of type 2 diabetes mellitus (T2DM) on bullous pemphigoid (BP) inpatients. AIMS: To evaluate the relative comorbidities, medical complications, and mortality rates between BP inpatients with and without T2DM. METHODS: All inpatients with a primary BP diagnosis in the National Inpatient Sample from 2003 to 2012 were queried. BP inpatients with or without T2DM were compared to identify disparities in relative comorbidities and medical complications. Comorbidities were established using the Agency for Healthcare Research and Quality standardized values. Medical complications were classified using ICD-9 codes. RESULTS: Of the 1978 BP patients identified, 660 (33.4%) had a concurrent diagnosis of T2DM. These patients had significantly higher rates of concurrent comorbidities, including chronic renal failure, congestive heart failure, iron deficiency anemia, hypertension, obesity, and peripheral vascular disease. On bivariate analysis, T2DM patients also had significantly higher rates of medical complications including acute kidney injury (14.5% vs. 10.1%, p = 0.004) and venous thromboembolism (1.8% vs. 0.5%, p = 0.012). On multivariable-adjusted analysis, the odds of venous thromboembolism (OR = 3.01, p = 0.027) remained increased. Inpatient mortality did not differ between the groups. CONCLUSIONS: Our findings suggest that BP inpatients with T2DM have a greater medical comorbidity and complication burden. However, inpatient mortality was not increased.

Survival Predictors of Head and Neck Burkitt's Lymphoma: An Analysis of the SEER Database.

OBJECTIVE: To analyze population-level data for Burkitt's lymphoma of the head and neck. STUDY DESIGN: Retrospective study of a national cancer database. SETTING: Academic medical center. METHODS: The SEER database (Surveillance, Epidemiology, and End Results) identified all patients with primary Burkitt's lymphoma of the head and neck from 1975 to 2015. Demographic, clinicopathologic, and treatment characteristics were analyzed. Multivariable Cox regressions analyzed factors associated with survival while controlling for baseline differences. RESULTS: A total of 920 patients with a mean (SD) age of 37.6 years (25.0) were identified. A majority of patients were White (82.8%) and male (72.3%). The most primary common sites included the lymph nodes (61.3%), pharynx (17.7%), and nasal cavity/paranasal sinuses (5.2%). The majority of patients received chemotherapy (90.5%), while fewer underwent surgery (42.1%) or radiotherapy (12.8%). Choice of treatment differed significantly among patients of different ages, year of diagnosis, primary site, nodal status, and Ann Arbor stage. Overall 10-year survival was 67.8%. On multivariable Cox regression, patients with older age (hazard ratio [HR], 1.05 per year; P < .001) and higher stage at presentation had increased risk of mortality (P < .001). Furthermore, cases diagnosed between 2006 and 2015 (HR, 0.35; P < .001) and 1996 and 2005 (HR, 0.53; P = .001) had lower mortality when compared with those diagnosed between 1975 and 1995. Treatment including surgery and chemotherapy tended to have the best survival (P < .001). CONCLUSION: Burkitt's lymphoma of the head and neck diagnosed in more recent years has had improved survival. Factors significantly associated with survival include age, Ann Arbor stage, and treatment regimen. Treatment including surgery and chemotherapy was associated with the highest survival.

Facial paralysis and vaccinations: a vaccine adverse event reporting system review.

BACKGROUND: Vaccinations are a cornerstone of preventative medicine in the USA. However, growing concerns regarding facial nerve palsy following vaccination exist. OBJECTIVE: This study aims to assess the occurrence of facial palsy as reported by the Vaccine Adverse Event Reporting System (VAERS) database. METHODS: A retrospective analysis of the VAERS database was performed for cases of 'Facial Palsy', 'Bell's Palsy', 'Facial Paralysis' and 'Ramsay Hunt Syndrome' between 2009 and 2018. Subgroup analysis was performed to determine gender, age, history of facial palsy, type of vaccine used, number of days until onset of symptoms and overall facial palsy rate. RESULTS: Nine hundred and forty-four entries met our inclusion criteria with 961 vaccine administrations resulting in facial paralysis. Facial palsy following vaccinations was evenly distributed across all age cohorts with two peaks between 60 and 74 years old and between 0 and 14 years old. Most patients were female (N = 526, 55.7%) without a reported history of facial palsy (N = 923, 97.8%). In 2009, reported incidence rate was 0.53%, as compared with 0.23% in 2018. The influenza vaccine had the greatest number of cases (N = 166, 17.3%), followed by the varicella (N = 87, 9.1%) and human papillomavirus vaccines (N = 47, 4.9%). CONCLUSIONS: With the SARS-CoV-2 pandemic and recent approvals of the vaccinations, there is growing concern of facial palsy following vaccination. Although it is a known adverse event following vaccination, the likelihood of facial palsy following vaccination is low, with only 0.26% of overall reported cases over a 10-year span.

Understanding giant cell sarcoma of the head and neck: A population-based study.

BACKGROUND: Giant cell sarcomas (GCS) are rare head and neck neoplasms. METHODS: The Surveillance, Epidemiology, and End Results (SEER) database was analyzed for all patients who have been diagnosed with GCS from 1973 to 2014. RESULTS: Four hundred and forty cases of GCS of the head and neck were identified. The average age at diagnosis was 74.4 years, 86.8% were white, 82.5% were male, 70.7% were insured, and 88.2% lived in an urban metropolitan region. Connective tissue was the most frequent primary site (42.5%). The 5Y-DSS rate was 91.1%, while the 5Y-OS was 54.6% for all cases. Patients treated with surgery alone had the highest 5Y-DSS rate of 94.5. T-classification odds ratio was a significant predictor of survival accounting for confounding variables on multivariate analysis. CONCLUSIONS: GCS presents most frequently in connective tissue of the head and neck with overall high probability of survival. The treatment of choice is surgery alone.

Panniculectomy Outcomes by Body Mass Index: an Analysis of 12,732 Cases.

PURPOSE: With an increasing rate of obesity in the USA, bariatric surgery has become widespread, resulting in a greater number of patients seeking panniculectomy. The authors aim to determine the complication profile of panniculectomies by body mass index (BMI). METHODS: The 2012-2018 National Surgical Quality Improvement Program database was queried for all panniculectomy cases. Patients were assigned to a category by their calculated BMI. Rates of complications were compared across BMI ranges. Demographics, comorbidities, and perioperative factors were compared between those with and without complications. Multivariable analyses were performed to analyze the associations between BMI ranges and post-surgical complications. RESULTS: Twelve thousand seven hundred thirty-two cases were analyzed, of which 1759 (13.8%) had at least one postoperative complication. As BMI increased, patients were more likely to experience postoperative complications (p<0.001). Patients experiencing complications were more likely to be male, older, of a higher BMI group, have a higher American Society of Anesthesiologists Personal Status classification, be an inpatient, have various comorbidities, or be undergoing a concurrent procedure. On multivariable analysis, patients who were overweight (OR=1.24, p=0.039), with class 1 (OR=1.72, p<0.001), class 2 (OR=2.10, p<0.001), or class 3 (OR=3.01, p<0.001) obesity were more likely to have a postoperative complication. Wound complications were particularly prevalent in patients who were overweight (OR=1.77, p=0.001) or with class 1 (OR=2.59, p<0.001), class 2 (OR=4.05, p<0.001), or class 3 (p=5.84, p<0.001) obesity compared to non-overweight patients. CONCLUSION: A higher BMI is associated with more postoperative complications, particularly wound healing complications, following panniculectomy in a dose-dependent manner.

Surgical Margin Status and Survival Following Resection of Sinonasal Mucosal Melanoma.

OBJECTIVES: Sinonasal mucosal melanoma (SNMM) is an aggressive cancer usually managed with surgical resection. This study evaluates the impact of treatment modality and positive surgical margin (PSM) on survival following resection of SNMM. STUDY DESIGN: Retrospective study of a national cancer registry. METHODS: The National Cancer Database was queried for cases of SNMM from 2010 to 2015. Data regarding patient demographics, tumor staging, and treatment modality were obtained. Survival rates were compared by margin status: PSM, negative (NSM), and no operation (0SM) using Kaplan-Meier analysis and log rank test. RESULTS: A total of 446 patients met inclusion criteria. Most cases were elderly (>66 years-old) (67.3%), female (54.3%), and white (89.5%). Cases of SNMM most commonly involved the nasal cavity (81.6%), were Stage 3 (60.0%), and underwent surgical resection at an academic center (65.0%). NSM and PSM were present in 59.0% and 26.9% of cases, respectively, while 14.1% of cases did not undergo surgical resection (0SM). Factors predictive of PSM included resection at a community hospital (OR 2.47) and Stage 4 disease (OR 2.07). The 2-year survival rates were 72.1% (95% CI 69.4-75.4%), 36.3% (95% CI 22.0-48.9), and 16.0% (95% CI 8.2-25.4%) for NSM, PSM and 0SM, respectively. Survival was statistically significant between NSM and PSM (Log rank <0.001) but not between 0SM and PSM (Log rank = 0.062). CONCLUSION: Our study emphasizes the need for NSM for SNMM as PSM did not demonstrate any significant improvement in survival when compared to 0SM. Our findings suggest that cases of SNMM are best managed at academic centers. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2429-2435, 2021.

Adverse Events Associated with Intranasal Sprays: An Analysis of the Food and Drug Administration Database and Literature Review.

BACKGROUND: Intranasal sprays (INSs) are commonly used medications for the treatment of many rhinologic conditions. Despite their popularity, an analysis of a nationwide reporting database and comparison to the available literature has never been performed. METHODS: The Food and Drug Administration Adverse Event Reporting System (FAERS) database was accessed to obtain adverse event (AE) records from 2014 to 2019 for varying INSs, including: 10 corticosteroids, 1 alpha adrenergic, and 3 antihistamines. The Proportional Reporting Ratios (PRR) and Reporting Odds Ratios (ROR) were calculated for dyspnea, anosmia, ageusia/dysgeusia, epistaxis, and headache. A PRR ≥ 2 or ROR ≥ 1 was considered significant. RESULTS: Corticosteroids had 98 864 total reported AEs to the database, followed by antihistamines (7011) and alpha adrenergics (2071). In total, dyspnea was reported 5843 times, followed by headache (4230), epistaxis (1205), ageusia/dysgeusia (920), and anosmia (312). Overall, PRR and ROR values for dyspnea ranged from 0.51 to 4.25 and 0.51 to 4.49; for dysgeusia/ageusia from 0.56 to 6.09 and 0.56 to 6.12; and for epistaxis from 1.03 to 27.24 and 1.03 to 30.76, respectively. All medications which listed anosmia within the top AEs had PRR and ROR values exceeding 2 and 1, respectively. The PRR for headache exceeded 2 for 1 medication and the ROR exceeded 1 in 7 medications. CONCLUSION: The AEs of dyspnea, anosmia, ageusia/dysgeusia, epistaxis, and headache are reported within the FAERS database for commonly prescribed INSs. When compared against the existing scientific literature, the clinical significance of this reporting tool from the FDA for these classes of medications remains unvalidated.

Quality, Reliability, and Readability of Online Information on Rhinoplasty.

BACKGROUND: With an ever-growing reliance on technology, patients are increasingly resorting to websites for their medical information. This study evaluates the readability, quality, and reliability of online information available on rhinoplasty provided by academic centers or impartial reference sources and private practice websites. METHODS: A cross-sectional study from July to August 2019 was performed looking at the first 42 informational websites on a Google search for the term nose job. Websites were categorized as belonging to impartial sources and academic centers or private practices. Two independent reviewers evaluated websites on their quality, readability, reliability, and technical qualities using several validated measures. The Health on the Net code (HONcode) and DISCERN questionnaire were used to assess the quality and reliability of the information presented on the websites. Significance tests were performed using SPSS Version 25. RESULTS: Of the 42 websites, 23 were impartial sources or academic centers (54.8%) and 19 were private practice websites (47.6%). The mean (±SD) for the HONcode and DISCERN scores were 5.7 (±2.8) and 2.6 (±0.7), respectively. The mean (SD) HONcode scores for impartial sources and private practice websites were 7.1 (±2.9) and 4.1 (±1.5), respectively (P < 0.001). The mean (±SD) DISCERN scores were 2.9 (±0.7) and 2.3 (±0.5), respectively (P = 0.009). There was no statistically significant difference in scores for readability and technical qualities. CONCLUSIONS: While impartial sources and academic centers score higher on quality and reliability scores, their scores were also low. These findings are concerning as many consumers use the information provided by online websites to guide decisions regarding their health.

Comparison of mortality and medical complications between older and younger malignant melanoma inpatients.

Previous studies have identified older age as a negative prognostic factor in malignant melanoma patients. To compare comorbidities, medical complications, and inpatient mortality between younger and older malignant melanoma inpatients. All adult patient encounters with a diagnosis of cutaneous malignant melanoma were identified using the 2003 to 2012 National Inpatient Sample database. Concurrent comorbidities and inpatient medical complications were queried. Comparisons were made between older and younger adults, defined as ≥65 years and 18 to 64 years, respectively. In total, 8153 patient encounters were identified in the database (51.6% older and 48.4% younger). Older adults had a higher prevalence of numerous comorbidities, including chronic pulmonary disease, chronic renal failure, congestive heart failure, diabetes mellitus, hypertension, hypothyroidism, peripheral vascular disease, and pulmonary circulation disorder (P < .001). In contrast, younger adults were more likely to have obesity (P < .001) and coagulopathy (P = .005). On multivariable analysis of medical complications, older adult inpatients were more likely to experience urinary tract infection (OR = 1.54, P = .021), but less likely to experience acute respiratory failure (OR = 0.46, P = .012) and venous thromboembolism (OR = 0.44, P = .026). Notably, inpatient mortality did not significantly differ. Older adult inpatients with malignant melanoma have different comorbidities than younger patients and have a larger overall comorbidity burden. Surprisingly, however, the odds of most inpatient medical complications and mortality were found to be similar in younger vs older patients.

Adverse Events Associated With Botox as Reported in a Food and Drug Administration Database.

BACKGROUND: Botulinum toxin treatment is the most frequently performed noninvasive cosmetic procedure performed in the USA. Because of its widespread use, an analysis of the adverse event (AE) profile of Botox injections is needed. METHODS: The FDA Adverse Event Report System was queried using an online web-based tool to determine the top 15 adverse events reported for four Botox brand names: Botox/Botox Cosmetic, Dysport, and Xeomin. The proportional reporting ratios (PRR) and relative odds ratios (ROR) were determined. A literature review was performed for eight AEs of clinical significance: eyelid/eyebrow ptosis, asthenia, muscular weakness, facial paresis, dysphagia, botulism, and death. RESULTS: Botox/Botox Cosmetic had 38367 AEs. Dysport had 3582 AEs. Xeomin had 1405 AEs. All drugs with reported cases of eyelid and eyebrow ptosis had significant PRR and ROR values. The PRR and ROR values for asthenia were not significant in any of the drugs and only reached significance for Dysport for muscular weakness and dysphagia. Both Botox/Botox Cosmetic and Dysport had elevated PRRs and RORs for facial paresis and botulism. While all drugs had at least one reported case of death related to Botox injection use, none of the PRR or ROR values were significant. CONCLUSION: Known AEs for Botox injection use include eyelid/brow ptosis and muscular weakness. Feared but rare complications of Botox injection use include dysphagia, botulism, and possibly death, owing to systemic spread of the toxin. This is the first study to analyze the AE data reported to the FDA on Botox injection use. EBM LEVEL: III.

Ratio of Lymph Node to Primary Tumor SUV on PET/CT Accurately Predicts Nodal Malignancy in Non-Small-Cell Lung Cancer.

UNLABELLED: Thoracic lymph nodes with marginally elevated maximum standardized uptake value (SUVmax) on PET/CT a diagnostic challenge in staging non-small-cell lung cancer. We evaluated the ratio of lymph node to primary tumor SUVmax (SUVN/T) in predicting nodal malignancy among 132 sampled nodes from 85 patients both a primary tumor SUVmax > 2.5 and LN SUVmax 2.0 to 6.0. SUVN/T was more accurate than SUVmax for this subset of patients. INTRODUCTION/BACKGROUND: Among non-small-cell lung cancers with appreciable functional activity, positron emission tomography/computed tomography (PET/CT) is the most accurate imaging modality for clinical staging. However, lymph nodes (LN) with marginally elevated standardized uptake value (SUV) present a diagnostic challenge. In this retrospective study, we hypothesized that normalizing the LN SUV by using the ratio of the LN to primary tumor SUVmax (SUVN/T) may be a better predictor of nodal malignancy than using SUVmax alone for nodes with low to intermediate SUV. PATIENTS AND METHODS: We identified 172 patients with newly diagnosed non-small-cell lung cancer who underwent pathologic LN staging and PET/CT within 31 days before biopsy. Receiver operating characteristic curves with area under the curve (AUC) calculations were used to evaluate SUVmax and SUVN/T for their ability to predict nodal malignancy for both the entire cohort of 504 LNs and a subset of 132 LNs from 85 patients who had both primary tumor SUVmax > 2.5 and LN SUVmax 2.0 to 6.0. RESULTS: In patients with primary tumor SUVmax > 2.5 and LN SUVmax 2.0 to 6.0, SUVN/T was significantly more accurate in predicting nodal malignancy (AUC, 0.846; 95% confidence interval, 0.775-0.917) than SUVmax (AUC, 0.653; 95% confidence interval, 0.548-0.759). The optimal cutoff value of SUVN/T to predict nodal malignancy was 0.28 (90% sensitivity, 68% specificity). Sensitivity was > 95% for SUVN/T < 0.21, whereas specificity was > 95% for SUVN/T > 0.50. CONCLUSION: The ratio of LN SUV to primary tumor SUV on PET/CT is more accurate than SUVmax when assessing nodes of low to intermediate SUV.

A Predictive Model for Lymph Node Involvement with Malignancy on PET/CT in Non-Small-Cell Lung Cancer.

INTRODUCTION: Accurate assessment of lymph node (LN) involvement with malignancy is critical to staging and management of non-small-cell lung cancer. The goal of this retrospective study was to determine the tumor and imaging characteristics independently associated with malignant involvement of LNs visualized on positron emission tomography/computed tomography (PET/CT). METHODS: From 2002 to 2011, 172 patients with newly diagnosed non-small-cell lung cancer underwent PET/CT within 31 days before LN biopsy. Among these patients, 504 anatomically defined, pathology-confirmed LNs were visualized on PET/CT. Logistic regression analysis was used to determine the associations between nodal involvement with malignancy and several clinical and imaging variables, including tumor histology, tumor grade, LN risk category in relation to the primary tumor location, pathologic findings from additional biopsied LNs, interval between PET/CT and biopsy, primary tumor largest dimension, primary tumor standardized uptake value (SUVmax), LN short-axis dimension, and LN SUVmax. RESULTS: On univariate analysis, adenocarcinoma histology (p = 0.010), high LN risk category (p < 0.001), larger LN short-axis dimension (p < 0.001), and higher LN SUVmax (p < 0.001) all correlated with nodal involvement. On multivariate analysis, adenocarcinoma histology (p = 0.003), high LN risk category (p = 0.005), and higher LN SUVmax (p < 0.001) correlated with nodal involvement, whereas LN short-axis dimension was no longer statistically significant (p = 0.180). A nomogram developed for clinical application based on this analysis had excellent concordance between predicted and observed results (concordance index, 0.95). CONCLUSION: Adenocarcinoma histology, higher LN SUVmax, and higher LN risk category independently correlate with nodal involvement with malignancy and may be used in a model to accurately predict the risk of a node's involvement with malignancy.