Major cardiovascular adverse events in older adults with early-stage triple-negative breast cancer treated with adjuvant taxane + anthracycline versus taxane-based chemotherapy regimens: A SEER-medicare study.

BACKGROUND: Triple-negative breast cancer (TNBC) is more aggressive as compared to other subtypes of breast cancer with characteristic metastatic patterns and a poor prognosis. The standard of care for early-stage TNBC is historically anthracycline and taxane-based chemotherapy (ATAX). Despite the effectiveness of this regimen, anthracyclines carry a small but important risk of cardiotoxicity, which is specifically a concern in the older population. This study evaluates major adverse cardiovascular events (MACE) in older women with TNBC treated with ATAX compared to taxane-based chemotherapy (TAX). METHODS: Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, we identified women aged 66 and older with TNBC diagnosed between 2010 and 2015 (N = 2215). We compared patient and clinical characteristics according to adjuvant chemotherapy regimen (chemotherapy versus no chemotherapy and ATAX versus TAX). Logistic regression was performed to estimate the odds ratios (OR) and 95% confidence intervals (CIs), Kaplan-Meier survival curves were generated to estimate three-year overall survival (OS) and cancer specific survival (CSS). Cox proportional hazards models were used to analyze OS and CSS while controlling for patient and tumor characteristics. MACE was defined as acute myocardial infarction, heart failure, potentially fatal arrhythmia, and cerebral vascular incidence. Few patients experienced a cardiac death and therefore this was excluded in the analysis. RESULTS: Of the 2215 patients in our cohort, most patients (n = 1334; 60.26%) received TAX compared to ATAX (n = 881; 39.78%). Patients who received ATAX were not statistically significantly more likely than those who received TAX to experience acute myocardial infarction, cerebral vascular accident (CVA), or potentially fatal arrhythmia when controlling for traditional risk factors. Among patients who experienced MACE, there was no difference in OS or CSS in patients who received TAX vs ATAX. Patients who received ATAX were less likely to develop heart failure than those who received TAX (OR 0.63, 95% CI [0.45-0.88], p < 0.01). Patients who developed MACE and who were > 76 years old had worse OS compared to those who experienced MACE and were age 66-75 years old (HR 1.67, 95% CI [1.07-2.62], p = 0.02). CONCLUSION: Among older women with TNBC, receipt of adjuvant chemotherapy with ATAX was not associated with increased risk of major adverse cardiac events. For those who experienced a cardiac event, there was no difference in survival amongst those who received TAX vs ATAX. Other factors including additional chemotherapy toxicities should be investigated as a potential etiology for the inferior OS previously observed with ATAX vs TAX in older women with node negative or 1-3 positive lymph nodes.

Clinical outcomes of adjuvant taxane plus anthracycline versus taxane-based chemotherapy regimens in older adults with node-positive, triple-negative breast cancer: A SEER-Medicare study.

BACKGROUND: Triple-negative breast cancer (TNBC) is a subtype of breast cancer associated with an aggressive clinical course. Adjuvant chemotherapy reduces the risk of recurrence and improves survival in patients with node-positive TNBC. The benefit of anthracycline plus taxane (ATAX) regimens compared with non-anthracycline-containing, taxane-based regimens (TAX) in older women with node-positive TNBC is not well characterised. METHODS: Using the Surveillance, Epidemiology, and End Results-Medicare database, we identified 1106 women with node-positive TNBC diagnosed at age 66 years and older between 2010 and 2015. We compared patient clinical characteristics according to adjuvant chemotherapy regimen (chemotherapy versus no chemotherapy and ATAX versus TAX). Logistic regression was performed to estimate the odds ratios (OR) and 95% confidence intervals (CIs). Kaplan-Meier survival curves were generated to estimate 3-year overall survival (OS) and cancer-specific survival (CSS). Cox proportional hazard models were used to analyse OS and CSS while controlling for patient and tumour characteristics. RESULTS: Of the 1106 patients in our cohort, 767 (69.3%) received adjuvant chemotherapy with ATAX (364/767, 47.5%), TAX (297/767, 39%) or other regimens (106/767, 13.8%). Independent predictors of which patients were more likely to receive ATAX versus TAX included more extensive nodal involvement (≥4), age, marital/partner status and non-cardiac comorbidities. There was a statistically significant improvement in 3-year CSS (81.8% versus 71.4%) and OS (70.7% versus 51.3%) with the use of any chemotherapy in our cohort (P < 0.01). Three-year CSS and OS for patients who received ATAX versus TAX were similar at 82.8% versus 83.7% (P = 0.80) and 74.2% versus 72.7% (P = 0.79), respectively. There was a trend towards improved CSS and OS in patients with four or more positive lymph nodes who received ATAX versus TAX (hazard ratio 0.66, 95% CI: 0.36-1.23, P = 0.19 and hazard ratio 0.68, 95% CI: 0.41-1.14, P = 0.14, respectively). CONCLUSION: Among older women with node-positive TNBC, a majority of patients received adjuvant chemotherapy, which was associated with an improvement in CSS and OS. When compared with TAX chemotherapy, there was a trend towards better outcomes with ATAX for patients with ≥4 nodes.

Landscape of Centralized Otolaryngology Research Efforts Grant Recipients Over the Past Decade.

OBJECTIVE: To investigate the demographics of CORE grant recipients (Centralized Otolaryngology Research Efforts) over the last decade and evaluate disparity among recipients as compared with otolaryngology overall. To assess whether procurement of a grant predicts pursuit of an academic career. STUDY DESIGN: Analysis of grant recipients' bibliometrics. SETTING: Academic medical center. METHODS: The list of recipients of grants from 2010 to 2019 was obtained from the website of the American Academy of Otolaryngology-Head and Neck Surgery. Demographics of recipients were collected through an internet search, including gender, race, residency program, and h-index. Recipients from 2010 were searched to determine current academic faculty rank. Univariate and multivariate analyses were used to compare these factors with otolaryngology overall. RESULTS: The distribution of gender among recipients over the last decade remained nearly constant, with no significant difference versus residents in otolaryngology (P > .05). However, there were significantly more female recipients when adjusted for gender differences in the field overall (P < .01). Asians were relatively overrepresented, while Black and Hispanic residents were underrepresented (P < .01). Many recipients (52.6%) trained at institutions recognized as the best training programs with reputations for quality research output. The h-index of recipients decreased over the last decade (P < .01). The h-index of duplicate winners was significantly higher than those of nonduplicate winners (P < .01). After adjusting for gender and rank, recipients were significantly more likely to hold academic positions (P < .01). CONCLUSION: CORE grants are favorably distributed as related to gender and racial disparities, and recipients frequently go on to achieve high levels of academic success.

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.

Helping Children with Special Needs: Who Receives Tympanostomy Tubes?

OBJECTIVES: Tympanostomy tubes can prevent sequelae of otitis media that adversely affect long term hearing and language development in children. These negative outcomes compound the existing difficulties faced by children who are already diagnosed with developmental disorders. This study aims to characterize this subset of children with developmental disorders undergoing myringotomy and tympanostomy tube insertion. METHODS: A retrospective review using the Kids' Inpatient Database (KID) was conducted, with codes from International Classification of Diseases, Ninth Revision used to query data from the years 2003 to 2012 to determine a study group of children with a diagnosis of a developmental disorder undergoing myringotomy and tympanostomy insertion. This group was compared statistically to patients undergoing these procedures who did not have a diagnosed developmental disorder. RESULTS: In total, 21 945 cases of patients with myringotomy with or without tympanostomy tube insertion were identified, of which 1200 (5.5%) had a diagnosis of a developmental disorder. Children with developmental disorders had a higher mean age (3.3 years vs 2.9 years, P = .002) and higher mean hospital charges ($43 704.77 vs $32 764.22, P = .003). This cohort also had higher proportions of black (17.6% vs 12.3%, P < .001) and Hispanic (23.9% vs 20.6%, P = .014) patients, and had lower rates of private insurance coverage (39.6% vs 49%, P < .001). CONCLUSION: The population of children with developmental disorders undergoing myringotomy or tympanostomy tube placement has a different demographic composition than the general population and faces distinct financial and insurance coverage burdens. Further study should be done to assess if these differences impact long term outcomes.

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.