To describe the association between active, environmental tobacco smoke (ETS) exposure and the prevalence of eustachian tube dysfunction (ETD) in the U.S. pediatric population.
Abstract Purpose: Guidelines for early-stage breast cancer allow for radiotherapy (RT) omission following breast conserving surgery (BCS) among older women, though high utilization of RT persists. This study explores surgeon referral and the effect of a productivity-based bonus metric for radiation oncologists in an academic institution with centralized quality assurance (QA) review. Methods: We evaluated patients > 70 years of age treated with BCS for ER+ pT1N0 breast cancer at a single tertiary cancer network between 2015-2018. The primary outcomes were radiation oncology referral and RT receipt. Covariables included patient and physician characteristics, and treatment decisions before versus after productivity metric implementation. Univariable generalized linear effects models explored associations between these outcomes and covariables. Results: Of 703 patients included, 483 (69%) were referred to radiation oncology and 273 (39%) received RT (among those referred, 57% received RT). No difference in RT receipt pre- versus post- productivity metric implementation was observed (p=0.57). RT receipt was associated with younger patient age (70-74 years, OR 2.66, 95% CI 1.54-4.57) and higher grade (grade 3, OR 7.75, 95% CI 3.33-18.07). Initial referral was associated with younger age (70-74, OR 5.64, 95% CI 3.37-0.45) and higher performance status (KPS ³90, OR 5.34, 95% CI 2.63-10.83). Conclusion: Non-referral to radiation oncology accounted for half of RT omission, but was based on age and KPS, in accordance with guidelines. Lack of radiation oncologist practice change in response to misaligned financial incentives is reassuring, potentially reflecting centralized QA review. Multi-institutional studies are needed to confirm these findings.
Abstract Brain metastasis is common in patients with breast cancer, and those with triple negative status have an even higher risk. Stereotactic radiosurgery (SRS) is preferred to whole brain radiation therapy (WBRT) in most patients. However, triple negative status is currently not considered when determining optimal radiation therapy. Given the aggressive nature of triple negative breast cancer, we evaluated a role for WBRT for all patients in this cohort. We conducted a single-institution retrospective cohort study to determine whether triple negative patients with brain metastases have a higher burden of intracranial disease and whether type of initial radiation therapy affects overall survival for this cohort of patients. 85 patients met the inclusion criteria for this study. 25% of patients had triple negative breast cancer, of which 91% received SRS and 53% of patients received WBRT. The average number of new brain metastases from time of initial brain imaging to radiation therapy was 0.67 (St.Dev:1.1) in the non-triple negative status patients and 2.6 (St. Dev:3.7) in the triple negative status patients (p=0.001). Using a cox proportional hazards model, it was found that whole brain radiotherapy does not significantly affect overall survival in patients with triple negative breast cancer (p = 0.96). Our findings highlight the highly aggressive intracranial nature of triple negative breast cancer. Indeed, the rate of increase in brain metastases is significantly higher for triple negative patients compared to non-triple negative patients. As a result, we evaluated whether triple negative patients would benefit from whole brain radiation regardless of findings on initial brain imaging. Despite 53% of patients receiving WBRT, our investigation found that there is no additional benefit to WBRT in triple negative breast cancer patients. These results suggest a need to re-evaluate the role of WBRT in the management of triple negative breast cancer.
Abstract Background: GP2 is a biologic nine amino acid peptide of the HER2/neu protein delivered in combination with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) that stimulates an immune response targeting HER2/neu expressing cancers, the combination known as GLSI-100. In a prospective, randomized, single-blinded, placebo-controlled, multicenter Phase IIb study, no recurrences were observed in the HER2+ population after 5 years of follow-up, if the patient was treated with GLSI-100, survived and was followed for more than 6 months (p = 0.0338). Immunotherapy elicited a potent response measured by skin tests and immunological assays. Of the 146 patients that have been treated with GLSI-100 over 4 clinical trials, GLSI-100 was well-tolerated and no serious adverse events were observed considered related to the immunotherapy. Method: This Phase III trial is a prospective, randomized, double-blinded, multi-center study. After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years for a total of 11 injections over 3 years. The participant duration of the trial will be 3 years treatment plus 1 additional year follow-up for a total of 4 years following the first year of treatment with trastuzumab-based therapy. Patients will be stratified based on residual disease status at surgery, hormone receptor status and region. Study Size – Interim Analysis: Approximately 498 patients will be enrolled. To detect a hazard ratio of 0.3 in invasive breast cancer free survival (IBCFS), 28 events will be required. An interim analysis for superiority and futility will be conducted when at least 14 events have occurred. This sample size provides 80% power if the annual rate of events in placebo patients is 2.4% or greater. Up to 100 non-HLA-A*02 subjects will be enrolled in an open-label arm. Eligibility Criteria: The patient population is defined by these key eligibility criteria: 1. HER2/neu positive and HLA-A*02 2. Residual disease or High risk pCR (Stage III at presentation) post neo-adjuvant therapy 3. Exclude Stage IV 4. Completed at least 90% of planned trastuzumab-based therapy Trial Objectives: 1. To determine if GP2 therapy increases IBCFS 2. To assess the safety profile of GP2 3. To monitor immunologic responses to treatment and assess relationship to efficacy and safety Contact information: Snehal Patel Greenwich LifeSciences, Inc. Stafford, TX Email: snehal.patel@greenwichlifesciences.com Website: greenwichlifesciences.com Funding: This trial is supported by Greenwich LifeSciences. Citation Format: Snehal Patel, Jaye Thompson, Mira Patel, F. Joseph Daugherty, C. Kent Osborne, Mothaffar Rimawi. Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01 [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT2-10-06.
Electronic Health Records (EHRs) have many clinical, financial, and logistical benefits, yet the extent of their accuracy is unknown. We compared patient self-reported data at emergency department (ED) presentations with the corresponding EHR, focusing on key demographics, physical characteristics, and social history. Emphasis was placed on understanding whether major life stressors were noted on patients’ charts and how that could impact quality of care. Life stressors are defined as life-altering and emotionally demanding or traumatic events. We enrolled a convenience sample of 357 ambulatory, English speaking, adult patients at the Vanderbilt University Medical Center Emergency Department, an urban, academic, tertiary care ED (annual census 70,000). We compared the EHR with self-reported data from bedside patient interviews, including information on demographics (age, sex, race, ethnicity), physical characteristics (height, weight), and life history (smoking, life stressors). Data was described using median and percent frequency, and it was analyzed using Cohen kappa statistics and Bland-Altman plots. Between EHR and patient-reports, sex and age matched in 99%, and race/ethnicity matched in 90%. Race was more discordant when the patient self-identified as multiple races, as it was only reflected in 24% of those patients’ EHRs. Weight, height, and smoking were similar between patient interviews and EHR. Of 281 self-reported life stressors, only 75 were recorded in the EHR. Although most demographic and clinical data were concordant, life stressors were frequently absent from the EHR which suggests a discrepancy in data collection and maintenance.
Loeys-Dietz syndrome (LDS) is an autosomal dominant connective tissue disorder associated with aortic aneurysm/dissection in children. However, LDS may also present with a host of orthopaedic conditions. This study aimed to elucidate the management of orthopaedic conditions and associated outcomes in patients with LDS.PubMed, Ovid MEDLINE, and Cochrane Library were systematically searched for primary articles regarding the management of orthopaedic conditions in patients with LDS. The goals and findings of each included study were described. Data regarding demographics, conditions studied, treatment modalities, and outcomes were extracted and analyzed.Three hundred sixty-two unique articles were retrieved, 13 of which were included, with 4 retrospective cohort studies and 9 case reports representing 435 patients. In total, 19.8% of patients presenting with orthopaedic conditions received surgical treatment;54.3% of them experienced adverse outcomes, and 44.4% required revision surgery. The mean age at surgery was 9.0 ± 2.1 years.Patients with LDS may require early surgical intervention for a variety of orthopaedic conditions and may be at an increased risk for surgical complications. The current LDS literature is primarily focused on spinal conditions with a relative paucity of data on the management of hip deformity, joint subluxation, clubfoot, and trauma. Additional research is required regarding orthopaedic management for this unique population.
Pituitary adenomas are among the most common central nervous system tumors. They represent a diverse group of neoplasms that may or may not secrete hormones based on their cell of origin. Epidemiologic studies have documented the incidence of pituitary adenomas within the general population to be as high as 16.7%. A growing body of work has helped to elucidate the pathogenesis of these tumors. Each subtype has been shown to demonstrate unique cellular changes potentially leading to tumorigenesis. Surgical advancements over several decades have included microsurgery and the employment of the endoscope for surgical resection. These advancements increase the likelihood of gross-total resection and have resulted in decreased patient morbidity.
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