Citations

TPS309 Background: Patients with oligometastatic colorectal cancer (CRC) often experience long-term progression-free survival and overall survival (OS) following aggressive local treatment of isolated metastases, especially in the liver. However, the effectiveness of local ablative therapies, such as microwave ablation (MWA) and stereotactic body radiation therapy (SBRT), in patients with inoperable limited metastatic CRC or those with additional metastases outside the liver or lungs, remains uncertain. Despite the historical use of local therapy for oligometastatic CRC, often influenced by provider bias rather than strong evidence, questions persist about the potential benefits of applying this approach to patients with more extensive disease. This trial aims to address this clinical challenge by evaluating the safety and efficacy of adding total ablative therapy (TAT) of all disease sites to standard systemic treatment in patients with limited metastatic CRC. Methods: A022101/NRG-GI009 is a randomized phase III study within the National Clinical Trials Network, set to enroll 364 patients with newly diagnosed metastatic CRC (BRAF wild-type, microsatellite stable). Patients with liver-only metastatic disease are excluded. Pre-registration during first-line systemic therapy induction is encouraged. Eligible lesions must be treatable with surgical resection, MWA, and/or SBRT. Patients without significant radiographic progression after 12-39 weeks of first-line systemic therapy, with 4 or fewer disease sites post-induction chemotherapy, will be randomized 1:1. Randomization will be stratified by the number of metastatic organ sites (1-2 vs. 3-4), timing of metastatic disease diagnosis (de novo vs. secondary), and the presence of metastatic disease outside the liver/lungs in at least one site. Patients in Arm 1 will receive TAT, targeting all metastatic sites with a combination of surgical resection, MWA, and/or SBRT, followed by standard systemic therapy. Patients in Arm 2 will continue with standard systemic therapy alone. The choice of systemic therapy is at the discretion of the medical oncologist and may include continued therapy, maintenance chemotherapy, or observation. The primary endpoint is OS, with secondary endpoints including event-free survival, treatment-related toxicities, and local recurrence. Exploratory biomarker analyses will also be conducted. The study requires 346 evaluable patients across the two arms to demonstrate an OS improvement with a hazard ratio of 0.7, providing 80% power with a one-sided alpha of 5%. The trial employs a group sequential design with two interim analyses (at 25% and 50% of events) to assess futility. The trial began in January 2023, and patient recruitment is ongoing. Clinical trial information: NCT05673148 .

Background: Urine mast cell mediator levels have found significant clinical utility in supporting the diagnosis of various allergic disorders in the adult population. There are few studies on the range of these mediator levels in the children and its clinical utility. Objectives: We determined the range of the urine mast cell mediator levels in children. Methods: Pediatric allergy and community-based pediatric clinics including children with and without an allergic disorder, respectively, served as the source of the study. Baseline urine mast cell mediator levels were obtained for all children. Demographics, atopic disorders, clinical symptoms and response to medication were documented. Results: Urine 2,3-Dinor-11Beta-Prostaglandin F2 Alpha (BPG) values were significantly higher in children with an underlying allergic disorder when compared to those without. Stratification based on age, sex and allergic disorder was performed in patients with an allergic disorder. Urine Leukotriene E 4 (LTE 4 ) and n-Methylhistamine (NMH) were significantly correlated with age (Spearman’s rho -0.4874 and -0.6902 respectively). With every year of age, the level of the urine NMH decreased by 18 units and urine LTE 4 by 3 units approximately. Urine LTE 4 and NMH levels were significantly higher in males when compared to females. Urine BPG levels were not significantly affected by age or sex. Conclusion: Distribution of urine mast cell mediator levels are slightly different from the values derived from studies in the adult population. Urine mast cell mediators may provide clinical utility in the diagnosis and management of allergic disorders. Further large-scale studies are warranted to validate clinical utility.

Fungal rhinosinusitis (FRS) can be classified into invasive and non-invasive forms, with the fungal ball (FB) representing a common non-invasive type with generally favorable outcomes post-operatively. The clinical presentation of FB can vary and be non-specific, and it is important to consider a wide differential diagnosis for sinonasal masses, including malignancy. We present the case of a 74-year-old female presenting with a two-year history of nasal obstruction and drainage. She has a history of breast cancer and prior maxillomandibular surgery, and imaging showed a poorly defined mass in the right maxillary sinus with possible hemorrhagic and/or proteinaceous content. Rigid nasal endoscopy revealed a friable mass, and endoscopic sinus surgery findings were consistent with FB. This case exemplifies the need to consider a broad set of differential diagnoses when evaluating sinonasal masses, especially if the patient has a prior malignancy or maxillomandibular surgical history, including FB and metastases to the paranasal sinuses. Given the presence of non-specific symptoms, it is important to consider early imaging for patients with distorted anatomy and a history of malignancy. Endoscopic sinus surgery, with high success rates, is the gold-standard treatment for FB.

Abstract Background Crohn’s disease (CD) treatment is associated with increased risks of infection and malignancies. Although the safety of certolizumab pegol (CZP) is well established, long-term data from community-based observational studies are lacking. Aim This study aimed to evaluate long-term safety outcomes of patients from the SECURE registry receiving CZP relative to other CD treatments, including corticosteroids, immunosuppressants, and biologics. The primary outcome of this observational study was the evaluation of malignancies. Methods Adult patients with CD were prospectively monitored for up to 8 years. Pre-specified data were collected for all enrolled patients. Adverse events of interest (AEoIs) were reported per 100 patient-years (PY) of exposure. Incidence rate ratios (IRRs) were calculated for AEoIs using multivariate regression analysis accounting for exposure to multiple treatments. Malignancies reported after any exposure to CZP were attributed to CZP. Post-hoc analyses were conducted to evaluate non-melanoma skin cancer (NMSC), lymphoma, and pregnancy outcomes. Results A total of 3072 patients were enrolled in the study. The risk of AEoIs was similar between patients with only CZP exposure versus comparator exposure. Among patients with any CZP exposure, there was a higher frequency of serious infections (IRR: 2.56 [95% confidence interval (CI): 2.00, 3.29]) and hypersensitivity or anaphylactic reactions (IRR: 4.11 [95% CI: 1.80, 9.38]) versus patients with comparator exposure. Malignancy rates were similar across groups; however, concomitant use of thiopurines was associated with higher odds of NMSC (odds ratio: 2.30 [95% CI: 1.09, 4.89]). Most cases of lymphoma (5/7) occurred in patients with exposure to thiopurines. Pregnancy outcomes were similar across groups. Conclusions No new safety signals were identified for CZP; the use of thiopurines was identified as a risk factor for NMSC. Trial registration NCT00844285.

Mortality rates from pulmonary embolism (PE) remain significant, highlighting the need for alternative treatment strategies beyond traditional anticoagulation. Percutaneous interventions, including mechanical thrombectomy and catheter-directed thrombolysis, are emerging as promising options. Given the complex pathophysiology and unique risk profiles of these patients, meticulous multidisciplinary planning is essential. Anesthesiologists play a central role in coordinating care and managing perioperative risks to improve outcomes. This article provides insights into best safety practices and shares experiences from a leading quaternary center. It offers guidance for anesthesia providers to proactively engage in comprehensive risk stratification, participate in multidisciplinary discussions, and support robust contingency planning for managing PE patients undergoing percutaneous interventions in non-operating room anesthesia settings.

Background: A vast amount of literature is available on the burden of acute ischemic stroke (AIS). Yet, most information on AIS burden does not stratify by stroke severity, and the inclusion of mild strokes (National Institute of Health Stroke Scale < 5) might obscure the true impact of moderate-to-severe AIS. Therefore, it is important to understand the literature as it pertains to the epidemiological, clinical, humanistic, and economic burden of moderate-to-severe AIS from a global perspective. Methods: A systematic literature review (SLR) was conducted, including articles published between January 2015 and June 2023. The clinical burden search focused on patients with moderate or severe AIS. Due to the paucity of evidence, the humanistic and economic burdens were evaluated based on overall AIS studies. Abstract and full-text screening were conducted by 2 reviewers, with data extraction completed by 1 reviewer. In all, 136 studies were included in the SLR. Results: AIS caused a substantial burden for patients and the healthcare system. The clinical burden of AIS (specifically severe AIS) resulted in high mortality and worse functional outcomes across multiple demographics (female sex, older age, and patients with comorbidities). The economic burden of overall AIS was substantial, with inpatient costs as the primary driver (a mean or median stay of 7 days). The highest inpatient costs were reported in South Korea ($45,180) and the United States ($38,470). Conclusions: The review highlighted the huge burden of moderate-to-severe AIS, with patients experiencing worse outcomes with increased stroke severity. Further focus is needed on outcomes relating to moderate-to-severe AIS to fully understand the burden of stroke in this patient population.

Background: The cumulative effect of repetitive subconcussive head impacts on neurocognitive function during youth contact sports remains largely unknown. There is a paucity of literature evaluating cumulative helmet forces over a season and their correlation with preseason and postseason cognitive performance tasks such as the King-Devick test (KDT). Hypothesis: Higher helmet forces recorded throughout a 10-week, 10-game youth football season would correlate with slower performance on postseason KDT. Study Design: Prospective cohort study. Level of Evidence: Level 3. Methods: A cohort of 58 youth football players (ages 9-13 years) underwent pre- and postseason KDT. Players wore SpeedFlex helmets (Riddell) fitted with InSite Impact Response System helmet accelerometers (Riddell) which recorded impacts of ≥15 g . Head impacts were tallied over a season and assigned a score of 1, 2, or 3 based on magnitude of g forces. Suspected concussions were correlated with KDT times and recorded instances of head impact. Pre- and postseason KDT scores were compared. Results: During the season, 2013 head impacts were recorded. Median (range) total cumulative force score was 24 (5-476); 6 players sustained head impacts concerning for concussion, and 4 were clinically diagnosed with concussions. Overall, postseason KDT times improved compared with preseason, with a median (range) change of −4.8 seconds (−7.6, −1.1). Analysis showed no correlation between changes in KDT time and total cumulative force score over the season. Conclusion: KDT times in youth football players did not change significantly based on head impact exposure over a single youth football season; most players’ KDT times improved from preseason to postseason. Clinical Relevance: Although our study did not show significant cognitive impact as measured by KDT over a single youth football season, the long-term effects of concussion on the immature brain and how it can impact cognitive development remains largely unknown and should be an area of ongoing study.