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Comparison of Unhoused and Domiciled Patients Evaluated for Trauma in a Level II Trauma Center.
No full textINTRODUCTION: California has one of the highest rates of homelessness in the United States. Unhoused individuals often have complex medical and behavioral health disorders, frequently complicated by substance use disorders. They have a significant risk of sustaining traumatic injuries. This report compares unhoused and domiciled patients treated at our Northern California trauma center.
METHODS: In this retrospective analysis of trauma patients we used data extracted from our institution\u27s Trauma Quality Improvement Program Trauma Registry for January 1, 2019-April 22, 2022 and compared characteristics of unhoused and domiciled individuals. All unhoused patients in the registry were included in the analysis, as well as an equal number of domiciled patients who were randomly selected during the same time frame. We described and compared demographic and clinical characteristics.
RESULTS: Of 8,529 patients in the registry, 181 (2.1%) were unhoused, and we selected 181 domiciled patients to compare. Unhoused patients were more likely male (83% vs. 61%, P \u3c .001) and younger (48.8 ± 12.3 vs. 55. 8 ± 23.7 years, P \u3c .001). Both cohorts had similar Injury Severity Scores. However, unhoused patients had a higher rate of hospital admissions (76.8% vs. 61.9%, P \u3c .001) and longer hospital stays than domiciled patients (4.0 [IQR 2.0-9.0] days vs. 3.0 [IQR 1.0-6.0] days, respectively; P = .02). A higher proportion of unhoused patients received alcohol-(85.6% vs. 74.6%, P = .01) and drug screening (56.4% vs. 30.4%, P \u3c .001) than domiciled patients. Of those screened for urine drugs, unhoused patients had a higher positive rate (76.5% vs. 50.9%, P \u3c .001). Unhoused patients were more frequently injured by assault (30.4% vs. 8.8%, P \u3c .001) or pedestrian strike (21.5% vs. 3.3%, P \u3c .001), whereas more domiciled patients were injured in falls (46.4% vs. 21.5%, P \u3c .001) and motor vehicle accidents (29.8% vs. 8.3%, P \u3c .001). Falls were most common in the oldest quartile for both groups. In both cohorts, a sharp object was the most common mechanism of assault injury (40.0% vs. 37.5%, respectively). Assault by firearm occurred in 14.5% of unhoused and 18.8% of domiciled patients. Overall mortality was 2.2%, with no significant difference between groups (1.7 vs. 2.8%, P = .70).
CONCLUSION: Unhoused patients were predominantly younger males with a higher incidence of substance use disorder and greater likelihood of injuries from assault and pedestrian strikes. Falls and assault with a sharp object were common in both cohorts. Unhoused patients were admitted more often and stayed longer in the hospital. Understanding the complexities of these patients can guide local and regional prevention and treatment measures
Phase 1 Study of INBRX-105, a TNFRSF9 (4-1BB) and PD-L1 Bispecific Antibody, in Patients With Select Solid Tumors.
No full textPURPOSE: INBRX-105, a tetravalent, PD-L1-targeted TNFRSF9 (4-1BB) agonist, demonstrated preclinical antitumor activity. This first-in-human study evaluated INBRX-105 in solid tumors.
PATIENTS AND METHODS: This open-label, 4-part, phase 1 study evaluated INBRX-105 alone or with pembrolizumab in adults with locally advanced/metastatic, unresectable solid tumors (NCT03809624). INBRX-105 was administered intravenously Q2W or Q4W in parts 1 (single-agent dose escalation; 0.001-3.0 mg/kg) and 2 (single-agent expansion) or Q3W in parts 3 (combination dose escalation; INBRX-105 0.03-1.0 mg/kg) and 4 (combination expansion). Part 2 enrolled patients with checkpoint inhibitor-relapsed/refractory (CPI-R/R) tumors. Part 4 enrolled patients with CPI-R/R or CPI-naive disease. The primary endpoint was safety and tolerability of INBRX-105. Preliminary clinical response was a secondary endpoint.
RESULTS: Of 160 patients assessed, 81 received monotherapy (median age, 65.0 years; female, 50.6%), and 79 combination therapy (median age, 64.0 years; female, 38.0%). The INBRX-105 maximum tolerated dose was 0.3 mg/kg Q3W. Head and neck squamous cell carcinoma (n=61) and non-small cell lung cancer (n=25) were the most common tumor types. The most common any-grade INBRX-105-related adverse events (AEs) were fatigue (monotherapy, 35.8%; combination, 17.7%), increased aspartate aminotransferase (25.9%; 15.2%), and nausea (19.8%; 17.7%). INBRX-105-related hepatic AEs occurred in 41 patients (monotherapy, n=25 [grade ≥3, n=11]; combination, n=16 [grade ≥3, n=6]). In all patients, the objective response rate was 8.8% (monotherapy, 3.7%; combination, 13.9% [CPI naive, 30.0%; CPI R/R, 8.6%]); disease control rate was 43.1%.
CONCLUSIONS: The low response rates and hepatic safety signals observed do not support further clinical development of INBRX-105
Patient-reported outcomes and time to symptomatic progression from PAPILLON: amivantamab plus chemotherapy vs chemotherapy as first-line treatment of EGFR exon 20 insertion-mutated advanced NSCLC.
No full textBACKGROUND: Epidermal growth factor receptor (EGFR) exon 20 insertions (Ex20ins) are the third most common type of EGFR mutation, occurring in up to 12% of EGFR-mutated non-small cell lung cancers (NSCLC). Ex20ins-mutated NSCLC can be resistant to most approved tyrosine kinase inhibitors (TKIs). The Phase III PAPILLON trial (NCT04538664) demonstrated that amivantamab plus chemotherapy significantly improves progression-free survival (PFS) compared to chemotherapy alone, leading to its approval as a first-line treatment for patients with Ex20ins NSCLC. PAPILLON further evaluated patient-reported outcomes (PROs) and time to symptomatic progression (TTSP).
METHODS: The open-label, multicenter trial randomized 308 treatment-naïve patients with advanced or metastatic NSCLC harboring Ex20ins to receive either amivantamab plus carboplatin-pemetrexed (n = 154) or chemotherapy alone (n = 154). TTSP was defined as the time to onset or worsening of lung cancer-related symptoms necessitating treatment change or clinical intervention, or death. PROs were assessed using the PROMIS PF8c and EORTC QLQ-C30.
RESULTS: At 12 months, 77 % of patients in the amivantamab-chemotherapy arm remained free of symptomatic progression versus 60 % in the chemotherapy arm (HR, 0.67; 95 % CI, 0.46-0.98; p = 0.04). Physical functioning and global health status PROs were maintained in both arms, with a higher proportion of patients treated in the amivantamab-chemotherapy arm reporting stable or improved quality of life at 6 and 12 months.
CONCLUSIONS: Amivantamab plus chemotherapy significantly delays symptomatic progression without compromising health-related quality of life, reinforcing its role as a first-line treatment for Ex20ins-mutated NSCLC
Glucagon-like receptor agonists and next-generation incretin-based medications: metabolic, cardiovascular, and renal benefits.
No full textGLP-1 receptor agonists were initially developed to treat type 2 diabetes and have had a transformative effect on its therapy, and are highly effective for glycaemic control, with the added benefit of bodyweight reduction and a low risk of causing hypoglycaemia. GLP-1 receptor agonists reduce risks for major adverse cardiovascular events (eg, non-fatal myocardial infarction, stroke, and cardiovascular death), and the risk of admission to or treatment within hospital for heart failure. These drugs reduce albuminuria and slow the decline in estimated glomerular filtration rate over time, therefore delaying or preventing kidney failure. Furthermore, GLP-1 receptor agonists (eg, liraglutide and semaglutide) and the dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor co-agonist tirzepatide have been approved for treatment of obesity, with clinical trials establishing benefits for various obesity-related conditions: prevention of type 2 diabetes; risk for major adverse cardiovascular events; heart failure, especially with preserved ejection fraction; regression of steatosis and prevention of fibrosis in steatotic liver disease; and symptomatic improvements in obstructive sleep apnoea and knee osteoarthritis. Current developments include the exploration of novel indications (eg, neurodegenerative diseases and substance use disorders) with suggestive evidence of efficacy, and the development of small-molecule GLP-1 receptor agonists for oral treatment to improve convenience. Dual (ie, GLP-1-glucagon and GLP-1-amylin) and triple (ie, GIP-GLP-1-glucagon) receptor agonists activating multiple receptors promise greater efficacy than mono-agonists, especially for weight loss. However, some clinical development programmes have a high burden of adverse gastrointestinal events, and dose-escalation regimens should be optimised to reach acceptable tolerability
