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FDA Approval Summary: Tovorafenib for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma.
Clin Cancer Res
January 2025
United States Food and Drug Administration, Silver Spring, Maryland, United States.
On April 23, 2024, FDA granted accelerated approval to tovorafenib, a type II RAF kinase inhibitor, for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. Efficacy was evaluated in FIREFLY-1 (NCT04775485), a single-arm, open-label, multicenter trial that enrolled patients 6 months to 25 years of age with relapsed or refractory pLGG with an activating BRAF alteration who had received prior systemic therapy. The major efficacy outcome measure was radiologic overall response rate (ORR), defined as the proportion of patients with complete response, partial response, or minor response as determined by blinded independent central review using Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria.
View Article and Find Full Text PDFElectronic Patient-Reported Outcome System Implementation in Outpatient Cardiovascular Care: A Randomized Clinical Trial.
JAMA Netw Open
January 2025
Department of Radiology, Keio University School of Medicine, Tokyo, Japan.
Importance: The integration of patient-reported outcome (PRO) assessments in cardiovascular care has encountered considerable obstacles despite their established clinical relevance.
Objective: To assess the impact of a physician- and patient-friendly electronic PRO (ePRO) monitoring system on the quality of cardiovascular care in clinical practice.
Design, Setting, And Participants: This open-label, multicenter, pilot randomized clinical trial was phase 2 of a multiphase study that was conducted from October 2022 to October 2023 and focused on the implementation and evaluation of an ePRO monitoring system in outpatient clinics in Japan.
Digital Meditation to Target Employee Stress: A Randomized Clinical Trial.
JAMA Netw Open
January 2025
Department of Psychiatry and Behavioral Sciences, University of California San Francisco.
Importance: Mindfulness meditation may improve well-being among employees; however, effects of digital meditation programs are poorly understood.
Objective: To evaluate the effects of digital meditation vs a waiting list condition on general and work-specific stress and whether greater engagement in the intervention moderates these effects.
Design, Setting, And Participants: This randomized clinical trial included a volunteer sample of adults (aged ≥18 years) employed at a large academic medical center who reported mild to moderate stress, had regular access to a web-connected device, and were fluent in English.
Buparlisib and Paclitaxel in Patients with Head and Neck Squamous Cell Carcinoma: Immunogenomic Biomarkers of Efficacy from the BERIL-1 Study.
Target Oncol
January 2025
Hematology-Oncology Service, Department of Medicine, Centre hospitalier de l'Université de Montréal (CHUM), 1000, rue Saint-Denis, Montreal, QC, Canada.
Background: BERIL-1 was a randomized phase 2 study that studied paclitaxel with either buparlisib, a pan-class I PIK3 inhibitor, or placebo in patients with recurrent or metastatic (R/M) head and neck squamous cell cancer (HNSCC). Considering the therapeutic paradigm shift with immune checkpoint inhibitors (ICIs) now approved in the first-line setting, we present an updated immunogenomic analysis of patients enrolled in BERIL-1, including patients with immune-infiltrated tumors.
Objective: The objective of this study was to identify biomarkers predictive of treatment efficacy in the context of the post-ICI therapeutic landscape.
Dementia Diagnosis Unawareness and Caregiver Burden in a Multi-ethnic Cohort.
J Gen Intern Med
January 2025
Department of Neurology, University of Michigan Medical School, Ann Arbor, MI, USA.
Background: Previous reports suggest patient and caregiver lack of awareness of dementia. Little is known about how this varies by ethnicity and how informal (family) caregiver burden is associated with knowing a dementia diagnosis.
Objective: To investigate whether participants with probable dementia were aware of a diagnosis provided by a physician and how this differed among Mexican American and non-Hispanic White participants; whether having a primary care physician was associated with dementia diagnosis unawareness; and the association of dementia diagnosis unawareness with caregiver burden.
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