Purpose: In phase I/II studies, nelipepimut-S (NP-S) plus GM-CSF vaccine was well tolerated and effectively raised HER2-specific immunity in patients with breast cancer. Results from a prespecified interim analysis of a phase III trial assessing NP-S + GM-CSF are reported.
Patients And Methods: This multicenter, randomized, double-blind phase III study enrolled females ≥18 years with T1-T3, HER2 low-expressing (IHC 1+/2+), node-positive breast cancer in the adjuvant setting. Patients received 1,000 μg NP-S + 250 μg GM-CSF or placebo + GM-CSF monthly for 6 months, then every 6 months through 36 months. The primary objective was disease-free survival (DFS). Protocol-specified imaging occurred annually. New abnormalities were categorized as recurrence events; biopsy confirmation was not mandated. The interim analysis was conducted as specified in the protocol after 73 DFS events.
Results: A total of 758 patients (mean age 51.8 years) were randomized. Adverse events were similar between groups; most common were injection-associated: erythema (84.3%), induration (55.8%), and pruritus (54.9%). There was no significant between-arms difference in DFS events at interim analysis at median follow-up (16.8 months). In the NP-S arm, imaging detected 54.1% of recurrence events in asymptomatic patients versus 29.2% in the placebo arm ( = 0.069).
Conclusions: NP-S was well tolerated. There was no significant difference in DFS events between NP-S and placebo. Use of mandated annual scans and image-detected recurrence events hastened the interim analysis contributing to early trial termination.
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http://dx.doi.org/10.1158/1078-0432.CCR-18-2867 | DOI Listing |
Int J Integr Care
December 2024
Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
Introduction: The SCUBY project aimed to provide knowledge on the scaling-up of an Integrated Care Package (ICP) for type 2 diabetes and hypertension across three distinct health systems (Cambodia, Slovenia, and Belgium). Here, we analyse the different elements of the country-specific scale-up roadmaps to identify similarities and differences, and share lessons learned.
Methods: Thematic analysis was used to derive crucial roadmap elements from key SCUBY documents (n = 20), including policy briefs, interim reports, research outputs, and consortium meeting notes.
Eur J Med Res
December 2024
Bloomsbury Institute of Intensive Care Medicine, Division of Medicine, University College London, London, UK.
Background: Dexamethasone 6 mg in patients with severe COVID-19 has been shown to decrease mortality and morbidity. The effects of higher doses of corticosteroid, that would further increase anti-inflammatory effects, are uncertain. The objective of our study was to assess the effect of 20 mg dexamethasone vs.
View Article and Find Full Text PDFBMC Cancer
December 2024
Department of Cancer Epidemiology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, 45008, China.
Background: It has been proposed that risk model-based strategies could serve as viable alternatives to traditional risk factor-based approaches in lung cancer screening; however, there has been no systematic discussion. In this review, we provide an overview of the benefits, harms, and cost-effectiveness of these two strategies in lung cancer screening application, as well as discussing possible future research directions.
Methods: Following the PRISMA guidelines, a comprehensive literature search was conducted across PubMed, Web of Science, Cochrane libraries, and EMBASE from January 1994 to April 2024.
Lancet
December 2024
Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, IN, USA.
Background: Spatial repellent products are used for prevention of insect bites, and a body of evidence exists on spatial repellent entomological efficacy. A new option for vector control, spatial repellent products are designed to release active ingredient into the air for disruption of human-vector contact thereby reducing human exposure to mosquito-borne pathogens. Clinical trials have shown spatial repellent epidemiological efficacy against Aedes-borne viruses but inconclusive outcomes against malaria.
View Article and Find Full Text PDFBr J Dermatol
December 2024
The Pennsylvania State University College of Medicine, Department of Dermatology, Hershey, PA, USA.
Background: Therapeutic options for mild hidradenitis suppurativa (HS) represent a significant gap in the current treatment landscape, with no FDA approved therapies for early stage HS. Topical JAnus Kinase inhibitors (JAKi) are a compelling option due to the known upregulation of inflammatory JAK signaling in HS lesions and the recent success of systemic JAKi for moderate to severe HS.
Objectives: This is a pilot, single-site, open-label, prospective 24-week clinical trial with topical ruxolitinib (NCT04414514).
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