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Making the Case for an International Childhood Cancer Data Partnership.
J Natl Cancer Inst
January 2025
Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA.
Childhood cancers are a heterogeneous group of rare diseases, accounting for less than 2% of all cancers diagnosed worldwide. Most countries, therefore, do not have enough cases to provide robust information on epidemiology, treatment, and late effects, especially for rarer types of cancer. Thus, only through a concerted effort to share data internationally will we be able to answer research questions that could not otherwise be answered.
View Article and Find Full Text PDFAccurate evaluation of factor VIII activity of efanesoctocog alfa in the presence of emicizumab.
J Thromb Haemost
January 2025
Centre de Référence de l'Hémophilie, Hospices Civils de Lyon, UR4609 Universite Claude Bernard Lyon 1, Lyon, France. Electronic address:
Background: Efanesoctocog is a B-domain-deleted, Fc-fusion FVIII linked to the D'D3 domain of VWF and two XTEN polypeptides, designed for an ultra-extended half-life for prophylaxis in hemophilia A, but also aiding in managing acute bleeding or surgery in patients on long-term emicizumab. However, no current laboratory method accurately measures FVIII levels in the presence of emicizumab. We hypothesized that the chromogenic (CSA) FVIII assay, specifically calibrated for efanesoctocog using bovine coagulation factors, could provide an accurate assessment of efanesoctocog activity.
View Article and Find Full Text PDFDurvalumab with or without bevacizumab with transarterial chemoembolisation in hepatocellular carcinoma (EMERALD-1): a multiregional, randomised, double-blind, placebo-controlled, phase 3 study.
Lancet
January 2025
Department of Diagnostic and Interventional Radiology, University of Pisa School of Medicine, Pisa, Italy.
Background: Transarterial chemoembolisation (TACE) is standard of care for patients with unresectable hepatocellular carcinoma that is amenable to embolisation; however, median progression-free survival is still approximately 7 months. We aimed to assess whether adding durvalumab, with or without bevacizumab, might improve progression-free survival.
Methods: In this multiregional, randomised, double-blind, placebo-controlled, phase 3 study (EMERALD-1), adults aged 18 years or older with unresectable hepatocellular carcinoma amenable to embolisation, an Eastern Cooperative Oncology Group performance status of 0 or 1 at enrolment, and at least one measurable intrahepatic lesion per modified Response Evaluation Criteria in Solid Tumours (RECIST) were enrolled at 157 medical sites including research centres and general and specialist hospitals in 18 countries.
Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study.
Lancet
January 2025
Mount Sinai Liver Cancer Program, Division of Liver Diseases, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Liver Cancer Translational Research Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic, Universitat de Barcelona, Barcelona, Spain; Institució Catalana de Recerca i Estudis Avançats, Barcelona, Spain. Electronic address:
Article Synopsis
- TACE is the standard treatment for patients with unresectable, non-metastatic hepatocellular carcinoma, and this study evaluates the effectiveness of adding lenvatinib and pembrolizumab to TACE compared to a placebo.
- The multicenter, randomised, double-blind phase 3 study (LEAP-012) involved participants from 137 sites across 33 countries who were randomly assigned to receive either TACE with the new drugs or TACE with a placebo.
- The primary endpoints were progression-free survival and overall survival, and the results reported are from the first interim analysis, which serves as the final analysis for progression-free survival.
Projections of Public Spending on Pharmaceuticals: A Review of Methods.
Pharmacoeconomics
January 2025
Belgian Health Care Knowledge Centre, Brussels, Belgium.
Background: Forecasting future public pharmaceutical expenditure is a challenge for healthcare payers, particularly owing to the unpredictability of new market introductions and their economic impact. No best-practice forecasting methods have been established so far. The literature distinguishes between the top-down approach, based on historical trends, and the bottom-up approach, using a combination of historical and horizon scanning data.
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