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| http://dx.doi.org/10.6004/jadpro.2015.6.3.5 | DOI Listing |
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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.
Drug classes associated with the development of fulminant type 1 diabetes: a retrospective analysis using the FDA adverse event reporting system database.
Expert Opin Drug Saf
January 2025
Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.
Background: Fulminant type 1 diabetes mellitus (FT1DM) is a severe subtype of type 1 diabetes characterized by rapid onset, metabolic disturbances, and irreversible insulin secretion failure. Recent studies have suggested associations between FT1DM and certain medications, warranting further investigation.
Objectives: This study aims to analyze drugs associated with an increased risk of FT1DM using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
A real-world drug safety surveillance study from the FAERS database of hepatocellular carcinoma patients receiving pembrolizumab alone and plus lenvatinib.
Sci Rep
January 2025
Department of Hepatobiliary and Pancreatic Surgery, Taihe Hospital, Affiliated Hospital of Hubei University of Medicine, Shiyan, 442000, Hubei, China.
Pembrolizumab plus Lenvatinib is regarded as a significant treatment option for advanced unresectable hepatocellular carcinoma (HCC). This study aims to meticulously monitor and identify adverse events (AEs) related to this combined therapy, enhance patient safety, and offer evidence-based recommendations for the appropriate use of these drugs. We gathered adverse drug reactions (ADRs)-related data from the FAERS database for HCC patients who received Pembrolizumab, both alone and in combination with Lenvatinib from the first quarter of 2014 to the fourth quarter of 2023.
View Article and Find Full Text PDFCirculating cytokine associations with clinical outcomes in melanoma patients treated with combination nivolumab plus ipilimumab.
Oncoimmunology
December 2025
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Nivolumab plus ipilimumab (aCTLA-4/aPD-1) combination therapy has significantly improved clinical outcomes in patients with metastatic melanoma, with 50%-60% of patients responding to treatment, but predictors of response are poorly characterized. We hypothesized that circulating cytokines and peripheral white blood cells may predict response to therapy and evaluated 15 cytokines and complete blood counts (CBC with differentials) from 89 patients with advanced melanoma treated with combination therapy from three points in time: pre-treatment, one month and approximately three months after starting therapy. Clinical endpoints evaluated included durable clinical benefit (DCB), progression-free survival (PFS), and overall survival (OS).
View Article and Find Full Text PDF[A New Molecular Targeted Agent for Gastric Cancer-The Anti-Claudin 18.2 Antibody, Zolbetuximab].
Gan To Kagaku Ryoho
November 2024
Dept. of Gastroenterology Gastrointestinal Oncology, National Cancer Center Hospital East.
The standard first-line treatment for unresectable advanced or recurrent gastric cancer(GC)and gastroesophageal junction cancer(GEJC)has been a platinum doublet chemotherapy. Trastuzumab with chemotherapy is the standard regimen for HER2-positive GC/GEJC. While, for HER2-negative cases, chemotherapy with or without immune checkpoint inhibitors (ICIs)such as nivolumab or pembrolizumab are regarded as the standard therapy.
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