Search results for "Safety profile"

Eribulin mesylate use as third-line therapy in patients with metastatic breast cancer (VESPRY): a prospective, multicentre, observational study

2019

Background: In real-world practice, eribulin mesylate provides significant survival benefit, with a manageable safety profile in heavily pretreated patients with metastatic breast cancer (MBC). Methods: In this prospective, open-label, multicentre, observational study we evaluated the effectiveness and tolerability of eribulin as third-line treatment in a homogeneous population. The primary endpoints were the safety profile and response in metastatic sites; secondary endpoints included the response in different subtypes, overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). Results: From 2013 to 2016, 118 women were treated in 21 Sicilian institutions; the …

Sorafenib for the treatment of hepatocellular carcinoma

2018

SUMMARY The multikinase inhibitor sorafenib, which inhibits targets related to tumor cell proliferation and angiogenesis, was the first systemic agent to demonstrate a significant improvement in the overall survival for patients with advanced hepatocellular carcinoma (HCC) in two large randomized controlled Phase III trials. Together with its manageable safety profile (mainly diarrhea, hand–foot skin reaction and fatigue), sorafenib was approved for the treatment of patients with (unresectable) HCC in 2007. Since then, sorafenib has been established as the standard of care in Child–Pugh A patients with advanced HCC or in those ineligible for or after failure of locoregional therapies in th…

Transarterial radioembolization for hepatocellular carcinoma: a review

2016

Rodolfo Sacco,1 Caterina Conte,2 Emanuele Tumino,1 Giuseppe Parisi,1 Sara Marceglia,3 Salvatore Metrangolo,1 Roberto Eggenhoffner,4 Giampaolo Bresci,1 Giuseppe Cabibbo,5 Luca Giacomelli4 1Department of Gastroenterology, Cisanello Hospital, Pisa, 2Endocrinology and Metabolic Diseases, Policlinico A. Gemelli, Università Cattolica del Sacro Cuore, Rome, 3Department of Engineering and Architecture, University of Trieste, Trieste, 4Department of Surgical Sciences and Integrated Diagnostics, School of Medicine, Genova University, Genoa, 5Section of Gastroenterology, DIBIMIS, University of Palermo, Palermo, Italy Abstract: Hepatocellular carcinoma (HCC) is the most common type of liver canc…

51P Pooled analysis safety profile of futibatinib in patients with advanced solid tumors, including intrahepatic cholangiocarcinoma (iCCA)

2021

P149 Once-daily tiotropium Respimat® add-on to at least ICS in adult patients with symptomatic asthma: pooled safety analysis: Abstract P149 Table 1

2015

Background A high proportion of patients with asthma are symptomatic despite at least ICS maintenance therapy. Five trials aimed to evaluate the safety of tiotropium Respimat® compared with placebo Respimat®, each as add-on to at least ICS in adult patients with symptomatic asthma. Methods Five Phase III and one Phase II randomised, double-blind, placebo-controlled, parallel-group trials. PrimoTinA-asthma® (48 weeks): tiotropium Respimat® 5 µg add-on to ICS + LABA (≥800 µg budesonide or equivalent); MezzoTinA-asthma® (24 weeks): tiotropium Respimat® 5 µg or 2.5 µg add-on to ICS (400–800 µg budesonide or equivalent); GraziaTinA-asthma® (12 weeks): tiotropium Respimat® 5 µg or 2.5 µg add-on t…

Erratum to “A combined measles, mumps, rubella and varicella vaccine (Priorix-Tetra™): Immunogenicity and safety profile” by Czajka et al. [Vaccine 2…

2012

Corrigendum to “A combined measles, mumps, rubella and varicella vaccine (Priorix-Tetra 〈trade〉): Immunogenicity and safety profile” Vaccine 27 (2009…

2010

ChemInform Abstract: A Highly Active System for the Metal-Free Aerobic Photocyanation of Tertiary Amines with Visible Light: Application to the Synth…

2016

A highly efficient metal-free catalytic system for the aerobic photocyanation of tertiary amines with visible light is reported. The use of air as terminal oxidant offers an improved safety profile compared with pure oxygen, the used compact fluorescent lamp (CFL) light sources are highly economical, and no halogenated solvents are required. This system not only proves to be effective for a wide variety of trialkylamines, pharmaceuticals, and alkaloids but remarkably also allows the lowest catalyst loading (0.00001 mol% or 0.1 ppm) ever reported for an organic dye. Bruylants reactions and C-alkylation/decyanations were performed on the obtained α-aminonitriles to demonstrate the postfunctio…

Evolution of the Regulatory Landscape for Immunomodulatory Compounds and Personalized Therapeutic Cancer Vaccines

2014

The term cancer immunotherapy covers a huge range of different therapeutic interventions based on highly diverse medicinal products. Some immunotherapy products such as monoclonal antibodies have successfully been developed during the last years and contributed to major advances in cancer therapy. Development of cancer vaccines seemed to be more challenging. Nevertheless, some promising candidates are currently in late-stage clinical development, and one product (sipuleucel-T) was recently approved in the United States (USA) and in the European Union (EU). Additionally, cell therapy approaches based on adoptive lymphocyte transfer have recently come into focus due to surprisingly efficient …

Clinical Efficacy of Laquinimod for the Treatment of Multiple Sclerosis; Pooled Analyses from the ALLEGRO and BRAVO Phase III Trials (S01.007)

2012

Objective: The current report provides detail on pooled analyses assessing the effect of laquinimod on relapse, disability, and brain atrophy measures from the recently completed phase III trials ALLEGRO and BRAVO. Background Laquinimod is an oral, CNS acting immunomodulator in development for the treatment of multiple sclerosis. Its impact on disability progression and brain atrophy, two indices of longterm outcome for patients with multiple sclerosis (MS) are being studied in its phase III trials. Design/Methods: MS patients (N=2437) were randomized to laquinimod (n=984) or placebo (n = 1006). In both trials, patients underwent neurological examinations including the Expanded Disability S…