Search results for "Surrogate endpoint"
showing 10 items of 71 documents
Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (…
2015
ABSTRACT The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of time-to-event end points in cancer randomized controlled trials. We relied on a consensus method based on a multidisciplinary panel of experts to develop these guidelines for trials on sarcomas and gastrointestinal stromal tumors. Background The use of potential surrogate end points for overall survival, such as disease-free survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCTs) in cancer. However, the definition of time-to-event (TTE) end points is rarely precise and lacks unif…
Physical therapy in heart failure with preserved ejection fraction: A systematic review.
2014
About 50% of patients with heart failure (HF) have preserved ejection fraction (HFpEF) which is especially common in elderly people with highly prevalent co-morbid conditions. HFpEF is usually defined as an ejection fraction equal to or greater than 50%, although some studies have used a limit as low as 40%. The prevalence of this syndrome is expected to increase over the next decades. The associated impact on mortality and hospital readmissions has made of this entity a major public health issue. Despite the fact that mortality and re-hospitalisation rates of HFpEF are similar to the syndrome of HF with reduced ejection fraction (HFrEF), currently there is no available evidence-based thera…
Treatment of Newly Diagnosed Moderate or Severe Chronic Graft-Versus-Host Disease with Prednisone and Everolimus (PredEver first): A Prospective Mult…
2019
Background Chronic graft-versus-host disease (cGVHD) is the major cause of treatment related morbidity and mortality after allogeneic stem cell transplantation (allo-HSCT). Recently Paul Martin et al. reported that treatment success at 1 year (defined as a patient being in partial (PR) or complete remission (CR) of cGVHD, in ongoing remission of underlying disease and not requiring any secondary treatment for cGVHD) was the only endpoint associated with clinical benefit. Strikingly this robust endpoint was only achieved in less than 20% of patients undergoing primary treatment for cGVHD. Therefore, although most patients show initial response to first-line therapy, long-term clinically mean…
High sCD36 plasma level is associated with steatosis and its severity in patients with genotype 1 chronic hepatitis C
2012
Soluble CD36 (sCD36) plasma levels, a known marker of cardiometabolic disorders, are associated with surrogate markers of steatosis, while experimental and human studies show a link between CD36 expression in the liver and steatosis. In a cohort of patients with genotype 1 chronic hepatitis C (G1 CHC), we tested the association of sCD36 plasma levels with host and viral factors and sustained virological response (SVR). One hundred and seventy-five consecutive biopsy-proven patients were studied. sCD36 plasma levels were assessed by an in-house ELISA. All biopsies were scored by one pathologist for staging and grading (Scheuer) and graded for steatosis, which was considered moderate-severe i…
Visceral adiposity index and exercise in non-alcoholic fatty liver disease: authors’ reply
2012
We thank Prof. Filik for his interest in our recent article. 2 He points to the fact that the interpretation of our results could be affected by lack of data on physical activity and diet. In response to this issue, we are aware that both physical activity and diet are able to affect not only anthropometric and metabolic parameters of visceral adiposity index (VAI) but also the severity of liver disease. Unfortunately, data on both physical activity and diet in our patients with biopsy-proven non-alcoholic fatty liver disease (NAFLD) are not available, even if we are confident that their variations should not significantly affect our results. In fact, in our study, we evaluated histological…
Inflammation, Endothelial Dysfunction and Arterial Stiffness as Therapeutic Targets in Cardiovascular Medicine
2016
In the last decades, many factors thought to be associated with the atherosclerotic process and cardiovascular events have been studied, and some of these have been shown to correlate with clinical outcome, such as arterial stiffness, endothelial dysfunction and immunoinflammatory markers. Arterial stiffness is an important surrogate marker that describes the capability of an artery to expand and contract in response to pressure changes. It can be assessed with different techniques, such as the evaluation of PWV and AIx. It is related to central systolic pressure and it is an independent predictor of cardiovascular morbidity and mortality in hypertensive patients, type 2 diabetes, end-stage…
Imaging appearance of treated hepatocellular carcinoma
2013
Surgical resection and imaging guided treatments play a crucial role in the management of hepatocellular carcinoma (HCC). Although the primary end point of treatment of HCC is survival, radiological response could be a surrogate end point of survival, and has a key role in HCC decision-making process. However, radiological assessment of HCC treatment efficacy is often controversial. There are few doubts on the evaluation of surgical resection; in fact, all known tumor sites should be removed. However, an unenhancing partial linear peripheral halo, in most cases, surrounding a fluid collection reducing in size during follow-up is demonstrated in successfully resected tumor with bipolar radio…
Renal protection by antihypertensive drugs
1998
During the last few years there has been a renewed interest in blood-pressure (BP)-induced kidney damage, owing to a progressive increase in the incidence and prevalence of hypertension and vascular diseases as a cause of end-stage renal disease (ESRD). The need to prevent ESRD demands continued efforts so as to identify early those people with hypertension who are at risk and to provide them with effective antihypertensive therapy. This review analyses what is needed in terms of surrogate endpoints for monitoring kidney damage and what is known about the impact of antihypertensive treatments in reducing the BP burden on the kidney in non-diabetic subjects. Although glomerular filtration ra…
A Large-Scale Trial Testing the Intensità of CYTOreductive Therapy to prevent Cardiovascular Events in Patients with Polycythemia Vera (CYTO-PV trial…
2012
Abstract Abstract 4 Introduction Current treatment recommendations in polycythemia vera (PV) have emphasized to maintain the hematocrit (HCT) values <0.45 based on hemorrheological notions, results of a few small observational retrospective studies and consensus of experts. However, post-hoc analysis of two large randomized clinical trials (namely PVSG-1 and ECLAP) failed to show a different incidence of major thrombosis when HCT levels were kept in the range between 0.40 and 0.50. So far, no randomized clinical trial has provided evidence-based data assessing the usefulness of tight HCT control in reducing thrombosis. Thus, uncertainty of the optimal HCT target exists in clinical practi…
Procalcitonin for the diagnosis of invasive candidiasis: what is the evidence?
2017
Abstracts Procalcitonin is a widely used marker for the evaluation of infection and sepsis and to guide antibiotic therapy. During the last decade, several studies evaluated its role and diagnostic performance as a surrogate marker for the identification of Candida spp. in suspected invasive candidiasis. A low serum level and a favorable negative predictive value are the main findings for procalcitonin in this setting. The aim of this report is to provide an updated brief summary of the evidence supporting the use of PCT for the management of invasive candidiasis.