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Surrogate endpoint

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https://www.readbyqxmd.com/read/28816230/plasma-pcsk9-levels-are-unrelated-to-arterial-stiffness-in-a-community-based-4-8-year-prospective-study
#1
J Han, X Wang, P Ye, R Cao, X Yang, W Xiao, Y Zhang, Y Bai, H Wu
Proprotein convertase subtilisin/kexin type 9 (PCSK9) is an important circulating serine protease in low-density lipoprotein cholesterol (LDL-C) metabolism. Increased plasma PCSK9 levels lead to increased plasma levels of LDL-C and an increased risk of cardiovascular disease (CVD). LDL-C is positively correlated with arterial stiffness, a surrogate endpoint of CVD. However, whether plasma levels of PCSK9 could influence arterial stiffness is still unclear. Our study examined the relationship between plasma levels of PCSK9 and arterial stiffness (carotid-femoral pulse wave velocity (cf-PWV)) in a community-based population...
August 17, 2017: Journal of Human Hypertension
https://www.readbyqxmd.com/read/28798271/the-search-for-surrogate-endpoints-in-trials-in-diffuse-large-b-cell-lymphoma-the-surrogate-endpoints-for-aggressive-lymphoma-project
#2
Daniel J Sargent, Qian Shi, Christopher R Flowers, Norbert Schmitz, Thomas M Habermann, Jocelyne Flament, Tommy Fu, Bertrand Coiffier
No abstract text is available yet for this article.
August 10, 2017: Oncologist
https://www.readbyqxmd.com/read/28797730/an-lasv-gpc-pseudotyped-virus-based-reporter-system-enables-evaluation-of-vaccines-in-mice-under-non-bsl-4-conditions
#3
Qianqian Li, Qiang Liu, Weijin Huang, Jiajing Wu, Jianhui Nie, Meng Wang, Chenyan Zhao, Li Zhang, Youchun Wang
Lassa virus (LASV) causes a severe hemorrhagic fever endemic throughout western Africa. Because of the ability to cause lethal disease in humans, limited treatment options, and potential as a bioweapon, the need for vaccines to prevent LASV epidemic is urgent. However, LASV vaccine development has been hindered by the lack of appropriate small animal models for efficacy evaluation independent of biosafety level four (BSL-4) facilities. Here we generated an LASV-glycoprotein precursor (GPC)-pseudotyped Human immunodeficiency virus containing firefly luciferase (Fluc) reporter gene as surrogate to develop a bioluminescent-imaging-based BALB/c mouse model for one-round infection under non-BSL-4 conditions, in which the bioluminescent intensity of Fluc was utilized as endpoint when evaluating vaccine efficacy...
August 7, 2017: Vaccine
https://www.readbyqxmd.com/read/28797473/biomarker-research-to-improve-clinical-outcomes-of-peritoneal-dialysis-consensus-of-the-european-training-and-research-in-peritoneal-dialysis-eutripd-network
#4
REVIEW
Christoph Aufricht, Robert Beelen, Matthias Eberl, Michel Fischbach, Donald Fraser, Achim Jörres, Klaus Kratochwill, Manuel LópezCabrera, Peter Rutherford, Claus-Peter Schmitt, Nicholas Topley, Janusz Witowski
Peritoneal dialysis (PD) therapy substantially requires biomarkers as tools to identify patients who are at the highest risk for PD-related complications and to guide personalized interventions that may improve clinical outcome in the individual patient. In this consensus article, members of the European Training and Research in Peritoneal Dialysis Network (EuTRiPD) review the current status of biomarker research in PD and suggest a selection of biomarkers that can be relevant to the care of PD patients and that are directly accessible in PD effluents...
August 8, 2017: Kidney International
https://www.readbyqxmd.com/read/28793848/18f-fdg-pet-ct-may-exclude-malignancy-in-sonographically-suspicious-and-scintigraphically-hypofunctional-thyroid-nodules-and-reduce-unnecessary-thyroid-surgeries
#5
Marcus Ruhlmann, Jürgen Ruhlmann, Rainer Görges, Ken Herrmann, Gerald Antoch, Hans-Wilhelm Keller, Verena Ruhlmann
BACKGROUND: The aim of this study was to evaluate whether [18F]-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) is useful in the further characterization of sonographically suspicious and scintigraphically hypofunctional thyroid nodules. METHODS: 65 patients with a sonographically suspicious thyroid nodules that were hypofunctional on 99m-Tc-pertechnetate scintigraphy (diameter > 1 cm) were retrospectively analyzed. All patients underwent evaluation with FDG-PET/CT...
August 10, 2017: Thyroid: Official Journal of the American Thyroid Association
https://www.readbyqxmd.com/read/28776727/comparing-and-combining-biomarkers-as-principal-surrogates-for-time-to-event-clinical-endpoints
#6
Erin E Gabriel, Michael C Sachs, Peter B Gilbert
No abstract text is available yet for this article.
September 20, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28764887/disease-free-survival-is-not-a-surrogate-endpoint-for-overall-survival-in-adjuvant-trials-of-pancreatic-cancer-a%C3%A2-systematic-review-of-randomized-trials
#7
Fausto Petrelli, Gianluca Tomasello, Michele Ghidini, Veronica Lonati, Rodolfo Passalacqua, Sandro Barni
BACKGROUND: Adjuvant chemotherapy (CT) is the standard of care for patients with resected pancreatic cancer (PC). Overall survival (OS) has traditionally represented the primary endpoint in randomized trials assessing adjuvant therapies for PC. The aim of this study was to assess if disease-free survival (DFS) was an adequate surrogate endpoint for OS in randomized trials of adjuvant therapy in PC. METHODS: A systematic literature search was conducted in PubMed, Web of Science, SCOPUS and Embase, Cochrane Library and the World Health Organization International Clinical Trials Registry Platform up to February 2nd, 2017...
July 29, 2017: HPB: the Official Journal of the International Hepato Pancreato Biliary Association
https://www.readbyqxmd.com/read/28759968/a-systematic-review-of-longitudinal-studies-which-measure-alzheimer-s-disease-biomarkers
#8
Emma Lawrence, Carolin Vegvari, Alison Ower, Christoforos Hadjichrysanthou, Frank De Wolf, Roy M Anderson
Alzheimer's disease (AD) is a progressive and fatal neurodegenerative disease, with no effective treatment or cure. A gold standard therapy would be treatment to slow or halt disease progression; however, knowledge of causation in the early stages of AD is very limited. In order to determine effective endpoints for possible therapies, a number of quantitative surrogate markers of disease progression have been suggested, including biochemical and imaging biomarkers. The dynamics of these various surrogate markers over time, particularly in relation to disease development, are, however, not well characterized...
July 25, 2017: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/28759384/cardiotoxic-effects-of-anthracycline-based-therapy-what-is-the-evidence-and-what-are-the-potential-harms
#9
REVIEW
Bennett E Levis, Phillip F Binkley, Charles L Shapiro
Despite the known cardiotoxic effects of doxorubicin and other anthracyclines, no evidence-based guidelines exist for the surveillance and prevention of chemotherapy-induced cardiotoxicity in adult survivors of breast cancer who have had limited previous doses of anthracyclines (ie, total cumulative dose 240 mg/m(2)), or limited-dose anthracyclines followed by trastuzumab-based regimens. Nonetheless, some national and international cardio-oncology and cardiac-imaging organisations recommend increased cardiac surveillance during or after treatment, measurement of cardiac biomarkers and other surrogate endpoints, and in some cases initiation of cardioprotective drug therapy in asymptomatic women...
August 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28758224/a-method-to-address-between-subject-heterogeneity-for-identification-of-principal-surrogate-markers-in-repeated-low-dose-challenge-hiv-vaccine-studies
#10
Andrew J Spieker, Ying Huang
Repeated low-dose challenge designs in nonhuman primate studies have recently received attention in the literature as a means of evaluating vaccines for HIV prevention and identifying immune surrogates for their protective effects. Existing methods for surrogate identification in this type of study design rely on the assumption of homogeneity across subjects (namely, independent infection risks after each challenge within each subject and conditional on covariates). In practice, random variation across subjects is likely to occur because of unmeasured biologic factors...
July 31, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28752290/factors-contributing-to-the-efficacy-effectiveness-gap-in-the-case-of-orphan-drugs-for-metabolic-diseases
#11
Y Schuller, C E M Hollak, C C Gispen-de Wied, V Stoyanova-Beninska, M Biegstraaten
INTRODUCTION: Authorization of orphan medicinal products (OMPs) is often based on studies with several methodological shortcomings. Hence, data are difficult to interpret and efficacy does not always correspond to real-world effectiveness. We investigated to what extent an efficacy-effectiveness gap exists for OMPs for metabolic diseases and set out to explore which factors contribute to it. METHODS: We included all OMPs for rare metabolic diseases authorized in the EU up to 1 January 2016...
July 27, 2017: Drugs
https://www.readbyqxmd.com/read/28747249/surrogacy-of-progression-free-survival-pfs-for-overall-survival-os-in-esophageal-cancer-trials-with-preoperative-therapy-literature-based-meta-analysis
#12
K Kataoka, K Nakamura, J Mizusawa, K Kato, J Eba, H Katayama, T Shibata, H Fukuda
BACKGROUND: There have been no reports evaluating progression-free survival (PFS) as a surrogate endpoint in resectable esophageal cancer. This study was conducted to evaluate the trial level correlations between PFS and overall survival (OS) in resectable esophageal cancer with preoperative therapy and to explore the potential benefit of PFS as a surrogate endpoint for OS. METHODS: A systematic literature search of randomized trials with preoperative chemotherapy or preoperative chemoradiotherapy for esophageal cancer reported from January 1990 to September 2014 was conducted using PubMed and the Cochrane Library...
July 15, 2017: European Journal of Surgical Oncology
https://www.readbyqxmd.com/read/28734900/molecular-imaging-in-stem-cell-based-therapies-of-cardiac-diseases
#13
REVIEW
Xiang Li, Marcus Hacker
In the past 15years, despite regenerative medicine has shown great potential for cardiovascular diseases, the outcome and safety of stem cell transplantation has shown controversial results in the published literature. Medical imaging might be useful for monitoring and quantification transplanted cells within the heart and to serially characterize the effects of stem cell therapy of the myocardium. From the multiple available noninvasive imaging techniques, magnetic resonance imaging and nuclear imaging by positron (PET) or single photon emission computer tomography (SPECT) are the most used clinical approaches to follow the fate of transplanted stem cells in vivo...
July 19, 2017: Advanced Drug Delivery Reviews
https://www.readbyqxmd.com/read/28733961/a-review-of-biomarkers-for-neurodegenerative-disease-will-they-swing-us-across-the-valley
#14
REVIEW
Thomas G Beach
Measures of the severity of cognitive impairment or parkinsonism are the usual endpoints in clinical trials for Alzheimer's disease (AD) and Parkinson's disease (PD), but are critically hampered by their lack of disease sensitivity and specificity. Due to the high failure rate of clinical trials, the rate of regulatory approval for efficacious new drugs has stagnated in the past few decades, with the gap between basic science discovery and clinical application metaphorically termed the "Valley of Death". While the causes for this are probably multiple and complex, the usage of biomarkers as surrogate endpoints, particularly when they are molecularly-specific for the disease, has achieved some success in cancer trials, and it is likely that neurodegenerative disease trials would benefit from the same approach...
July 2017: Neurology and Therapy
https://www.readbyqxmd.com/read/28733182/the-association-of-depressive-symptoms-with-rates-of-acute-exacerbations-in-patients-with-copd-results-from-a-3-year-longitudinal-follow-up-of-the-eclipse-cohort
#15
Abebaw Mengistu Yohannes, Hana Mülerová, Kim Lavoie, Jorgen Vestbo, Steve I Rennard, Emile Wouters, Nicola A Hanania
BACKGROUND: Depression increases disability and health care utilization in older patients with chronic obstructive pulmonary disease (COPD). OBJECTIVES: To determine contribution of depressive symptoms to the incidence of moderate-severe and severe acute exacerbations of COPD (AECOPD) over 3 years. DESIGN: We analyzed data collected from a prospective cohort of patients with COPD (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints; ECLIPSE)...
July 18, 2017: Journal of the American Medical Directors Association
https://www.readbyqxmd.com/read/28728605/surrogate-endpoints-in-oncology-when-are-they-acceptable-for-regulatory-and-clinical-decisions-and-are-they-currently-overused
#16
Robert Kemp, Vinay Prasad
BACKGROUND: Surrogate outcomes are not intrinsically beneficial to patients, but are designed to be easier and faster to measure than clinically meaningful outcomes. The use of surrogates as an endpoint in clinical trials and basis for regulatory approval is common, and frequently exceeds the guidance given by regulatory bodies. DISCUSSION: In this article, we demonstrate that the use of surrogates in oncology is widespread and increasing. At the same time, the strength of association between the surrogates used and clinically meaningful outcomes is often unknown or weak...
July 21, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28726172/combined-treatment-for-non-small-cell-lung-cancer-and-breast-cancer-patients-with-brain-metastases-with-whole-brain-radiotherapy-and-temozolomide-a-systematic-review-and-meta-analysis
#17
REVIEW
Jingru Tian, Yien Luo, Juanjuan Xiang, Jingqun Tang
Brain metastasis is the leading cause of death among advanced non-small cell lung cancer (NSCLC) and breast cancer patients. The standard treatment for brain metastases is radiotherapy. The combination of radiotherapy and chemotherapy has been tested. However, the management of brain metastases has yet to be successful. Here, we aimed to determine the efficacy and safety of whole brain radiotherapy (WBRT) alone or in combination with temozolomide (TMZ) in NSCLC and breast cancer patients with brain metastases...
July 19, 2017: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/28724330/immunotherapy-advances-for-mesothelioma-treatment
#18
Emyr Bakker, Alice Guazzelli, Firozeh Ashtiani, Constantinos Demonacos, Marija Krstic-Demonacos, Luciano Mutti
Mesothelioma is a rare type of cancer that is strongly tied to asbestos exposure. Despite application of different modalities such as chemotherapy, radiotherapy and surgery, patient prognosis remains very poor and therapies are ineffective. Much research currently focuses on the application of novel approaches such as immunotherapy towards this disease. Areas covered: The types, stages and aetiology of mesothelioma are detailed, followed by a discussion of the current treatment options such as radiotherapy, surgery, and chemotherapy...
July 31, 2017: Expert Review of Anticancer Therapy
https://www.readbyqxmd.com/read/28721038/toxicity-based-toxicokinetic-toxicodynamic-assessment-of-bioaccumulation-and-nanotoxicity-of-zerovalent-iron-nanoparticles-in-caenorhabditis-elegans
#19
Ying-Fei Yang, Yi-Jun Lin, Chung-Min Liao
Elucidating the relationships between the toxicity-based-toxicokinetic (TBTK)/toxicodynamic (TD) properties of engineered nanomaterials and their nanotoxicity is crucial for human health-risk analysis. Zerovalent iron (Fe(0)) nanoparticles (NPs) are one of the most prominent NPs applied in remediating contaminated soils and groundwater. However, there are concerns that Fe(0)NP application contributes to long-term environmental and human health impacts. The nematode Caenorhabditis elegans is a surrogate in vivo model that has been successfully applied to assess the potential nanotoxicity of these nanomaterials...
2017: International Journal of Nanomedicine
https://www.readbyqxmd.com/read/28718896/nomograms-for-preoperative-prediction-of-axillary-nodal-status-in-breast-cancer
#20
L Dihge, P-O Bendahl, L Rydén
BACKGROUND: Axillary staging in patients with breast cancer and clinically node-negative disease is performed by sentinel node biopsy (SLNB). The aim of this study was to integrate feasible preoperative variables into nomograms to guide clinicians in stratifying treatment options into no axillary staging for patients with non-metastatic disease (N0), SLNB for those with one or two metastases, and axillary lymph node dissection (ALND) for patients with three or more metastases. METHODS: Patients presenting to Skåne University Hospital, Lund, with breast cancer were included in a prospectively maintained registry between January 2009 and December 2012...
July 18, 2017: British Journal of Surgery
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