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https://www.readbyqxmd.com/read/29778079/advances-in-understanding-the-response-of-fish-to-linear-alcohols-in-the-environment
#1
Scott E Belanger, Jane M Rawlings, Ricky Stackhouse
Short to long chain alcohols have a range of ecotoxicity to aquatic life driven by hydrophobic interactions with biological membranes. Carbon chain length and octanol:water partitioning coefficients are surrogates for hydrophobicity and strongly relate to aquatic toxicity. In these investigations, the toxicity of ethanol to 1-n-dodecanol to juvenile fish in standard acute toxicity tests is reviewed. Toxicity tests employing fish embryos (zebrafish Danio rerio and fathead minnow Pimephales promelas) in the Fish Embryo Test (OECD 236) format were conducted from C2 to C10 to compare against standard juvenile fish toxicity...
April 25, 2018: Chemosphere
https://www.readbyqxmd.com/read/29775220/cystatin-c-is-a-more-reliable-biomarker-for-determining-egfr-to-support-drug-development-studies
#2
REVIEW
Sumit Kar, Sabina Paglialunga, Rafiqul Islam
Glomerular filtration rate (GFR) is routinely used as a surrogate endpoint for the development of investigational drugs in clinical trials. GFR and staging of chronic kidney disease are typically assessed by measuring the concentration of endogenous serum biomarkers such as albumin and creatinine. However, creatinine is subject to high biological variability, and levels of creatinine do not rise until nearly 50% of kidney function is damaged, leading to inaccurate chronic kidney disease staging and false negatives...
May 18, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29773430/surrogate-endpoints-and-risk-adaptive-strategies-in-previously-untreated-follicular-lymphoma
#3
REVIEW
Mayur S Narkhede, Bruce D Cheson
Follicular lymphoma is the second most common subtype of non-Hodgkin lymphoma with an estimated 3.18 cases per 100,000 people. Despite the prolongation of survival with chemoimmunotherapy, variability in response to initial treatment and outcome still exists. Whereas prolonging overall survival is important, it is generally an unreasonable primary endpoint in the front-line setting. The long follow-up needed and the influence of subsequent therapies creates a potential bias. Thus, clinical trials require approximately 5 to 8 years from activation to completion and analysis of outcomes...
May 5, 2018: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/29769294/pulmonary-function-tests-as-outcomes-for-systemic-sclerosis-interstitial-lung-disease
#4
REVIEW
Melissa Caron, Sabrina Hoa, Marie Hudson, Kevin Schwartzman, Russell Steele
Interstitial lung disease (ILD) is the leading cause of morbidity and mortality in systemic sclerosis (SSc). We performed a systematic review to characterise the use and validation of pulmonary function tests (PFTs) as surrogate markers for systemic sclerosis-associated interstitial lung disease (SSc-ILD) progression.Five electronic databases were searched to identify all relevant studies. Included studies either used at least one PFT measure as a longitudinal outcome for SSc-ILD progression ( i.e. outcome studies) and/or reported at least one classical measure of validity for the PFTs in SSc-ILD ( i...
June 30, 2018: European Respiratory Review: An Official Journal of the European Respiratory Society
https://www.readbyqxmd.com/read/29761474/lipids-apolipoproteins-and-inflammatory-biomarkers-of-cv-risk-what-have-we-learned
#5
David Rhainds, Mathieu R Brodeur, Jean-Claude Tardif
Cardiovascular diseases (CVD) are the first cause of death in the world. CVD risk is influenced by multiple factors, some non-modifiable such as age, sex and genetic background, and others modifiable. Great progress has been made over the last decades in the identification of biomarkers of incident or recurrent CV risk and surrogate endpoints of CV outcomes. We present the current state of knowledge for CV biomarkers in plasma including lipids, apolipoproteins, inflammation-related, and emerging omics-based biomarkers...
May 15, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29759146/mrd-testing-in-multiple-myeloma-from-a-surrogate-marker-of-clinical-outcomes-to-an-every-day-clinical-tool
#6
EDITORIAL
Ola Landgren
Minimal residual disease (MRD) testing in multiple myeloma is here to stay. Studies show that MRD negativity is consistently associated with longer progression-free survival (PFS). It is just a matter of time until MRD negativity will become a regulatory endpoint for drug approval. Until that can happen, more analysis will be required to define the exact details of MRD in the regulatory setting. For example, for randomized studies there is need to define the amount of improvement in MRD negativity between the experimental arm and the control arm at a given time-point for a drug to obtain regulatory accelerated approval...
January 2018: Seminars in Hematology
https://www.readbyqxmd.com/read/29753821/thromboelastography-is-associated-with-surrogates-for-bleeding-after-pediatric-cardiac-surgery
#7
Sirisha Emani, Lynn A Sleeper, David Faraoni, Michelle Mulone, Fatoumata Diallo, James A DiNardo, Juan Ibla, Sitaram M Emani
BACKGROUND: Perioperative bleeding is a common complication in pediatric patients undergoing cardiac surgery. Although thromboelastography (TEG) has been utilized in patients undergoing adult cardiac surgery, limited data are available in pediatric patients. We hypothesize that TEG parameters may be associated with surrogate endpoints for postoperative bleeding in pediatric patients undergoing complex cardiac surgery. METHODS: In a retrospective study, TEG was obtained after protamine administration and upon intensive care unit (ICU) admission in pediatric patients (≤ 18yrs) undergoing cardiac surgery requiring cardiopulmonary bypass...
May 10, 2018: Annals of Thoracic Surgery
https://www.readbyqxmd.com/read/29743019/predictive-biomarkers-for-death-and-rehospitalization-in-comorbid-frail-elderly-heart-failure-patients
#8
Cristina Pacho, Mar Domingo, Raquel Núñez, Josep Lupón, Julio Núñez, Jaume Barallat, Pedro Moliner, Marta de Antonio, Javier Santesmases, Germán Cediel, Santiago Roura, M Cruz Pastor, Jordi Tor, Antoni Bayes-Genis
BACKGROUND: Heart failure (HF) is associated with a high rate of readmissions within 30 days post-discharge and in the following year, especially in frail elderly patients. Biomarker data are scarce in this high-risk population. This study assessed the value of early post-discharge circulating levels of ST2, NT-proBNP, CA125, and hs-TnI for predicting 30-day and 1-year outcomes in comorbid frail elderly patients with HF with mainly preserved ejection fraction (HFpEF). METHODS: Blood samples were obtained at the first visit shortly after discharge (4...
May 9, 2018: BMC Geriatrics
https://www.readbyqxmd.com/read/29742811/primary-sclerosing-cholangitis-risk-estimate-tool-presto-predicts-outcomes-in-psc-a-derivation-validation-study-using-machine-learning
#9
John E Eaton, Mette Vesterhus, Bryan M McCauley, Elizabeth J Atkinson, Erik M Schlicht, Brian D Juran, Andrea A Gossard, Nicholas F LaRusso, Gregory J Gores, Tom H Karlsen, Konstantinos N Lazaridis
BACKGROUND & AIMS: Improved methods are needed to risk stratify and predict outcomes in patients with primary sclerosing cholangitis (PSC). Therefore, we sought to derive and validate a new prediction model and compare its performance to existing surrogate markers. METHODS: The model was derived using 509 subjects from a multicenter North American cohort and validated in an international multicenter cohort (n=278). Gradient boosting, a machine based learning technique, was used to create the model...
May 9, 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29727915/three-month-posttreatment-prostate-specific-antigen-level-as-a-biomarker-of-treatment-response-in-patients-with-intermediate-risk-or-high-risk-prostate-cancer-treated-with-androgen-deprivation-therapy-and-radiotherapy
#10
Alex K Bryant, Anthony V D'Amico, Paul L Nguyen, John P Einck, Christopher J Kane, Rana R McKay, Daniel R Simpson, Arno J Mundt, James D Murphy, Brent S Rose
BACKGROUND: Prostate-specific antigen (PSA) measurement after definitive radiotherapy (RT) and androgen deprivation therapy for localized prostate cancer has been proposed as an early prognostic biomarker. In the current study, the authors investigated the association between 3-month post-RT PSA level and biochemical progression-free survival (bPFS), prostate cancer-specific survival (PCSS), and overall survival (OS). METHODS: A total of 5783 patients with intermediate-risk or high-risk localized prostate cancer who were diagnosed between 2000 and 2015 and treated with RT and androgen deprivation therapy were identified from Veterans Affairs data...
May 4, 2018: Cancer
https://www.readbyqxmd.com/read/29718095/neoadjuvant-rectal-score-as-individual-level-surrogate-for-disease-free-survival-in-rectal-cancer-in-the-cao-aro-aio-04-randomized-phase-3-trial
#11
E Fokas, R Fietkau, A Hartmann, W Hohenberger, R Grützmann, M Ghadimi, T Liersch, P Ströbel, G G Grabenbauer, U Graeven, R-D Hofheinz, C-H Köhne, C Wittekind, R Sauer, M Kaufmann, T Hothorn, C Rödel
BACKGROUND: Surrogate endpoints in rectal cancer after preoperative chemoradiation are lacking as their statistical validation poses major challenges, including confirmation based on large phase 3 trials. We examined the prognostic role and individual-level surrogacy of neoadjuvant rectal (NAR) score that incorporates weighted cT, ypT and ypN categories for disease-free survival (DFS) in 1191 patients with rectal carcinoma treated within the CAO/ARO/AIO-04 phase 3 trial. PATIENTS AND METHODS: Cox regression models adjusted for treatment arm, resection status, and NAR score were used in multivariable analysis...
April 27, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29703826/neoadjuvant-endpoints-response-criteria-proposed
#12
(no author information available yet)
Lung cancer experts propose using immune-related pathologic response criteria to evaluate lung tumors in neoadjuvant trials of checkpoint inhibitors, and suggest using major pathologic response as a surrogate endpoint for all preoperative lung cancer studies.
April 27, 2018: Cancer Discovery
https://www.readbyqxmd.com/read/29703262/migalastat-improves-diarrhea-in-patients-with-fabry-disease-clinical-biomarker-correlations-from-the-phase-3-facets-trial
#13
Raphael Schiffmann, Daniel G Bichet, Ana Jovanovic, Derralynn A Hughes, Roberto Giugliani, Ulla Feldt-Rasmussen, Suma P Shankar, Laura Barisoni, Robert B Colvin, J Charles Jennette, Fred Holdbrook, Andrew Mulberg, Jeffrey P Castelli, Nina Skuban, Jay A Barth, Kathleen Nicholls
BACKGROUND: Fabry disease is frequently characterized by gastrointestinal symptoms, including diarrhea. Migalastat is an orally-administered small molecule approved to treat the symptoms of Fabry disease in patients with amenable mutations. METHODS: We evaluated minimal clinically important differences (MCID) in diarrhea based on the corresponding domain of the patient-reported Gastrointestinal Symptom Rating Scale (GSRS) in patients with Fabry disease and amenable mutations (N = 50) treated with migalastat 150 mg every other day or placebo during the phase 3 FACETS trial (NCT00925301)...
April 27, 2018: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/29702074/retinal-neuroprotection-overcoming-the-translational-roadblocks
#14
Thomas J Wubben, Cagri G Besirli, Mark W Johnson, David N Zacks
PURPOSE: To elucidate the issues that have prevented successful translation of neuroprotective therapeutic modalities for retinal disease from the pre-clinical to the clinical realm and to suggest strategies to circumvent these barriers in order to develop novel treatments to prevent vision loss. DESIGN: Interpretive essay. METHODS: Review and synthesis of selected reports of neuroprotective approaches for retinal disease, with interpretation and perspective...
April 24, 2018: American Journal of Ophthalmology
https://www.readbyqxmd.com/read/29701875/estimation-of-the-optimal-surrogate-based-on-a-randomized-trial
#15
Brenda L Price, Peter B Gilbert, Mark J van der Laan
A common scientific problem is to determine a surrogate outcome for a long-term outcome so that future randomized studies can restrict themselves to only collecting the surrogate outcome. We consider the setting that we observe n independent and identically distributed observations of a random variable consisting of baseline covariates, a treatment, a vector of candidate surrogate outcomes at an intermediate time point, and the final outcome of interest at a final time point. We assume the treatment is randomized, conditional on the baseline covariates...
April 27, 2018: Biometrics
https://www.readbyqxmd.com/read/29697005/primary-breast-diffuse-large-b-cell-lymphoma-treatment-strategies-and-patterns-of-failure
#16
Ethan B Ludmir, Sarah A Milgrom, Chelsea C Pinnix, Jillian R Gunther, Jason Westin, Yasuhiro Oki, Luis E Fayad, L Jeffrey Medeiros, Bouthaina S Dabaja, Loretta J Nastoupil
Treatment strategies and outcomes were assessed in 25 patients with primary breast diffuse large B-cell lymphoma (PB-DLBCL) treated between 1995 and 2016. We specifically investigated the timing of recurrence, and the roles of radiotherapy (RT) and central nervous system prophylaxis (CNS PPX). Fifty-two percent of patients received RT, and 28% received CNS PPX. Fourteen patients (56%) experienced recurrence, with 76% of relapses occurring ≥24 months after diagnosis, in contrast to reports supporting the use of 24-month event-free survival as a surrogate endpoint in the general DLBCL population...
April 26, 2018: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/29683188/prediction-of-major-complications-after-hepatectomy-using-liver-stiffness-values-determined-by-magnetic-resonance-elastography
#17
N Sato, A Kenjo, T Kimura, R Okada, T Ishigame, Y Kofunato, T Shimura, K Abe, H Ohira, S Marubashi
BACKGROUND: Liver fibrosis is a risk factor for hepatectomy but cannot be determined accurately before hepatectomy because diagnostic procedures are too invasive. Magnetic resonance elastography (MRE) can determine liver stiffness (LS), a surrogate marker for assessing liver fibrosis, non-invasively. The aim of this study was to investigate whether the LS value determined by MRE is predictive of major complications after hepatectomy. METHODS: This prospective study enrolled consecutive patients who underwent hepatic resection between April 2013 and August 2016...
April 23, 2018: British Journal of Surgery
https://www.readbyqxmd.com/read/29679113/increased-evidence-for-the-prognostic-value-of-fdg-uptake-on-late-treatment-pet-in-non-tumour-affected-oesophagus-in-irradiated-patients-with-oesophageal-carcinoma
#18
Yimin Li, Frank Hofheinz, Christian Furth, Chen Lili, Wu Hua, Pirus Ghadjar, Sebastian Zschaeck
PURPOSE: 18 F-FDG uptake in irradiated non-tumour-affected oesophagus (NTO) on restaging PET is a potential surrogate for the measurement of radiation-induced inflammation. Radiation-induced inflammation itself has been shown to be of high prognostic relevance in patients undergoing preoperative radiochemotherapy (RCT) for locally advanced oesophageal cancer. We assessed the prognostic relevance of FDG uptake in the NTO in an independent cohort of patients treated with definitive RCT...
April 21, 2018: European Journal of Nuclear Medicine and Molecular Imaging
https://www.readbyqxmd.com/read/29672914/revisiting-the-nih-taskforce-on-the-research-needs-of-eosinophil-associated-diseases-re-tread
#19
REVIEW
Paneez Khoury, Praveen Akuthota, Steven J Ackerman, Joseph R Arron, Bruce S Bochner, Margaret H Collins, Jean-Emmanuel Kahn, Patricia C Fulkerson, Gerald J Gleich, Rashmi Gopal-Srivastava, Elizabeth A Jacobsen, Kristen M Leiferman, Levi-Schaffer Francesca, Sameer K Mathur, Michael Minnicozzi, Calman Prussin, Marc E Rothenberg, Florence Roufosse, Kathleen Sable, Dagmar Simon, Hans-Uwe Simon, Lisa A Spencer, Jonathan Steinfeld, Andrew J Wardlaw, Michael E Wechsler, Peter F Weller, Amy D Klion
BACKGROUND: Eosinophil-associated diseases (EADs) are rare, heterogeneous disorders characterized by the presence of eosinophils in tissues and/or peripheral blood resulting in immunopathology. The heterogeneity of tissue involvement, lack of sufficient animal models, technical challenges in working with eosinophils, and lack of standardized histopathologic approaches have hampered progress in basic research. Additionally, clinical trials and drug development for rare EADs are limited by the lack of primary and surrogate endpoints, biomarkers, and validated patient-reported outcomes...
April 19, 2018: Journal of Leukocyte Biology
https://www.readbyqxmd.com/read/29662649/-18-fdg-pet-ct-and-molecular-markers-to-predict-response-to-neoadjuvant-chemotherapy-and-outcome-in-her2-negative-advanced-luminal-breast-cancers-patients
#20
Patricia de Cremoux, Lucie Biard, Brigitte Poirot, Philippe Bertheau, Luis Teixeira, Jacqueline Lehmann-Che, Fatiha A Bouhidel, Pascal Merlet, Marc Espié, Matthieu Resche-Rigon, Christos Sotiriou, David Groheux
Background: The efficacy of neoadjuvant chemotherapy regimens in advanced luminal breast cancer patients is difficult to predict. Intrinsic properties of breast tumors, including altered gene expression profile and dynamic evaluation of metabolic properties of tumor cells using positron emission tomography/computed tomography (PET/CT) of tumor cells, have been identified to guide patient's prognosis. The aim of this study is to determine if both analyses may improve the prediction of response to neoadjuvant chemotherapy in ER-positive / HER2-negative breast cancers (BCs) patients...
March 27, 2018: Oncotarget
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