keyword
MENU ▼
Read by QxMD icon Read
search

Surrogate endpoints

keyword
https://www.readbyqxmd.com/read/28728605/surrogate-endpoints-in-oncology-when-are-they-acceptable-for-regulatory-and-clinical-decisions-and-are-they-currently-overused
#1
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
#2
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
#3
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 20, 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
#4
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
#5
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
https://www.readbyqxmd.com/read/28712615/predicting-real-world-effectiveness-of-cancer-therapies-using-overall-survival-and-progression-free-survival-from-clinical-trials-empirical-evidence-for-the-asco-value-framework
#6
Darius N Lakdawalla, Jason Shafrin, Ningqi Hou, Desi Peneva, Seanna Vine, Jinhee Park, Jie Zhang, Ron Brookmeyer, Robert A Figlin
OBJECTIVES: To measure the relationship between randomized controlled trial (RCT) efficacy and real-world effectiveness for oncology treatments as well as how this relationship varies depending on an RCT's use of surrogate versus overall survival (OS) endpoints. METHODS: We abstracted treatment efficacy measures from 21 phase III RCTs reporting OS and either progression-free survival or time to progression endpoints in breast, colorectal, lung, ovarian, and pancreatic cancers...
July 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28709997/methodological-challenges-identified-for-the-evaluation-of-clinical-effectiveness-in-the-context-of-accelerated-regulatory-approval-an-overview
#7
REVIEW
Nerys Woolacott, Mark Corbett, Julie Jones-Diette, Robert Hodgson
BACKGROUND: Regulatory authorities are approving innovative therapies with limited evidence. Whilst this level of data is sufficient for the regulator to establish an acceptable risk-benefit balance, it is problematic for downstream health technology assessment, where assessment of cost-effectiveness requires reliable estimates of effectiveness relative to existing clinical practice. Some key issues associated with a limited evidence base include using data, from non-randomised studies, from small single-arm trials, or from single-centre trials; and using surrogate endpoints...
July 11, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28708930/effects-of-high-intensity-aerobic-interval-training-on-cardiovascular-disease-risk-in-testicular-cancer-survivors-a-phase-2-randomized-controlled-trial
#8
Scott C Adams, Darren S DeLorey, Margie H Davenport, Michael K Stickland, Adrian S Fairey, Scott North, Alexander Szczotka, Kerry S Courneya
BACKGROUND: Testicular cancer survivors (TCS) have an increased risk of treatment-related cardiovascular disease (CVD), which may limit their overall survival. We evaluated the effects of high-intensity aerobic interval training (HIIT) on traditional and novel CVD risk factors and surrogate markers of mortality in a population-based sample of TCS. METHODS: This phase 2 trial (ClinicalTrials.gov identifier NCT02459132) randomly assigned 63 TCS to usual care (UC) or 12 weeks of supervised HIIT (ie, alternating periods of vigorous-intensity and light-intensity aerobic exercise)...
July 14, 2017: Cancer
https://www.readbyqxmd.com/read/28684542/progression-free-survival-as-a-surrogate-endpoint-in-advanced-neuroendocrine-neoplasms
#9
Hiroshi Imaoka, Mitsuhito Sasaki, Hideaki Takahashi, Yusuke Hashimoto, Izumi Ohno, Shuichi Mitsunaga, Kazuo Watanabe, Kumiko Umemoto, Gen Kimura, Yuko Suzuki, Masafumi Ikeda
In oncology clinical trials, overall survival (OS) is considered the gold standard outcome measure. In phase III trials for neuroendocrine neoplasms (NENs), however, progression-free survival (PFS) is more frequently used, as NENs are relatively rare and indolent neoplasms. But this surrogacy of PFS for OS has never been systematically validated. We therefore performed a literature-based analysis of phase II and III trials for NENs to evaluate the correlation between PFS and OS in NENs treated with medical treatment...
July 6, 2017: Endocrine-related Cancer
https://www.readbyqxmd.com/read/28683428/validation-of-rapid-algal-bioassay-using-delayed-fluorescence-in-an-interlaboratory-ring-study
#10
Masakazu Katsumata, Yuko Ikushima, Keith Bennett, Yukiko Sato, Ayano Takeuchi, Norihisa Tatarazako, Tomoyuki Hakamata
Algal growth inhibition tests are generally used to determine the toxic effects of chemical substances on algae growth. In this report, we describe a rapid and simple test procedure using delayed fluorescence (DF) to determine chemical toxicities more rapidly than the conventional 72h or 96h growth inhibition tests. We assess the suitability of DF to serve as an alternative endpoint for biomass production and determine the variability by an interlaboratory ring study using a typical reference toxicant 3,5-dichlorophenol (DCP)...
July 3, 2017: Science of the Total Environment
https://www.readbyqxmd.com/read/28681681/a-poisson-approach-to-the-validation-of-failure-time-surrogate-endpoints-in-individual-patient-data-meta-analyses
#11
Federico Rotolo, Xavier Paoletti, Tomasz Burzykowski, Marc Buyse, Stefan Michiels
Surrogate endpoints are often used in clinical trials instead of well-established hard endpoints for practical convenience. The meta-analytic approach relies on two measures of surrogacy: one at the individual level and one at the trial level. In the survival data setting, a two-step model based on copulas is commonly used. We present a new approach which employs a bivariate survival model with an individual random effect shared between the two endpoints and correlated treatment-by-trial interactions. We fit this model using auxiliary mixed Poisson models...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/28678765/surrogate-endpoint-for-overall-survival-in-assessment-of-adjuvant-therapies-after-curative-treatment-for-hepatocellular-carcinoma-a-re-analysis-of-meta-analyses-of-individual-patients-data
#12
Hong-Bo Huan, Li-Li Wu, Wan-Yee Lau, Xu-Dong Wen, Liang Zhang, Da-Peng Yang, Xi-Shu Wang, Ping Bie, Feng Xia
The gold standard endpoint to evaluate the effect of treatment for hepatocellular carcinoma (HCC) is overall survival (OS), but it requires a longer follow-up period to observe. This study aimed to identify whether disease-free survival (DFS) could be used as a surrogate endpoint for OS to assess the efficacy of adjuvant therapies after curative treatment (surgical resection and ablation) for HCC patients. A systematic review was conducted to identify trials about curative treatment combined with or without adjuvant therapies (interferon, IFN; or transarterial chemoembolization, TACE) for HCC...
June 29, 2017: Oncotarget
https://www.readbyqxmd.com/read/28667449/patient-preferences-a-trojan-horse-for-evidence-based-medicine
#13
Afschin Gandjour
The evidence-based medicine (EBM) movement has long acknowledged the relevance of patient preferences and values. According to EBM, clinicians first clarify the medical evidence about the benefits and burdens of the treatment in question and then, as a second step, elicit values and preferences from patients. Importantly, however, values are placed on patient-relevant outcomes. Surrogate endpoints are only used if their validity is proven. This article shows that some recent patient-preference studies attribute value to surrogate endpoints even when there is no improvement in patient-relevant outcomes...
June 30, 2017: European Journal of Health Economics: HEPAC: Health Economics in Prevention and Care
https://www.readbyqxmd.com/read/28663056/from-in-vitro-to-in-vivo-integration-of-the-virtual-cell-based-assay-with-physiologically-based-kinetic-modelling
#14
Alicia Paini, Jose Vicente Sala Benito, Jos Bessems, Andrew P Worth
Physiologically based kinetic (PBK) models and the virtual cell based assay can be linked to form so called physiologically based dynamic (PBD) models. This study illustrates the development and application of a PBK model for prediction of estragole-induced DNA adduct formation and hepatotoxicity in humans. To address the hepatotoxicity, HepaRG cells were used as a surrogate for liver cells, with cell viability being used as the in vitro toxicological endpoint. Information on DNA adduct formation was taken from the literature...
June 27, 2017: Toxicology in Vitro: An International Journal Published in Association with BIBRA
https://www.readbyqxmd.com/read/28663047/diagnostic-and-prognostic-value-of-mir-1-and-mir-29b-on-adverse-ventricular-remodeling-after-acute-myocardial-infarction-the-sitagrami-mir-analysis
#15
U Grabmaier, S Clauss, L Gross, I Klier, W M Franz, G Steinbeck, R Wakili, H D Theiss, C Brenner
BACKGROUND: MicroRNAs (miRs) have shown to exert fibrotic and anti-fibrotic effects in preclinical models of acute myocardial infarction (AMI). The aim of this study was to evaluate miR-1, miR-21, miR-29b and miR-92a as circulating biomarkers for adverse ventricular remodeling (AVR) in post-AMI patients. METHODS: Plasma levels of miR-1, miR-21, miR-29b and miR-92a were measured in 44 patients of the SITAGRAMI trial population at day 4, day 9 and 6month after AMI and in 18 matched controls (CTL)...
June 19, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28655060/biomarkers-and-surrogate-endpoints-in-uveitis-the-impact-of-quantitative-imaging
#16
REVIEW
Alastair K Denniston, Pearse A Keane, Sunil K Srivastava
Purpose: Uveitis is a major cause of sight loss across the world. The reliable assessment of intraocular inflammation in uveitis ('disease activity') is essential in order to score disease severity and response to treatment. In this review, we describe how 'quantitative imaging', the approach of using automated analysis and measurement algorithms across both standard and emerging imaging modalities, can develop objective instrument-based measures of disease activity. Methods: This is a narrative review based on searches of the current world literature using terms related to quantitative imaging techniques in uveitis, supplemented by clinical trial registry data, and expert knowledge of surrogate endpoints and outcome measures in ophthalmology...
May 1, 2017: Investigative Ophthalmology & Visual Science
https://www.readbyqxmd.com/read/28653408/evaluating-principal-surrogate-markers-in-vaccine-trials-in-the-presence-of-multiphase-sampling
#17
Ying Huang
This article focuses on the evaluation of vaccine-induced immune responses as principal surrogate markers for predicting a given vaccine's effect on the clinical endpoint of interest. To address the problem of missing potential outcomes under the principal surrogate framework, we can utilize baseline predictors of the immune biomarker(s) or vaccinate uninfected placebo recipients at the end of the trial and measure their immune biomarkers. Examples of good baseline predictors are baseline immune responses when subjects enrolled in the trial have been previously exposed to the same antigen, as in our motivating application of the Zostavax Efficacy and Safety Trial (ZEST)...
June 26, 2017: Biometrics
https://www.readbyqxmd.com/read/28649875/potential-benefits-of-zolpidem-in-disorders-of-consciousness
#18
Afsaneh Noormandi, Maryam Shahrokhi, Hossein Khalili
It has been suggested that zolpidem may arouse patients with decreased level of consciousness. Zolpidem may partially or even completely reverse abnormal cell metabolism following brain damage. In this article, available evidences regarding effects of zolpidem on disorders of consciousnesswere reviewed. Areas covered: A literature review was conducted using PubMed, Scopus, Medline, Cochrane central register of controlled trials, Cochrane database systematic reviews and Google scholar as online databases. Search Keywords were 'vegetative state','minimally conscious state','semi-comatose', 'arousal', 'zolpidem', 'wakefulness', 'awareness', and 'loss of consciousness'...
June 26, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28647412/real-world-data-to-assess-changes-in-low-density-lipoprotein-cholesterol-and-predicted-cardiovascular-risk-after-ezetimibe-discontinuation-post-reporting-of-the-ezetimibe-and-simvastatin-in-hypercholesterolemia-enhances-atherosclerosis-regression-trial
#19
Harold E Bays, Mehul D Patel, Panagiotis Mavros, Dena R Ramey, Joanne E Tomassini, Andrew M Tershakovec, Carl A Baxter
BACKGROUND: The 2008 Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) study demonstrated ezetimibe + simvastatin vs simvastatin alone had a neutral effect on the surrogate endpoint of carotid intima-media thickness. Subsequent media portrayal of the study prompted ezetimibe discontinuation in many patients. OBJECTIVE: The objective of the study was to assess the impact of ENHANCE reporting on ezetimibe discontinuation, low-density lipoprotein cholesterol (LDL-C) changes, and potential cardiovascular disease (CVD) risk...
May 8, 2017: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/28638797/recurrence-free-survival-as-a-putative-surrogate-for-overall-survival-in-phase-iii-trials-of-curative-intent-treatment-of-colorectal-liver-metastases-systematic-review
#20
Raphael L C Araujo, Paulo Herman, Rachel P Riechelmann
AIM: To verify whether recurrence-free survival (RFS) surrogates overall survival (OS) in phase III trials for resectable colorectal liver metastases (CRLM). METHODS: MEDLINE, EMBASE, and Scopus databases were consulted. Eligible studies were phase III trials testing any type of systemic therapy (neoadjuvant, adjuvant or perioperative) added to surgery in patients with resectable CRLM. A linear regression model based on hazard ratios (HR) of OS and RFS was performed...
June 10, 2017: World Journal of Clinical Oncology
keyword
keyword
14869
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"