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Clinical trial end point and surrogate

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https://www.readbyqxmd.com/read/28099439/single-versus-serial-measurements-of-neuron-specific-enolase-and-prediction-of-poor-neurological-outcome-in-persistently-unconscious-patients-after-out-of-hospital-cardiac-arrest-a-ttm-trial-substudy
#1
Sebastian Wiberg, Christian Hassager, Pascal Stammet, Matilde Winther-Jensen, Jakob Hartvig Thomsen, David Erlinge, Michael Wanscher, Niklas Nielsen, Tommaso Pellis, Anders Åneman, Hans Friberg, Jan Hovdenes, Janneke Horn, Jørn Wetterslev, John Bro-Jeppesen, Matthew P Wise, Michael Kuiper, Tobias Cronberg, Yvan Gasche, Yvan Devaux, Jesper Kjaergaard
BACKGROUND: Prediction of neurological outcome is a crucial part of post cardiac arrest care and prediction in patients remaining unconscious and/or sedated after rewarming from targeted temperature management (TTM) remains difficult. Current guidelines suggest the use of serial measurements of the biomarker neuron-specific enolase (NSE) in combination with other predictors of outcome in patients admitted after out-of-hospital cardiac arrest (OHCA). This study sought to investigate the ability of NSE to predict poor outcome in patients remaining unconscious at day three after OHCA...
2017: PloS One
https://www.readbyqxmd.com/read/28097317/surrogate-end-points-for-all-cause-mortality-in-men-with-localized-unfavorable-risk-prostate-cancer-treated-with-radiation-therapy-vs-radiation-therapy-plus-androgen-deprivation-therapy-a-secondary-analysis-of-a-randomized-clinical-trial
#2
Trevor J Royce, Ming-Hui Chen, Jing Wu, Marian Loffredo, Andrew A Renshaw, Philip W Kantoff, Anthony V D'Amico
Importance: Several surrogates for prostate cancer-specific mortality satisfying the Prentice criteria exist, but whether these are surrogates for all-cause mortality, and how their performance compares, is unknown. Objective: To ascertain and compare the performance of 4 candidate surrogates (prostate-specific antigen [PSA] failure, PSA nadir >0.5 ng/mL, PSA doubling time <9 months, and interval to PSA failure <30 months) for all-cause mortality using the proportion of treatment-effect metric...
January 12, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28095160/minimal-loss-of-lifetime-for-patients-with-diffuse-large-b-cell-lymphoma-in-remission-and-event-free-24-months-after-treatment-a-danish-population-based-study
#3
Lasse Hjort Jakobsen, Martin Bøgsted, Peter de Nully Brown, Bente Arboe, Judit Jørgensen, Thomas Stauffer Larsen, Maja Bech Juul, Lene Schurmann, Linda Højberg, Olav Jonas Bergmann, Therese Lassen, Pär Lars Josefsson, Paw Jensen, Hans Erik Johnsen, Tarec Christoffer El-Galaly
Purpose The general outlook for patients with diffuse large B-cell lymphoma (DLBCL) in first remission is important information for patients and for planning post-treatment follow-up. The purpose of this study was to evaluate the survival of patients with DLBCL in remission compared with a matched general population. Methods A total of 1,621 patients from the Danish Lymphoma Registry who were newly diagnosed with DLBCL between 2003 and 2011 were included in this study. All patients were ≥ 16 years of age at diagnosis and had achieved complete remission or complete remission unconfirmed after first-line rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or R-CHOP-like therapy...
January 17, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28061544/findings-from-the-adjuvant-colon-cancer-end-points-accent-collaborative-group-the-power-of-pooled-individual-patient-data-from-multiple-clinical-trials
#4
Lindsay A Renfro, Daniel J Sargent
The Adjuvant Colon Cancer End Points (ACCENT) Collaborative Group was formed 15 years ago to address scientific questions in early stage colon cancer that could best be answered by pooling individual patient data across many randomized clinical trials. Today, the ACCENT database contains detailed information collected from over 40,000 patients enrolled onto 27 major adjuvant colon cancer trials conducted between 1977 and 2009. Since its inception, the ACCENT group has led many sophisticated analyses addressing a variety of clinical questions, such as the long-term survivorship of colon cancer patients by treatment, the time course of oxaliplatin benefit, and support for the use of disease-free survival (DFS) as a surrogate endpoint for overall survival (OS), among many others...
December 2016: Chinese Clinical Oncology
https://www.readbyqxmd.com/read/28029309/thirty-month-complete-response-as-a-surrogate-end-point-in-first-line-follicular-lymphoma-therapy-an-individual-patient-level-analysis-of-multiple-randomized-trials
#5
Qian Shi, Christopher R Flowers, Wolfgang Hiddemann, Robert Marcus, Michael Herold, Anton Hagenbeek, Eva Kimby, Howard Hochster, Umberto Vitolo, Bruce A Peterson, Emmanuel Gyan, Michele Ghielmini, Tina Nielsen, Sabine De Bedout, Tommy Fu, Nancy Valente, Nathan H Fowler, Eva Hoster, Marco Ladetto, Franck Morschhauser, Emanuele Zucca, Gilles Salles, Daniel J Sargent
Purpose Follicular lymphoma (FL) is an indolent cancer, with effective but rarely curative treatment options. As a standard study end point for first-line FL therapy, progression-free survival (PFS) requires extended follow-up (median PFS, > 7 years). To provide patients with earlier access to newer therapies, an earlier end point to expedite clinical trials is needed. Our objective was to formally assess the complete response rate at 30 months (CR30) after initiation of induction therapy as a potential surrogate end point for PFS in first-line FL therapy...
December 28, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28003879/should-hydrogen-therapy-be-included-in-a-musculoskeletal-medicine-routine
#6
Sergej M Ostojic
Molecular hydrogen (H 2) has recently been recognized as a potential novel therapeutic agent in biomedicine. Initially proposed to be a possible treatment for certain types of neuromuscular disorders, cardio-metabolic diseases and cancer, H 2 improved clinical end-points and surrogate markers in several clinical trials, mainly acting as an anti-inflammatory agent and powerful antioxidant. In this paper, the medicinal properties of H 2 in musculoskeletal medicine are discussed with the aim to provide an updated and practical overview for health professionals working in this field...
2016: F1000Research
https://www.readbyqxmd.com/read/27998881/cholesterol-paradox-a-correlate-does-not-a-surrogate-make
#7
Robert DuBroff
The global campaign to lower cholesterol by diet and drugs has failed to thwart the developing pandemic of coronary heart disease around the world. Some experts believe this failure is due to the explosive rise in obesity and diabetes, but it is equally plausible that the cholesterol hypothesis, which posits that lowering cholesterol prevents cardiovascular disease, is incorrect. The recently presented ACCELERATE trial dumbfounded many experts by failing to demonstrate any cardiovascular benefit of evacetrapib despite dramatically lowering low-density lipoprotein cholesterol and raising high-density lipoprotein cholesterol in high-risk patients with coronary disease...
December 20, 2016: Evidence-based Medicine
https://www.readbyqxmd.com/read/27979038/baseline-assessment-and-comparison-of-arterial-anatomy-hyperemic-flow-and-skeletal-muscle-perfusion-in-peripheral-artery-disease-the-cardiovascular-cell-therapy-research-network-patients-with-intermittent-claudication-injected-with-aldh-bright-cells-cctrn-pace
#8
Bharath Ambale Venkatesh, Victor Nauffal, Chikara Noda, Tomoki Fujii, Phillip C Yang, Judy Bettencourt, Erin P Ricketts, Michael Murphy, Nicholas J Leeper, Lem Moyé, Ray F Ebert, Raja Muthupillai, David A Bluemke, Emerson C Perin, Alan T Hirsch, João A C Lima
BACKGROUND: Peripheral artery disease (PAD) is important to public health as a major contributor to cardiovascular morbidity and mortality. Recent developments in magnetic resonance imaging (MRI) techniques permit improved assessment of PAD anatomy and physiology, and may serve as surrogate end points after proangiogenic therapies. METHODS: The PACE study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the physiologic impact and potential clinical efficacy of autologous bone marrow-derived ALDH(br) stem cells...
January 2017: American Heart Journal
https://www.readbyqxmd.com/read/27913502/mrd-in-aml-does-it-already-guide-therapy-decision-making
#9
Gert Ossenkoppele, Gerrit Jan Schuurhuis
Prognostic factors determined at diagnosis are predictive for outcome whereas achievement of morphological complete remission (CR) is still an important end point during treatment. Residual disease after therapy may reflect the sum of all diagnosis and postdiagnosis resistance mechanisms/factors; its measurement could hypothetically be very instrumental for guiding treatment. The possibility of defining residual disease (minimal residual disease [MRD]) far below the level of 5% blast cells is changing the landscape of risk classification...
December 2, 2016: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/27913493/novel-agents-in-follicular-lymphoma-choosing-the-best-target
#10
Laurie H Sehn
Outcomes in patients with follicular lymphoma (FL) have improved dramatically over the last decade. However, novel agents are greatly needed for those who exhibit treatment resistance, in order to minimize lifelong toxicity and to enable combinations that may allow us to achieve the elusive goal of cure. Biological advances have led to the discovery of a large number of potential therapeutic targets and the development of a plethora of novel agents designed to exploit these processes. Possible targets include tumor cell surface markers, key components of intracellular pathways and epigenetic mechanisms, and reactive cells of the microenvironment...
December 2, 2016: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/27900954/renin-angiotensin-aldosterone-system-blockade-in-diabetic-kidney-disease-a-critical-and-contrarian-point-of-view
#11
REVIEW
Mohamed E Elrggal, Shaaban M S Ahmed, Meguid El Nahas
Diabetes mellitus is the most common cause of end-stage renal disease (ESRD) worldwide. Diabetic kidney disease (DKD) is associated with high morbidity and cardiovascular mortality. A number of guidelines and recommendations have been issued over the years recommending the use of renin-angiotensin-aldosterone system (RAAS) blockade in the management of DKD. This critical analysis takes a contrarian view, based on a selection of key clinical trials in the field, to argue that albuminuria should not be considered a target for treatment but instead a surrogate marker of DKD progression...
November 2016: Saudi Journal of Kidney Diseases and Transplantation
https://www.readbyqxmd.com/read/27881506/development-and-evolution-of-a-hierarchical-clinical-composite-end-point-for-the-evaluation-of-drugs-and-devices-for-acute-and-chronic-heart-failure-a-20-year-perspective
#12
Milton Packer
Traditional approaches to the assessment of new treatments for heart failure have generally evaluated individual components of the syndrome at fixed points in time or have relied on surrogate physiological measures that are poorly correlated with the clinical status of patients. Conventional time-to-event trials that focus on morbidity and mortality represent an important methodological advance, but they generally assign undue weight to clinical events of less importance and are insensitive to difference in functional capacity among individuals who do not experience a clinical event during follow-up...
November 22, 2016: Circulation
https://www.readbyqxmd.com/read/27846007/carotid-intima-media-thickness-as-a-cardiovascular-risk-factor-and-imaging-pathway-of-atherosclerosis
#13
Osmar Antonio Centurión
Assessment of carotid intima-media thickness (IMT) has emerged as a simple and noninvasive technique for measuring atherosclerotic burden. Although serum biomarkers have been linked to the risk of developing atherosclerosis, carotid IMT has the theoretical advantage of directly visualizing a final consequence of the disease itself, namely atherosclerosis in the vessel wall. The current widespread application of carotid IMT measurements has been based on the validity, standardization, and reproducibility of the measurement and the evidence that an increased carotid IMT can be regarded as an attractive biomarker of atherosclerosis and of increased cardiovascular risk, potentially useful as a therapeutic target in those at increased cardiovascular risk...
December 2016: Critical Pathways in Cardiology
https://www.readbyqxmd.com/read/27678348/challenges-of-advanced-hepatocellular-carcinoma
#14
REVIEW
Stefano Colagrande, Andrea L Inghilesi, Sami Aburas, Gian G Taliani, Cosimo Nardi, Fabio Marra
Hepatocellular carcinoma (HCC) is an aggressive malignancy, resulting as the third cause of death by cancer each year. The management of patients with HCC is complex, as both the tumour stage and any underlying liver disease must be considered conjointly. Although surveillance by imaging, clinical and biochemical parameters is routinely performed, a lot of patients suffering from cirrhosis have an advanced stage HCC at the first diagnosis. Advanced stage HCC includes heterogeneous groups of patients with different clinical condition and radiological features and sorafenib is the only approved treatment according to Barcelona Clinic Liver Cancer...
September 14, 2016: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/27660042/a-medical-device-grade-t1-and-ecv-phantom-for-global-t1-mapping-quality-assurance-the-t1-mapping-and-ecv-standardization-in-cardiovascular-magnetic-resonance-t1mes-program
#15
Gabriella Captur, Peter Gatehouse, Kathryn E Keenan, Friso G Heslinga, Ruediger Bruehl, Marcel Prothmann, Martin J Graves, Richard J Eames, Camilla Torlasco, Giulia Benedetti, Jacqueline Donovan, Bernd Ittermann, Redha Boubertakh, Andrew Bathgate, Celine Royet, Wenjie Pang, Reza Nezafat, Michael Salerno, Peter Kellman, James C Moon
BACKGROUND: T1 mapping and extracellular volume (ECV) have the potential to guide patient care and serve as surrogate end-points in clinical trials, but measurements differ between cardiovascular magnetic resonance (CMR) scanners and pulse sequences. To help deliver T1 mapping to global clinical care, we developed a phantom-based quality assurance (QA) system for verification of measurement stability over time at individual sites, with further aims of generalization of results across sites, vendor systems, software versions and imaging sequences...
September 22, 2016: Journal of Cardiovascular Magnetic Resonance
https://www.readbyqxmd.com/read/27650765/using-serum-urate-as-a-validated-surrogate-end-point-for-flares-in-patients-with-gout-protocol-for-a-systematic-review-and-meta-regression-analysis
#16
Melanie B Morillon, Lisa Stamp, William Taylor, Jaap Fransen, Nicola Dalbeth, Jasvinder A Singh, Robin Christensen, Marissa Lassere
INTRODUCTION: Gout is the most common inflammatory arthritis in men over 40 years of age. Long-term urate-lowering therapy is considered a key strategy for effective gout management. The primary outcome measure for efficacy in clinical trials of urate-lowering therapy is serum urate levels, effectively acting as a surrogate for patient-centred outcomes such as frequency of gout attacks or pain. Yet it is not clearly demonstrated that the strength of the relationship between serum urate and clinically relevant outcomes is sufficiently strong for serum urate to be considered an adequate surrogate...
September 20, 2016: BMJ Open
https://www.readbyqxmd.com/read/27598745/systemic-treatment-for-advanced-hepatocellular-carcinoma-the-search-of-new-agents-to-join-sorafenib-in-the-effective-therapeutic-armamentarium
#17
Andrea Ribeiro de Souza, Maria Reig, Jordi Bruix
INTRODUCTION: Hepatocelullar carcinoma (HCC) is the third leading cause of cancer-related death worldwide. Despite the implementation of screening programs for high-risk individuals, a significant proportion of patients present with advanced disease at the moment of diagnosis. AREAS COVERED: In this review we will focus in the current treatment of advanced HCC, the research that has been done in the past few years, the achievements and failures in this setting and future perspectives...
October 2016: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/27557438/adult-stem-cell-therapy-and-heart-failure-2000-to-2016-a-systematic-review
#18
Patricia K Nguyen, June-Wha Rhee, Joseph C Wu
Importance: Stem cell therapy is a promising treatment strategy for patients with heart failure, which accounts for more than 10% of deaths in the United States annually. Despite more than a decade of research, further investigation is still needed to determine whether stem cell regenerative therapy is an effective treatment strategy and can be routinely implemented in clinical practice. Objective: To describe the progress in cardiac stem cell regenerative therapy using adult stem cells and to highlight the merits and limitations of clinical trials performed to date...
August 24, 2016: JAMA Cardiology
https://www.readbyqxmd.com/read/27515695/moderator-s-view-treatment-of-iga-nephropathy-getting-comfortable-with-uncertainty
#19
Richard J Glassock
A Polar Views discussion by Pozzi and Rauen et al. on the interpretation and clinical application of the recently published Supportive Versus Immunosuppressive Therapy of Progressive IgA Nephropathy (STOP-IgAN) trial has elucidated important points concerning potential strengths and weaknesses of this landmark randomized trial. This critical examination of the impact of steroid monotherapy or steroid plus an immunosuppressive (IS) agent compared with 'supportive' therapy with inhibitors of the renin-angiotensin system (RAS) has enhanced our appreciation of the importance of rigorous application of titrated RAS inhibition in high-risk patients with persistent proteinuria >0...
August 11, 2016: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/27451020/progression-free-survival-as-a-surrogate-for-overall-survival-in-first-line-chemotherapy-for-advanced-pancreatic-cancer
#20
Tsuyoshi Hamada, Yousuke Nakai, Hiroyuki Isayama, Hideo Yasunaga, Hiroki Matsui, Naminatsu Takahara, Suguru Mizuno, Hirofumi Kogure, Saburo Matsubara, Natsuyo Yamamoto, Minoru Tada, Kazuhiko Koike
BACKGROUND: Overall survival (OS), as the primary end-point in first-line chemotherapy trials, requires a prolonged follow-up time and may be confounded by subsequent regimens. This study aimed to evaluate the correlation between OS and surrogate end-points (progression-free survival [PFS], response rate and disease control rate), and to identify a potential surrogate for OS in advanced pancreatic cancer. METHODS: Based on an electronic search, we identified randomized controlled phase II and III trials of first-line chemotherapy for advanced pancreatic cancer...
September 2016: European Journal of Cancer
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