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https://www.readbyqxmd.com/read/28929484/post-marketing-research-and-its-outcome-for-novel-anticancer-agents-approved-by-both-the-fda-and-ema-between-2005-and-2010-a-cross-sectional-study
#1
Jean-David Zeitoun, Gabriel Baron, Alexandre Vivot, Ignacio Atal, Nicholas S Downing, Joseph S Ross, Philippe Ravaud
Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment...
September 20, 2017: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/28921820/systematic-review-and-network-meta-analysis-on-the-relative-efficacy-of-osteoporotic-medications-men-with-prostate-cancer-on-continuous-androgen-deprivation-therapy%C3%A2-to-reduce-risk-of-fragility-fractures
#2
REVIEW
Yeesha Poon, Petros Pechlivanoglou, Shabbir M H Alibhai, David Naimark, Jeffrey S Hoch, Emmanuel Papadimitropoulos, Mary-Ellen Hogan, Murray Krahn
BACKGROUND: Androgen deprivation therapy (ADT) is an effective treatment for men with advanced prostate cancer, but loss of bone mineral density (BMD) is a major risk factor for fractures. This analysis evaluated the relative effectiveness of osteoporosis treatments using BMD as a surrogate endpoint for fragility fractures in men on continuous ADT. METHOD: We included randomized controlled trials studying bisphosphonates, denosumab, toremifene, and raloxifene in patients with non-metastatic prostate cancer on ADT for review...
September 18, 2017: BJU International
https://www.readbyqxmd.com/read/28916466/a-multi-centered-epidemiological-study-evaluating-the-validity-of-the-treatment-difficulty-indices-developed-by-the-japan-prosthodontic-society
#3
Takuo Kuboki, Tetsuo Ichikawa, Kazuyoshi Baba, Masanori Fujisawa, Hironobu Sato, Hideki Aita, Shigeto Koyama, Masayuki Hideshima, Yuji Sato, Hiroyuki Wake, Aya Kimura-Ono, Kan Nagao, Yorika Kodaira-Ueda, Katsushi Tamaki, Shinsuke Sadamori, Kazuhiro Tsuga, Yasuhiro Nishi, Takashi Sawase, Hisashi Koshino, Shin-Ichi Masumi, Kaoru Sakurai, Kanji Ishibashi, Takashi Ohyama, Yasumasa Akagawa, Toshihiro Hirai, Keiichi Sasaki, Kiyoshi Koyano, Hirofumi Yatani, Hideo Matsumura
PURPOSE: The Japan Prosthodontic Society developed a multi-axis assessment protocol to evaluate the complex variations in patients who need prosthodontic care, and to classify the level of treatment difficulty. A previous report found the protocol to be sufficiently reliable. The purpose of this multi-center cohort study was to evaluate the validity of this multi-axis assessment protocol. METHODS: The treatment difficulty was evaluated using the multi-axis assessment protocol before starting prosthodontic treatment...
September 12, 2017: Journal of Prosthodontic Research
https://www.readbyqxmd.com/read/28903444/early-tumour-shrinkage-as-a-survival-predictor-in-patients-with-recurrent-glioblastoma-treated-with-bevacizumab-in-the-avareg-randomized-phase-ii-study
#4
Alba A Brandes, Gaetano Finocchiaro, Vittorina Zagonel, Michele Reni, Alessandra Fabi, Claudia Caserta, Alicia Tosoni, Marica Eoli, Giuseppe Lombardi, Matteo Clavarezza, Alexandro Paccapelo, Stefania Bartolini, Luigi Cirillo, Raffaele Agati, Enrico Franceschi
BACKGROUND: Disease assessment for recurrent glioblastoma (GBM) represents a challenge, especially with the use of antiangiogenic agents. Moreover, validated neuroradiological predictors of outcome are lacking. Recently, the concept of early tumor shrinkage (ETS) has been developed to better assess the ability of treatments in determining a rapid and remarkable tumor response. The aim of the study was to evaluate the role of ETS in predicting survival of GBM patients treated with BEV...
August 15, 2017: Oncotarget
https://www.readbyqxmd.com/read/28889347/decline-in-estimated-glomerular-filtration-rate-is-associated-with-risk-of-end-stage-renal-disease-in-type-2-diabetes-with-macroalbuminuria-an-observational-study-from-jdncs
#5
Miho Shimizu, Kengo Furuichi, Tadashi Toyama, Tomoaki Funamoto, Shinji Kitajima, Akinori Hara, Daisuke Ogawa, Daisuke Koya, Kenzo Ikeda, Yoshitaka Koshino, Yukie Kurokawa, Hideharu Abe, Kiyoshi Mori, Masaaki Nakayama, Yoshio Konishi, Ken-Ichi Samejima, Masaru Matsui, Hiroyuki Yamauchi, Tomohito Gohda, Kei Fukami, Daisuke Nagata, Hidenori Yamazaki, Yukio Yuzawa, Yoshiki Suzuki, Shouichi Fujimoto, Shoichi Maruyama, Sawako Kato, Takero Naito, Kenichi Yoshimura, Hitoshi Yokoyama, Takashi Wada
BACKGROUND: There is increased interest in surrogate endpoints for clinical trials of chronic kidney disease. METHODS: In this nationwide observational study of 456 patients with type 2 diabetes and clinically suspected diabetic nephropathy followed for a median of 4.2 years, we evaluated the association between estimated glomerular filtration rate (eGFR) and albuminuria at baseline or during follow-up and risk of ESRD. RESULTS: Low eGFR (<60 mL/min/1...
September 9, 2017: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/28888522/sleep-disordered-breathing-and-heart-failure-what-does-the-future-hold
#6
REVIEW
Martin R Cowie, Angela M Gallagher
Most patients with heart failure (HF) have sleep-disordered breathing (SDB), with central (rather than obstructive) sleep apnea becoming the predominant form in patients with more severe disease. Cyclical apnea and hypopneas are associated with sleep disturbance, hypoxemia, hemodynamic changes, and sympathetic activation. These patients have a worse prognosis than those without SDB. Mask-based therapies of positive airway pressure targeted at SDB can improve measures of sleep quality and can partially normalize the sleep and respiratory physiology...
August 30, 2017: JACC. Heart Failure
https://www.readbyqxmd.com/read/28884361/importance-of-glomerular-filtration-rate-change-as-surrogate-endpoint-for-the-future-incidence-of-end-stage-renal-disease-in-general-japanese-population-community-based-cohort-study
#7
Eiichiro Kanda, Tomoko Usui, Naoki Kashihara, Chiho Iseki, Kunitoshi Iseki, Masaomi Nangaku
BACKGROUND: Because of the necessity for extended period and large costs until the event occurs, surrogate endpoints are indispensable for implementation of clinical studies to improve chronic kidney disease (CKD) patients' prognosis. METHODS: Subjects with serum creatinine level for a baseline period over 1-3 years were enrolled (n = 69,238) in this community-based prospective cohort study in Okinawa, Japan, and followed up for 15 years. The endpoint was end-stage renal disease (ESRD)...
September 7, 2017: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/28881354/preoperative-capecitabine-oxaliplatin-and-irinotecan-in-resectable-gastric-or-gastroesophageal-junction-cancer-pathological-response-as-primary-endpoint-and-fdg-pet-predictions
#8
Rosa Berenato, Federica Morano, Filippo Pietrantonio, Christian Cotsoglou, Marta Caporale, Gabriele Infante, Alessandro Pellegrinelli, Alessandra Alessi, Carlo Battiston, Jorgelina Coppa, Barbara Padovano, Alessia Mennitto, Monica Niger, Giovanni Fucà, Silvia Lazzati, Giorgio Greco, Gabriele Delconte, Filippo de Braud, Vincenzo Mazzaferro, Maria Di Bartolomeo
OBJECTIVES: This phase II trial was aimed at assessing the safety and activity of capecitabine, oxaliplatin, and irinotecan (COI regimen) as a preoperative treatment for resectable gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. METHODS: Patients affected by T3-T4/N0-N+/M0 GC/GEJ cancer were treated with the COI regimen for 4 cycles followed by restaging and gastroresection with D2 lymphadenectomy. Four postoperative cycles were scheduled. The primary endpoint was pathological response rate according to Becker et al...
September 8, 2017: Oncology
https://www.readbyqxmd.com/read/28880053/liver-fibrosis-the-2017-state-of-art
#9
Gian P Caviglia, Chiara Rosso, Sharmila Fagoonee, Giorgio M Saracco, Rinaldo Pellicano
Liver fibrosis is a wound-healing response to a wide spectrum of chronic liver injuries. It is characterized by loss of hepatocytes and alteration in hepatic architecture following an imbalance between extracellular matrix synthesis and degradation. Irrespectively of underlying etiology, fibrosis may progress to cirrhosis and specific pathogenetic mechanisms as well as different disease patterns may be identified according to etiology. Liver biopsy is still considered the gold standard for fibrosis assessment, despite the fact that it is invasive, has poor patient compliance and is not exempt of complications...
September 5, 2017: Panminerva Medica
https://www.readbyqxmd.com/read/28865437/the-top-tertile-of-hematocrit-change-during-hospitalization-is-associated-with-lower-risk-of-mortality-in-acute-heart-failure-patients
#10
Haobin Zhou, Tianyu Xu, Yuli Huang, Qiong Zhan, Xingfu Huang, Qingchun Zeng, Dingli Xu
BACKGROUND: Hemoconcentration has been proposed as surrogate for changes in volume status among patients hospitalized with acute heart failure (AHF) and is associated with a favorable outcome. However, there is a dearth of research assessing the clinical outcomes of hospitalized patients with hemoconcentration, hemodilution and unchanged volume status. METHODS: We enrolled 510 consecutive patients hospitalized for AHF from April 2011 to July 2015. Hematocrit (HCT) levels were measured at admission and either at discharge or on approximately the seventh day of admission...
September 2, 2017: BMC Cardiovascular Disorders
https://www.readbyqxmd.com/read/28864724/immuno-oncology-trial-endpoints-capturing-clinically-meaningful-activity
#11
EDITORIAL
Valsamo Anagnostou, Mark Yarchoan, Aaron R Hansen, Hao Wang, Franco Verde, Elad Sharon, Deborah Collyar, Laura Q M Chow, Patrick M Forde
Immuno-oncology (I-O) has required a shift in the established paradigm of toxicity and response assessment in clinical research. The design and interpretation of cancer clinical trials has been primarily driven by conventional toxicity and efficacy patterns observed with chemotherapy and targeted agents, which are insufficient to fully inform clinical trial design and guide therapeutic decisions in I-O. Responses to immune-targeted agents follow nonlinear dose-response and dose-toxicity kinetics mandating the development of novel response evaluation criteria...
September 1, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28864095/minimal-residual-disease-in-chronic-lymphocytic-leukaemia
#12
REVIEW
José Antonio García Vela, José Antonio García Marco
Minimal residual disease (MRD) assessment is an important endpoint in the treatment of chronic lymphocytic leukaemia (CLL). It is highly predictive of prolonged progression-free survival (PFS) and overall survival and could be considered a surrogate for PFS in the context of chemoimmunotherapy based treatment. Evaluation of MRD level by flow cytometry or molecular techniques in the era of the new BCR and Bcl-2 targeted inhibitors could identify the most cost-effective and durable treatment sequencing. A therapeutic approach guided by the level of MRD might also determine which patients would benefit from an early stop or consolidation therapy...
August 29, 2017: Medicina Clínica
https://www.readbyqxmd.com/read/28851688/surrogate-endpoint-id-d-for-prostate-cancer-trials
#13
(no author information available yet)
Metastasis-free survival is a strong surrogate for overall survival for men with localized prostate cancer, a meta-analysis shows. The intermediate outcome measure could help accelerate the evaluation of novel adjuvant therapies in this patient population.
August 29, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28844157/validation-of-genetic-predictors-of-late-radiation-induced-morbidity-in-prostate-cancer-patients
#14
Line M H Schack, Stine E Petersen, Steffen Nielsen, Lilly Lundby, Morten Høyer, Lise Bentzen, Jens Overgaard, Christian N Andreassen, Jan Alsner
INTRODUCTION: Normal tissue morbidity sets the dose limit for radiotherapy (RT) in cancer treatment and has importance for quality of life for cancer survivors. A previous study of prostate cancer patients treated with RT generated clinical data for radiation-induced morbidity measured by anorectal physiological methods and validated questionnaires. Other studies have identified genetic predictors associated with late radiation-induced morbidity outcome. We have expanded biobank material aiming to validate single nucleotide polymorphisms (SNPs) and a gene expression classifier with endpoints on patient-reported outcomes and biomechanical properties of the anorectum from our cohort matching originally published endpoints...
August 26, 2017: Acta Oncologica
https://www.readbyqxmd.com/read/28844036/from-state-of-the-art-cell-therapy-to-endogenous-cardiac-repair
#15
Werner Mohl, Timothy D Henry, Dejan Milasinovic, Filomain Nguemo, Juergen Hescheler, Emerson C Perin
Clinical heart failure prevention and contemporary therapy often involve breaking the vicious cycle of global haemodynamic consequences of myocardial decay. The lack of effective regenerative therapies results in a primary focus on preventing further deterioration of cardiac performance. The cellular transplantation hypothesis has been evaluated in many different preclinical models and a handful of important clinical trials. The primary expectation that cellular transplants will be embedded into failing myocardium and fuse with existing functioning cells appears unlikely...
August 25, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28835682/outcome-switching-in-randomized-controlled-oncology-trials-reporting-on-surrogate-endpoints-a-cross-sectional-analysis
#16
Alberto Falk Delgado, Anna Falk Delgado
Inconsistent reporting of clinical trials is well-known in the literature. Despite this, factors associated with poor practice such as outcome switching in clinical trials are poorly understood. We performed a cross-sectional analysis to evaluate the prevalence of, and the factors associated with outcome switching. PubMed and Embase were searched for pharmaceutical randomized controlled trials (RCTs) in oncology reporting on a surrogate primary outcome published in 2015. Outcome switching was present in 18% (39/216)...
August 23, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28829251/challenges-in-development-of-sperm-repositories-for-biomedical-fishes-quality-control-in-small-bodied-species
#17
Leticia Torres, Yue Liu, Amy Guitreau, Huiping Yang, Terrence R Tiersch
Quality control (QC) is essential for reproducible and efficient functioning of germplasm repositories. However, many biomedical fish models present significant QC challenges due to small body sizes (<5 cm) and miniscule sperm volumes (<5 μL). Using minimal volumes of sperm, we used Zebrafish to evaluate common QC endpoints as surrogates for fertilization success along sequential steps of cryopreservation. First, concentrations of calibration bead suspensions were evaluated with a Makler(®) counting chamber by using different sample volumes and mixing methods...
August 22, 2017: Zebrafish
https://www.readbyqxmd.com/read/28816230/plasma-pcsk9-levels-are-unrelated-to-arterial-stiffness-in-a-community-based-4-8-year-prospective-study
#18
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
#19
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
#20
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
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