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https://www.readbyqxmd.com/read/28738235/treatment-decisions-in-metastatic-colorectal-cancer-beyond-first-and-second-line-combination-therapies
#1
REVIEW
A Vogel, R D Hofheinz, S Kubicka, D Arnold
Median overall survival (OS) of patients with metastatic colorectal cancer (mCRC) has reached up to 30months in recent clinical trials of first line therapies. Following disease progression after the standard in both, 1st and 2nd line, combination chemotherapy with monoclonal antibodies, many patients maintain a good performance status and a significant proportion is motivated to undergo further therapy. Choices of treatment beyond the second line setting for mCRC are therefore becoming increasingly important...
May 4, 2017: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/28738158/efficient-interfacially-driven-vehiculization-of-corticosteroids-by-pulmonary-surfactant
#2
Alberto Hidalgo, Fabrizio Salomone, Nieves Fresno, Guillermo Orellana, Antonio Cruz, Jesus Perez-Gil
Pulmonary surfactant is a crucial system to stabilize the respiratory air-liquid interface. Furthermore, pulmonary surfactant has been proposed as an effective method for targeting drugs to the lungs. However, few studies have examined in detail the mechanisms of incorporation of drugs into surfactant, the impact of the presence of drugs on pulmonary surfactant performance at the interface under physiologically-meaningful conditions, or the ability of pulmonary surfactant to use the air-liquid interface to vehiculise drugs to long distances...
July 24, 2017: Langmuir: the ACS Journal of Surfaces and Colloids
https://www.readbyqxmd.com/read/28737050/efficacy-of-elagolix-in-the-treatment-of-endometriosis
#3
Alexandra Perricos, René Wenzl
Much research has gone into developing medications that can be used to alleviate endometriosis-associated symptoms. In addition to already established medications, a new GnRH antagonist, elagolix, is in development. The novelty of this drug compared to other GnRH antagonists, is its nonpeptide structure, allowing it to be administered orally. Areas covered: We analyzed several Phase I, II and III clinical trials that have evaluated the safety and efficacy of this new medication. Expert opinion: Since many medications have been put on the market and have gained popularity for the treatment of endometriosis-associated symptoms, the demonstration of equality or superiority of effect, tolerability, as well as patient compliance should be assessed when introducing a new drug...
July 24, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28736633/biologics-in-gastrointestinal-and-pancreatic-neuroendocrine-tumors
#4
REVIEW
Iris H Liu, Pamela L Kunz
The development of biologic agents has ushered in a new era of precision medicine, opening the door to new therapeutic options designed to intelligently target cancer cells and their promoting factors, while leaving normal cells relatively unharmed. Biologics for the treatment of neuroendocrine tumors (NETs) have followed in the footsteps of regimens targeting pathways upregulated in other cancers, including the vascular endothelial growth factor (VEGF) and the mammalian target of rapamycin (mTOR). Through a number of clinical trials, the mTOR inhibitor everolimus and the receptor tyrosine kinase (RTK) inhibitor sunitinib were recently approved for NETs...
June 2017: Journal of Gastrointestinal Oncology
https://www.readbyqxmd.com/read/28735109/design-and-rationale-for-a-real-world-observational-cohort-of-patients-with-nonalcoholic-fatty-liver-disease-the-target-nash-study
#5
A Sidney Barritt, Norman Gitlin, Samuel Klein, Anna S Lok, Rohit Loomba, Laura Malahias, Margaret Powell, Miriam B Vos, L Michael Weiss, Kenneth Cusi, Brent A Neuschwander-Tetri, Arun Sanyal
Nonalcoholic fatty liver disease (NAFLD) is highly prevalent and can lead to cirrhosis, hepatocellular carcinoma, and end-stage liver disease. NAFLD comprises the spectrum from simple steatosis (nonalcoholic fatty liver, NAFL), to steatosis with inflammation (nonalcoholic steatohepatitis, NASH). Current primary therapy recommended for NAFLD is weight loss induced by lifestyle modification. The difficulty in achieving this has led to robust pharmacological therapy development. While new drugs may show efficacy in selected phase II/III clinical trial populations, their real-world effectiveness is unknown...
July 19, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28735072/long-term-outcomes-of-adults-with-first-relapsed-refractory-systemic-anaplastic-large-cell-lymphoma-in-the%C3%A2-pre-brentuximab-vedotin-era-a-lysa-sfgm-tc-study
#6
Alexandre Morel, Josette Brière, Laurence Lamant, Michaël Loschi, Corinne Haioun, Richard Delarue, Olivier Tournilhac, Emmanuel Bachy, Anne Sonet, Sandy Amorim, Camille Laurent, Philippe Gaulard, Hervé Tilly, David Sibon
BACKGROUND: Long-term outcomes of adults with first-relapsed/refractory (R/R) systemic anaplastic large-cell lymphoma (ALCL) are not definitively established and should be evaluated. PATIENTS AND METHODS: We previously published the long-term outcomes of adults with ALCL initially treated with polychemotherapy in LYmphoma Study Association (LYSA) prospective clinical trials conducted during the pre-brentuximab vedotin era. Herein, we report the long-term outcomes of those patients after the first-relapsed/refractory (R/R) events...
July 20, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28733961/a-review-of-biomarkers-for-neurodegenerative-disease-will-they-swing-us-across-the-valley
#7
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/28733956/amyloid-beta-and-tau-as-alzheimer-s-disease-blood-biomarkers-promise-from-new-technologies
#8
REVIEW
Lih-Fen Lue, Andre Guerra, Douglas G Walker
The utility of the levels of amyloid beta (Aβ) peptide and tau in blood for diagnosis, drug development, and assessment of clinical trials for Alzheimer's disease (AD) has not been established. The lack of availability of ultra-sensitive assays is one critical issue that has impeded progress. The levels of Aβ species and tau in plasma and serum are much lower than levels in cerebrospinal fluid. Furthermore, plasma or serum contain high levels of assay-interfering factors, resulting in difficulties in the commonly used singulex or multiplex ELISA platforms...
July 2017: Neurology and Therapy
https://www.readbyqxmd.com/read/28731876/neuraxial-drug-delivery-for-the-management-of-cancer-pain-cost-updates-and-society-guidelines
#9
Collin F M Clarke
PURPOSE OF REVIEW: The present study discusses the utilization of neuraxial drug delivery (NDD) for the management of cancer pain, based on recent trials, reviews, and guidelines with a focus on cost analysis. RECENT FINDINGS: Almost all recent publications suggest that more stringent research is needed to improve evidence on NDD, particularly as conflicting reports exist regarding cost effectiveness of drug delivery systems. The combination of local anesthetics and opioids, with or without clonidine, continues to be reported as beneficial with the utilization of patient controlled systems providing an advantage over continuous ones...
July 20, 2017: Current Opinion in Anaesthesiology
https://www.readbyqxmd.com/read/28731207/polyclonal-and-monoclonal-antibodies-for-treating-acute-rejection-episodes-in-kidney-transplant-recipients
#10
REVIEW
Angela C Webster, Sunny Wu, Krishna Tallapragada, Min Young Park, Jeremy R Chapman, Sue J Carr
BACKGROUND: Registry data shows that the incidence of acute rejection has been steadily falling. Approximately 10% to 35% of kidney recipients will undergo treatment for at least one episode of acute rejection within the first post-transplant year. Treatment options include pulsed steroid therapy, the use of an antibody preparation, the alteration of background immunosuppression, or combinations of these options. Over recent years, new treatment strategies have evolved, and in many parts of the world there has been an increase in use of tacrolimus and mycophenolate and a reduction in the use of cyclosporin and azathioprine use as baseline immunosuppression to prevent acute rejection...
July 20, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28729382/recommended-clinical-trial-end-points-for-dialysis-catheters
#11
Michael Allon, Deborah J Brouwer-Maier, Kenneth Abreo, Kevin M Baskin, Kay Bregel, Deepa H Chand, Andrea M Easom, Leonard Mermel, Michele H Mokrzycki, Priti R Patel, Prabir Roy-Chaudhury, Surendra Shenoy, Rudolph P Valentini, Haimanot Wasse
Central venous catheters are used frequently in patients on hemodialysis as a bridge to a permanent vascular access. They are prone to frequent complications, including catheter-related bloodstream infection, catheter dysfunction, and central vein obstruction. There is a compelling need to develop new drugs or devices to prevent central venous catheter complications. We convened a multidisciplinary panel of experts to propose standardized definitions of catheter end points to guide the design of future clinical trials seeking approval from the Food and Drug Administration...
July 20, 2017: Clinical Journal of the American Society of Nephrology: CJASN
https://www.readbyqxmd.com/read/28729250/stellarex-drug-coated-balloon-for-treatment-of-femoropopliteal-disease-12-month-outcomes-from-the-randomized-illumenate-pivotal-and-pharmacokinetic-studies
#12
Prakash Krishnan, Peter Faries, Khusrow Niazi, Ash Jain, Ravish Sachar, William B Bachinsky, Joseph A Cardenas, Martin Werner, Marianne Brodmann, J A Mustapha, Carlos I Mena-Hurtado, Michael R Jaff, Andrew H Holden, Sean P Lyden
Background -Drug-coated balloons (DCB) are a predominant revascularization therapy for symptomatic femoropopliteal artery disease. Due to differences in excipients, paclitaxel dose and coating morphologies, varying clinical outcomes have been observed with different DCBs. We report the results of two studies investigating the pharmacokinetic (PK) and clinical outcomes of a new DCB to treat femoropopliteal disease. Methods -In the ILLUMENATE Pivotal Study, 300 symptomatic patients (Rutherford class 2-4), were randomized to DCB (N=200) or standard angioplasty (PTA) (N=100)...
July 20, 2017: Circulation
https://www.readbyqxmd.com/read/28728496/a-missing-piece-in-clinical-trial-inspections-in-latin-america-interviews-with-research-subjects-in-peru
#13
Gabriela E Minaya, Duilio J Fuentes-Delgado, Antonio Ugalde, Núria Homedes
Most regulatory agencies conduct clinical trial (CT) site inspections, but the experiences and behaviors of the research subjects and their knowledge of the rights and obligations that ensue from participating in a CT are seldom explored. The authors assessed the technical feasibility of incorporating interviews with participants in CT inspections. This article analyzes the responses of 13 CT participants, 14% ( n = 96) of those included in three tuberculosis (TB) CTs. Participants did not object to being interviewed and provided information not obtained during regular inspections...
July 1, 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28725965/medulloblastoma-experimental-models-and-reality
#14
REVIEW
Julia E Neumann, Fredrik J Swartling, Ulrich Schüller
Medulloblastoma is the most frequent malignant brain tumor in childhood, but it may also affect infants, adolescents, and young adults. Recent advances in the understanding of the disease have shed light on molecular and clinical heterogeneity, which is now reflected in the updated WHO classification of brain tumors. At the same time, it is well accepted that preclinical research and clinical trials have to be subgroup-specific. Hence, valid models have to be generated specifically for every medulloblastoma subgroup to properly mimic molecular fingerprints, clinical features, and responsiveness to targeted therapies...
July 19, 2017: Acta Neuropathologica
https://www.readbyqxmd.com/read/28725955/biologics-in-juvenile-idiopathic-arthritis-a-narrative-review
#15
REVIEW
Federica Vanoni, Francesca Minoia, Clara Malattia
In the past years, pediatric rheumatology has seen a revolution in the treatments for rheumatic diseases, particularly juvenile idiopathic arthritis. Even if nonsteroidal anti-inflammatory drugs (NSAID), intra-articular corticosteroids (IAC) injections, and methotrexate remain the mainstay of the treatment for JIA patients, in aggressive disease, these treatments may be not sufficient to reach disease remission and to prevent long-term disability. Comprehension of immunological mechanisms involved in the pathogenesis of the diseases allowed to conceive new drugs targeting specific steps of the immune response...
July 20, 2017: European Journal of Pediatrics
https://www.readbyqxmd.com/read/28724415/identification-and-characterization-of-the-antiplasmodial-activity-of-hsp90-inhibitors
#16
Claribel Murillo-Solano, Chunmin Dong, Cecilia G Sanchez, Juan C Pizarro
BACKGROUND: The recent reduction in mortality due to malaria is being threatened by the appearance of Plasmodium falciparum parasites that are resistant to artemisinin in Southeast Asia. To limit the impact of resistant parasites and their spread across the world, there is a need to validate anti-malarial drug targets and identify new leads that will serve as foundations for future drug development programmes targeting malaria. Towards that end, the antiplasmodial potential of several Hsp90 inhibitors was characterized...
July 19, 2017: Malaria Journal
https://www.readbyqxmd.com/read/28723489/immunotherapy-for-renal-cancer-sequencing-and-combinations
#17
REVIEW
Grant D Stewart, Maria De Santis, Bernard Escudier, Thomas Powles, Guru Sonpavde
CONTEXT: Current therapy for renal cell carcinoma (RCC) generally consists of the sequential administration of single agent therapy. Given the advent of T-cell checkpoint inhibitors, the role of combinations including these agents is being intensely interrogated. OBJECTIVE: To evaluate ongoing trials of combinations including immunotherapy and sequencing of agents to treat RCC. EVIDENCE ACQUISITION: Recent data and ongoing trials were analyzed to evaluate the direction of research in this arena...
December 15, 2016: European Urology Focus
https://www.readbyqxmd.com/read/28723476/charting-recent-progress-and-challenges-in-metastatic-castration-resistant-prostate-cancer-is-there-an-optimal-treatment-sequence
#18
REVIEW
Stéphane Oudard, Pablo Maroto, Gaston Demonty, Winald R Gerritsen
CONTEXT: Recent developments in the treatment of metastatic castration-resistant prostate cancer (mCRPC) have led to uncertainty about the optimal sequence of agents. OBJECTIVE: To review and assess treatment options and sequence in patients with mCRPC. EVIDENCE ACQUISITION: To identify data on the optimal use of approved treatments, we searched PubMed for studies on the use of recently approved agents for men with mCRPC published before March 2015...
October 2016: European Urology Focus
https://www.readbyqxmd.com/read/28722159/commentary-changes-are-still-needed-on-multiple-co-primary-endpoints
#19
Christy Chuang-Stein, Jianjun David Li
The Food and Drug Administration in the United States issued a much-awaited draft guidance on 'Multiple Endpoints in Clinical Trials' in January 2017. The draft guidance is well written and contains consistent message on the technical implementation of the principles laid out in the guidance. In this commentary, we raise a question on applying the principles to studies designed from a safety perspective. We then direct our attention to issues related to multiple co-primary endpoints. In a paper published in the Drug Information Journal in 2007, Offen et al...
July 19, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28722080/-a-surgery-oriented-classification-in-conversion-therapy-of-gastric-cancer
#20
Ziyu Li, Kan Xue, Jiafu Ji
Clinical practice showed that some advanced gastric cancer (AGC) patients achieved long-term survival after surgery, whereas some benefited from non-surgical treatment. In recent years, with the emergence of new drugs, diversity of treatment and development of multi-disciplinary team, the concept of conversion therapy comes into attention. Owing to diverse phenotypes with scattered cases, publications are mainly case reports or small sample studies from single centers, which makes it hard to acquire high-level evidence...
July 25, 2017: Zhonghua Wei Chang Wai Ke za Zhi, Chinese Journal of Gastrointestinal Surgery
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