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clinical trial phase III

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https://www.readbyqxmd.com/read/28214655/identification-of-microrna-biomarkers-for-response-of-advanced-soft-tissue-sarcomas-to-eribulin-translational-results-of-the-eortc-62052-trial
#1
Erik A C Wiemer, Agnieszka Wozniak, Herman Burger, Marcel Smid, Giuseppe Floris, Axelle Nzokirantevye, Raf Sciot, Stefan Sleijfer, Patrick Schöffski
BACKGROUND: Recent phase II and III clinical trials demonstrated anti-tumour activity of eribulin, a tubulin-interacting cytotoxic agent, in patients with metastatic soft tissue sarcoma (STS). In this exploratory study, we aimed to identify putative microRNA biomarkers that associate with eribulin sensitivity or resistance in STS. MATERIALS AND METHODS: Archival tumour tissue from primary tumours or metastatic lesions was collected prior to eribulin treatment, from 65 consenting patients involved in the EORTC trial 62052...
February 16, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28214596/early-non-response-to-certolizumab-pegol-in-rheumatoid-arthritis-predicts-treatment-failure-at-one-year-data-from-a-randomised-phase-iii-clinical-trial
#2
Francis Berenbaum, Thao Pham, Pascal Claudepierre, Thibault de Chalus, Jean-Michel Joubert, Carine Saadoun, Lionel Riou França, Bruno Fautrel
OBJECTIVES: To compare different early clinical criteria of non-response determined at three months as predictors of clinical failure at one year in patients with rheumatoid arthritis starting therapy with certolizumab pegol. METHODS: Data were derived from a randomised Phase III clinical trial in patients with rheumatoid arthritis who failed to respond to methotrexate monotherapy. Patients included in this post-hoc analysis were treated with certolizumab pegol (400mg qd reduced to 200mg qd after one month) and with methotrexate...
February 15, 2017: Joint, Bone, Spine: Revue du Rhumatisme
https://www.readbyqxmd.com/read/28213685/prasugrel-for-japanese-patients-with-acute-coronary-syndrome-in-short-term-clinical-practice-prasfit-practice-i-a-postmarketing-observational-study
#3
Masato Nakamura, Tomoko Iizuka, Kei Sagawa, Kenji Abe, Shuichi Chikada, Miyuki Arai
: Data on prasugrel use in Japanese patients are limited to phase II/III clinical trials. This early postmarketing observational study evaluated the safety and efficacy of short-term prasugrel use in patients with acute coronary syndrome (ACS) in real-world clinical settings in Japan. From May 2014 to January 2015, we enrolled consecutive patients with ACS requiring percutaneous coronary intervention in each institution. Each patient started prasugrel treatment ≥1 month before the end of the study period...
February 17, 2017: Cardiovascular Intervention and Therapeutics
https://www.readbyqxmd.com/read/28212543/metabotropic-glutamate-receptors-as-a-new-therapeutic-target-for-malignant-gliomas
#4
REVIEW
Mery Stefani Leivas Pereira, Fábio Klamt, Chairini Cássia Thomé, Paulo Valdeci Worm, Diogo Losch de Oliveira
Metabotropic glutamate receptors (mGluR) are predominantly involved in maintenance of cellular homeostasis of central nervous system. However, evidences have suggested other roles of mGluR in human tumors. Aberrant mGluR signaling has been shown to participate in transformation and maintenance of various cancer types, including malignant brain tumors. This review intends to summarize recent findings regarding the involvement of mGluR-mediated intracellular signaling pathways in progression, aggressiveness, and recurrence of malignant gliomas, mainly glioblastomas (GBM), highlighting the potential therapeutic applications of mGluR ligands...
February 12, 2017: Oncotarget
https://www.readbyqxmd.com/read/28211007/daclizumab-a-review-in-relapsing-multiple-sclerosis
#5
Matt Shirley
Daclizumab (Zinbryta(®); previously known as daclizumab high-yield process) is a therapeutic monoclonal antibody that has recently been approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Daclizumab is a humanized IgG1 monoclonal antibody directed against CD25, the alpha subunit of the high-affinity interleukin-2 receptor. As demonstrated in the phase III DECIDE trial, once-monthly subcutaneous daclizumab was superior to once-weekly intramuscular interferon (IFN) β-1a in reducing the clinical relapse rate and radiological measures of disease in patients with relapsing-remitting MS...
February 17, 2017: Drugs
https://www.readbyqxmd.com/read/28209746/a-phase-ii-randomized-trial-go27827-of-first-line-folfox-plus-bevacizumab-with-or-without-the-met-inhibitor-onartuzumab-in-patients-with-metastatic-colorectal-cancer
#6
Johanna C Bendell, Howard Hochster, Lowell L Hart, Irfan Firdaus, Joseph R Mace, Joshua J McFarlane, Mark Kozloff, Daniel Catenacci, Jessie J Hsu, Stephen P Hack, David S Shames, See-Chun Phan, Hartmut Koeppen, Allen L Cohn
BACKGROUND: Dysregulated hepatocyte growth factor/mesenchymal-epithelial transition (MET) signaling is associated with poor prognosis and resistance to vascular endothelial growth factor inhibition in metastatic colorectal cancer (mCRC). We report outcomes from a double-blind, multicenter phase II trial of the MET inhibitor onartuzumab in combination with mFOLFOX-6 and bevacizumab for mCRC (GO27827; NCT01418222). MATERIALS AND METHODS: Patients were randomized 1:1 to receive onartuzumab (10 mg/kg intravenously [IV]) or placebo plus mFOLFOX-6 and bevacizumab (5 mg/kg IV)...
February 16, 2017: Oncologist
https://www.readbyqxmd.com/read/28208695/the-role-of-inhaled-loxapine-in-the-treatment-of-acute-agitation-in-patients-with-psychiatric-disorders-a-clinical-review
#7
REVIEW
Domenico de Berardis, Michele Fornaro, Laura Orsolini, Felice Iasevoli, Carmine Tomasetti, Andrea de Bartolomeis, Nicola Serroni, Alessandro Valchera, Alessandro Carano, Federica Vellante, Stefano Marini, Monica Piersanti, Giampaolo Perna, Giovanni Martinotti, Massimo Di Giannantonio
Loxapine is a first generation antipsychotic, belonging to the dibenzoxazepine class. Recently, loxapine has been reformulated at a lower dose, producing an inhaled powder that can be directly administered to the lungs to treat the agitation associated with psychiatric disorders, such as schizophrenia and bipolar disorder. Thus, the aim of this narrative and clinical mini-review was to evaluate the efficacy and tolerability of inhaled loxapine in the treatment of acute agitation in patients with psychiatric disorders...
February 8, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28208197/reversal-of-direct-oral-anticoagulants-current-status-and-future-directions
#8
Jeffrey I Weitz
Direct oral anticoagulants (DOACs) are increasingly used for prevention and treatment of venous thromboembolism and for prevention of stroke in patients with nonvalvular atrial fibrillation. In phase III clinical trials that included more than 100,000 patients, the DOACs were at least as effective as vitamin K antagonists (VKAs) and were associated with less serious bleeding, particularly less intracranial bleeding. Real-world evidence supports these outcomes. Despite this, some physicians and patients are concerned about serious bleeding or emergencies unless specific reversal agents for the DOACs are available...
February 2017: Seminars in Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28205060/validation-of-the-jcog-prognostic-index-in-advanced-gastric-cancer-using-individual-patient-data-from-the-spirits-and-g-sox-trials
#9
Daisuke Takahari, Junki Mizusawa, Wasaburo Koizumi, Ichinosuke Hyodo, Narikazu Boku
BACKGROUND: In a phase III study for advanced gastric cancer (AGC), the Japan Clinical Oncology Group (JCOG) 9912 trial, we previously identified the following four prognostic factors-performance status ≥1, number of metastatic sites ≥2, no prior gastrectomy, and abnormal serum alkaline phosphatase levels-and proposed a prognostic index (good risk with 0 or 1 factor, moderate risk with 2 or 3 factors, and poor risk with all 4 factors). To assess the generalizability of this index, we attempted an external validation study using an independent data set...
February 16, 2017: Gastric Cancer
https://www.readbyqxmd.com/read/28202353/the-potential-clinical-promise-of-multimodality-metronomic-chemotherapy-revealed-by-preclinical-studies-of-metastatic-disease
#10
Robert S Kerbel, Yuval Shaked
We present a rationale for further clinical development and assessment of metronomic chemotherapy on the basis of unexpected results obtained in translational mouse models of cancer involving treatment of advanced metastatic disease. Historically, mouse cancer therapy models have been dominated by treating established primary tumors or early stage low volume microscopic disease. Treatment of primary tumors is also almost always the case when using genetically engineered mouse models (GEMMS) of cancer or patient-derived xenografts (PDXs)...
February 12, 2017: Cancer Letters
https://www.readbyqxmd.com/read/28202000/safety-and-efficacy-of-lobaplatin-combined-with-5-fluorouracil-as-first-line-induction-chemotherapy-followed-by-lobaplatin-radiotherapy-in-locally-advanced-nasopharyngeal-carcinoma-preliminary-results-of-a-prospective-phase-ii-trial
#11
Liang-Ru Ke, Wei-Xiong Xia, Wen-Ze Qiu, Xin-Jun Huang, Jing Yang, Ya-Hui Yu, Hu Liang, Guo-Ying Liu, Yan-Fang Ye, Yan-Qun Xiang, Xiang Guo, Xing Lv
BACKGROUND: Due to improvements in imaging and radiological techniques as well as the use of chemotherapy, distant metastasis has become the predominant mode of treatment failure in patients with locally advanced nasopharyngeal carcinoma (LA-NPC). Platinum-based systemic chemotherapy has shown survival benefits and is now the standard strategy for systemic therapy in patients with LA-NPC. Notably, the third-generation platinum reagent lobaplatin has shown anti-tumor effects in several solid tumors with lower incidences of gastrointestinal, hepatic and renal toxicity relative to other platinum drugs...
February 15, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28201994/risedronate-therapy-in-patients-with-mild-to-moderate-chronic-kidney-disease-with-osteoporosis-post-hoc-analysis-of-data-from-the-risedronate-phase-iii-clinical-trials
#12
Takashi Shigematsu, Ryoichi Muraoka, Toshitsugu Sugimoto, Yoshiki Nishizawa
BACKGROUND: The clinical effect of bisphosphonate treatment has not been clearly evaluated by kidney function in Japanese Chronic Kidney Disease (CKD) patients with osteoporosis. This study analyzed the data from three risedronate Japanese phase III trials. The clinical effect of risedronate therapy was evaluated in CKD patients with osteoporosis. METHODS: The Japanese clinical trials involved 852 subjects who received risedronate (2.5 mg once daily or 17.5 mg once weekly) and whose estimated glomerular filtration rate (eGFR) were calculable and at ≥ 30 mL/min...
February 15, 2017: BMC Nephrology
https://www.readbyqxmd.com/read/28199143/randomized-trial-comparing-r-chop-versus-high-dose-sequential-chemotherapy-in-high-risk-patients-with-diffuse-large-b-cell-lymphomas
#13
Sergio Cortelazzo, Corrado Tarella, Alessandro Massimo Gianni, Marco Ladetto, Anna Maria Barbui, Andrea Rossi, Giuseppe Gritti, Paolo Corradini, Massimo Di Nicola, Caterina Patti, Antonino Mulé, Manuela Zanni, Valerio Zoli, Atto Billio, Andrea Piccin, Giovanni Negri, Claudia Castellino, Francesco Di Raimondo, Andrés J M Ferreri, Fabio Benedetti, Giorgio La Nasa, Guido Gini, Livio Trentin, Maurizio Frezzato, Leonardo Flenghi, Simona Falorio, Marco Chilosi, Riccardo Bruna, Valentina Tabanelli, Stefano Pileri, Arianna Masciulli, Federica Delaini, Cristina Boschini, Alessandro Rambaldi
Purpose The benefit of high-dose chemotherapy with autologous stem-cell transplantation (ASCT) as first-line treatment in patients with diffuse large B-cell lymphomas is still a matter of debate. To address this point, we designed a randomized phase III trial to compare rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)-14 (eight cycles) with rituximab plus high-dose sequential chemotherapy (R-HDS) with ASCT. Patients and Methods From June 2005 to June 2011, 246 high-risk patients with a high-intermediate (56%) or high (44%) International Prognostic Index score were randomly assigned to the R-CHOP or R-HDS arm, and 235 were analyzed by intent to treat...
November 20, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28197755/direct-oral-anticoagulants-for-extended-duration-thromboprophylaxis-in-hospitalized-medically-ill-patients-are-we-there-yet
#14
Majed S Al Yami, Osamah M Alfayez, Sawsan M Kurdi, Razan Alsheikh
Despite a recommended 7-10 days of thromboprophylaxis, medically ill patients remain at increased risk of developing venous thromboembolism (VTE) after hospital discharge. Here, we present a contemporary review on the efficacy and safety of extended-duration thromboprophylaxis with direct oral anticoagulants (DOACs) in hospitalized medically ill patients. A search of publication and trial databases of controlled trials conducted from 2010 to 2016 using the key terms apixaban, rivaroxaban, and betrixaban showed three phase III trials that met our search criteria...
February 14, 2017: Journal of Thrombosis and Thrombolysis
https://www.readbyqxmd.com/read/28197738/vaccines-for-staphylococcus-aureus-and-target-populations
#15
Clarissa Pozzi, Reuben Olaniyi, Lassi Liljeroos, Ilaria Galgani, Rino Rappuoli, Fabio Bagnoli
Staphylococcus aureus is a leading pathogen in surgical site, intensive care unit, and skin infections, as well as healthcare-associated pneumonias. These infections are associated with an enormous burden of morbidity, mortality, and increase of hospital length of stay and patient cost. S. aureus is impressively fast in acquiring antibiotic resistance, and multidrug-resistant strains are a serious threat to human health. Due to resistance or insufficient effectiveness, antibiotics and bundle measures leave a tremendous unmet medical need worldwide...
February 15, 2017: Current Topics in Microbiology and Immunology
https://www.readbyqxmd.com/read/28194999/upper-airway-stimulation-for-obstructive-sleep-apnea
#16
M Boyd Gillespie, Ryan J Soose, B Tucker Woodson, Kingman P Strohl, Joachim T Maurer, Nico de Vries, David L Steward, Jonathan Z Baskin, M Safwan Badr, Ho-Sheng Lin, Tapan A Padhya, Sam Mickelson, W McDowell Anderson, Olivier M Vanderveken, Patrick J Strollo
Objective To assess patient-based outcomes of participants in a large cohort study-the STAR trial (Stimulation Therapy for Apnea Reduction)-48 months after implantation with an upper airway stimulation system for moderate to severe obstructive sleep apnea. Study Design A multicenter prospective cohort study. Setting Industry-supported multicenter academic and clinical setting. Subjects Participants (n = 91) at 48 months from a cohort of 126 implanted participants. Methods A total of 126 participants received an implanted upper airway stimulation system in a prospective phase III trial...
February 1, 2017: Otolaryngology—Head and Neck Surgery
https://www.readbyqxmd.com/read/28193231/association-of-osteopontin-with-specific-prognostic-factors-and-survival-in-adjuvant-breast-cancer-trials-of-the-hellenic-cooperative-oncology-group
#17
Amanda Psyrri, Konstantine T Kalogeras, Ralph M Wirtz, George Kouvatseas, Georgia Karayannopoulou, Anna Goussia, Flora Zagouri, Elke Veltrup, Eleni Timotheadou, Helen Gogas, Angelos Koutras, Georgios Lazaridis, Christos Christodoulou, George Pentheroudakis, Panagiota Economopoulou, Apostolos Laskarakis, Petroula Arapantoni-Dadioti, Anna Batistatou, Maria Sotiropoulou, Gerasimos Aravantinos, Pavlos Papakostas, Paris Kosmidis, Dimitrios Pectasides, George Fountzilas
BACKGROUND: The shift towards an earlier diagnosis of breast cancer (BC) highlights the need for biomarkers that would identify patients at risk for relapse and metastatic spread and indicate the potential value of additional treatment strategies. Osteopontin (OPN) is a matricellular protein that has been suggested to be a potential biomarker in BC. In the present study, we used archived BC patient samples to assess the clinical utility of OPN. METHODS: Formalin-fixed paraffin-embedded tumor tissue samples from 975 patients were collected from two large phase III randomized adjuvant chemotherapy trials (HE10/97 and HE10/00) that included patients with high risk BC...
February 13, 2017: Journal of Translational Medicine
https://www.readbyqxmd.com/read/28193189/assessment-of-dha-on-reducing-early-preterm-birth-the-adore-randomized-controlled-trial-protocol
#18
Susan E Carlson, Byron J Gajewski, Christina J Valentine, Lynette K Rogers, Carl P Weiner, Emily A DeFranco, Catalin S Buhimschi
BACKGROUND: Preterm birth contributes to 0.5 million deliveries in the United States (one of eight pregnancies) and poses a huge burden on public health with costs in the billions. Of particular concern is that the rate of earliest preterm birth (<34 weeks) (ePTB), which has decreased little since 1990 and has the greatest impact on the overall infant mortality, resulting in the greatest cost to society. Docosahexaenoic acid (DHA) supplementation provides a potential high yield, low risk strategy to reduce early preterm delivery in the US by up to 75%...
February 13, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28192641/effects-of-induction-docetaxel-platinum-and-fluorouracil-chemotherapy-in-patients-with-stage-iii-or-iva-b-nasopharyngeal-cancer-treated-with-concurrent-chemoradiation-therapy-final-results-of-2-parallel-phase-2-clinical-trials
#19
Lin Kong, Youwang Zhang, Chaosu Hu, Ye Guo, Jiade J Lu
BACKGROUND: The effects of docetaxel, platinum, and fluorouracil (TPF) induction chemotherapy plus concurrent chemoradiotherapy (CCRT) on locoregionally advanced nasopharyngeal cancer (NPC) are unclear. This study examined the long-term outcomes of the addition of this regimen to CCRT for stage III and IVA/B NPC. METHODS: Two parallel, single-arm phase 2 trials were performed synchronously to evaluate the efficacy and toxicity of TPF-based induction chemotherapy in patients with stage III or IVA/B NPC...
February 13, 2017: Cancer
https://www.readbyqxmd.com/read/28191006/capability-of-neutrophils-to-form-nets-is-not-directly-influenced-by-a-cma-targeting-peptide
#20
Christian Maueröder, Nicolas Schall, Frédéric Meyer, Aparna Mahajan, Benjamin Garnier, Jonas Hahn, Deborah Kienhöfer, Markus H Hoffmann, Sylviane Muller
During inflammatory reaction, neutrophils exhibit numerous cellular and immunological functions, notably the formation of neutrophil extracellular traps (NETs) and autophagy. NETs are composed of decondensed chromatin fibers coated with various antimicrobial molecules derived from neutrophil granules. NETs participate in antimicrobial defense and can also display detrimental roles and notably trigger some of the immune features of systemic lupus erythematosus (SLE) and other autoimmune diseases. Autophagy is a complex and finely regulated mechanism involved in the cell survival/death balance that may be connected to NET formation...
2017: Frontiers in Immunology
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