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Phase III trials

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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/28214653/neoadjuvant-chemotherapy-followed-by-concurrent-chemoradiotherapy-versus-concurrent-chemoradiotherapy-alone-in-locoregionally-advanced-nasopharyngeal-carcinoma-a-phase-iii-multicentre-randomised-controlled-trial
#2
Su-Mei Cao, Qi Yang, Ling Guo, Hai-Qiang Mai, Hao-Yuan Mo, Ka-Jia Cao, Chao-Nan Qian, Chong Zhao, Yan-Qun Xiang, Xiu-Ping Zhang, Zhi-Xiong Lin, Wei-Xiong Li, Qing Liu, Fang Qiu, Rui Sun, Qiu-Yan Chen, Pei-Yu Huang, Dong-Hua Luo, Yi-Jun Hua, Yi-Shan Wu, Xing Lv, Lin Wang, Wei-Xiong Xia, Lin-Quan Tang, Yan-Fang Ye, Ming-Yuan Chen, Xiang Guo, Ming-Huang Hong
BACKGROUND: The role of neoadjuvant chemotherapy (NACT) for locoregionally advanced nasopharyngeal carcinoma (NPC) is unclear. We aimed to evaluate the feasibility and efficacy of NACT followed by concurrent chemoradiotherapy (CCRT) versus CCRT alone in locoregionally advanced NPC. METHODS: Patients with stage III-IVB (excluding T3N0-1) NPC were randomly assigned to receive NACT followed by CCRT (investigational arm) or CCRT alone (control arm). Both arms were treated with 80 mg/m(2) cisplatin every 3 weeks concurrently with radiotherapy...
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
#3
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
#4
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/28213005/is-clarithromycin-a-potential-treatment-for-cachexia-in-people-with-lung-cancer-a-feasibility-study
#5
Sarah Awan, Vincent Crosby, Vanessa Potter, Ivo Hennig, David Baldwin, Mehluli Ndlovu, Sharon Paradine, Andrew Wilcock
Clarithromycin may improve cachexia and survival in non-small cell lung cancer (NSCLC), but adequately controlled data are lacking. This study was undertaken primarily to inform the feasibility and scale of a phase III trial. Eligible consenting patients with stage IV NSCLC and cachexia were to be randomized to receive either clarithromycin 250mg twice daily or placebo for eight weeks. Aspects of trial feasibility recorded included numbers eligible, approached and recruited, together with adherence and completion of treatment and assessments...
February 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28212543/metabotropic-glutamate-receptors-as-a-new-therapeutic-target-for-malignant-gliomas
#6
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
#7
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/28210563/neoadjuvant-therapy-for-treatment-of-breast-cancer-the-way-forward-or-simply-a-convenient-option-for-patients
#8
COMMENT
Abhishek Chatterjee, John K Erban
The complexity of managing early stage breast cancer is well known. Optimal treatment is increasingly multidisciplinary and in the modern era informed by sophisticated molecular tools to help select and guide therapy. Major phase III trials have determined that the order of systemic therapy relative to surgery does not influence important endpoints such as event free survival and overall survival (OS), but questions remain as to how best to utilize these most essential services. For example, there is still uncertainty regarding the ideal timing, intensity, and duration of proposed therapy...
February 2017: Gland Surgery
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
#9
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/28209443/continued-benefit-to-rectal-separation-for-prostate-radiation-therapy-final-results-of%C3%A2-a%C3%A2-phase-iii-trial
#10
Daniel A Hamstra, Neil Mariados, John Sylvester, Dhiren Shah, Lawrence Karsh, Richard Hudes, David Beyer, Steven Kurtzman, Jeffrey Bogart, R Alex Hsi, Michael Kos, Rodney Ellis, Mark Logsdon, Shawn Zimberg, Kevin Forsythe, Hong Zhang, Edward Soffen, Patrick Francke, Constantine Mantz, Peter Rossi, Theodore DeWeese, Stephanie Daignault-Newton, Benjamin W Fischer-Valuck, Anupama Chundury, Hiram Gay, Walter Bosch, Jeff Michalski
PURPOSE: SpaceOAR, a Food and Drug Administration-approved hydrogel intended to create a rectal-prostate space, was evaluated in a single-blind phase III trial of image guided intensity modulated radiation therapy. A total of 222 men were randomized 2:1 to the spacer or control group and received 79.2 Gy in 1.8-Gy fractions to the prostate with or without the seminal vesicles. The present study reports the final results with a median follow-up period of 3 years. METHODS AND MATERIALS: Cumulative (Common Terminology Criteria for Adverse Events, version 4...
December 23, 2016: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/28209070/assessment-of-quality-of-life-in-phase-iii-trials-of-radiotherapy-in-localized-or-locally-advanced-head-and-neck-cancer-over-the-past-17-years
#11
Gustavo Nader Marta, Everardo D Saad
BACKGROUND: We investigated the extent to which health-related quality of life (HRQOL) parameters have been used as endpoints in recent phase III trials on radiotherapy for head and neck cancer, as well as the frequency and correlates of significant HRQOL gains. METHODS: Using the medical subject headings "head and neck neoplasms" and "radiotherapy", we searched PubMed for the main paper reporting phase III trials published between 1/1999 and 12/2015 in 16 leading journals...
January 2017: Annals of Palliative Medicine
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
#12
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
#13
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
#14
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/28203424/a-phase-iii-multicenter-randomized-controlled-trial-of-neo-adjuvant-chemotherapy-paclitaxel-plus-cisplatin-versus-surgery-alone-for-stage-iia-iiib-esophageal-squamous-cell-carcinoma
#15
Yan Zheng, Yin Li, Xianben Liu, Ruixiang Zhang, Zongfei Wang, Haibo Sun, Shilei Liu
BACKGROUND: The survival benefits of neoadjuvant chemotherapy (NAC) for esophagus squamous cell carcinoma (ESCC) remains controversial. The surgical procedure was not well defined in NAC strategy, in past trials. The different surgical procedure and different levels of lymphadenectomy may decrease the survival benefits from NAC. The new chemotherapy regimen with paclitaxel is promising. The purpose of this study is to confirm the superiority of paclitaxel, cisplatin and McKeown esophagectomy with total two-field lymphadenectomy compared with surgery alone for ESCC...
January 2017: Journal of Thoracic Disease
https://www.readbyqxmd.com/read/28203303/refractory-carcinoid-syndrome-a-review-of-treatment-options
#16
REVIEW
Rachel P Riechelmann, Allan A Pereira, Juliana F M Rego, Frederico P Costa
Carcinoid syndrome (CSy) is a constellation of symptoms that may commonly present in patients with well differentiated neuroendocrine tumors (NETs), with somatostatin analogs (SSAs) being the first-line option for symptom management. However, symptomatic progression eventually occurs and in this scenario of a refractory CSy; several treatment options have been studied such as dose escalation of SSA, interferon and liver-directed therapies. Nevertheless, recent phase III trials have contributed to the understanding and management of this condition...
February 2017: Therapeutic Advances in Medical Oncology
https://www.readbyqxmd.com/read/28203092/nab-paclitaxel-plus-gemcitabine-for-metastatic-pancreatic-cancer-a-subgroup-analysis-of-the-western-european-cohort-of-the-mpact-trial
#17
Josep Tabernero, Volker Kunzmann, Werner Scheithauer, Michele Reni, Jack Shiansong Li, Stefano Ferrara, Kamel Djazouli
PURPOSE: The global Phase III MPACT trial demonstrated superior efficacy of nab-paclitaxel plus gemcitabine over gemcitabine alone as first-line treatment for metastatic pancreatic cancer. Region was a randomization stratification factor in the MPACT trial. This subgroup analysis of MPACT examined efficacy and safety of patients treated in Western Europe. PATIENTS AND METHODS: Patients received nab-paclitaxel plus gemcitabine or gemcitabine alone as first-line treatment for metastatic pancreatic cancer as previously described...
2017: OncoTargets and Therapy
https://www.readbyqxmd.com/read/28202353/the-potential-clinical-promise-of-multimodality-metronomic-chemotherapy-revealed-by-preclinical-studies-of-metastatic-disease
#18
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
#19
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
#20
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
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