ROMANA 3: A phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia

© The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Background: Cancer anorexia-cachexia is a debilitating condition frequently observed in NSCLC patients, characterized by decreased body weight, reduced food intake, and impaired quality of life. Anamorelin, a novel selective ghrelin receptor agonist, has anabolic and appetite-enhancing activities. Patients and methods: ROMANA 3 was a safety extension study of two phase 3, double-blind studies that assessed safety and efficacy of anamorelin in advanced NSCLC patients with cachexia. Patients with preserved Eastern Cooperative Oncology Group ≤ 2 after completing 12 weeks (w) on the ROMANA 1 or ROMANA 2 trials (0-12 weeks) could enroll in ROMANA 3 and continue to receive anamorelin 100 mg or placebo once daily for an additional 12w (12-24 weeks). The primary endpoint of ROMANA 3 was anamorelin safety/tolerability (12-24 weeks). Secondary endpoints included changes in body weight, handgrip strength (HGS), and symptom burden (0-24 weeks). Results: Of the 703 patients who completed ROMANA 1 and ROMANA 2, 513 patients entered ROMANA 3 (anamorelin, N = 345, mean age 62.0 years; placebo, N = 168; mean age 62.2 years). During ROMANA 3, anamorelin and placebo groups had similar incidences of treatment-emergent adverse events (TEAEs; 52.2% versus 55.7%), grade ≥ 3 TEAEs (22.4% versus 21.6%), and serious TEAEs (12.8% versus 12.6%). There were 36 (10.5%) and 23 (13.8%) deaths in the anamorelin and placebo groups, respectively; none were drug-related. Improvements in body weight and anorexia-cachexia symptoms observed in the original trials were consistently maintained over 12-24 weeks. Anamorelin, versus placebo, significantly increased body weight from baseline of original trials at all time points (P < 0.0001) and improved anorexia-cachexia symptoms at weeks 3, 6, 9, 12, and 16 (P < 0.05). No significant improvement in HGS was seen in either group. Conclusion: During the 12-24 weeks ROMANA 3 trial, anamorelin continued to be well tolerated. Over the entire 0-24w treatment period, body weight and symptom burden were improved with anamorelin

Effect of Interspecific Yeast Hybrids for Secondary In-Bottle Alcoholic Fermentation of English Sparkling Wines

In sparkling winemaking, only a few yeast strains are regularly used for the secondary in-bottle alcoholic fermentation (SiBAF). Recently, advances in yeast development programs have yielded new breeds of interspecific wine yeast hybrids that ferment efficiently while producing novel flavors and aromas. In this work, the chemical and sensorial impacts of the use of interspecific yeast hybrids for SiBAF were studied using three commercial English base wines prepared for SiBAF using two commercial and four novel interspecific hybrids. After 12 months of lees aging, the chemical and macromolecular composition, phenolic profile, foaming, viscosity and sensory properties of the resulting 13 wines were assessed. Chemically, the yeast strains did not result in significant differences in the main wine parameters, while some differences in their macromolecular contents and sensory characteristics were noticeable. The foamability was mostly unaffected by the strain used; however, some effect on the foam stability was noticeable, likely due to the differences in polysaccharides released into the wines by the yeast strains. The wines exhibited different sensory characteristics in terms of aroma and bouquet, balance, finish, overall liking and preference, but these were mostly attributable to the differences in the base wines rather than the strain used for SiBAF. Novel interspecific yeast hybrids can be used for the elaboration of sparkling wines, as they provided wines with chemical characteristics, flavor and aroma attributes similar to those of commonly used commercial Saccharomyces cerevisiae strains

FUENTES, JOSEFA, HERNÁNDEZ, LOLINA [Material gráfico]

BCopia digital. Madrid : Ministerio de Educación, Cultura y Deporte, 201

The influence of different culture microenvironments on the generation of dendritic cells from non-small-cell lung cancer patients

This study extends the model developed in Williams and Seaman’s [Williams, J. J. and Seaman, A. E. (2010). Corporate Governance and Mindfulness: The Impact of Management Accounting Systems Change, The Journal of Applied Business Research, Vol. 26, No. 5, pp. 1-17] exploratory paper examining the moderating effects of management accounting systems (MAS) change on the corporate governance/mindfulness relationship for a Canadian sample of 124 top-level accounting professionals. Canonical correlation analysis was applied to the linkage of multiple cognitive processes of mindfulness (Weick and Sutcliffe, 2001; 2007) and the governance dimensions of performance and conformance specified by the International Federation of Accountants (2009), underpinned by the moderating effects of five different components of MAS change, which yielded 13 significant relationships. The latter were subsequently analyzed for important gestalts (i.e., patterns) in the overall relationship, and assessed within the context of aligning professional accounting practices involving systems changes to the IFAC (2009) governance framework. These findings appear to have implications for improved governance structures in practice as well as offering a rich foundation for future research

Contextual adaptation of the Personnel Evaluation Standards for assessing faculty evaluation systems in developing countries: the case of Iran

<p>Abstract</p> <p>Background</p> <p>Faculty evaluations can identify needs to be addressed in effective development programs. Generic evaluation models exist, but these require adaptation to a particular context of interest. We report on one approach to such adaptation in the context of medical education in Iran, which is integrated into the delivery and management of healthcare services nationwide.</p> <p>Methods</p> <p>Using a triangulation design, interviews with senior faculty leaders were conducted to identify relevant areas for faculty evaluation. We then adapted the published checklist of the Personnel Evaluation Standards to fit the Iranian medical universities' context by considering faculty members' diverse roles. Then the adapted instrument was administered to faculty at twelve medical schools in Iran.</p> <p>Results</p> <p>The interviews revealed poor linkages between existing forms of development and evaluation, imbalance between the faculty work components and evaluated areas, inappropriate feedback and use of information in decision making. The principles of Personnel Evaluation Standards addressed almost all of these concerns and were used to assess the existing faculty evaluation system and also adapted to evaluate the core faculty roles. The survey response rate was 74%. Responses showed that the four principles in all faculty members' roles were met <it>occasionally </it>to <it>frequently</it>. Evaluation of teaching and research had the highest mean scores, while clinical and healthcare services, institutional administration, and self-development had the lowest mean scores. There were statistically significant differences between small medium and large medical schools (p < 0.000).</p> <p>Conclusion</p> <p>The adapted Personnel Evaluation Standards appears to be valid and applicable for monitoring and continuous improvement of a faculty evaluation system in the context of medical universities in Iran. The approach developed here provides a more balanced assessment of multiple faculty roles, including educational, clinical and healthcare services. In order to address identified deficiencies, the evaluation system should recognize, document, and uniformly reward those activities that are vital to the academic mission. Inclusion of personal developmental concerns in the evaluation discussion is essential for evaluation systems.</p

Establishing an online resource to facilitate global collaboration and inclusion of underrepresented populations:Experience from the MJFF Global Genetic Parkinson's Disease Project

Parkinson's disease (PD) is the fastest-growing neurodegenerative disorder, currently affecting ~7 million people worldwide. PD is clinically and genetically heterogeneous, with at least 10% of all cases explained by a monogenic cause or strong genetic risk factor. However, the vast majority of our present data on monogenic PD is based on the investigation of patients of European White ancestry, leaving a large knowledge gap on monogenic PD in underrepresented populations. Gene-targeted therapies are being developed at a fast pace and have started entering clinical trials. In light of these developments, building a global network of centers working on monogenic PD, fostering collaborative research, and establishing a clinical trial-ready cohort is imperative. Based on a systematic review of the English literature on monogenic PD and a successful team science approach, we have built up a network of 59 sites worldwide and have collected information on the availability of data, biomaterials, and facilities. To enable access to this resource and to foster collaboration across centers, as well as between academia and industry, we have developed an interactive map and online tool allowing for a quick overview of available resources, along with an option to filter for specific items of interest. This initiative is currently being merged with the Global Parkinson's Genetics Program (GP2), which will attract additional centers with a focus on underrepresented sites. This growing resource and tool will facilitate collaborative research and impact the development and testing of new therapies for monogenic and potentially for idiopathic PD patients.</p