11 research outputs found
Health-Related Quality of Life in Metastatic, Hormone-Sensitive Prostate Cancer: ENZAMET (ANZUP 1304), an International, Randomized Phase III Trial Led by ANZUP
Purpose: We previously reported that enzalutamide improved overall survival when added to standard of care in metastatic, hormone-sensitive prostate cancer. Here, we report its effects on aspects of health-related quality of life (HRQL). Methods: HRQL was assessed with the European Organisation for Research and Treatment of Cancer core quality-of-life questionnaire and QLM-PR25 at weeks 0, 4, 12, and then every 12 weeks until progression. Scores from week 4 to 156 were analyzed with repeated measures modeling to calculate group means and differences. Deterioration-free survival was from random assignment until the earliest of death, clinical progression, discontinuation of study treatment, or a worsening of 10 points or more from baseline in fatigue, physical function, cognitive function, or overall health and quality of life (OHQL). HRQL scores range from 0 (lowest possible) to 100 (highest possible). Results: HRQL was assessed in 1,042 of 1,125 participants (93%). Differences in means favored control over enzalutamide for fatigue (5.2, 95% CI, 3.6 to 6.9; P , .001), cognitive function (4.0, 95% CI, 2.5 to 5.5; P , .001), and physical function (2.6, 95% CI, 1.3 to 3.9; P , .001), but not OHQL (1.2, 95% CI, 20.2 to 2.7; P 5 .1). Deterioration-free survival rates at 3 years, and log-rank P values comparing the whole distributions, favored enzalutamide over control for OHQL (31% v 17%; P , .0001), cognitive function (31% v 20%; P 5 .001), and physical function (31% v 22%; P , .001), but not fatigue (24% v 18%; P 5 .16). The effects of enzalutamide on HRQL were independent of baseline characteristics. Conclusion: Enzalutamide was associated with worsening of self-reported fatigue, cognitive function, and physical function, but not OHQL. Enzalutamide was associated with improved deterioration-free survival for OHQL, physical function, and cognitive function because delays in disease progression outweighed early deteriorations in these aspects of HRQL.Martin R. Stockler ... Christopher J. Sweeney ... et. a
Overall survival of men with metachronous metastatic hormone-sensitive prostate cancer treated with enzalutamide and androgen deprivation therapy
Abstract not available.Christopher J. Sweeney, Andrew J. Martin, Martin R. Stockler, Stephen Begbie, Kim N. Chi, Simon Chowdhury, Xanthi Coskinas, Mark Frydenberg, Wendy E. Hague, Lisa G. Horvath, Anthony M. Joshua, Nicola J. Lawrence, Gavin M. Marx, John McCaffrey, Ray McDermott, Margaret McJannett, Scott A. North, Francis Parnis, Wendy Parulekar, David W. Pook, M. Neil Reaume, Shahneen K. Sandhu, Alvin Tan, Thean Hsiang Tan, Alastair Thomson, Emily Tu, Francisco Vera-Badillo, Scott G. Williams, Sonia Yip, Alison Y. Zhang, Robert R. Zielinski, Ian D. Davis, for the ENZAMET Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
Health-related quality of life in metastatic, hormone-sensitive prostate cancer : ENZAMET (ANZUP 1304), an international, randomized phase iii trial led by ANZUP
PURPOSE We previously reported that enzalutamide improved overall survival when added to standard of care in metastatic, hormone-sensitive prostate cancer. Here, we report its effects on aspects of health-related quality of life (HRQL). METHODS HRQL was assessed with the European Organisation for Research and Treatment of Cancer core quality-of-life questionnaire and QLM-PR25 at weeks 0, 4, 12, and then every 12 weeks until progression. Scores from week 4 to 156 were analyzed with repeated measures modeling to calculate group means and differences. Deterioration-free survival was from random assignment until the earliest of death, clinical progression, discontinuation of study treatment, or a worsening of 10 points or more from baseline in fatigue, physical function, cognitive function, or overall health and quality of life (OHQL). HRQL scores range from 0 (lowest possible) to 100 (highest possible). RESULTS HRQL was assessed in 1,042 of 1,125 participants (93%). Differences in means favored control over enzalutamide for fatigue (5.2, 95% CI, 3.6 to 6.9; P, .001), cognitive function (4.0, 95% CI, 2.5 to 5.5; P, .001), and physical function (2.6, 95% CI, 1.3 to 3.9; P, .001), but not OHQL (1.2, 95% CI, 20.2 to 2.7; P 5 .1). Deterioration-free survival rates at 3 years, and log-rank P values comparing the whole distributions, favored enzalutamide over control for OHQL (31% v 17%; P, .0001), cognitive function (31% v 20%; P 5 .001), and physical function (31% v 22%; P, .001), but not fatigue (24% v 18%; P 5 .16). The effects of enzalutamide on HRQL were independent of baseline characteristics. CONCLUSION Enzalutamide was associated with worsening of self-reported fatigue, cognitive function, and physical function, but not OHQL. Enzalutamide was associated with improved deterioration-free survival for OHQL, physical function, and cognitive function because delays in disease progression outweighed early deteriorations in these aspects of HRQL
A study on the laser spatter and the oxidation reactions during selective laser melting of 316L stainless steel, Al-Si10-Mg, and Ti-6Al-4V
The creation of an object by selective laser melting (SLM) occurs by melting contiguous areas of a powder bed according to a corresponding digital model. It is therefore clear that the success of this metal Additive Manufacturing (AM) technology relies on the comprehension of the events that take place during the melting and solidification of the powder bed. This study was designed to understand the generation of the laser spatter that is commonly observed during SLM and the potential effects that the spatter has on the processing of 316L stainless steel, Al-Si10-Mg, and Ti-6Al-4V. With the exception of Ti-6Al-4V, the characterization of the laser spatter revealed the presence of surface oxides enriched in the most volatile alloying elements of the materials. The study will discuss the implication of this finding on the material quality of the built parts
'What the electorate can be expected to swallow': Nationalisation, transnationalism and the shifting boundaries of the state in post-war Britain
This article attempts to show that there were three key elements to the changing policy mix as regards state economic intervention and ownership in post-war Britain. These have been relatively neglected by economic historians in favour of questions concerning 'objective' performance. They were: the uncertainty, confusion and competition of the two main political parties as to what the nationalised sector was for; attempts to escape an unpopular and bureaucratic policy model; and recommendations and techniques copied from other countries. It is posited that these three analytical categories provide an explanation for the shifting boundaries of the state in post-war Britain.nationalisation, intervention, public opinion, investment, transnationalism,
Health-status outcomes with invasive or conservative care in coronary disease
BACKGROUND In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients. METHODS We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency. RESULTS At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina). CONCLUSIONS In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline