Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial

Background Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear. Methods RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. Findings Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61–69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1–10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4–82·5) in the no ADT group and 80·4% (76·6–83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths. Interpretation Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial

Background Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. Methods RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov , NCT00541047 . Findings Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612–0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths. Interpretation Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy. Funding Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society

Women's Agency through Fashion in North Korea's Transition

North Korean women's fashion has changed in the context of women's relatively recently assumed role as critical actors in North Korea's market-dependent economy. Through examination of changes in women's fashion we learn more about how the way women choose to dress can become an agentic and empowering process. The article argues that the case of North Korean women and their dress practice can inform our understanding of how women, even in the most oppressive of circumstances, develop tactics to manipulate the systems and social order that seek to control them. North Korean women have enacted upon their agency deliberately, getting away with what they can while simultaneously skilfully avoiding the dire consequences of being identified as actors who dare to disrupt the status quo. This type of agency is not always understood or appreciated by Western liberal frames and sensibilities of agency that centralise notions of individualism and freedom. This nuanced appreciation of women's agency has the potential to expand the "rights, choices and autonomy" Western discourse of women's agency in ways that are inclusive of women who live, and sometimes manage to thrive, in the face of extreme oppression. This paper is informed by the authors' field notes from trips to North Korea and by 45 in-depth interviews with North Korean refugees, regular visitors to North Korea and NGO workers

Selling solutions: Emerging patterns of product-service linkage in the Australian economy

The focus of the study reported here is the different forms of service provision strategies appearing across the Australian economy. Specifically, the study looks at the various ways in which firms link products and services, whether in single packages or other forms. What we found led us to question the common notion that \u27manufacturing matters, but services succeed\u27. The data gathered show how many firms in both manufacturing and service industries are putting together products and services into \u27packages\u27, suggesting the need for a broader review of how a service-rich economy may work at firm level

We need ABS arts and sports data to understand our culture

The Australian Bureau of Statistics (ABS) last week released its 2014-2018 forward work plan. The work plan confirms the June media release that arts and sport data will disappear from the ABS-funded component of culture, sport and recreation statistics collection as part of ongoing expenditure reductions of A$50 million over three years started under the previous Labor government. This includes the disbanding of the National Centre for Culture and Recreation Statistics that strategically directed the ABS data collection and reporting in this area. The implications are significant where for example the ABS General Social Survey under “social conditions” no longer makes any reference to arts or sport data. A culture built on volunteers Australia prides itself on its artistic capacity, sporting ability and participation, as well as the selflessness of its volunteer workforce across all sectors of civil society. The majority of arts and sport are delivered by the not-for-profit sector through volunteer workforces. It is disappointing that the ABS has had to make decisions to severely curtail data collection and reporting in these important areas of citizenship. From the grassroots sports grounds, to community arts centres, to national sport and arts organisations with their focus on excellence, all have significant contributions from their organisation’s volunteer workforces. Not-for-profit organisations that manage these volunteer workforces are, according to ABS data, one of the biggest employers in Australia. They account for some 1 million employees or 8.6 They contributed A$55 billion to Australia’s economy in 2012-13. This was an increase of A$22 billion on 2006-07 (up from$34 billion, or 3.4% of GDP, in 2006/2007). The not-for-profit sector generated income of A$107.5 billion (up from A$76 billion in 2006/2007) and has been at the forefront of developing a more innovative approach to its activities through social enterprise. The loss of the arts and sports data is compounded by the loss of the module on volunteering, which has documented the changing nature of volunteering over time. What is as disconcerting is that the General Social Survey has also discarded its modules on indigeneity and disability. We know that these two groups are vulnerable, marginalised and excluded from many areas of social participation. This data source has been invaluable for monitoring improvements or setbacks to social participation over time. While key stakeholders may choose to fill the data and reporting space left by the ABS, the likelihood of this occurring given the budgetary squeeze in Canberra is questionable. For example, the Committee of Australian Sport and Recreation Officials and its predecessor organisation co-funded with the ABS the Exercise Recreation and Sport Survey 2001-2010. Why we need this data The data collected by the Australian Bureau of Statistics, and the General Social Survey in particular, provides the means to understanding and enhancing the economic, social and cultural impact of the not-for profit, arts and sport sectors on Australian society. Research based on this data helps ensure evidence-based policies and educative tools that enable industry practitioners to understand and embrace best practice standards. Without a central mechanism such as the ABS, sector-wide datasets cannot be compiled. This creates two important issues that cannot be established without the data: the accountability of the sectors (including parts thereof that are not-for-profits that gain tax advantages and collect funds from the public) is undermined. research needed to inform policy and educate practitioners and the wider community about best practice relating to a wide range of these sectors\u27 activities, including standards of governance, legal compliance, fundraising and reporting, cannot be generated. More fundamentally, without data we are not in a position to say anything meaningful about Australian sport, arts or not for profits. We will lack answers to questions that range from the most straightforward – how many sports, arts or not-for-profit organisations are there in Australia? – to more complex ones, such as how does one assess the cumulative social and economic impact of these important sectors. Data that shapes policy When it suits, ministers revel in Australia’s sporting prowess and cultural creativity; careful development and evaluation of policies in these areas are another matter. Of the 62 policies/discussion papers that the Coalition took to the 2013 federal election, not one referred to the arts or sport. Yet, we have a Minister for the Arts in Senator George Brandis and a Minister for Sport in Peter Dutton. The report of the 2009 government-appointed Independent Sport Panel, chaired by industrialist David Crawford, declared that there was “an extraordinary dearth of robust data on participation in sport” and that a “lack of fundamental data on most aspects of the sport sector substantially inhibits an evidence-based approach to the development of policies and strategies”. While the federal government does not have responsibility for delivery of arts and sport facilities and programs at grassroots level (since this falls largely to state/territory and local governments and the not-for-profit sector) it has been widely accepted, at least since the 1980s, that data on participation levels should be collected at national level. It is only from independently gathered data from the ABS or other public agency stakeholders that policy-relevant information such as the following is brought to light: Despite the success of Australia’s elite swimmers in international competition, less than 8% of Australian adults swim, even once, in the course of a year, and this figure is falling. It’s an unbelievable figure! Success at Olympics does not lead to a “trickle-down effect” of increased participation in Olympic sport by the public. Only 25% of Australian adults visit a museum, even once, in the course of a year – while this proportion has increased since 2000, it is lower than it was in the mid-1990s. While Australians appear obsessed with sport, 90% of Australians receptively participated in at least one art form and 40% had creatively participated in the arts and only 7% had no artistic engagement in the last 12 months. Now governments of all persuasions are encouraging organisations in these sectors to supplement their income from other sources, especially philanthropy. In a 2014 speech to the Australian Council of Social Service (ACOSS) conference, Social Services Minister Kevin Andrews outlined his vision of civil society, arguing that civil society should not be created nor controlled by the state as too much intervention denies citizens the opportunity to achieve something for themselves. To summarise the ideas presented, civil society should stand apart and on its own two feet. However, without information to inform a case for support, funds are unlikely to be forthcoming from a hard-nosed corporate sector which demands social returns on its investment. This loss of data is shortsighted, ill considered and to the detriment of good governance, innovation and creativity in arts, sport and the wider not-for-profit sector, which is driven by being at the forefront of understanding social trends. We implore the decision-makers to reconsider the loss or significant cutback or reduced reporting of such important data for understanding the size, dimensions, dynamism and contributions of Australia’s civil society. Simon Darcy has received funding from the Australian Research Council, the Australian Sports Commission, Australian Paralympic Committee and is currently completing a research grant with Arts NSW. He is a current member of the Disability Council of NSW that advises the NSW Minister for Disability. Bronwen Dalton is a member of the board for the New South Wales Centre for Volunteering   Image: Dr J Photography / Flick

Representing the disadvantaged in Australian politics: the role of advocacy organisations

In recent years, there has been debate and criticism over the influence that non-government organisations may have on public policy decisions. Bronwen Dalton and Mark Lyons assess the roles of NGOs, looking both at their external impacts through public participation and involvement in policy processes, and also at NGOs\u27 internal structures that provide varying degrees of democratic participation for their members. Representatives of a selected number of NGOs were interviewed for the report