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  1. Jim Marshall (not a doctor) said ... Xofigo (Radium-223) has been recommended to go on the PBS. The conditions just published include: Previous Docetaxel, or unsuitability for Docetaxel; No previous enzalutamide (Xtandi) (or intolerance); No previous abiraterone (Zytiga) (or intolerance); So if a man has 2 or more bone metastases (mets) on the PBS his doctor will have to choose only one of: Xtandi (enzalutamide); Zytiga (abiraterone); Xofigo (Radium-233). If a man does not qualify for PBS Xofigo, doses cost about $7,000, with up to 6 doses the normal treatment. ... end Jim From the Public Summary Document – November 2017 PBAC Meeting Patients must have ≥ 2 skeletal metastases AND Patient must have a WHO performance status of 2 or less AND Patient must have failed treatment with docetaxel due to resistance or intolerance; OR Patient must be unsuitable for docetaxel treatment on the basis of predicted intolerance to docetaxel AND The treatment must not be used in combination with chemotherapy. AND The patient must not receive PBS-subsidised 223Ra if progressive disease develops while on 223Ra AND The patient must not have received prior treatment with abiraterone or enzalutamide; OR The patient must have developed intolerance to enzalutamide requiring permanent withdrawal AND The patient must have developed intolerance to abiraterone requiring permanent withdrawal.
  2. During the phone-in meeting we held this morning (23 March 2018), there was discussion about Xofigo (Radium-223). The question arose of whether Xofigo gave both pain relief and longer survival. During that discussion, I mentioned that I had discussed Xofigo with American Medical Oncologist Alicia Morgans, and that this was on video. This is the video: A report on the ALSYMPCA trial of Xofigo (Radium-223) (previously called Alpharadin) can be found here. http://www.nejm.org/doi/full/10.1056/NEJMoa1213755 You can find all our videos on our YouTube channel: YouTube.com/JimJimJimJim Jim
  3. Considerations relating to Radium-223 Therapy. I found this to be worthwhile for anyone with advanced metastatic disease predominately in the bones that may wish to discuss this treatment with their oncologist. Please note: The possible combination treatment with Abiraterone has been discontinued as it is now considered to be dangerous (see post on this site). However the rest of the presentation is informative and up to date. For a simpler more understandable version of Radium-223 Therapy check out our own JimJImJimJIm version on this site.Just go to the top bar and click on:- Our You Tube videos. This video is an excerpt from Dr. Eric Rohren's state of the art presentation on Radium-223. This discussion includes the operationalization of Radium-223 at MD Anderson. In addition treatment it contains a review of the different agents available for imaging skeletal metastases in patients with metastatic castration-resistant prostate cancer. It also takes a look at patient prognosis and survival data. This video is on the Uro Today site and it is intended for a professional audience. To go to this video just click on this link https://tinyurl.com/ybe9augt
  4. There are two committees that recommend public expenditure on medical treatments in Australia - the Medical Services Advisory Committee (MSAC) and the Pharmaceutical Benefits Advisory Committee (PBAC). The MSAC approved the use of Xofigo for prostate cancer patients in 2014. The PBAC announced approval of Xofigo for prostate cancer patients today (15 December 2017). The delays were due in part to this being the first treatment that needs to be paid for by both Medicare and the PBS. New rules had to be made. Ministerial approval can be expected in the near future, and men who need this treatment for prostate cancer in the bones will be able to get it. Many of our members sent submissions to both the MSAC and the PBAC, and I am convinced that had a big part to play in the result. Members should know that although I fronted this campaign, speaking to parliamentary lunches, and to public meetings and parliamentarians in marginal electorates, and making the videos, all Executive Committee members contributed to the campaign, and that one, the late Paul Hobson, was the real driving force behind this result. Thanks go to all who contributed. Jim Marshall Convenor Australian Advanced Prostate Cancer Support Group
  5. Radium-223 Radiographic Response: From the Desk of the Associate Editor URO Today Commentary by Andrew Armstrong, MD,ScM, FACP, USA This is a very brief summary of the take away from this study - Follow the link at the bottom of the article for complete details Radium-223 is best used early, before extensive soft tissue metastases occurs, and before the risk of spinal cord compression increases. (Note: Soft tissue disease is not being treated whilst Radium-223 therapy is being administered, it is not effective against soft tissue tumors.) For this reason when being treated with Radium 223 - concurrent use of systemic therapies should be considered in patients with soft tumors/extra-skeletal metastases. Ongoing trials of Radium-223 with enzalutamide, abiraterone, sipuleucel-T, atezolizumab, PARP inhibitors, docetaxel, and other combinations should clarify the optimal combination approaches to controlling bone and soft tissue/visceral metastases. Patients should be followed carefully for pain flare and are likely to need opiate dose titration during therapy. Concurrent care by a palliative care specialist should be strongly considered, given the life expectancy and palliative needs for these patients. Written by: Andrew Armstrong, MD, Dr. Armstrong is Associate Professor of Medicine, Surgery, Pharmacology and Cancer Biology and Associate Director of the Duke Cancer Institute Genitourinary Clinical Research Program Full Text :- Imaging response during therapy with radium-223 for castration-resistant prostate cancer with bone metastases—analysis of an international multicenter database https://tinyurl.com/yba4zcpv
  6. A member recently asked about the availability of Xofigo (Radium-223) in the UK: Xofigo in UK England Post-chemo on NHS Pre-chemo on Cancer Drugs Fund Scotland Pre-chemo on Scottish Medicines Consortium Post-chemo on Scottish Medicines Consortium Northern Ireland and Wales Pre-chemo not covered Post-chemo on NHS
  7. As you probably know, we have been campaigning to have the advanced prostate cancer treatment Xofigo (Radium-223) made available under Medicare for Australian men. As part of this, this week our Convenor, Jim Marshall (JimJimJimJim), will speak on this at events in Biloela and Nowra. Hosts in Biloela will be Ken O'Dowd MP, Member for Flynn, Qld and Biloela Mens Shed. Hosts in Nowra will be Ann Sudmalis MP, Member for Gilmore, NSW and the Bomaderry Advanced Prostate Men’s Group. Prostate Cancer Foundation of Australia (PCFA) CEO, Anthony Lowe, will also speak, and local media will be invited to interview the speakers after the event. Other people involved in organising these events include: Geoff Lester-PCFA Ambassador Gladstone Rockhampton Prostate Cancer Support Group Judy Cornick- Prostate Cancer Specialist Nurse Rockhampton Lloyd Younger- PCFA Ambassador Rockhampton Leigh Bowman -Shoalhaven Prostate Cancer Support Group Evan Kallipolitis, PCFA Community Engagement On this journey, Jim will stop at Gladstone on the nights of Tuesday 4 April 2017 and Wednesday 5 April, and in Sydney on the nights of Thursday 6 April 2017 and Friday 7 April 2017. If you would like to meet Jim and have a chat in Gladstone or in Woolloomooloo, just reply to this email. Jim would also like to meet anyone who can make it to the Biloela or Nowra events, but pressure of the event timetables mean long chats are unlikely on event days. The Biloela event Wednesday 5 April 2017 10:00 AM Callide Valley Men’s Shed, Valentine Plains Rd, Biloela QLD 4715 The Nowra event Friday 7 April 2017 9:30 AM Nowra Golf Club, Fairway Dr North Nowra NSW 2541 If you haven't yet seen the Xofigo (Radium-223) video yet, it's here: Jim had last week off in Caloundra, and Cyclone Debbie was the main feature. Jim's travel plans above may also be affected by the aftermath of Debbie.
  8. Click here to read "A Brief Update of the Current Landscape of Bone Targeted Therapies for Prostate Cancer" by Joel Nowak of Malecare. Radium 223 (Xofigo) has been approved for use in Australia. However it is not publicly subsidised. This means that its cost effectively puts it out of reach of most Australian men with advanced prostate cancer. Your committee is lobbying to try to get Radium 223 (Xofigo) publicly subsidised. However it's unlikely to be publicly subsidised in the near future.
  9. Xofigo (radium 223) is a radioactive material that specifically targets bone metastases from prostate cancer. Xofigo (radium 223) is administered intravenously in hospital and is regarded as a medical service. This means that the application for it to be publicly funded must be made to the Medical Services Advisory Committee. The applications for new cancer drugs to be publicly funded are made to the Pharmaceutical Benefits Advisory Committee. According to Bayer, the manufacturer of Xofigo (radium 223), the policies that apply to listing on the Medical Benefits Schedule are different from the policies that apply to listing on the Pharmaceutical Benefits Scheme. April 2014 Recommendation that Xofigo be listed on the Medical Benefits Schedule. It has been more than 2 years since the Medical Services Advisory Committee recommended that Xofigo (radium 223) be listed on the Medical Benefits Schedule. Bayer disagreed with the proposed pricing arrangements that the Medical Services Advisory Committee recommended. What's happening now? Unfortunately, nothing. There appears to be a stalemate. A fellow Victorian sufferer with advanced prostate cancer has shared with me the copy of a recent letter that he has received from Bayer.
  10. You will have noticed that the other members of our Executive Committee (Alan Barlee, Nev Black, Paul Hobson, Tony Maxwell) make an enormous contribution to our monthly phone-in meetings, to information and discussion posted on our website (JimJimJimJim.com), and to general support of our members by phone, email, and at Face-to-a-name members' meetings. What you may not be aware of is that your Executive Committee also spends much time and effort in advocacy duties on behalf of the group. Below are some advocacy events held during the past year. Please be aware that where I am listed as the sole attendee below, most often, most of the background work has been done by other members of the Executive Committee. Health Week Launch This event, co-sponsored by the Prostate Cancer Foundation of Australia (PCFA) and Astellas (vendors of Xtandi (enzalutamide)) was a press briefing in Sydney to help the press focus on actual men with advanced prostate cancer in their Health Week reporting. After a formal presentation, Paul, Alan, Tony and I joined PCFA CEO Anthony Lowe in one-on-on discussions with members of the press about advanced prostate cancer and with Astellas staff about getting Xtandi (enzalutamide) on the PBS pre-chemotherapy. Later in the day I caught up with Sydney members of our group, and in the evening attended the Westmead Prostate Cancer Support Group. Before flying back next morning I met with Professor Peter Croucher at the Garvan Institute of Medical Research to discuss the research Professor Croucher's team is doing on finding and treating cancer that moves to bones. Multi-parametric MRI scan and biopsy The Medical Services Advisory Committee (MSAC) is an independent expert committee that recommends to the Minister which procedures should go on the Medicare Benefits Schedule (MBS). A multi-parametric MRI is a scan which can show more detail of prostate cancer, especially in the prostate. Australia's Radiation Oncologists made an application to have the multi-parametric MRI made a Medicare item. Your Executive Committee made a submission on your behalf to the MSAC supporting this application. Pharmaceutical Benefits Advisory Committee (PBAC) review The PBAC is the independent expert committee that recommends to the Minister which drugs should go on the PBS. You may remember that, as the result of submissions by our group and of many personal submissions on the drugs Zytiga (abiraterone) and Xtandi (enzalutamide) that I was invited to appear before the Senate Inquiry into the availability of new, innovative and specialist cancer drugs in Australia. Just one week after the Inquiry ended, Minister for Health Sussan Ley announced a review of the PBAC to "address technical methods issues raised by the PBAC and stakeholders". A team at the University of Adelaide prepared a new set of guidelines for the operations of the PBAC, and Tony Maxwell and I attended the PBAC Guidelines Review - Presentation Forum in Sydney. Amongst a large group of pharmaceutical and medical experts, Tony's contribution beginning "I am a patient ... " had a striking effect. With not enough room for my scooter in the morning tea room I had to stay in the main auditorium. The only other person there was PBAC Chair, Professor Andrew Wilson, setting up his slides. When he finished setting up, he came over and we had quite a long and productive talk. Office of the Minister for Health All members of your Executive Committee met with Mark Kinsela, Senior Advisor to the Minister for Health at the office of the Minister in Canberra to discuss issues of import to men with advanced prostate cancer. In the generous 1 hour 20 minutes we were given we were able to cover many issues, and felt we were given a well-informed and probing hearing. Access on the PBS to the drugs Zytiga (abiraterone) and Xtandi (enzalutamide) before chemotherapy, and access on medicare to the radiotherapy drug Xofigo (Radium-223) were, of course an important focus of the discussion. PCFA support groups meeting I met with PCFA senior staffers Amanda Pomery (National Manager, Support & Community) and Katie Dundas (Manager, Community Awareness and Education) a few weeks ago to talk about our issues as a support group. The changes that are happening to our website at the moment, and the new flexibility we have with our phone-in meetings are a couple of the results. (Our next phone-in meeting will be an early evening one - a roundtable at 5:30 pm on Friday 24 June 2016.) Getting Bayer Xofigo on Medicare Earlier this month when plans for a meeting at Bayer in Sydney fell through, senior staff of Bayer Pharmaceutical and PCFA CEO Anthony Lowe flew to Brisbane to speak to me about the problems of getting Xofigo (Radium-223) on Medicare, as a result of a letter your Executive Committee had sent to Bayer. It turned out that Bayer now feels able to re-reconsider an earlier approach they had abandoned, and that as a result of our discussion on Medical Services Advisory Committee (MSAC) guidelines they will more clearly identify the logjams and get back to us. Election 2016 Your Executive Committee had made suggestions to PCFA about presenting a comprehensive policy document to parties for their support. Meeting with PCFA CEO Anthony Lowe, I came to support his opinion that a single policy item presented to all party leaders in person by Anthony would be in the best interests of men with prostate cancer. Executive Committee members concurred later in the day. One week later, while visiting Launceston General Hospital in Tasmania, Shadow Minister King announced that the Labor Party has committed to securing the existing Department of Health funded prostate cancer nursing positions for a further 3 years from 30 June 2017 and will fund an additional 14 prostate cancer nurses across Australia. Anthony was scheduled to meet with other party leaders. Getting Zytiga (abiraterone) on PBS pre-chemotherapy Your Executive Committee sought to meet with Janssen (a Johnson & Johnson subsidiary) to discuss progress on getting Zytiga (abiraterone) on the PBS pre-chemotherapy. As a result, Janssen brought together a Prostate Cancer Patient Working Group meeting in partnership with PCFA last Friday 27th May 2016 in a meeting room at Sydney Domestic Airport. Anthony Lowe and Katie Dundas of PCFA, Paul Hobson, Alan Barlee, Nev Black, Graham Bloomfield, Kerry Drinkwater, David Abrahams, Zeni Muhiji and I attended. Several of those attending had abiraterone experience. We heard a presentation from Prof Gavin Marx on current therapeutics in advanced prostate cancer, and had some hours talking with Janssen staff about issues. Disclosure Your Executive Committee and other members taking part in the above advocacy activities above have signed various commercial-in-confidence agreements and will not be free to discuss details in those cases. Only one of the activities listed above included a financial recompense for time contributed. PCFA contributed travel costs in several cases, but travel and accommodation for the Canberra meeting were met by committee members themselves. Personal note An amazing thing about the Executive Committee members who assist me in running the Australian Advanced Prostate Cancer Support Group is that, as well as the enormous work they do for us, each takes a central role in their local Prostate Cancer Support Group, and on various research project teams, and general prostate cancer activities, stepping forward whenever a person is needed. We have made great strides with our advocacy in the past three years. Members' submissions to the PBAC have paid an important part. But on top of that, the vital part paid by the other members of the Executive Committee, especially in the past year, had laid an important foundation for the next year. We can look forward to the reform of the PBAC/PBS process and hopefully getting pre-chemo approval for Zytiga, Xtandi and Xofigo at least. I am proud to work with these men and with this group. Jim Marshall Convenor Australian Advanced Prostate Cancer Support Group
  11. The Malecare Advanced Prostate Cancer Blog reported on research data presented at the 7th European Multidisciplinary Meeting on Urological Cancers held in Barcelona from 12-15 November 2015. Patients who were treated with abiraterone acetate (Zytiga) or denosumab at the same time as they were treated with Ra-223 had better Overall Survival. Patients who had a good ECOG performance status*, no pain and low alkaline phosphatase (ALP)# had significantly longer Overall Survival. * ECOG performance status Clinical trials require the use of standard criteria for measuring how the disease impacts a patient’s daily living abilities (known to physicians and researchers as a patient’s performance status). The ECOG Scale of Performance Status is one such measurement. It describes a patient’s level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The scale was developed by the Eastern Cooperative Oncology Group (ECOG). # Alkaline phosphatase (ALP) This is a protein that the body produces mainly in the liver and in bones. With prostate cancer, elevated levels of ALP are associated with the formation of metastases in the bones.
  12. http://tinyurl.com/pcwv6zd Information in the above reference indicates that the administration of Xofigo/Alpharadin/Radium 223 in company with abiraterone/Zytiga increased the effectiveness of Xofigo as well as overall survival. Combining EBRT (External Beam Radiation Therapy) with Xofigo increased likelihood of bone marrow failure.
  13. Paul Edwards

    Xofigo Update

    The US Federal Drugs Administration approved the use of Radium 223 (Brand name Xofigo also called Alpharadin) two years ago. The well-known US prostate oncologist Dr Mark Scholz gives an update on the experience of his clinic in using the drug. Click on this link to read his article. Xofigo is not yet available in Australia on the PBS
  14. Thanks to Chuck Maack for drawing our attention to the report of a recent presentation by Dr Oliver A Sartor who was the principal North American investigator for the clinical trial that led to the approval by the United States Food and Drug Administration (FDA) for radium 223 (brand name Xofigo). In 2013 the FDA approved radium 223 for treatment for patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. Dr Sartor said that determining whether or not a patient had symptoms of bone metastases could often be a grey area. He considered the extent of bone metastases was more important than the presence of pain in determining whether to treat a patient with radium 223. Dr Sartor was treating patients with metastatic castration-resistant prostate cancer who had a significant burden of bone-metastatic disease, even though they might not be considered symptomatic. After nearly a year of clinical use, Dr Sartor said that the optimal setting for radium 223 appeared to be in combination with new hormonal therapies such as Abiraterone (Xytiga) and Enzalutamide (Xtandi). At present a large multi-country Stage III clinical trial is about to start recruiting in Australia: Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms Dr Sartor said large clinical trials would be needed before radium 223 could be considered for use on patients who did not have metastatic disease or were not castration-resistant.
  15. Paul Edwards

    Xofigo (Radium 223) - Getting there

    At its April 2014 meeting the Medical Services Advisory Committee considered an application by Bayer to list Xofigo (radium 223) on the Medicare Benefits Schedule. Xofigo (radium 223) is a new drug which significantly increases life expectancy and quality of life for men with castration-resistant prostate cancer who have bone metastases. The advice to the Health Minister from the Medical Services Advisory Committee has now been made public. The good news is that the Medical Services Advisory Committee has recommended that Xofigo be supported for public funding and listed on the Medicare Benefits Schedule. However, the price for Xofigo recommended by the Medical Services Advisory Committee was not acceptable to Bayer. It's not uncommon for the Government to reject the initial price claimed by a drug company or for a drug company to reject the inital price offered by the Government Bayer is continuing to negotiate the price of the drug with the Government. Bayer said that it "hopes to resolve the outstanding issues...... and to provide Australian patients with access to the drug in a timely manner".
  16. Xofigo is a new drug which significantly increases life expectancy and quality of life for men with castration-resistant prostate cancer who have bone metastases. Xofigo has already been approved for use in the United States, United Kingdom and Europe. The Medical Services Advisory Committee is meeting next month (April ) to consider whether to approve Xofigo for use in Australia. You can help to get Xofigo approved for use in Australia. Please write a letter of support to Professor Robyn Ward, the Chair of Medical Services Advisory Committee and to your local Federal Member of Parliament, as soon as possible. Ask your family and friends to write too. The campaign to have Xofigo approved for use in Australia is being organised by the Prostate Cancer Foundation of Australia. Please see attached a letter from Dr Anthony Lowe, Chief Executive Officer of PCFA. Also attached is a sample letter for you to use, should you wish, some tips and suggestions for writing your own letter, and a list of key contact people to address. Letter from Dr Anthony Lowe-1.doc Sample letter.doc Letter suggestions-1.doc Key Contacts.doc
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