Europa Uomo on Course for a Busy Year

Andre DeschampsLast weekend we held our General Assembly in Malahide, Ireland. 21 of our members were represented.

As per our statutes, the membership appointed 4 new board members (see elsewhere in this issue) and approved the accounts and the budget for next year.

For the first time we were able to combine our organisational business with training for our members. We also consulted the membership about the feasibility of an important study on patient quality of life in prostate cancer care. It is now up to the new Board to analyse the results and make decisions, based on that feedback.

I would like to thank all who have contributed to the success of the General Assembly.

Once more I would like to give special thanks to Ken Mastris, who has served the board for 6 years, 3 of those as Chairman. Ken has given countless hours and days to serve his fellow patients and it will be difficult for me to match his efforts. I know Ken’s heart is still with us and I am sure Europa Uomo will be able to count on him again.

I look forward to working with the new Board and all our members over the next year.

André Deschamps

Chairman

New Board of Europa Uomo

The annual General Assembly of Europa Uomo was held in Malahide, Ireland on June 8th and 9th 2018. The outgoing Chairman, Ken Mastris, had completed his maximum two terms and Christian Arnold had resigned.  Treasurer André Deschamps and Secretary John Dowling were each standing for second 3-year terms.  This meant that there were four Board positions to be filled.  A total of 5 candidates were duly nominated.  The election procedure was supervised by Hannu Tavio (Finland).

The four successful candidates, elected by secret ballot, were Günter Carl, André Deschamps, John Dowling and Ioannis Vanezos.  The Board then met and elected the officers (see below).  Good luck to all the Board members for the coming year.

The Board of Europa Uomo for 2018-2019 consists of:

André Deschamps (Belgium)                  Chairman

Will Jansen (Netherlands)                     Vice-Chairman

Stig Lindahl (Sweden)                           Vice-Chairman

John Dowling (Ireland)                          Secretary

Ioannis (John) Vanezos (Cyprus)             Treasurer

Ernst-Günther Carl (Germany)

Pentti Tuohimaa (Finland)

 

 

Where are we now on the prostate cancer screening issue?

psa prostate cancer test

By Roland Muntz, President of ANAMACAP, France
Translated by Christian Arnold, edited by Judy Higgins

Historical background 

Before the start of PSA blood testing (discovered in 1979 by Wang), prostate cancer could only be diagnosed through rectal examination – not well received by patients -nor by their GPs. Consequently prostate cancer was generally diagnosed at the metastatic stage (concurrent with bone pain) and led to men’s death in horrendous conditions.
From 1990 well publicised campaigns were launched in the US about PSA screening followed by biopsy, which made possible the diagnosis and treatment of large numbers of aggressive cancers. The death rate due to prostate cancer duly decreased.
But after some years using intensive screening, rates of aggressive cancers (linked to high levels of PSA) diminished; focus was then placed on patients with PSA levels lower than before. As a consequence, many false positives were found, leading to overtreatment of benign prostate cancers after unnecessary biopsy – these slow­growing cancers were not at that time identified as such.
In 2012 the US Preventive Services Task Force, while recognizing PSA screening had shown real results in terms of decreased deaths, emphasised that the negative consequences could surpass benefits when looking at quality of life. And as a surprise to both patients and doctors, US PSTF decided to stop recommending PSA testing. Other countries followed without argument. The outcome was obvious: return to a time prior to PSA, seeing more and more prostate cancers diagnosed at a late stage, not to mention metastatic cancer.
Faced with such a disastrous turn, the US PSTF are this year reversing these erroneous guidelines. Other countries are to follow, with a particular position for France, which is resisting, with guidelines issued by Haute Authorite de Sante (HAS) hostile to PSA screening. Despite this, the test is widely used in France – but in an anarchic way.

What is the current problem?

A common mistake lies in the simplistic definition of PSA test value. It is not a specific test of prostate cancer but merely a measure of prostatic disorder, and for prostate cancer it is a grading test, indicating a need for follow up tests.
The chance of prostate cancer diagnosis following blood PSA test are now well known:

 

psa test results

 

In the overall population 70% of men over 40 years show a PSA level <1.5 ng/ml and can safely be monitored with PSA testing every 4 years. The real danger begins within the 1.5 to 4 ng/ml range, but risk doesn’t mean cancer, and even when cancer is present, radical treatment is not always necessary; often active surveillance can be enough. In this respect PSA is a marker of risk and not a starting point for biopsies and cancer treatment.

The real issue is primarily educational. PSA tests are prescribed by GPs upon (or without) patients’ demand. In France, HAS guidelines require that prior to testing, GPs discuss the pros and cons of PSA testing with patients. Are they doing the same when they prescribe a cholesterol analysis, blood pressure or weight measurement for more widespread illnesses such as diabetes, hypertension and obesity? In no way! In these cases they discuss treatment after results are made available.

Results should be handled in the same way with PSA and prostate cancer. In 70% of cases PSA will be below 1.5ng/ml – no need to discuss at length in these cases, the patient will be asked to revisit PSA testing 4 years later.

When the result is > 1.5 ng/ml, draw no hasty conclusions: this level means merely that the patient is more at risk of prostate cancer. He will be asked to retest every year or to seek additional tests for a diagnosis. The goal being, as far as possible, to avoid unnecessary biopsies (over-diagnosis) whose outcome can sometimes be serious infection, which in France alone takes a toll of 10 deaths every year.

When millimeter-sized adenocarcinomas are discovered within the prostate following a biopsy, no hasty therapy decision should be made: such a diagnosis means the patient is at risk of developing an evolving risk (metastasis 15 years later). A detailed grading with regular surveillance every 6 months will be proposed to that patient, or otherwise a conservative treatment. The purpose of this is to avoid pursuing radical treatments automatically, particularly prostatectomies, which take a toll of almost 400 deaths annually in our country, not to mention clear after-effects (urinary and/or sexual). This death rate comes to 10,000 deaths in 20 years, aside from the illness itself. As a comparison ‘mediator’ was responsible for 1,800 deaths over 33 years. Where is our Irène FRACHON ? (whisleblower who revealed the ‘mediator’ case in France)

A solution

Currently, imaging advances for prostate (multiparametric MRI) and centralised reading availability allows not only the detection and location of a given tumour, but also measures its aggressiveness, which both justifies and finely-tunes subsequent biopsies. In such a way, over-diagnosis (too many negative biopsies; due to false-positive PSA) would be reduced and overtreatment (aggressive treatment of benign cancers) would also be reduced.

Monitoring of prostate screening is as important as for any other screening programme:

  • reimbursement of cost of PSA testing only when asked by National Health Service (Assurance Maladie in France), except for registered cancers
  • stopping reimbursement of unnecessary (and often spontaneously prescribed, by any practitioner) free/total PSA tests, similarly for costly testing for markers of second stage (like PCA3, Phi), taking into account imaging advances.
  • MRI should be processed within agreed centers in a programme, as mammograms are, in order to avoid multiple prostatic MRI prescribed in a disorderly way without reason;
  • Analysis and monitoring by HAS of measured pros and cons of prostatectomy when a cancer is detected, registered and managed.

Today, available tools allow us to raise both the sensitivity and specificity of prostate cancer screening to levels over 95%. No other cancer enjoys such levels of efficiency in screening.

Consequently, the prostate cancer screening issue can be looked at in a new way that questions former positions of opponents to screening.

There is an urgency ‘to stop such a massacre’, shouted again this year by a professional opponent to screening of prostate cancer, as if a blood analysis made from the crook of the arm could be the cause of any death!

Because of such dogmatic positions, we are led to witness real massacre, with almost 9,000 deaths every year in France, due to a lack of early diagnosis, and more than 10,000 men left disabled following prostatectomies without any clear benefit in terms of survival.  In addition, huge financial amounts spent on unnecessary invasive treatments  and new priceless molecular therapies. And whatever solution we arrive at, it must be better than falling into unmonitored screening:

‘What have you done? Nothing’ said Simone Veil to her opponents (on the abortion issue in 1974 in France), contrite when facing the truth that they were keeping to themselves.

All the ones concerned by the screening issue watch each other, awaiting any move on this subject to criticize in order to preserve their interests.

Many of our doctors, either GPs, urologists or oncologists are not interested in this issue to avoid any dispute and debate and at the end are satisfied with a status quo that protects their professional life: GPs, thanks to HAS guidelines hostile to screening feel free of any responsibility; biologists take advantage of disorder in PSA or free PSA testing prescriptions; urologists enjoy large revenues drawn from prostate cancer and oncologists are pampered by big pharma, who are producing new molecules for hormone or chemotherapy.

Patients and their natural spokesmen, institutions such as ANAMACAP, have to shake this conservatism in order to drastically reduce rates of unnecessary biopsies, prostatectomies and radiotherapies, along with metastatc cancer with all its long-haul treatments.

The Ministry of Health must listen to these words kindly, because they match the  absolute priority included  within its global prevention policy. Along with the Chairman of our Scientific Board (Prof. Olivier Cussenot), I ask him to listen to us in order to draft a strategy, which would produce great savings for our country’s budget, and moreover, would be an important step in monitoring the coming prostate cancer epidemic.

Roland Muntz, President of ANAMACAP, France

 

 

 

Almost 4 in 10 Prostate Cancer Diagnoses in UK are Late

The BBC has recently featured a report by the UK charity Orchid, which found a “worrying trend” of 37% of prostate cancer cases diagnosed late, at stages three or four. The comparable figure in the US is only 8%.
According to the BBC report, Orchid chief executive Rebecca Porta said: “With prostate cancer due to be the most prevalent cancer in the UK within the next 12 years, we are facing a potential crisis in terms of diagnostics, treatment and patient care. Urgent action needs to be taken now.”
http://www.bbc.com/news/health-43669439

The Orchid report, entitled “Prostate Cancer – Britain’s Growing Problem” also found that 23% of cases are diagnosed in hospital Accident & Emergency Departments, the majority of these cases being already at an advanced stage at the time of diagnosis. In addition, the analysis found that 42% of prostate cancer patients had seen their GP about their symptoms twice or more before they were referred (with 6% seen 5 or more times before referral). The report includes a comprehensive analysis of current and future aspects of patient care in the UK:
“Experts in the report point out deficiencies in the current approach to prostate cancer diagnostics. With the debate over the effectiveness of PSA tests still continuing there is a call for a unified, efficient and effective testing programme for those at high risk and those with worrying symptoms. “There is an urgent need for better tests to define how aggressive a prostate cancer is from the outset, building on diagnostic tests like MRI scans and new biopsy techniques which help to more accurately define the extent of the prostate cancer. This would enable us to counsel patients with more certainty whether the prostate cancer identified is suitable for active surveillance or requires urgent surgery and treatment” says Greg Shaw, Consultant Urological Surgeon at University College London Hospitals.”

https://orchid-cancer.org.uk/news/new-report-reveals-4-in-10-prostate-cancer-cases-are-diagnosed-late-and-an-impending-crisis-in-prostate-cancer-provision/

The foreword of the report, by Rebecca Porta, Chief Executive of Orchid, concludes: “Prostate cancer cases are set to rise dramatically over the next decade. With added support, a refocus on patient needs and a willingness to accept that prostate cancer will become the UK’s most prevalent cancer, together we can make sure we are skilled and ready to tackle this growing cancer, save lives and deliver better outcomes for men.”
The report also contains Orchid’s recommendations for urgent action by policymakers to address the growing Prostate Cancer problem in the UK.

Original report (PDF):
https://orchid-cancer.org.uk/wp-content/uploads/2018/04/April-2018-Report-Spread-2.pdf

PCa on the Beeb

On March 6th the BBC Radio 4’s ‘Inside Health’ carried a half-hour programme on Prostate Cancer with some of the UK’s leading clinicians and researchers such as Freddie Hamdy and Mark Emberton featured and many issues explained for the lay listener.

Download MP3 and listen back on this link:
https://www.bbc.co.uk/programmes/b09tdyk1

PSA Testing Does Not Save Lives, Major UK Study Concludes

Death rates from Prostate Cancer over 10 years among symptomless men who underwent once-off screening were identical to those who did not. This indicates that PSA levels are a poor indicator of the presence or severity of Prostate Cancer, and underlines fears that positive screening results cause unnecessary anxiety and overtreatment that alters quality of life, without improving outcomes.

Article:
https://www.telegraph.co.uk/news/2018/03/06/prostate-screening-saves-no-lives-may-do-harm-good/

Original study:
https://jamanetwork.com/journals/jama/article-abstract/2673968?redirect=true

See also JAMA editorial:
https://jamanetwork.com/journals/jama/article-abstract/2673950?redirect=true

What? Where? – What Men Don’t Know…

location prostateIt seems that 9 out of 10 British men do not know what the prostate gland does. More than half of British men don’t know where their prostate is located. Almost 1 in 5 British men did not know they had a prostate. These results are from a survey by Prostate Cancer UK.  Would the results be much different for men in any other European country? Yet, prostate cancer is now the leading cause of cancer in British men. Figures released last month showed that it is now responsible for more deaths annually in men than breast cancer is in women.

Read more at http://www.BBC.co.uk/news/health-36105272

Full survey results:
https://prostatecanceruk.org/for-health-professionals/our-projects/public-awareness-study

FDA Approves Apalutamide for Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

The US Food and Drugs Administration has approved Apalutamide (Erleada) for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). The drug is now the first FDA-approved treatment in this setting.

Non-Metastatic Castrate-Resistant Prostate Cancer is where men on Androgen Deprivation Treatment experience a rising PSA but where scans do not reveal the location of a new tumour.  This new drug appears to delay the actual onset of metastases or spread for about 2 years.

The approval is based on the phase III SPARTAN trial in which apalutamide reduced the risk of metastasis or death by 72% in patients with non-metastatic CRPC. The median metastasis-free survival (MFS) was 40.5 months in the apalutamide arm versus 16.2 months in the placebo arm.

“The FDA evaluates a variety of methods that measure a drug’s effect, called endpoints, in the approval of oncology drugs. This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “In the trial supporting approval, Erleada had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public.”

The company, Janssen, which obtained the FDA approval has also made an application to the European Medicines Agency for marketing authorisation for the same drug.

Read more on the following link.

http://www.onclive.com/web-exclusives/fda-approves-apalutamide-for-nonmetastatic-castrationresistant-prostate-cancer

Richard Pazdur, MD

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