Tag Archives: Sarcoma

And also… it was results day!

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This afternoon I met with my new consultant at the Royal Marsden to receive the results of my 6 monthly scans.

ALL CLEAR!  Bring it on… another 6 months under my belt.

I had a lovely chat with my new consultant.  What a wonderful Dr.  We were able to discuss a whole host of things that have been raised via the Phyllodes Support Group.  He’s assisting with putting some ‘advice sheets’ together for the Group and also investigating some links to other research I flagged today.  Interesting also as he has been working in the US for many years and understands the differences between the US and UK for Phyllodes.  Very useful insights.

He shook my hand and congratulated me when I told him I managed to get Phyllodes mentioned on TV today!

Genetic Testing

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In August 2011 one of my co-administrators in the Phyllodes Support Group posted in the group a request for 1,000 people who had been diagnosed with sarcoma to be part of a sarcoma research project on 23andMe.  The project was sponsored by 5 charities, Beat Sarcoma, Sarcoma UK, Association of Cancer Online Resources, Sarcoma Foundation of America and Sarcoma Alliance.  The aim was to genetically test 1,000 people who’d already been diagnosed with a sarcoma and see if this testing would find a link between us all.

A spit sample with the aim of producing a valuable research outcome that may help thousands of others in the future.  Of course, I registered immediately.

As part of the testing process each participant received their genetic test results free of charge.  I’d never considered having genetic testing so for me the test results were an added bonus.

Between my spit sample being collected by a DHL courier (who looked horrified when I had to declare the content of the package being sent to the US), and my receiving the results I found myself wondering what I would find out, whether I should even read the results, what I would do IF it told me something I’d not like to know.

At the time in the UK the process for genetic testing was to be referred by your Dr and to have counselling as part of the test.  The counselling is carried out before, during and after your test results to ensure you’re able to cope with the results and what you would do should they not be what you expected.

However as I was participating in a project run via the US, counselling was not offered and I’d not thought it would be of concern when I signed up.

Me being me, decided that I should do my own ‘counselling’ and, as far as I’m able, ensure that I’m in the best mental state to manage any results – good or bad.  I made myself consider what it would be like if I opened the email to discover that I was high risk of an illness, what I would do, who I should tell etc.  I made myself not only consider it but imagine that was the result.  I needed to know how I’d cope and what I would do in those circumstances.

So when I received an email “Your 23andMe Results are Ready!‏”, I felt prepared.  Although I confess to not opening the email for an hour or so whilst I paced and reconsidered what I’d do.

I was fascinated when I opened up the results.  How could a little bit of spit identify that I had blonde straighter hair on average, blue eyes and if a smoker, likely to smoke more!  All correct although I’ve now not smoked for years.

Within Disease risk, I discovered that I’m slightly higher at risk of coronary heart disease, ulcerative colitis, breast cancer, celiac, Crohn’s and Lupus.  But these are all relative.  On most of them I’m only very slightly higher and still it’s only 0.5% chance where the average population is 0.2%.   I can see however that one might read that as over twice the risk of the average population rather than 99.5% risk of NOT having the disease.

With all statistics and numbers it’s difficult to interpret them without emotion and to understand percentage risks in a way that’s meaningful.

I was however angry when I read my results for multiple sclerosis.  Mum had MS and my Aunt was diagnosed after Mum in the early 90s.  I remember Mum telling me that as MS is something that generally passes down the female line, according to her Dr I had now a 50:50 risk of being diagnosed with MS.  I’ll admit that this has weighed heavily on my mind since then and has infuenced decisions I’ve made in my life.  One of my school friends, Belinda, was diagnosed in her 20s with MS and passed away a few years after diagnosis.  And I’ve watched Mum become less able and eventually pass away from MS.  So when the results of my 23andMe genetic testing indicated that my risk of being diagnosed with MS was less than the average population, I was livid.  I was furious that I’d spent 25 years worrying about it.  Every time I had numbness or tingling in my fingers and toes, when my eyesight was playing up and many other ‘symptoms’, I’d wondered if it was the start of MS.  Ironically over the years I’ve never thought that they could have been wrong… 25 years ago they knew far less than they now know!

So what else did my results show me?  Actually I’m quite healthy!  For the most part I’ve a typical result or one that isn’t far off the average population.  I also know I have an increased sensitivity to Warfarin… so should I ever be prescribed this, I will know to tell the Dr that I need a decreased dose!  Nothing of note within my Carrier Status.  Only disease risks that are more than double the average population are melanoma (3.6%), celiac (0.7%) and lupus (0.5%)… but they’re still only very small percentages so I’m not going to worrry about them.

Since my first registration I’ve received regular updates from 23andMe when new research comes to light and my results are re-assessed.  I’ve been fascinated to read them.

Within 23andMe you are able to link your results to others and many of us from our Phyllodes Support Group who took part in the trial have done this.  We thought it may be interesting to see if there were traits/risks that we could identify between our small cohort group.  Sadly we couldn’t see anything that stood out with the exception that many of us had higher than average auto-immune disease risks.

So why this post now?

23andMe have just launched in the UK.  This means that anyone is able, for a price, to obtain their own genetic testing via 23andMe and without genetic counselling.  It’s a service accessible via the internet.

Germany are considering 23andMe being available there.  This week I was asked my views on it and asked to record a piece for their TV channel ZDF.  You can see it here from about 4.10.

Inevitably there’s been lots of discussion about whether it’s a good thing.  Whether genetic testing should be allowed without counselling?  Whether the results provided by 23andMe are accurate enough and using up to date data?  My view, is ‘Yes’ but with caution.  Anyone undertaking genetic testing needs to consider why they’re doing it.  What they want to know/understand from the test results.  How they’d deal with the results being good or bad.  Who they’d tell.

I wouldn’t have had my genetic testing carried out were it not for the Sarcoma Community Project.  However I’m pleased I did.  I feel I know more about myself, my health and my risks than before.

 

Mammogram time

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You’ll remember I recently went for my six monthly scans which are all part of the follow up regimen following my diagnosis with malignant phyllodes and DCIS.  You may also remember that they had ‘forgotten’ to book my annual mammogram.  I’ve had some truly frustrating phone calls and several tears whilst trying to ‘remind’ the team what was agreed as a good regimen to monitor my health.

My appointment letter was received a few days ago and today I went into the RMH for my mammogram.  Unlike when I was there a few weeks ago, the clinic was virtually empty and I was seen immediately.  It’s crazy when I think about me having to chase and WANT a mammogram.  They’re usually painful and as my breasts get more lumpy with age and scar tissue they are becoming even more painful.  The mammographer was kind and tried to be as quick as possible but needed to take quite a few scans covering lots of tissue and angles.  Part of me wishes I didn’t need to do them at all as the pain is so bad (today was truly dreadful) but I also know that these are the best way to identify changes and see any Phyllodes appear.

Next stop is my appointment with the sarcoma team (and I presume a new consultant) for the results of the ultrasound, chest x-ray and now mammogram.  Only a few more sleepless nights…

Regular scans

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You listen to me every 6 months talk about the follow up scans, the scanxiety and the results.

Well it’s that time again.  It explains why I’m more than a little antsy too.  No matter whether I’m thinking about it or not, somewhere in the depths of my brain is a little voice saying ‘maybe this time’.  With every twinge or pain that I get in my boobs (and believe me I get a lot) or my back, I wonder if it’s related.  I still get shooting pains which apparently is from the surgery and when I’ve previously discussed the pain with the consultants, I’m told that perhaps this is ‘normal’ for me.  But what IS normal?  How can I differentiate what would have been there anyway and what is because of the surgeries or phyllodes?

I digress but perhaps you might understand why I get anxious.  So last Friday I trotted along to the Royal Marsden.  Appointment card, request for a chest x-ray and letters making and changing my ultrasound appointment firmly in my hand.  I hadn’t received a mammogram appointment letter but presumed that this would be booked in when I got there and that the letter hadn’t yet arrived – previous experience of my receiving the appointment letter after the appointment had taken place fresh in mind!

The waiting room for ultrasound is full but we’re seen quickly.  I’m greeted by my usual lovely sonographer and introduced to a trainee sonographer who is due to qualify into the Marsden in a few months.  I mention that I’ve not received a mammogram appointment.  The trainee does the first exam.  It’s painful as she goes over lumps and bumps (I presume scar tissue) and on occasion stops to have a closer examination of areas.  It’s a little off-putting watching her face as she thinks she see something and hasn’t quite mastered the poker face yet – I guess that’s part of her training.  Then my usual sonographer takes over and they discuss their findings – “usual ‘oddness’, scar tissue and lobular neoplasia” but nothing unusual for me and apparently nothing to worry about.  I’m reminded that I should follow up for a mammogram appointment today.

Next stop chest x-ray.  This is such a quick procedure.  Stand in front of a black panel and breathe.  All done.  I was keen to get this x-ray today.  I’ve had a weird ‘catch’ in my breath and occasional wheezing of late… I’m hoping it relates to the virus I had a few months ago and nothing more sinister.

Now to head to the Outpatients Reception to see if I can find out about the missing mammogram.  I’m given a telephone number for a sarcoma CNS.  I call internally to discover the team are all in an MDT meeting.  Disappointed I head off and leave the Marsden.

I’ll get my results from my consultant at the next appointment which is in 5 weeks time.  It’s ridiculous that the results appointment is so long after the scans – more scanxiety!

Yesterday however I managed to speak to the sarcoma CNS.  She wasn’t sure why I hadn’t had a mammogram appointment and went away to check.  My consultant has now left the Marsden and apparently I’m now under a different consultant but my mammograms are under the breast cancer team.  WHY???

According to whomever she spoke with, I don’t need mammograms in my followup and that an ultrasound and chest x-ray is enough.  Aggggggh the agreed followup was for annual mammogram and six monthly ultrasounds and chest x-rays because Phyllodes doesn’t always show up on ultrasound until it’s grown bigger.  I explained this as calmly as I could… and then promptly burst into tears when I hung up the phone.

The Marsden are great.  They’re a centre for excellence for sarcoma.  BUT I’m waiting for an appointment that actually goes according to plan.  A time when I don’t have to run around the hospital chasing up something or booking in to a different location or calling up to find out what’s going on.  Truly I’m not sure but assume that within the hospital they have a multitude of non-communicating IT systems.  If only the realised the anxiety that these inefficiencies caused to their patients and carers.  I know I’m not the only this happens to as am often having my ear bashed in the waiting room listening to someone else’s anxiety.

So I guess I’ll have to wait for the sarcoma CNS to call me back.  And then wait for the mammogram appointment.  Or perhaps wait until my consultant appointment in July for the results of the ultrasound and chest x-ray.  Discuss with the consultant in July about my having a mammogram, get that booked in, turn up for another appointment and then have to have a further consultant appointment for the result.  Just as well I’m not in full-time employment with all these days off.

I wonder who my new consultant is?

NCIN Conference 2014 (Day 1)

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The NCIN (National Cancer Intelligence Network) is a UK-wide initiative, working to drive improvements in standards of cancer care and clinical outcomes by improving and using the information collected about cancer patients for analysis, publication and research.

When I was first aware of the NCIN, their goal was “To develop the best cancer information service of any large country in the world – by 2012”.

Because of the work they continue to do, UK clinicians, medics, researchers, NHS purse holders, pharma, charities and, of course, patients are now able to draw on an incredible amount of useful data-sets.  This data enables measures to improve outcomes, drug development, research projects, awareness and own patient care.

This year I was honoured to be invited again to attend the NCIN Conference with a bursary place and below is a summary from my notes at the Conference.  Wherever available I have added links to presentations.

Cancer Outcomes Conference 2014 – the power of information
Sponsored by Cancer Research UK and Macmillan

Chris Carrigan
Director of NCIN Public Health England (PHE) 

Chris opened the conference and welcomed those attending.  This year’s conference attendance is larger than ever before with over 570 people attending.  With national and international spread from primary to end of life, charities and patients.

Chris (@C_Carrigan) wrote a blog at the start of the conference on twitter on how bringing people together can improve cancer outcomes – read here

Harnessing the power of information to deliver quality and innovation in cancer surveillance, services and outcomes

Chair: Prof Brian Ferguson
Knowledge Transfer and Innovation Director at PHE
“Innovation at the heart of Public Health England.

Kris Hallenga
Coppafeel! @krispop @coppafeelpeople
Ensuring everyone stands the best chance of surviving breast cancer

Kris#NCIN2014, Let’s talk boobs

Kris ‘story’ is well documented not least on an incredible documentary that has just been shown on TV “Dying to Live“.

Kris was 22 when she noticed lump.  She ignored for a long time. Eventually went to GP and told more likely to be hormonal.  Went travelling and noticed the lump was getting bigger. Returned to GP. Told nothing. Mum got involved. Returned to GP. 8 months after first going to GP was referred and told breast cancer and spread to spine.

1 in 15,000 chance of getting breast cancer under 25.

“You beat the odds in getting the disease and can beat the odds to get rid of cancer.”

2 months into treatment Kris researched why she didn’t know more about cancer at a younger age and what to expect.

She knew she couldn’t change her diagnosis but she could make it better.  Or as Kris said “You can’t polish a turd… but you can roll it in glitter…”

She kept hearing “Early detection is the best form of defence.”  Why wasn’t there breast cancer awareness in schools, universities, 6th form colleges?  Surely that’d lead to earlier detection.

So Kris thought about where she could reach these young people.   Armed with CoppaFeel! stickers set off to a festival.  Whilst facepainting with her twin sister people started approaching and talking about boobs.  Talking about breast cancer.  Talking about checking yourself.

CoppaFeel! are now a regular set up at music festivals, university campus and many other locations filled with younger people.

As well as Kris and her sister talking about boobs, there are now the Boobettes – young women who’ve been diagnosed with Breast Cancer.  They go into and talk at schools and events about their experiences and awareness and early diagnosis.

Kris has asked “What does BC mean to young people?” and got these answers (amongst others) – life-stopping, turmoil, depressing, threatening, damaging… not good and words that put you off from checking your boobs.
It is a very treatable disease if diagnosed early.

1 in 3 are diagnosed with cancer.  Early diagnosis is key.  #rethinkcancer is a campaign to bring cancer education into schools, colleges and universities.  “I know it will help and I know they want to know it… I’ve spent the last 5 years speaking with them.”

Put an end to late diagnosis of cancer.

Kris Rethink Cancer

The stats of tomorrow are the young people of today… it can happen to young people. It should go through the mind or every GP and medical professional out there.

“If you have influence please use it. If you have colleagues please pass the message on. If you have boobs, please check them.

Think boobs.”

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Prof John Newton
Chief Knowledge Officer, PHE
Cancer – A public health perspective

Presentation

So many things to learn from what Kris was saying. Behind every statistic and data is a real person like Kris. This should be a reminder.

4 things we need to do:

  • Prevention
  • Diagnosing cancer early
  • Make sure very patient gets the best treatment
  • Care of people who are living with cancer, whatever the outcome

Struck by Cancer Research UK stats that 40% of cancers are preventable. There is a huge challenge but we as a population need to address it.

Good news is that we have the best treatment services and charities in the UK. We have some of the best intelligence systems in the world. The best Cancer Registry.

No doubt that cancer intelligence NCIN has played it’s part in improvements. More that we could do with the data to improve outcomes and prevent cancers.

How do we build NCIN in Public Health England to get even better outcomes?

Mission – “To protect and improve the nations health and to address inequalities working with national and local government, the NHS, industry, academia, the public and the voluntary and community sector”

Broken down into manageable chunks – outcome focused.

  • Helping people to live longer and more healthy lives by reducing preventable deaths and the burden of ill health associated with smoking, obesity etc
  • Reducing the burden of disease and disability in life by focusing on preventing and recovery.
  • Protecting the country from infectious diseases and environmental hazards
  • Supporting families
  • Health in the workplace
  • Promoting development of place based public health systems
  • Developing our own capacity and capability to provide professional scientific and delivery expertise

PHE’s jewels in the crown:

  • National Screening Programme
  • National Cancer Registration Service
  • National Cancer Intelligence Network.

PHE inherited some strong partnerships with many including:
National Cancer Peer Review and National Cancer Research Institute.

PHE have a significant local presence:

  • 4 regions, 15 centres
  • 8 cancer registration teams
  • Central coordination and analytical team
  • 8 knowledge and intelligence teams around the country

Track record of delivery is increasing….

  • National Cancer Registration Service
  • Completed the national migration
  • Data going out trusts
  • Published staging data
  • Cancer analysis system implemented
  • Prostate cancer data network

Our public health perspective:
NCIN

  • Be clear on cancer campaign evaluations have been carried out for lung, blood in pee, breast cancer in over 70s, ovarian, oesophago-gastric, lung reminder and local skin cancer pilot.
  • Analytical work by the central and knowledge and intelligence teams
    • 16 data briefings, 23 in depth reports, 9 press releases
      17 journal articles, profiles, toolkits, routes to diagnosis, workshops for clinicans…
  • New office for data release is established and now operational
  • Reports analytics from the page impressions on our websites show an increase both nationally and internationally.

Collaborative work:

  • Deprivation report with CRUK
  • Routes from Diagnosis with Macmillan
  • Less common cancers – Cancer 52

The patient portal:

  • NCRS and NCIN
  • Brians Trust
  • Cancer Research UK

Summary/Future Look

  • Cancer remains as a significant public health issue
  • Many national cancer bodies inside PHE brings definite synergies, some of which we are now seeing, but there is much more to do… we want your help with it.
  • Growing demands for our intelligence capacity
  • NCIN will grow and flourish as a partnership and as part of PHE’s integrated cancer programme.

Increasing value to assets whilst data, partnerships and resources continue to flourish and grow.  We need to work together to ensure that this data and these collaborations continue to demonstrate improvement for cancer outcomes.

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Sean Duffy
National Clinical Director for Cancer – NHS England
Progress on the delivery of optimal care for cancer patients in the new NHS

Presentation

Optimal cancer care in the new NHS – an absolute commitment to deliver services for better outcomes.

The survival challenge

  • Mortality improvements v survival gap
    • Although we’ve made gains in the survival in the UK. Other countries have also had improvements.  We need not to equal the other countries improvements but to ensure our improvements are greater.
    • Eurocare 5 (2013 analysis of 2007 data)
  • Stage at presentation and earlier diagnosis.
    • We need a cultural and system shift to lead a stage shift.
    • Primary care interface – % flows
      • GP direct access to tests. Does it make a difference. On average access to test should make a difference for 6% cases. BUT hides 15-20% for cases such as stomach, ovarian, pancreas, renal, brain.
    • Route to diagnoss, England 2006-2008
      • All cancers emergency presentations 24%

Ownership of treatment decision
We should ask every MDT in every hospital to look at least once a year at the decisions it has made (treatments) and what it has meant for its patients (outcomes).  By revisiting these decisions they may be able to see improvements or identify changes that need to be made.

National datasets for cancer should enable the work – chemo, radiotherapy and outcomes data
National audits need to be used more.
Transparency is essential

12 senate geographies for the cancer map. If they took a grip of their own survival curves then we could be in a better position.
Plea – Own your 1 year survival and work collaboratively together.

Selection bias

  • Age and outcomes
    • 34% of 80-84 and 43% of 85+ are diagnosed via emergency route compared to 25% of 70-79 year olds.
  • Age and treatment
    • Access to treatment of the older population is variable. There is an age bias that exists and the data sets demonstrate this. Not just for surgery but also chemo, radio and access to a cancer nurse specialist.
    • Perhaps there could be a co-morbitity and late stage diagnosis but not completely responsible for decline in survival in older patients.
    • Older patients get less chemotherapy delivery for colorectal patients.

Structure

  • Key factors that influence greatest impact is access
  • The question of volume and outcomes
  • Community of care, not individual or isolated providers
  • Redefine the model – ideal structure within given senate geographers based on IOG principles and evidence.

What is best and where?

Summary

  • Gap in survival to tackle together.
  • Effective plan for early diagnosis to ensure the front end of our health care system delivers what you need it to.
  • Local MDT and senate geography focus on outcomes as a result of treatment decisions is vital to improve survival.
  • There is an inherent age bias that if tackled could yield significant survival benefits.
  • The evidence for volume linked to survival outcome cannot be ignored.

Q&A

Q (Kathy – London Cancer Alliance) – What has happened with the key recommendation in 1995 re early diagnosis?  Ambition was to go much further than they did at the time. The data at that time wasn’t as robust as at the moment. We have to be driven by the evidence. Any change moving forward has to be with improvements.
A (Michael CR_UK) – Are you talking to your colleagues in Scotland Wales and N Ireland about how to tackle the problems as a UK wide problem?
We are an English organisation but we are doing as much as we can with the UK. Spoke last week with the Welsh Health Minister (who are producing a white paper which is very interesting). Certainly on research we are very keen to work across the UK. Every reason and possibility of working across the UK not just England.
Julia Vern NCIN public health lead – UK and Ireland Association of Cancer Registries – absolutely a priority for all of us.

Q (Bob – Former NHS professional and lay rep) – Where is recent data?
A – Pointing you to the right person for the data question.

Q (Ian – Patient) – Emphasis is always on the clinicians rather than the patients. If there was more of a focus on the patient not the clinicians then I think you would see more survival times. Supporting stop smoking, diet etc particularly those of the poorer socioeconomic groups.
A – I think you’re right. Workstreams should be looking at exercise and other actions as a joint initiative between NHS England and Public Health England.
Approach moves away from a health service that provides testament for someone who is ill, rather than helping patients help themselves before they become a patient… it needs collaboration with charities, education and health care systems.

Q (Ms Clifton – Clic Sergeant) – Early/late diagnosis. GP dismissal of patients. Is any research done on looking at the reasons for late diagnosis or sending for tests in primary care?
A – How long have we got? There is a lot of research and simple things that primary care have developed to be more proactive. Got plenty to base a plan and are working on it. Key for me is that this is about public and primary care behaviour. The new changes should enable us to have more conversations and changes in this area.
Kris – We ran a focus group with some GPs. Reduction of the younger patients and also looked at the flip side of empowering patients about what you expect from a GP visit. Makes a huge difference.

Q – (Sara Hyams CR_UK) – Pick up on the age issue. How do we get more on the agenda for early diagnosis of the younger patients? i.e. under 30. How can we also improve things at the other end of the scale too?

Q – CCG – when would staging data be available to CCG levels?
A – Staging data has already been published. By CCG I understand it’s going to be June. NCIN is publishing it later this month.

Q – Health intelligence officer – I’ve got a 23 year old daughter. All this activity around data and intelligence isn’t worth anything unless it is used for the benefit of the patients.

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Plenary 1 – Outcomes for young people with cancer: matching commissioning guidance with the evidence

Martin McCabe
Chair of NCIN Young Patient Oncologist

NICE guidance on improving outcomes for young people and children with cancer.  (“CYP” children & young people)

  • Care co-ordinated as close to home as possible
  • Networks should meet the needs of CYP with cancer
  • MDT should provide cancer acre
  • Each CYP with cancer should have a key worker
  • Care appropriate to CYPs age and type of cancer
  • CYP with cancer should be offered the chance to take part in research trials
  • Treatment should be based on agreed protocols
  • Sufficient specialist staff
  • A register of all cancers in people aged 15-24

National Registry of Childhood Tumours
Established in England, Soctland and Wales in 1962

Childhood cancer isn’t well fit with ICCD coding so they have their own code. Birch coding.

TYA cancer
Teenage and Adult with Cancer TYAC founded in 2004.

In children cancer is always rare. Rare because it’s found in a child or because it is rare anyway.

Looking at survival AND important is quality of survival for children and young people.

Treated at a Principle Treatment Centre… but what happens when they’re referred out of the PTC?

One of the main advancements in childhood cancers is the enrollment of children into clinical trials. New paper from NCRI to be published very shortly which demonstrates this.

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Kathy Pritchard-Jones
UCL London Cancer
Paediatric clinical outcomes research – UK policy and the role of the European Network of Cancer Research in Children and Adolescents – early diagnosis

Talking about the European agenda for paediatric cancer clinical outcomes research.
ENCCA European network for cancer research in children and adolescents 2011-15
SIOP European standard of care for children with cancer
ExPO-r-NET European Expert Paed Oncology Research Network for Diagnostics and Treatment

Outcomes research

  • Outcomes seeks to provide evidence bout which intervention work best
  • Study of the end results of health services to take account opatients experience and costs to society
  • Provide scientific evidence

NHS Outcomes of framework

  • What can we really measure that is important to patients?

ENCCA – in 4th year of operation

  • Building a strategy to enable biology driven clinical and pre-clinical research. Tissue sampling, biobanking and sharing tissue across boundaries, training for clinicians, researchers and scientist. Long term sustainability of encca is bringing together national paed and cross cutting research groups to take it forward.

Why has overall mortality for children with neuroblastoma in the UK worsened?  Is it because there’s no trial currently open?

Infants with cancer have the highest rate of early mortality. Can we improve their model of care?

Equal access across Europe. Appointed by DG-SANCO to pilot how cross-border research can be done correctly?

Collaboration, defining entities, regulatory, embedding teaching and research.

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Tony Moran
Public Health England
Survival trends for young patients in the UK – the good and the bad diagnosis

Background
Lower survival in UK than several other countries
Rate of improvement slower in TYA than other age groups?

[Once the presentation is available, I’ll upload it here]

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Kathryn O’Hara
The Christie NHS Foundation Trust
Referral to and from specialist Centres- how widespread is the practice?

Presentation

Normal for 0-14 year olds to be under the principle treatment centres classified by extent of shared care. It’s not consistent in all areas.

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Plenary 2 – Living with and beyond cancer
Heather Monteverde
GM of Northern Ireland with Macmillan Cancer

Presentation

Considering living with and beyond cancer is a newly adopted consideration… relatively. So many changes within cancer with chemo, radiotherapy, surgery etc.

Consequences of treatment or late affects have a huge impact on the quality of life of people living with and beyond a cancer diagnosis. This also needs to be addressed. The physical as well as the emotional and psychosocial issues.

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Raoul Reulen
Uni of Birmingham
Teenage and Young Adult Cancer Survival study

Approx 225,000 5-yr survivors
Population based cohort
Diagnosed 1971-2006
Age 15-39
Covers England and Wales

Study link

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Matthew Francis
Public Health England, Knowledge and Intelligence Team, West Midlands
Method of identifying stage IV cancer

Presentation – please refer for charts and graphs.

Matthew spoke about the differences in staging sarcoma compared to other cancers.  The usual methods of staging include tumour size, nodal involvement and if there are any distant metastases identified.

With reference to sarcoma patients only 2% of those diagnosed with stage IV actually comply with these staging rules.  This makes it increasingly difficult to make comparisons and potentially contribute to a less favourable outcome.

In addition the rarity of sarcoma:
450 bone sarcomas new diagnosis
2,800 soft tissue sarcoma new diagnosis
less than 1% of malignancy
occur in different anatomical locations.

Detailed staging data is not available for patients with sarcoma.

Metastases site recording in HES can be the only identifier but this information isn’t always recorded.

4,602 new cases of bone sarcoma
20% of had metastases at diagnosis
27,913 soft tissue sarcoma between 2000-2010
3,602 13% had metastases

Soft tissue sarcoma – some sites have space for growth i.e. abdominal or breast where the tumours have space to grow and therefore not diagnosed as quickly i.e. may be identified at diagnosis with metastases.

Conclusions
Staging data for sarcoma is incomplete.
Those with metastases have significantly poorer outcomes.
The methodology used to identify stage IV sarcoma patients could be applied to other cancer data sites and assist the National Cancer Registration Service.

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Chris Brown
National Cancer Registry Ireland
Using routine prescribing data to identify comorbidities in ovarian cancer patients

Presentation

Please refer to the slides and data of the presentation.

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Plenary 2 – “Show me the data!” – information and intelligence for your ovarian cancer service

Chair: Annwen Jones
Target Ovarian Cancer

Presentation

Ovarian cancer outcomes could be improved. NCIN has provided hard evidence that outcomes can improve and also provided data and insights to shape policy and practice.
7,000 cases diagnosed each year
3/4 of cases aged 55 years and over
4th most common cause of death from cancer in women
4,300 women die each year
Late diagnosis is a major issue

Before 2007 (i.e. before NCIN) we had very little and incomplete data that was also unreliable.

32% of women diagnosed with ovarian cancer via admission to A&E v 24% of all cancers
15% of women die within two months of diagnosis.

Pathfinder Study – Target Ovarian Cancer – 2009, 2012, 2015… ongoing study.
Looks at patient delay, GP delay and system delay.

[Key findings published to date click here]

International benchmarking partnership (ICBP):
1 yr survival for ovarian cancer in England lags behind comparable countries
5 year survival difference results from 1 year difference. In England we do quite well at this point.

Data shows that there are wide regional differences in survival.

What is the underlying cause of variation and what more can we do to improve survival for all women with ovarian cancer? What does the data intelligence that we currently have tell us? What further data do we need?

Put patients at the heart… policymakers, patient organisations, commissioners and clinicians around patients.  The patient must be central.

Screen Shot 2014-08-18 at 13.14.34

The value of data to patient organisations:
Policy – impossible to influence policy without robust data.
Charity – we have to make sure that we’re spending the donations wisely. Data helps make decisions and priorities as a charity.
Patient choice – patients with a voice.  Personal note – it was wonderful to see the faces of patients on Annwen’s slide particularly that of my gorgeous smiling friend, Tish, who I miss so very much.  Tish was such a wonderful patient advocate for Target and others diagnosed with ovarian cancer.

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Dr Andy Nordin
Chair NCIN Gynaecological Cancer site specific clinical reference group
Ovarian caner in the UK: the emerging picture

ICBP – opportunity to compare outcomes with other high quality data countries such as Australia, Cancer, Denmark, Norway, Sweden 1996-2007

Gynae cancer hub with NCIN run through of projects carried out.

Results are improving in younger women but data identified that it hasn’t improved in the older patients. NCIN were then able to look at this area too.

Routes to Diagnosis in November 2010 we all know was that a great many people present as emergency presentation… ovarian is one that indicates this highly.

Short term ovarian case mortality:

  • why the elderly
  • late presentation
  • reluctance for referral
  • performance status
  • patient preference
  • access to specialist surgery
  • access to chemo
  • national variation

There needs to be more specialisation at a surgical level.  To look at the number of consultants by caseload and acknowledge that they should be doing more than 15 cases per year.  This surgery should NOT be undertaken by general surgeons but by specialist surgeons in specialist centres.

More use should be made of the cancer e-atlas

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Jason Poole
Associate Director, Public Health England
Short term ovarian cancer mortality in and across England

ICBP
Early results 2006-2009:
5288 women 31% died in the first year
2,592 died in first 2 months

3 contributory factors:
emergency presentation
advanced age
non-specific tumour morphology

case-mix analyses

  • women 2008-2010 resident in England, ages 15-99
  • data from national cancer data repository
  • HES inpatent and outpaitient
  • Ovarian cancer including fallopian tube and primary peritoneal cancers
  • Excl borderline tumours, sarcoma, germ cell tumours
  • 15,000 women in analysis

Patient outcome – excess mortality ie over and above ‘normal’ population mortality
3 periods of analysis – diagnosis to 1m, 1mto 6m; 6-12m

case mix factors

  • age groups
  • deprivation quintile
  • comorbidity
  • route to diagnosis
  • stage
  • morphology
  • treatment
  • basis of diagnosis

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Dr Rob Gornall
Clinical Director Cancer Services
The challenge of improving cancer services by commissioning pathways – the increasing value of data

Presentation

Rob’s presentation reiterated a great many of the points earlier regarding early diagnosis, variation in primary and secondary care services, complex commissioning pathways, patient behaviour and perception of risk.

Please refer to the presentation for more data on the above but please note there are graphic photographs.

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Louise Bayne
CEO Ovacome
Robust data – the value to patients and patient organisations of the NCIN

Why is the NCIN data required and quality of it so important?:

  • demographically representative
  • statistically significant sample size
  • non biased enquiry motive
  • highly skilled practitioners
  • published in full

Without NCIN data, charities need to look inwards for data sources and information. That has intrinsic problems about it.  Attract a sub-set of the cancer community who are not representative. Might be questionable motives as to why a charity has come up with a news story or report.

Why does this matter?

Data is used for:

  • NICE decisions on access of treatments.
  • shaping research proposals
  • commissioning
  • advocacy programs
  • patient information
  • individual treatment choice

Without excellent data patient organisation activities risk being characterised as:

  • opinion drive
  • biased
  • questionable motives

Leading to:

  • wasted resources
  • lobby fatigue
  • harm to misrepresented clinical sectors
  • poorer outcomes for community

Making the data count

  • Quality profiles – annual report using NCIN/DH data to provide a local picture of service/standards
  • Available on the Ovacome website
  • Parliamentary outreach day with Ovacome members lobbying their MPs
  • Circumvents clinical gagging clauses
  • Puts clinicians in the driving seat – we don’t say what’s to happen – clinical empowered to suggest improvements
  • Last year resulted in Secretary of State intervention, improvements to the data collection, the recruitment of clinical staff and improvements in clinical service (in one centre the development of a GP helpline)

The drive to improve diagnosis:

  • the majority of women have advanced stage disease at diagnosis
  • received wisdom – ovarian cancer is a silent killler – only symptomatic at advanced stage

But the studies said differently….

Using data for improving diagnosis:
BEAT campaign Bloating Eating Abdominal Talking.

Survivors teaching students

Commissioning – why NCIN is now essential
Commissioning challenges us to consider business as usual or optimal practice
To drive improvement trustworthy data is essential
However gaps in data remain a challenge

 

PPI Group – Imperial/Cancer Research – Meeting

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A fascinating meeting this evening of the Patient and Public Involvement Group from Imperial College and Cancer Research.

We meet regularly however often we discuss aspects that I’m unable to share with you so I don’t post a blog entry about every meeting.  However some of the tweets/facebook posts about upcoming events or opinion may be posted from Living Beyond Diagnosis accounts.

Tonight’s meeting was slightly different to our usual discussions.  In that many of the agenda items related to artistic and creative projects that it is hoped will support, aid and influence both patients and the public.

I am unable to go into the finer detail but wanted to share a little about the items and ask for your feedback.

Artwork in hospitals and cancer clinics.  An artist has been commissioned to produce some artwork for display in a very busy hospital cancer clinic.  Tonight he was able to share with us a few of his ideas of what he would like to produce and also to hear our feedback and comments on the proposed work.  His medium is ceramics and his aim is for the artwork to be uplifting for patients, intriguing and engaging for those who may visit the clinic often and perhaps to also be further dimensional to include some more medical references and in particular research and cells.

No mean feat ahead of this chap.

What a wonderful project… for him to create and of course for others to enjoy.

The discussions this evening were varied.  Some were very much for it being engaging and uplifting.  Some felt that if it had medical references to research and cells it may be too much in this clinic but others thought it may bring about discussion and hope.  We discussed where it should be placed.. or perhaps could it transcend both the reception desk and surrounding walls?  Perhaps to include some clever lighting?  There are many considerations and much planning to also ensure that no matter where you sit or walk within the clinic you can enjoy the artwork.

What would be your considerations?

Video Project.  We were presented with a video project that has been taking place over the past 6 months.  Video cameras were given to 9 women who had been diagnosed with breast cancer (some with secondary breast cancer).  Each women was asked simply to record whatever they liked.  Some did a ‘talking heads’ approach of short interviews to camera; others were determined to show their families and life living WITH cancer; most of them showed bad times as well as the good; living with side effects; what the treatment and drug regime was like; and so much more.

The videos have been sensitively edited (with each of the women involved) and the task of how best to use the honest and open footage to educate the public and also support and inform others diagnosed.

The aim is that it will become part of an art installation where each video is played continuously on 9 walls of a gallery.  Thereby giving the ‘viewer’ the opportunity to watch all or part of each journey.

It is also hoped to edit the footage (approximately 2hrs for each lady) down to a documentary length and to be able to get it onto the TV.

We also discussed the possibility of some of it being used for the training of people working with cancer patients.  Medical professionals but also HR/employers.  Perhaps in a similar way to the GP Training film that I was involved in that is now part of the London Deanery GP training.

Where else do you think this could be used?

I suggested that in addition to the current footage perhaps another video project might be looking at the 360* surrounding the diagnosed.  For example taking a point in time of the diagnosis (perhaps being told of cancer, the start of treatment, surgery dates etc) and asking the diagnosed to tell what that moment was like as well as their colleague, husband/wife, child, parent, neighbour, friend etc etc.  To demonstrate that cancer affects much more than the individual and allowing others to understand.

Portrait Project.  A fascinating project created and considered by a lady herself diagnosed with secondary breast cancer and recently told that she is now in palliative stages.  Her background is in visual media and she would like to share her journey through photographs.  HOWEVER not of herself but highlighting the wonderful team of medical professionals that have been part of her journey, have been keeping her alive and indeed for whom she is truly grateful.  She would like to say thank you and for others to know that a cancer patient’s journey is filled with teams of professionals who work together for the best outcome.

She has put together a team of photographers, videographers, editors and other talented people who will be responsible for capturing each and everyone who’s been involved in ‘keeping her alive’.  From the nurses, breast consultant, sarcoma consultant, oncologist, heart specialist, plastic surgeon, wig fitter, receptionist, cleaner, anesthetist etc etc.  They are asked (and with her guidance) that each portrait will show the person behind the white coat as well as acknowledge the work they have done.

It is aimed that this portrait project will be finished and on display in SW London in September of this year.

Tissue Collection.  At this point, I can’t tell you everything about this agenda item.  However I would like your opinion please.

A great deal of cancer research is carried out on tissue samples taken from patients via a biopsy or surgical excision.  Sadly not everyone knows how to donate tissue to research projects and, historically, consultants are concerned about having discussions about research with patients so this may be overlooked.

My question to you is at what point and with whom do you think you should have a discussion about tissue collection for research purposes?  Was it discussed with you?  How did you feel about it?

Are you aware that cancer cells change during a cancer ‘journey’ and particularly if it spreads to other parts of the body.  There is therefore huge value in tissue samples being examined from each part of the body affected and indeed researchers feel that this information will help guide to the best outcome for individual treatment.

Another taboo that needs to also be overcome (in my opinion) is that of tissue donation after death.  Researchers again have huge value in looking at the tissue of a deceased patient.  If they are able to compare the tissue with that taken from a primary tumour and again any secondary tumours, they believe this may also aid them in understanding cancer development and further treatments.

Would you give your specific consent to tissue sample being taken after you death?  When and how do you think it should be discussed?

Breast Cancer Lecture Series.  There next in the series – “The Secondary Breast Clinical Nurse Specialist: her role in breast cancer patient care.  6-7pm 15th July at Maggie’s Centre, Charing Cross Hospital.

These lectures are in an informal setting and after the talk you are invited, and encouraged, to ask questions of the speaker.  Please do pass on the invitation to others.  If you’re interested in attending please email Kelly Gleason k.gleason@imperial.ac.uk as places are limited to approximately 20 people.

I’d love to hear from you about any of the points above.

Sarcoma UK Voices – The Big Conversation

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Sarcoma UK are today holding their first Voices event.  ‘Changing the landscape for sarcoma’ AKA The Big Conversation.

TBC_Logo

An early start for me to travel from London to Birmingham for a 9am start.  Eeek that’s a time of day I try to avoid and I can report that the only others I spotted as I ventured to the tube line was 1 dog walker, 1 jogger and the binmen!

If I’m honest, I wasn’t sure what to expect from today. I’ll do my best below to summarise for you.

9-10am – Registration.  I was very pleased to see some familiar faces and be able to catch up with them, find out how they are, what’s happening in their lives and receive/give a few hugs too!  I so value the camaraderie between patients, carers and patient/carer advocates.  The positive actions of each person attending and sadly often news of those who have passed away.

10-13:00 – The Current Landscape for Sarcoma

Welcome – Lindsey Bennister and Roger Wilson

I have attached links to the presentations given however have also added a few of the notes/highlights that I wrote down during the day.

Key challenges in sarcoma – Presentation 1 – Professor Rob Grimer, Professor of Orthopaedic Oncology at Royal Orthopaedic Hospital Birmingham; Sarcoma UK trustee

As reported in the Mail newspaper – 1 in 4 cancers are missed or misdiagnosed in the UK.  However the headline they omitted was – 90% of sarcomas are missed or misdiagnosed in the UK.

1% of radiotherapy patients may get a radio-induced osteosarcoma in later life.

85% of people with 4 of the following ‘signs’ will be a sarcoma:
– lump larger than 5cm
– increasing in size
– deed to the deep fascia
– pain
– any recurrence of a previously excised lump.

Only 15% of sarcoma patients make it onto the 2 week wait rule.

Average time that people live with symptoms BEFORE visiting a doctor for sarcoma is 1.5 years.

Shocking results that younger people don’t tell their parents/teachers/friends about lumps until they have to!  Speak out about lumps – the earliest they are diagnosed they can be excised and treated.

Rob also spoke about a campaign that was carried out with GPs and golf balls. 988818_630607356993015_844328854_nThe premise was to alert GPs that any lump bigger than a golf ball (42mm) should have a diagnosis at a specialist sarcoma centre.  Help spread the word!

The sarcoma patient experience (findings from the National Cancer Patient Experience Survey) – Presentation 2 – Reg Race, Quality Health

Reg talked about the changes that have been influenced by the National Cancer Patient Experience Survey and some of the information that was highlighted by the results.  For the most part the attached presentation slides are self-explanatory but the main highlights were:

Patients with a named cancer nurse specialist have a better prognosis.  We need to ensure that within the NHS CNSs are available to all.

Did you know you were entitled to free prescriptions when undergoing treatment for cancer?  Most don’t but the difference in cost to a patient can be crucial to them keeping up with the drug treatment.

Not enough information about sarcoma available AND given to patients. How can we improve this?

Sarcoma patients fare badly in referral and diagnosis times.  More awareness needs to be made to the public but also referral routes for the professionals.

There is still a large (unresourced) quantity of emotional and psychological aspects to a sarcoma diagnosis.

Education for the younger population to be ‘body aware’, open to speak with adults about concerns and to report lumps and bumps when they first are noticed.

Some improvements have been made and we, collectively, need to continue to get changes made.

NHS sarcoma services: how are sarcoma services set up in the new NHS? –  Presentation 3 – Professor Jeremy Whelan, Professor of Cancer Medicine & Consultant Medical Oncologist at The London Sarcoma Service, University College Hospital; Chair of the Sarcoma Clinical Reference Group

This presentation (see attached) shows in detail the structure (as it stands today) for the NHS within the new ‘world’.  This may well change.  However it’s clear from the slides that it’s complex, there are a great deal of aspects to consider and there are voices much louder than the sarcoma and rare cancer ones.  We need to ensure that we are not forgotten.  That our pathway is as robust as that of other more common illnesses.

Maximising the voice of sarcoma patients and carers in changing the current landscape –  Presentation 4 – Derek Stewart OBE, Chair of Throat Cancer Foundation; Associate Director for Involvement in National Institute for Health Research, Clinical Research Network UK

Derek, as always, gave a truly engaging presentation.  Derek spoke about the importance and value of the patient/carer voice.  The various places that you can be involved and the level of involvement that you may wish to offer.  There is much more available than there ever was and don’t be put off and assume it will become a full time job!  Some committees and boards only meet twice a year.  Others more often.  Some roles can be done by email or online feedback and others require you to attend offices.  Some simply by speaking about sarcoma or offering to drop in leaflets to local medical facilities.

The important message however is that no matter how you are involved, your voice is crucial to ensuring improvement and changes for the sarcoma landscape.

14-16:15 – Changing the Landscape for Sarcoma

There were four workshops arranged for the afternoon and we were each asked prior to attending the day to choose two to attend.

Supporting others/protecting yourself – practice techniques – Jo Ham

I had chosen this session as I have, within the past 4 years, supported others, spoken at events and participated in conferences without thinking about the impact it has on me.  Of course I’m happy to give of myself whenever asked however often ‘retelling’ my story or delving into my experience can take me back to a place I never wanted to return.  Supporting others I’d like to be better at, listening without offering answers or advice is something that I know I can improve upon.  Lastly, loss.  Losing friends to cancer, whether they be people I’ve known for years or know because of my diagnosis, is incredibly tough.  Learning how to manage those emotions but not to switch off and stop feeling is also something I’m aware of needing.

Jo Ham, the facilitator for this session started by turning the workshop heading on it’s head.  She explained that we should protect ourselves BEFORE helping others.  A little like the oxygen masks on a plane – fix your own before helping anyone else!

Jo explained some techniques to protect yourself relating to anxiety, relaxation and breathing.  Noticing anxiety appearing and how to take control of it.  The A-W-A-R-E technique:  Accept the anxiety; Watch the anxiety; Act with the anxiety; Repeat the above steps; Expect the best.

She explained about Dr Siegal’s hand model of the brain and how to use it effectively.  Here’s a great clip

Breathing into the diaphragm and counting… in for 7 and out for 11.  The 7/11 technique.

Below is a picture with a couple of the exercise notes.  You should be able to click on the picture to enlarge and read.

Recently Updated3We then did a short exercise about ‘reflective listening’ to help us support others.

A very useful workshop but indeed way too short in time to really be effective.  Many of the exercises and principles were similar to ones I’ve learnt at Penny Brohn Cancer Caring Centre in Bristol.  I was pleased when another workshop attendee suggested that people should get in touch with Penny Brohn and attend a Living Well course.  Within my feedback and a conversation with Lindsey Bennister, I also suggested a collaborative event with Penny Brohn to host a Living Well course.

The power of your personal story: how to tell your story to raise awareness and bring about change – Graham Bound

Graham’s introduction to this workshop was to tell us about his experience with sharing his story, raising awareness for Sarcoma UK and the profile of Sarcoma generally.  His background is as a writer (http://www.penguin-news.com/index.php/component/flexicontent/23-features/25-a-stange-sense-of-bereavement-by-graham-bound) and therefore has experience of dealing with written publications and telling your story.  Graham explained his ‘journey’ and how valued a patient/carer experience is in so many ways.  He spoke about how to write or be interviewed for a piece, the pros and cons, pitfalls and tips and tricks.

The main point was to ensure that we not only mention cancer but our types of rare cancer, Sarcoma and the charity Sarcoma UK in as many appropriate places as possible.

Graham’s account was very insightful, from the point of someone who has used the written word to speak about his experience and raise awareness.  I wonder though if this workshop should be co-hosted by a media professional who can provide small vignettes and tips and tricks to work with the media – TV, radio and written word.

Final Plenary – Lindsey Bennister and Roger Wilson

I don’t think I was alone in wondering where the day had gone.  Seriously it had flown by in what seems like minutes.  The closing plenary reflected the same.

Recently Updated4

A wonderful day, too short in time, lots covered and lots to take forward to making it an annual event.  Clearly it was a valued day by so many people.  People at differing stages of their experiences and journeys and I hope one where all attendees came away with ‘action points’, clarification and new friends.  I also hope the ‘professionals’ present also learnt from their day with patients/carers.

Sarcoma SPAEN Conference – Day 2

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Dr Rachel Brindley (Clinical Psychologist) and Elaine Stewart (Cancer Support Specialist), London Maggie’s Cancer Centre
Morning Talk – What to do when treatment comes to an end? – Practical, emotional and psychological issues

What’s it like to be facing this diagnosis in your country?
What are the challenges?

  • Majority of people say they weren’t offered support.  But the search for information helped however it was their way of coping which might not be right for others.
  • Misunderstanding of what palliative and hospice care is.  Perhaps the communication isn’t good enough to understand what options are.  Discussions between Patient and Dr need to be better to understand the options but also to think about what is the job of an oncologist, palliative care, hospice etc.  Learning a new language.

What are the supports?
What are the main psychological issues that people with advanced disease face?

  • Living with uncertainty.  Realise the disease is progressing and recurrences but not knowing and living along side the disease whilst maintaining a quality of life.
  • Significant adjustment process that needs supporting.  Adjusting to the knowledge of advanced disease but finding your new place.
  • Fear of future of family if I die?

Ripple effect of cancer:
Medical – treatment effects, nutritional needs, physical
Quality of life – Sleep, leisure activity, shopping, socialising (eg meals)
Relationships – Changing roles, sexuality…
Difficult emotions – Low mood, anxiety, guilt, shame, anger (at disease, at family at God)
Self Image – Body image, self-esteem, confidence
Existential–Spiritual – Meaning of life, create a legacy, purpose…
Financial/Legal – Work status, holiday insurance…

Q – Psychological support to the physicians?
A – It’s also a burden on the clinicians and medical team.  Is this why they’re not best to share bad news.

Fears and questions about death and dying?
What are some of the fears?
What do people want to know?
What is it like talking about these?

Can be victims of complementary and alternative therapy?

Italian Dr shared a story – Shocked on his very first day of work in new role in LA, he was taken into patient’s room.  Colleague starts talking.. in next few hours/days explains respiratory and cardiac arrest is near.  We can resuscitate and will only delay a few days.  Shocked about how brutal they were with the patient.
In Italy the percentage of patients with this kind of information is only 1% or less that are given details about death and dying.  In Italy many patients don’t want to know they are going to die.  Physicians problems start much earlier than this point.

Very individual choice about knowing what is going on.. time to clear things, discuss with relatives, friends etc think about funeral and future of family.

Patient choice… has to be a sensitive and individual choice by patient.

When do you discuss?
Again very individual to find the time to discuss.  Discuss in part.   Listen to learn what the other person needs to hear.

Fears about death and dying
Fears about dying:
1.     Fear of the process of dying
2.     Fear of the consequences of death for loved ones
3.     Existential fear of death itself

Planning Ahead
What does this mean to you?
What would be helpful for you to think about?
What resources are available to help you to plan ahead?

  • Comment from member of the audience: for many in the UK we have never experienced death in the first 40 or so years of our life.   Death isn’t talked about.
  • Comment from another member of the audience: – Clinician discussions are often very different and difficult.  Training for clinicians and learning to signpost and be honest to refer.

Stages of Grief – Kubler-Ross
Denial -> Anger -> Bargaining -> (Anxiety) -> Depression -> Acceptance
Not a case of working through but cycling back.  Perhaps anxiety is missing on the diagram?
Perhaps should be ‘Not knowing’ at the beginning of diagram.
Some people may never get to the Acceptance phase but back and forth earlier on –ie they’re not able to accept death.
Perhaps include Guilt

Self-Care
Close involvement with people at end of life involves managing complex medical problems and working with high levels of emotional distress

Discussion
Consider the impact that working with people with advanced disease may have on you and other professionals.

1.     What signs would you want to be alerted to in
a.     Yourself?
b.     Others?
2.     What strategies do you feel would be helpful/important in preventing and managing these?

“The heart must first pump blood to itself” – S.L. Shapiro
Support staff teams
Opportunities to debrief and reflect after difficult/distressing incidents
Opportunities to discuss what went well
Peer or individual supervision
Access to training, appropriate information
Time – to reflect on work, and for own needs
Feedback from senior management: positive, constructive
Balance between work and home life.

How might you be able to carry on some of these conversations/ideas when you get home?

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ADVOCACY MARKET PLACE SESSIONS
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Barbara Dore. Chair, Gist Support UK, SPAEN
How to Organise Patient Group Meetings

Think about and objectives for patient meeting.

Objectives

  • Information/Education
  • Exchange between patients
  • Support (you are not alone)
  • Patient empowerment
  • Relationships with
    • Experts who may speak at meetings
    • Industry experts.
    • If near clinic/training/university then perhaps invite team/students etc.
  • Reasons to donate (not just in terms of money.  Can also be their time).
  • Finding volunteers

Session formats

  • Lecture presentation
  • Workshops
  • Case studies
  • Panel discussions
  • New experiences (yoga…)
  • Background sessions psychological support etc)
  • Vary the pace of the meeting during the day/meeting
  • No more than 2 hours without a break.
  • Networking time!

Topics/Speakers

  • Consider the audience
    • Previous feedback
    • Newcomers/experienced
  • Variety of subjects – from the academic, technical and practical
  • Structure the day – after lunch spot needs interactive and care in planning.
  • Interaction keeps the audience engaged.
  • Brief the speaker as to content
    • Ask them if they want time cues
  • Reminder 1 week beforehand
  • Prepare some questions for Q&A
  • Write and thank speakers afterwards

Location

  • Budget
  • Site visit
  • Accessibility
    • Travel easy?
    • Disabled access
    • Car parking?
  • Layout – flow
  • Resources
    • A/v
    • Poster display
    • Flip charts
  • Registration desk.
    • Name labels,
    • programs
  • Signposting to meeting
  • Refreshments (every 2-2.5hrs)
  • Networking

Volunteers
Staff during the meeting

  • Registration Desk
  • Assistance to guests
  • Passing microphones around
  • Collecting evaluation form
  • Taking note from the meeting report
  • Distributing papers (Agenda etc)
  • Photographing
  • Getting Contact details
  • Circulating and meetings/ welcoming all participants
  • Getting photograph permission

Announcing the meeting

  • Inform and invite all attendees
  • Experts physicians nurses clinic
  • Invitation letters/leaflets posters
  • Invite by Email postal delivery, Facebook, twitter, website, email group
  • Press
  • Online calendar
  • Continuity slides.  Welcoming slide before presentation and also slide for lunch or welcome back to the afternoon session.

The Day

  • Meet and Greet
  • Network in Breaks
  • Feedback?
  • Think about next time.

Enjoy

~~~~~~~~~~

Roger Wilson and Claire Kelleher, Sarcoma UK
Patient Group Survey

Why do we do questionnaires?

  • need to get information
  • need to get opinions
  • experiences
  • often get new ideas

Need to be quite clear about objectives for survey.

Sarcoma UK is a patient led organisation.  Likes to involve patients in any initiative and involvement.   Part of Information Standard process is you must involve target participants ie patients.  Done by various means, feedback or through email, telephone, speak to people at support groups etc.

Clear objectives in mind when thinking about questionnaire.
Who do you want to contact?  Patients?  Carers

  • How will you contact them?
  • How are you going to find them?
  • How will they respond?
  • How will you record numbers in a meeting and is there any value?
  • Do you need documented or formal responses?

Once you’ve got data from responses what will you do with those replies?  Putting the data from the questionnaire into a spreadsheet for analysis is time-consuming.

  • How will you handle their replies and analyse the responses?
  • Once you have an analysis what are you going to do with it?

Got to have these things sorted in your mind before you start the survey process.  Otherwise it may be past its use by date by the time you use the analysis.

Claire – How we’ve used our surveys.  At British Sarcoma Group Conference in February we asked specifically about written information.
Asked the group in workshop (patients, clinicians and CNSs) what they thought of information (using Macmillan and Cancer Research UK’s written info). Most people said too complex and difficult to understand ie the lesson learnt use simplest terms that we can.
Negative feedback re glossaries – most people in the workshops found it difficult to flit back to glossary rather than explaining what a word means as they go along.

Survey about information and support – what info have you found? When did you receive it?  Etc… so Sarcoma UK can understand what patients are experiencing and better support patients as they should be.

Collate research data.  One reason why survey used?
Use methodologies and tools that have been validated academically.  So that the data can be taken seriously by professional bodies (wherever possible).

One of the tools that is most readily available is the EQ5D which looks at quality of life.

Is this form truly useful for cancer/sarcoma patients?

Currently working with Royal Marsden for sarcoma patients with advanced cancer.

Claire – Example of how patients’ information can be used within gynae-sarcomas.
There is a gap of information around this type of sarcoma.
People upon diagnosis not given information… there is very little.
Sarcoma UK are developing a booklet.
They have an information review panel (both patient review panel and a professional review panel).
All information goes through the process first with the professional panel looking for inaccuracies.
Next to the patient review panel – is it easy to understand? Is it the information they want to see?

One problem we had is that there isn’t that many people we have on the information review panel with this type of sarcoma.
We put a call out to the women we knew about to invite them to be involved in the review panel.
In January we’re holding a Webinar (with Maggies) to offer information and advice to ladies with gynae-sarcomas and also to gather information about what they would like to include in the information leaflet.

The information leaflet is then due to be published early next year and will be available on the Sarcoma UK website to download.

We do get it wrong as well…
IMG_4133
80 responses.
People had written all over the form and written on the back of the form.  Realised they were only scratching the surface with this survey.  Didn’t look at it well enough or in depth.
Hadn’t expected to also see hospital doctors lack of sarcoma information as well as GP (which had been expected).
If we’d been able to test the survey with 10 or 12 patients beforehand, Roger thinks a very different survey would have gone out.

Ended up writing a three page analysis of this survey which frankly was a load of waffle as the real conclusions had no data to support them as it was supplied anecdotally in the margins of the form rather than as answers to not very well worded questions.

Lesson – get objectives right before you start and test the questions to ensure you are asking the right questions in the right way to the right people.

Q – how would you deal with when a patient asks for privacy in answering a questionnaire.
A – Responses are anonymous.  Don’t ask for other personal information that might identify someone.
If someone doesn’t want to give information… they don’t have to.

~~~~~~~~~~

Ian Judson, The Royal Marsden Hospital UK
Marco Fiore, Istituto Nazionale Tumori Milan, Italy
Strategies for Metastasis in Sarcomas and Gist – Perspective of oncologist and surgeon

50% of people diagnosed with sarcoma will NEVER have another problem after primary treatment.

~~~~~~~~~~

Ian Judson – Sarcoma Unit, Royal Marsden
Management of metastatic disease – soft tissue sarcoma and GIST

What are the roles of chemotherapy for soft tissue sarcomas?

  • Palliation of advanced local or metastatic disease
  • Pre-operative treatment for large tumours?
  • Adjuvant chemo in large, high grade, extremity tumours?

Palliative treatment of advance disease.  Crudely if you lump all sarcoma together the median survival isn’t great. Probably about a year.

We did a trial in the EORTC combination v single agent – the 62012 trial

Slight improvement in progression free survival but no significant improvement in overall survival.

How can we use this data?

  • If objective is response – tumour shrinkage or remove specific symptom (pressure on nerve) then justified in using combination therapy.
  • If objective is palliation, then no real value in using combination therapy… single agent treatment (consequential if needed) is probably best.

What subtypes are particularly sensitive to chemotherapy?

  • Most sensitive subtypes appear to be
    • Synovial sarcoma
    • Myxoid/round cell liposarcoma
    • Uterine leiomysosarcoma
    • Other?
  • But N.B. – data are sparse on individual disease outcomes.

Other effective agents.  We use a combination of agents depending on the sarcoma type.  But we’re dealing with small numbers and difficult to assess.

Hormone sensitive sarcomas

  • Endometrial stromal sarcomas & some low grade ER/PR+ leiomyosarcomas, respond to oestrogen deprivation
  • In premonopausal women GnRH agonists or oophorectomy
  • In postmenopausal women – aromatase inhibitors
  • We usually use letrozole

When is chemo unhelpful?

What’s the future?

Molecular biological information that we can translate into new treatment.
In part:
Some tumours, types, mutations can be difficult to treat or apply a ‘rule’.

Some progress with translocations (chromosome swapping) ie synovial sarcoma translocations
Chromosomal amplifications – ie when it copies and becomes a driver for the sarcoma.

Median survival is improving as we discover more.   We have more drugs being used.  Differing regimens.

Conclusion
Range of treatments available for treating metastatic sarcoma.

PHYLLODES – COULD BE SARCOMA OR CARCINOMA (hence confusion about where it sits in medical teams)

~~~~~~~~~~

Marco Fiore, Instituto Nazionale Tumori Milan, Italy
Strategies for metastases in Sarcomas and GIST – A surgeon’s perspective

Looking at surgeries about how we run trials.
Conclusion should perhaps be that it is about patient choice and perhaps the studies should be addressed retrospectively in order to obtain patient randomisation.  Patient choice needs to be made with sufficient information to make an informed choice.

~~~~~~~~~~

AFTERNOON SESSION – SARCOMA TRACK

~~~~~~~~~~

Jean Yves Blay, Centre Leon Barard Lyon, France
Update on new and ongoing trials

There are many clinical trials….

  • You understood for clinical trials that we are dealing with a very well structured setting.  The majority of trials are done in multiple continents.
  • We are moving from a situation doing trials in all sarcoma sub-sets to a situation where we are targeting histologies.  This is changing the landscape an adds a level of complexity.  The end of the story will be not only focusing on sub-types but molecular sub-types within.  Results in small number of patients and work collectively globally.  It will not be possible to demonstrate the use of an agent

3 messages

  • Global approach
  • Histology Driven
  • Very important in know randomised trials, approval of the agent and prove that something is superior to another.

Bone sarcomas

  • Osteosarcoma
    • OS2006
      • Exploring bisphosphonates in a randomised setting
      • FSG, EORTC, others
    • Euramos 2?  5 years to do the first trial.  What next in Euramos 2 trial?
    • Country specific trials.
  • Ewing
    • Ewing 2012 (FP7)
      • Comparing VDC/IE to VIDE (comparing US regimen to the European regimen)
      • Exploring bisphosphonates
    • EuroEwing trial
      • Piloted by the German group.
  • PoC studies in Ewing/Osteo
    • Mifamurtide, linsitinib (EuroSARC WP6)
  • Chrondrosarcoma
    • PoC study of neoadjuvant mTOR inhibition
    • Hh inhibitors (vismodegib) negative
    • EuroSarc projects
  • Chordoma
  • Trials on mTOR, TKI (imatinib, sorafenib) completed

Soft tissue sarcomas

  • Neoadjuvant
    • Histology tailored treatment in EuroSARC (WP5)
      • ISG, GEIS, PSG, FR

Trying to address if we should give the same treatment.

  • Adjuvant chemotherapy
    • IRCI Uterine LMS 0 vs 4GT/4Doxo
      • US, EU (GOG, EORTC, UK)

Unsolved question in soft tissue sarcoma.  This is not the standard for all patients and we do not know who will or won’t benefit.
IRCI – this was the first trial in the US.. no treatment –v- combination treatment. It’s hoped it will answer the important question on this sub-type.

  • Surgery
    • Prospective trial of no treatment in desmoids (FR)

Phase 2 study of no treatment.  Often not mentioned.  This is where desmoids are not affecting other things.

  • (Neo)Adjuvant radiotherapy
    • Retroperitoneal sarcoma (EuroSARC WP4) exploring in selected localisation of disease.
    • Vortext tiral (UK)
    • SAR01 trial (FR) no radiotherapy with wide margin

Largest clinical trials are in the advanced phase:
Advanced phase – randomised trials
First line

  • Palifosfamide (closed Ziopharm sponsor)
  • TRS trial (Pharammar, completed) – Needs further investigation.
  • NCRI GT vs Doxo (UK) – Recruiting well – 220 out of 250 patients.  ASCO 2015
  • EorTC Trust Trial (closed for accrual).  Exploring agent in first line setting.
  • Dox +/-TH302 (ongoing, Threshold sponsor)
  • IRCI EORTC/UK in HGUS  High grade undifferentiated uterine sarcoma.
  • Taxol+/-Bevacizumab (FR, Angiosarcoma) – Close to completion of accrual.

Only a few trials are addressing in histological sub-types.

Subsequent lines

  • Trabectedine vs DTIC (JNJ, US, L-sarcomas)
  • Eribuline vs DTIC (Eisai, World, L-sarcomas)
  • Sunitinib vc cediranib (US NCI, ASPS)
  • Regorafenib vs – 0 (FR, all comers)
  • CDK4 inhibitor vs 0 in (US/World WD/DD LPS)
  • MV vsPazopanib (FR, Desmoids)
  • Cediranib vs BSC (UK ASPS)

Phase 1/11 trials

  • Subset specific (right question?)
  • Target specific (phase I/II)
  • Molecular immunotherapy.  Contrasting what was done in the 90s.  Watch in next 2 years to see new trials of this kind.
  • Passive immunotherapy.  Means antibody which is labelled with a nesotope and recognised.
  • Treated the driver target across histotypes

EORTC Network of Core Institutions
EORTC protocol 9010 (EudraCT number 2011-001988-52 NCT01524926)

Probably the future of what we are going to do in sarcoma.

Q&A Session
Q – Moving much more to molecular selection of patients in clinical trials.  Is the pathologist going to become more important in making the selection decisions.
A – The role of the pathologist is central.  This question is debated often.  How do we link pathologist to molecular biologist?  Research to routine is very challenging.

We need to bring up a budget wall with people talking to each other and exchanging information.  Challenging not sure.  If a pathologist is a real molecular biologist you’re fortunate!

~~~~~~~~~~
Short profiles of sarcoma subtypes
~~~~~~~~~~

Hans Keulen, Chordoma Foundation NL
Chordoma

Brief introduction into Chordoma and introduction to clinical trials
What is Chordoma?

  • Malignant tumour arising from the bone of the skull base and spine
  • It is a cancer and has a tenancy to be locally invasive and a tenancy to spread (metastasize)
  • It’s origin is traced to remnants of primitive embryonal cells called the “notochord”

Demographics

  • 5 % of the primary bone tumours are located in the spine
  • 8% of the spinal tumours are Chordomas
  • Incidence <0,7-1:1,000.000
  • Grows at skull base (Clivus, 35%), sacrum (50%) other spinal (15%)
  • Strikes people of all ages, most diagnosed in the 50s for sacral and 40s for other types
  • More frequent in men than women.

Phylum Chordata: Subphylum vertebrata

  • 550 million years ago Chordates emerged from the common ancestor
  • Presence of the notochord is the most prominent feature of the Phylum Chordata
  • Notochord is ectodermal and guides developed

Fate of the notochord

  • The notochord is essential for the creation of the embryo
  • Usually disappeared 10 weeks after gestation
  • The notochord should not be there at the latest after 10 years.
  • There are a lot of factors that can arrest the disappearance.

Recent discovery is that a certain gene called Brachyury (t-box gene).  Essential for development.  Absence is lethal.

Notochord and brachyury
Brachyury is over expressed in chordomas and many epithelial cancers.
Brachyury is expressed in chordomas but not in other bone and cartilage tumours.
Approximately 10% of chordoma patients it is familial.
Duplication of brachyrury gene has been observed in familial chrodomas.
When you inhibit brachyury in chordoma patients you will stop it growing.

Recent discovery from UCL – www.ncbi.nlm.nih.gov/pubmed/23064415

97% of chordoma patients harbor at least one allele of the common nonsynomymous SNP rs2305089 in the brachyury gene

Research is imperative.

Benign notochordal cell tumour (BNCT)
Should anything be done at this point?

Current treatment of chordoma
First line is still surgery.  Piece by piece or enbloc depending on location.
Sometimes stabilisation of the spine is required.
Radiation therapy is a high dose (usually 3x dose of breast cancer)  Specialised types, mostly proton beam or carbon ion.

Implications

  • Prognosis for chordoma patients Is not that good.
  • High rate of recurrence
  • A lot of people get a lot of mutilating surgeries.
  • Sacral chordoma usually in a wheelchair
  • Survival rate has gone up but sometimes at a cost of added mobility.

In the past we saw only 10% of mets.  However recently mets in sacral chordoma has recently been recorded that these are as high as 30%.  There is doubt if this might be due to surgery not being good enough – possibly caused by seeding.
No chemotherapy
20-20% cure rate.

Survival
Median was 6.29 years

Remarks – survival is increasing to 7-9 years, but with increased morbidity from surgery and radiation.

Chordoma vs Chondrosarcoma
Mistaken on routine histology
Epithelial v Mesenchymal origin
Immunohistochemistry
Cytokeratin
Brachyruy
Survival
Much better for chrondrosarcoma (gr1)
Misdiagnosis is less common now.

Recent developments
Using Carbon Ion instead of Proton radiation particularly in sacral chordomas night even replace surgery as first line treatment (ECCO 2013)

Radiation before or during surgery offers promising results with respect to recurrence and seeding.

Increasing number of target identified for trials with existing drugs.

Other trials….. not just drugs
e.g. Carbon Ion vs Proton Beam radiation – HIT Heidelberg

Carbon Ion vs Proton Beam radiation – HIT Heidelberg

About Chordoma Foundation
We are a very small patient group.  Worldwide we are less than Sarcoma UK!

Our mission is to improve, extend and ultimately save the lives of chordoma patients by:
Accelerating the development of more effective treatments
Helping patients across the world.

One in a million, on a mission – Chordoma Foundation

~~~~~~~~~~

Beatrice Seddon, UCL Hospital NHS Trust UK
Uterine Sarcoma

Gynaecological sarcomas – where are we in 2013?

Incidence of gynae sacomas
1985 – 2009 5950 gynae sarcomas diagnosed in the UK
9.2 case per million female population
285 cases diagnosed in 2009
Peak incidence 30-60 years

NCIN Gynae sarcoma report soon to be published.

Classification WHO 2003
Uterine Mesenchymal tumours *****
Smooth muscle tumours
Endometrial stromal tumours

Do not include malignant mixed Mullerian tumours

Location of tumours
85% of gynae sarcoma arise in the uterus
7% I the ovary
4% in the uterine malignancies

Sloan Kettering uterine leiomysosarcoma nomogram – overall survival probability prediction tools

Management of gynae sarcoma
Surgery – Most important component of treatment

~~~~~~~~~~

Marco Fiore
The interdisciplinary process of diagnosis in soft tissue sarcoma

MDT involved
Pathologist, medical Oncologist, thoracic surgeon
Web based National Rare tumours network, radiation oncologist
Surgical oncologist Radiologist

Sarcoma MDT
Many specialists have routine activity with MDT team.

Weekly routine meetings with the specialists, pathologic round, clinical round and MDT outpatients.

Biopsy
Any deep mass OR bigger than 5cm OR increasing in size

  • Hystologic exam (better than cytologic)
  • Think about possible surgical incision
  • Keep high-level of clinical suspicion
    • Be aware of usual misdiagnosis -> deep large ‘hematomas’ are virtually impossible if no trauma history and/or anticoagulant drugs.

Core-needle biopsy
Local clinic
Usually two samples.

Pathologist – new classifications WHO classification of soft tissue tumours

In common cancer they are white or black
Benign – no problem.
Malignant – diagnosis of cancer.

Within soft tissue transfer it is a scale of white, greys and black,
Benign, Intermediate aggressive tumour, (locally aggressive) or (rarely metastasizing)  Malignant.

Different decision for soft tissue sarcoma diagnosis.

Soft tissue sarcomas can be diagnosed anywhere in the body and surgery on sites can be very varied yet the tumour type could be the same histology.  Anatomic constraints.

First think the overall strategy:

  • Histology specific (and grade)
    • Combination of natural history
    • Different sensitivity to different drugs
    • Different radio-sensitivity
  • Site specific
    • Respectability
    • Reconstruction needs

What I can do + what the tumour can do = What I should do.

Please note, overall strategy should think in advance.

Sometimes it’s important for the surgeon to consider what to do rather than rush into it… difficult as most patients want surgery immediately but caution may in fact be best for the outcome.

Pushing tumour margins Or with infiltrative margins.

External lesions it may be better (angiosarcoma photo used) to have any chemo after surgery… that way the surgeon can see exactly where they need to perform surgery.

Functional outcome is an issue.  Needs planning to ensure that particularly with arms etc that reconstruction of nerves etc is also planned to provide patient with best outcome.

Cosmetic outcome can be problematic.  Such as on the head and neck.  Plastic surgeon should also be consulted as part of the planning.

INT – treatment criteria
Changing over time 1987-2007

  • Less amputations.  Decreased from the 1st to the 4th period (9% -> 3% -> 1% -> 1%)
  • Concurrent chemo—radiation therapy.  Preoperatively

Local recurrence was improved.  Survival did not change.  Functional outcome and quality of life did.

One-shot approach.  You need to think in advance for this strategy.

  • Re-excision: up to 50% of the cases referred to tertiary centres.
  • Impact on public health costs /reimbursement criteria??
  • Impact on extension of final surgery and functional outcome.
  • Psychological impact on patient and family (unexpected diagnosis: whoops! – delayed diagnosis – second opinion change diagnosis in 30%)
  • No prognostic impact.

Retroperitonal soft tissue sarcoma
Probability of finding via CT scan is low.

Biopsy remains the gold standard in diagnosing sarcoma!

~~~~~~~~~~

Julia Hill, Deputy National Programme Director, National Cancer Peer Review, UK
Peer review of quality of treatment, access to treatment and centres of excellence.

What is Peer Review?

  • Quality assurance programme based on National Guidance and National Standards.
  • For Sarcoma this wa the Improving Outcomes Guidance.
  • Guidance by nature is guidance and cannot specifically be measured.  Need to be benchmarked.
  • It’s not a statutory function but well supported in NHS.

Development of peer review

  • Developed initially around cancer services.  Broadening outside of cancer.
  • First reviews took place in 2001.  Been through many reviews and remodelling.
  • Number of independent reviews support the continuation with recommended support.

Aims of Peer Review

  • Providing safe services
  • Improving quality and effectiveness of care
  • Improving the patient and carer experience
  • Undertaking independent, fair reviews of services
  • Providing development and learning for all
  • Encouraging the dissemination of good practice.

Key principles of Peer Review

  • Clinically led
  • Consistent in delivery
  • Developmental
  • Focus on coordination within and across the organisation and pathway
  • Peer to peer.  Clinicians working in the area reviewing clinicians and teams.
  • Integration with other review systems.  Hopefully no duplicating information.
  • User/Carer involvement.

Benefits of the Peer Review Programme

  • Proven to be a catalyst for change.
  • Developmental programme
  • Provides director of services and information across the country
  • Identify any risks in the service by visiting and bringing to the attention we can get these involved quickly
  • We have a lot of clinicians involved in process (3-3,500 clinicians who review)
  • Rapid sharing
  • Provision of timely benchmarking data.

The Peer Review Methodology
Annual Self Assessment -> Internal Validation -> External verification -> Peer review visits.

Reviewing evidence

  • Quality measures.  Ask teams to provide evidence documents to keep workload minimal.  We ask for doctors that the team would be using in every day… work programme, operation policy, annual report.
  • Narrative report against key themes… for structure and function.  What membership of teams.  What’s the training.  Patient pathways and clinical guidelines.  Patient experience.  How do get patient feedback.
  • Clinical outcomes.  We are moving toward looking at clinical outcomes.

Development of the measures
National guidance
Expert Groups – nurses, allied health professionals, dieticians etc and also patients.
Consultation – get together to create a set of measures for the service.
Formal consultation – for approx 3 months.
Editing – meet again and edit etc.
Publication – measures reviewed on an annual basis to take into account changes in national guidelines.

Measures for Sarcoma published in August 2011 – NCAT Manual for Cancer Services – Sarcoma Measures
Cover aspects:

  • Sarcoma Advisory Group
  • Trust – inc Diagnostic Clinics
  • MDT – Bone and soft tissue.

What makes up a peer review visit:
Purpose:

  • Provide an opportunity to meet with members of a service to determine compliance with the quality measures.
  • Identify any broader issues relating to the delivery of a quality and safe service including a review of clinical indicators.
  • Provide a further external check on internal quality assurance processes.

Look at the wider picture of how the team functions against how they’re delivering against clinical indicators.

Who are Reviewers?
MDT – service users, clinicians, AHPs, Managers and commissioners…
Peers are people who have been trained and working in the same discipline as the people they are reviewing.

We don’t have reviewers reviewing the trust next door but are objective of the pathways.

Selection Criteria for a Peer Review Visit

  • We don’t visit all the centres but do a risk based target for the visit.  Are they meeting national guidance.
  • Were there any risks identified previously that have still not been involved.
  • We’re asked by organisations to visit.
  • Compliance against measures with lowest performance grouping… If teams are still not reaching 50% of measures then we need to go in and see what the problem is.
  • Concerns regarding the Internal Validation process.

2012/13 Peer Review Visits
12 Sarcoma Advisory Groups
145 Trusts, 19 Diagnostic teams
15 MDTs

Good Practice
Generally good provision for TYA Support for this patient group nationally
Good patient involvement overall and good examples of support
Good entry into clinical trials

Immediate risks
Inadequate referral population
Below 100 patients

Serious Concerns

  • Inadequate CNS provision
  • Lack of attendance at the SMDT by radiology and pathology
  • Lack of oncology capacity (non-surgical oncology)
  • Ambiguous/fragmented pathways (retroperitoneal and site specific)
  • Poor pathway/MDT governance / Data

Recurring Themes
Reiterate points before, particular issue was some Self Assessment Groups do not benefit from same support as more matter NSSGs

Clinical Outcomes
Clinical Indicators for sarcoma were introduced in April 2013:

  • % patients treated in Sarcoma centres
  • Caseload by Sarcoma centre
  • % patients receiving surgery
  • Readmission rates within 30 days of surgery
  • % patients with a recorded stage.

Working with NCIN to provide service profiles for each of our teams.  Ie Cancer Service Profiles for Breast cancer   Comprise of demographic data, specialist team, throughput, meeting times, practice, outcomes and recovery and Patient experience.

Outcomes of Peer Review

  • Confirm quality of services
  • Identify shortcomings and publish
  • Publish reports about quality of services
  • Timely information for commissioning
  • Validate information which is available to other stakeholders

My Cancer Treatment – is the website that patients can then see and compare local services and check what the results are for their local hospital etc.
Click on Find out more to see the narrative of the report.

We know that not only patients are looking at the website – commissioners are also doing so.

Sarcoma UK have prepared and posted on their website a summary of the Patient Experience Survey results

~~~~~~~

SPAEN Partnerships and Collaborations

Progress in Rare Cancer Care
Collaborations and Networks

EORTC and EURO/SARC
Winette van der Graaf, Chair EORTC STSG, Netherlands and Estelle Lecointe, SPAEN France

What drives us as a sarcoma specialist?
If you work on frequent cancers, do randomised trials.  If you work on rare cancers – find friends..

What is EORTC
Exists for 50 years.
Important institute in Europe.   Main aim is to collaborative academic research throughout Europe to improve the outcome for cancer patients.

There also groups that breaching these tumour groups such as elderly, quality of life, biomarkers etc

One family of sarcoma group.

Throughout Europe
Soft Tissue Bone Sarcoma Group

  • Throughout Europe
  • Randomised phase 2 an 3 studies
  • Interesting partner for Pharma.  Difficult in a rare disease to get pharma involved however with big databases they’re interested!
  • Big and relevant data bases
  • Gets support from EORTC,
  • Platform of discussing studies in such rare disease.  But also a platform of finding friends and collaborations.   We are all busy with a very rare disease for which there are not so many people available.
  • Collaborative spirit.

Organisation of STBSG

  • Board of group, period of 9 years
  • ExCo with charis of the subcommittees
  • 2 group’s meeting a year
  • Young investigators of the group.  Welcome new members interested in doing studies in sarcoma.

Group gets a scientific audit every 3 years.   So we are audited on the way we behave and want to see minutes and outcome and publications and all activities.   Proud to say the last audit took place this year and we ranked very high.  Always hope that you will have good advisors to make it even better.

Subcommittees

  • Local treatment – radiotherapy, surgery
  • Systemic treatment – chemo targeted agents
  • Pathology
  • Imaging.  Radiologist part of design of studies.
  • Quality of life since 2012
  • Public relations, starting from 2013
  • … pre-clinical group to look at what’s going on in other institutes (to be set up)

Collaboration with…

  • National groups in France, Germany, Spain, Italy, British, etc
  • Some members are members of World Sarcoma Network.  Number is increasing.
  • Pharmaceutical companies
  • EU grants and education (this needs to be extended)

Open studies…
Very few later stage open studies at the moment.    Working hard to get new studies active.

STRASS and CREATE studies.

New intiatives

  • Many database studies

Discussions about

  • Osteosarcoma French Study
  • Ewing sarcoma (FP7)
  • Liposarcoma CDK4 inhibitor
  • GIST: fist line, second line, third line
  • Elderly study: cyclophospharmide/prednisolone
  • Imaging studies on STRASS

World Sarcoma Network
This is a totally different institution created in 2009 by enthusiastic people in the sarcoma field.  Cooperative group gathering the main reference centres to stimulate rapid clinical drug development for sarcomas.
Enable clinical studies that could not be completed by the cooperative groups or at a national and continental level.  Where it needs a global level to discuss.

In Europe, in Australia Peter Mac, Ludwig Institute Australia

World Sarcoma Network the challenges

  • If you have no institute location and no funding how can you organise it.  Busy of thinking of a model of how to do this.  We have the international rare cancer initiative.
  • Very rare disease – unattractive for Pharma
  • ‘Sarcoma of the year’ 2013 gynae sarcomas.  If we are not more concrete what we are aiming at then for the outer world it will be a vague institute of nice people but no objective.
  • Biannual meetings during ASCO and CTOS

Examples of successful collaborations

  • Trials in GIST
  • EORTC – Italian and Australasian Sarcoma Group Centres in the US

With the input from all of you, there will be many more studies to come…

~~~~~~~~

EuroSARC

Jean Yves Blay, Centre Leon Barard Lyon, France
European Clinical Trials in Rare Sarcomas within an integrated translational trial network

How do we get funding for collaborative working?
Each network gets funding from different parts but how do we bring these together?

Where grants from EuroSARC came together.    Tools to enable this network of networks to move in the right direction.

Some times successful in some projects but other times on our own we may be unsuccessful.

We can build something on the basis of international grants.

GOAL – EuroSARC project – Academic clinical trials with a limited number of partners but inclusive for all networks and all groups.

Interaction between clinical research <-> Translational research <-> basic research

Objectives
To address major academic questions
Involve reference centres
Tod design structure and implement 9 innovative investigator driving clinical trials of different scales on a multinational level, evaluating novel

Conclusions

  • An important support for Ebased on previous work
  • Academic research only
  • Difficulties/problems
  • Adaption to the context/change of plans.

www.eurosarc.eu website

Website
1.     About sarcomas
2.     2 Eurosarc project
3.     Eurosarc clinical trials
4.     Patient and public info
5.     Utilities
6.     Members section

Sarcoma SPAEN Conference – Day 1

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This is the third year I’ve attended the SPAEN conference. The three days are always action packed, exhausting, thought provoking and inspirational. The delegates attending are from throughout Europe and most of whom have a personal interest in improving the cancer landscape. There are a great many organisations represented and crossing borders, sharing knowledge, experience and information. Importantly working collaboratively on projects, without ego or personal gain. There’s a great deal that charities and businesses alike could learn from this group!

This blog entry is taken from my extensive notes at the conference and I hope will be useful to many. I am quite sure that SPAEN will soon post their own conference report on their website so please be sure to check back.

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The Opening Welcome was given jointly by Roger Wilson and Markus Wartenberg

It is a testament to the organisation that this is the fourth year this conference has taken place and membership, interest and outcomes continue to grow. Despite being a European conference we have this year also attendee representatives from USA, China and Australia. Their aim of attending is to understand how a patient group like SPAEN operates, listen to stories and examples from attendees and take back these learnings to their own countries.

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Raz Dewji, Director – Clinical Scientist, GlaxoSmithKline Oncology Global Medical Affairs, UK
GSK Europe welcomes SPAEN to UK London as the main conference sponsor

“A personal perspective on the impact the ‘Patients Voice’ in drug development”

A journey that has been incredibly emotional. I’ve learnt how important it is to understand and hear what patients are asking for. Hopefully some of the work that we are doing and other companies are doing is now reflecting the voice that you collectively and as individuals have been delivering at different levels of the few years that we have known each other. I feel very humbled.

A little bit about GSK
GSK is a science led global healthcare company researches and develops innovative medicines, vaccines and consumer healthcare products.

Mission statement – do more feel better and live longer.

A lot of you have contributed in some shape or form to the journey I’ve had in the past 7 years and hopefully able to share some of those insights with you.

Less than 10% of patients with rare diseases are ‘treated’ on a global basis.

GSK concentrating a team on 200 different rare diseases.

Patient centric medicine is an area that is becoming much more focussed and a growing need to understand the patient.

Partnerships between organisations like GSK (Pharma) and patient advocacy groups are critical to bring new treatment options to those who are in need of them. GSK is very proud to be a long-term supporter of SPAEN.

GSK – Focus on the Patient Initiative

  • Post approval Disease Awareness. Once we have a new medicine approved we then work externally to raise the awareness for the disease.
  • Simplification of the information consent form and process (for clinical trials). Really important to try to get some of those documents into a manageable form where patients feel comfortable and the information they are provided with is appropriate not full of legal jargon.
  • Engagement with patients and physicians at different levels. Clinical trial space – to understand the trial and get feedback. How has a trial been for patients? What was your experience?
  • Treatment adherence initiatives. Helping patients to take medications appropriately. Increasing focus on developing oral medications rather than intravenously… however there can be challenges for side effects and also getting patients to remember to take the medication.
  • Working with the patient support groups.

Post approval Disease Awareness
GSK took on an advertisement raising awareness to physicians to what a challenging disease Soft Tissue Sarcoma is – Raising Awareness of a Challenging Disease advertisement.

My first encounter with sarcoma was in 1991…
At the time I was working as ‘study monitor’ based in Brussels doing a lot of work in different oncology drugs.
I was working with a patient and realised that she had the same date of birth as my brother. It still gives him quite a jolt of reality recalling the challenge in these phase 1 trials. These are usually in older patients except often in sarcoma patients who tend to be younger. A very emotional moment to realise my brother was the same age as this patient and this has stayed with me.

In 2006 I joined GSK as indication lead for pazopanib in advanced soft tissue sarcoma (‘STS’)…
Phase 1 trial had good results of the 6 patients entered… 4 had stable disease by 6 months.

Key milestones for pazopanib in a STS
September 1996 – Program Initiation
Nov 2001 – Candidate Selection
December 2002 – First in Human Dose
October 2005 – 1st STS Patient Dosed (Phase 2)
Sept 2007 – Proof of Concept
March 2008 – Phase 3 Commitment
Oct 2008 – 1st STS patient dosed (Phase 3)
June 2011 – Supplemental NDA Submission
April 2012 – US FDA Approval
August 2012 – EMA Approval

Collaboration with EORTC Soft Tissue and Bone Sarcoma Group Phase 2 and 3
He met with Prof Judson at the Royal Marsden to talk specifically about patient cases. That collaboration has driven the project forward and made him appreciate what a unique community the sarcoma community really is.

Without Sarcoma UK and SPAEN – patients in the UK would not have been able to participate in the PALETTE Phase 3 study. Double blind, placebo controlled trial.

Randomising into placebo without opportunity to cross over within the study.
Without intervention from patient groups it may well have not been able to take place.

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GETTING THE BEST OUT OF YOUR THERAPY
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Markus Wartenberg – SPAEN, Germany
Status report from the SPAEN task force ‘Therapy and side effect management’. Problems and experiences from other advocates – examples of adherence tools?

Oral targeted therapies:

Often patients attitudes/statements:

  •  I am doing fine, I don’t want to spoil my day with feeling unwell.
  • Nausea /diarrhoea reminds me of having this disease – every day.
  • Drug holidays: to have a great weekend or vacations.
  • Doing well after time: Let’s return to normal life
  • Adjuvant settings: No ‘detectable’ tumour. It’s only for prophylaxis…
  • Poor packaging – complicated dosing schedule – forgetfulness.

Often in reality…
Drs attempts at therapy and side effect management. Attitudes/statements:

  • 5 minutes of information: basis for the therapy offered. Is this enough?
  • Let’s see each other in 3 months….
  • If you have any side effects, contact your GP. Would GPs know?
  • Reduction from 12 to 4 different drugs. This many drugs to manage side effects? Needs to be assessed.
  • Others don’t have this problem. This must be psychologically.Underrated: Dermatology, dental treatment, high blood pressure.

There are also side effects that are not visible to the Dr or the patients.. ie high blood pressure (unless it’s measured before and after). Nausea can’t be measured… and lots more.

Insights:

  • Modern systemic oral treatments will not work in a patient who does not take his medication.
  • Adherence is an issue but it not only a patient issue. Could this have an impact from the media? Is it that the drugs are provided without a side effect management explained and information. Seeking information from other patients or a patient group where a GP perhaps doesn’t know… consequence is that they may take drug holidays ie underdosed with this type of treatment.

Issues for Healthcare Professionals:

  • Misled assumption: Cancer! My patient is taking his medicine.
  • Often: Lack of expertise, experience, time, maintenance (especially in rare cancers).
  • No/less time dedicated to adherence and therapy/side effect management
  • Problem: Do healthcare systems incentivise maintenance?

Patients may not always report:

  • Side effects (or the full extent of the side effects on their Quality of Life)
  • Drugs holidays or modifications to dosing schedules
  • All of the medications, supplements, treatments they are taking for side effect management.

Factors for adherence and persistence: Paper written by Rob Horne – UCL School of Pharmacy)

  • Personal factors such as where people don’t trust medicine
  • Interaction with the system.
  • Treatment factors that might play a role for the patient. (Dosing. Some instances flexible dosing may be prescribed and have a better effect.)
  • Treatment duration – is it possible to treat on a long term basis if this is better. What’s the situation of progression? Should the drug be stopped? – Side effect management. What about prophylactic? All these need to be considered for Optimum Efficacy.
  • How good is the patient/Dr communication on these issues? What kind of questions are raised by the patient and indeed the Dr.
  • We always talk about ‘the patient’… are we always using the same process for every ‘patient’ or perhaps they should be treated individually.

Maximising patient outcomes with targeted agents:
Target agents: a new era in systematic treatment.
-> Patient needs to benefit from a therapy for as long as possible
-> Three key factors for optimum efficacy
-> Adherence
-> Getting the most out of your therapy.

Joining forces for access, quality, innovations and changes.
Communication and cooperation between all groups including healthcare pharma and patients is needed.

When a survey was conducted they discovered that – Less than 50% knew about the standard supportive actions.

Informing and educating the medical people who, in turn educate the patients.
More awareness and support. Brochures at patient and physicians meetings.

Relaunching new website working on a specific tool as an online database of side effect management. What are the real issues? What are the interaction that patients can do? Hopeful that medics will use it also.

  • Working on a patient guide on therapy and side effect management.
  • Also developed another patient guide, about complementary therapy and nutrition. What can I eat if one of my side effect affects my mouth, ulcers or the like? Patients also have to be aware of the side effects that may be because of the complementary therapy or nutrition etc as it could adversely react to the conventional medicine.
  • Engage with industry to be involved with patient materials. They have to be valuable to patients, patient friendly and written in a way that can be understood by the patients.
  • Physician training for teams on dermatology with oncologists/nurses/Drs. They can then best understand these side effects. Need a combination to work on these issues and involve dermatologists in the process.

Potential activities:
Patient advocacy groups

  • Information education of patients and carers
  • Information about influencing factors – complementary medicine and nutrition
  • Hotlines, info-materials, treatment diaries
  • Together with experts: practical recommendation.
  • Own studies/surveys (Evidence) with support of industry and experts
  • Online – Database “Side Effect Management”
    • Mailing list and/or forum exchange
    • Listings: Centres – best therapy care.

Healthcare industry:

  • Are packaging and dose schedules – is it patient friendly?
  • Studies: side effects not only ‘grading’ but also ‘duration’…
  • Real life studies – reg. dosing and outcome…
  • Congresses, conferences, symposia; Awareness!!
  • Information and education (doctors, nurses, pharmacists, etc)
  • Support/train local networks: Oncologists and nurses and dermatologists
  • Health policy: Compensation for time, communication, support
  • Develop material for patients – BUT together with Patient Awareness Groups
  • If care packages not via Medicals via Patient Awareness Groups (make it measurable on the holistic assessment?)
  • Materials and tools to support adherence
  • Not “company specific” Engagements with other pharmaceutical companies.

Oral target therapies in Sarcomas/GIST:
Professional therapy – and side effect management as the main factor for adherence. Our patients must get the BEST benefit for as long as possible from these kind of treatment with an acceptable quality of life.

TALK TO YOUR PATIENTS ABOUT TAKING THEIR MEDICINE!

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Dr Francesco Pignatti, Scientific and Regulatory Management Department, European Medicines Agency, UK (“EMA”)
The process of authorisation for new generic drugs

What are generics?
Defined as essentially similar products. Must contain the same qualitative or quantitative composition in active substances as the originator. Same pharmaceutical form and studies to prove it’s working in an appropriate way.

Approx a 40% saving at the time a generic medicine is introduced.

What data are required?
Chemical, and pharmaceutical aspects (Quality)

  • Same requirements as for the product.

Non-clinical studies (in vitro studies, animal studies)

  • Often no studies required for generic product

Clinical studies

  • Only bioequivalence required for generic product (no need for traditional phase 1-3 development)

In essence: “if the fraction of the dose absorbed is the same, the human body should always do the same with the absorbed compound”

Bioequivalence
It may be that the ‘packaging’ ie the tablet form or coating makes it’s absorption being different.

Issues related to bioequivalence

  • Biowavier
    • For different strengths
    • Using the BCS classification approach
  • Parent compound versus active metabolite
  • Investigation in fed versus fasting state
  • Handling of outliers

EMA experience

  • Initial evaluation application by type
  • Average active time taken for evaluation is 171 days… no different from other drugs.
  • Rejection rate is about 10%
  • Whenever generic or another drug is approved, it goes on their website and more general information about what generic drugs are www.ema.europa.eu

Questions:
Q. What about the psychological impact of changing from a drug that works to a ‘generic’ drug that they don’t know works?
A. Would have to understand there is a risk and if so what is it.
Q. Why is the patient responding to that drug? Will it be the same with the generic.
A – The active ingredient is the same and it is hitting the target. Objectively it should have no different response. Psychologically it would have to be considered on an individual basis and perhaps needs to be managed accordingly. Patient preference issue should be reviewed by the Dr.

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REIMBURSEMENT PROCESS; BEING INVOLVED, BEING LISTENED TO AND BUILDING OWN EVIDENCE
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Dr Karen Facey, Honorary Senior Research FelLow, University of Glasgow, Introduction to Health Technology Assessment (“HTA”)
How can patient groups be involved in the process of access to new therapies? – Health Policy Consultant, UK

Health Technology Assessment

  • What do patients have to contribute?
  • Providing evidence to HTA
  • Participating effectively in the HTA process
  • Principles of patient involvement in HTA

Difficult decisions

  • Do new treatments and procedures add value compared to current treatment?
  • Should the health system invest in them?
  • If we invest in a new treatment there is an ‘opportunity cost’ – we must take investment away from somewhere else in the system.
  • How do we decide what the priorities are?

In times of austerity we need to look at how to make a fair decision about how to spend the budget fair for the population we are serving.

How do we decide what to stop investing in?

Since NICE involvement there has been an increasing use of this process called Health Technology Assessment. It’s meant to be a fair systematic evaluation of the clinical effectiveness and/or cost effectiveness and/or social and ethical impact of a health technology on the lives of patients and the health care system. Should we invest to get that amount of benefit?

Health Technology Assessment International – http://www.htai.org

Ethical issues come in strongly for trials.

HTA is being used more and more for where to spend money.

Health Technologies.
A ‘health technology’ is any intervention that may be used to promote health, to prevent diagnose or treat disease or for rehabilitation or long term care.

This includes education, vaccines and much more.

Another part of assessment should be to determine ‘which patients will benefit most from it?’ How long they should get it and if they don’t respond what next?

HTA and decision making is often considered a bridge between scientific evidence and decision-making.

Patients have unique knowledge and perspectives that can inform.

Patients and carers experiences:
Living with an illness

  • No one knows better what it is like to live with an illness day in day out, than those who are doing this – the patients and their family and friends who care for the.

How can patients perspectives in HTA be a route to robust evidence and fair deliberation?

Patients and carers can contribute to HTA

  • By providing EVIDENCE about their experiences and preferences
  • Through PARTICIPATION in the HTA process.

Within the Scottish Medical Commission’s Submission of Evidence Template – SMC 04/12.

Section 3 – views of patients. Carers and families.

Patient evidence:

  • Ideally, concise and balanced overview that reflects the range of patients perspectives
  • Variations in clinical practice
  • Personal perspectives about benefits and difficulties with the technology.
  • Views on rules for starting and stopping treatment
  • Evidence and facts NOT emotions.

Watch the lay people present their case to the Scottish Parliament – Health and Sport Committee Scottish Parliament on 29th January 2013. This demonstrates the importance of presenting evidence, facts and presenting as if a well run business.

Clinical trials vs patient benefit

Some tips about how to gather patient experiences and preparing the evidence:

  • Review helpline questions
  • Survey/questionnaires
  • Social networking
  • Patient stories (videos)
  • Qualitative research (interview, focus groups…)

Build an evidence base!

There is a research project of the HTA – Patient/Citizen Involvement Sub-Group (PCISG)

Through this sub-group there is participation in the HTA process at every stage:

  • Study design to produce evidence
  • HTA topic selection
  • Scoping
  • Submission of evidence
  • Presentation of patient experience to expert committee
  • Sitting on an HTA decision making committee
  • Commenting on recommendations
  • Patient friendly summaries
  • Dissemination/communications
  • Designing and reviewing patient engagement processes
  • Use HTA to inform charity investments
  • Contribution to governmental review of HTA.

Increasing there are opportunities for patients to get involved in designing the patient engagement policies.

Scoping

  • Population
    • What patients?
    • When an agency starts a process it looks to what patients should be considered.
  • Intervention
  • What medicine, what dose, duration, how’s it administered etc.
  • Comparators
  • Outcome – what matters to patients?

Communicating to a committee

  • Understand your audience and how you are allowed to participate
  • Identify what other experts will be involved and seek to provide unique knowledge.
  • Be prepared with written evidence to refer to
  • Know how long you have to speak – top 3 messages
  • Facts, not emotions.

Tips for writing your consultation response (NICE-IPP)

  • Evaluation of efficacy and safety – not costs.
  • Doesn’t need to be lengthy or comment on everything
  • Short, focussed response
  • Be specific about the procedure
  • Balanced positive and negative
  • No local issues.

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Eric Lowe, Chief Executive Myeloma UK
Build your own evidence base – experiences with NICE in the UK

Eric speaks about his involvement on behalf of Myeloma UK with HTA. Taken part successfully in 20 HTA appraisals. Very steep learning curve and some of the toughest experience.

Reimbursement increasingly a huge issue – tremendous problem across the world even in wealthy countries.

HTA is expanding and evolving.

My view is that in 5 years time the UK is going to be a great place as HTA continues to evolve.

Dumbing down health economics, public health doctors and government – empowering HTA.

Biggest mistake of working with patient groups is that they don’t appreciate the wider agenda ie not just about patients.

Work with NICE and help them do their job properly. Help them to create a new environment rather than butt against them.

Being involved…

  • Patient groups need to be crystal clear on what their ole is and isn’t. It’s a huge commitment to be involved in an appraisal so it is important that patients and patient groups are as effective as they can be.
  • They must also try to represent at the patient view beyond the emotional and angry. Got to behave a s a professional cognisant of all the aspects and being able to represent the case.

Being listened to…

  • Need to be seen as both a patient and a key opinion leader
  • They must understand the broad and competing issues around the table and then take up a compelling but balanced and credible position.
  • Early engagement is critical. It is important to go into an appraisal with a detailed understanding of the technology and the opinions and positions of other stakeholders.
  • Patient groups should engage with the company and clinicians to find out their views and opinions.

How early should you get involved?… Phase II study group or before!!

Must ensure that all representatives engage prior to that point to get consensus and agree on the issues and objections. They should work collectively to submit a cohesive and consistent submission rather than sending in several potentially very different submissions which may show that there is a poor understanding and little agreement about the benefits and/or impact of a new technology.

Building evidence…

  • Patent groups need to think about conducting research to provide evidence for their arguments.
  • Anecdotal is not good enough so by conducting studies of patient preference, values and impact etc. puts you in a much stronger position and gives the approval committee more certainty around what impact a new technology may or may not have.
  • Be careful about quality of life.
  • Need to think way I advance of the beginning of the appraisal to give time to conduct, analyse and write up their evidence/data
  • Patients also have a role in ensuring the clinical evidence is fit for purpose.
  • Patient groups also need to encourage industry to work with NICE Scientific Advice and also attempt to influence the clinical trial designs of registration studies or to encourage additional evidence development to address the evidence gaps. The service is available to help… only 10% of companies use the service!!!

Myeloma UK have established a national clinical trials network. We worked with pharma ahead of time, looked at the trial compared to NICE and then designed a phase 2 academic study to deal with.

Summary

  • Reimbursement issues are increasingly challenging
  • HTA is here to stay, is evolving and expanding.
  • Specialist expertise is needed
  • Inputs needs to be better, crap in crap out. Much more important than that… it’s based on a Phase 3 Global Licensing study… quite often that is very different to clinical practice… even if NICE say yes to the drug we need to make sure we can translate it into effective clinical practice.
  • Done properly it’s a good thing and patient groups should embrace it and make it work for them.
  • HTA is only part of the process and not the end.

Be partners and help involve HTA from the inside.