The role of patients’ organisations
Algarve, Portugal, 15th October 2015
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ECPC: "Nothing about us, without us"
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Representing 369 cancer patient groups in 46 countries
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All cancers – common and rare
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Run and governed by patients
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Promoting timely access to appropriate prevention, screening, early
diagnosis, treatment and care for all cancer patients
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Reducing disparity and inequity across the EU
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Encouraging the advance of cancer research & innovation
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Increasing cancer patients' influence over European health and research
policy
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ECPC: cancer patients’ recognised voice
ECPC represents cancer patients within:
• European Commission
• Joint Action on Cancer Control – CanCon;
• European Commission’s Expert Group on Cancer
Control
• European Medicines Agency
• Patients’ and Consumers’ Working Party
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Patients as co-researchers:
ECPC Scientific activites
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RARECARENet
Problem: few countries (e.g France) have recognised
specialised centres for rare cancers
•The Project
• Chafea financed project
• Consortium of 11 partners
• ECPC Deliverables
• A list of 144 Rare Cancer patient organisations across Europe
• An online library with information on rare cancers:
• diagnosis, treatment and follow-up
• The identification of Centres of Excelence for rare cancers in
Europe (ongoing)
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RARECARENet
FINDINGS
Are rare cancers mentioned in NCPs?
Yes
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No mention
Only Childhood cancers/Rare
diseases
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Not applicable/ No NCP
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Number fo Rare Cancer patients
organisation per Member State
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eSMART
• Objectives:
• demonstrate the effects of a real-time, mobile phone based,
remote patient monitoring intervention on key patient outcomes
and delivery of care provided to people with cancer during and
after chemotherapy
• Outcome:
• Creation of areal-time, mobile phone based remote patient
monitoring system, the Advanced Symptom Management
System (ASyMS)
• Test of the ASyMS
• ECPC’s role:
• Provide guidance from the patient perspective;
• Dissemination
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Empowerment through projects
• : prevention, early detection, improved treatments
through translational research
ECPC’s role: dissemination - from the lab to the patient
in collaboration with eCancer
• BIOBANKING
• Biobanking glossary and Frequently Asked Question
• Publication launched this week – AVAILABLE NOW
• BIOMARKERS
• Video on importance of biomarkers for cancer patients
AVAILABLE ON ECPC.ORG
• Empowering patients through PERSONALISED MEDICINE
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New needs, New rights
Novel technologies and new therapeutic options satisfy
grant patients new opportunities
From these opportunities arose a set of new needs of
cancer patients, to which MUST correspond new rights
There are few particularly important ones, relevant for
EuroCanPlatform:
• Survivorship – concept of cured people
• Biobanking
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Europe’s 10 million cancer survivors
INCIDENCE
2,4 million
MORTALITY
1,7 million
5 YEARS PREVALENCE
8,5 million
Fonte: OECD – UICC, 2012
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The concept of cured patient:
The AIRTUM Study
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The concept of cured patient:
The AIRTUM Study
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The concept of cured patient:
The AIRTUM Study
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A new paradigm for survivorship
• Survivorship rates are on the rise, but great inequalities
still exist! (EUROCARE-5)
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60
50
40
30
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0
Colorectal
cancer
Northern
Europe
Central
Europe
Southern
Europe
Eastern
Europe
• Quality of life: different survivors with different needs!
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Cancer treatments and
second malignant neoplasm (SMN):
17- 19 % of all new primary malignancies occur in individuals who have
already survived a primary malignancy: cancers have more than doubled in
the last 3 decades (1979 -2009).
The risks are associated with radiotherapy, chemotherapy
and hormonal agents treatment.
Screening to detect cancers early ought in principle to have a considerable
potential to reduce the incidence of mortality from SMNs. National
recommendations for breast cancer after HL and childhood have been
produced in the UK and US
Prostate cancer patients may develop an increase in fat mass
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Cardiovascular disease
after cancer therapy
Radiation-related disease include:
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coronary artery disease
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myocardial dysfunction
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pericarditis
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valvular heath disease
Clinical end-points often do not occur until at least 10-15 years after
exposure
Chemotherapy (Anthracyclines) is a well known example of
Cardiotoxicity.
Trastuzumab has a low risk of progressive cardiac disease
LONG-TERM FOLLOW UP IS NEEDED.
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Metabolic syndrome:
a cluster of metabolic disorders
Key components of the syndrome are:
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decreased insulin sensitivity
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Hypertension
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overweight
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adverse lipid profile
Metabolic syndrome may contribute to increased CVD risks in:
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prostate cancer patients
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survivors of testicular cancer (TC)
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childhood malignancies
Following standard CISPLATIN-based chemotherapy, TC survivors have an
increased prevalence of the metabolic syndrome associated with
decreased serum testosterone concentration.
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Sexual disfunction and infertility
Damage to nerves, blood vessels and hormones are consequences of
cancer treatment’s toxicity
• ½ of the man and woman treated for the pelvic malignancies
• ¼ of people with other types of cancer are affected by these symptoms
Chemotherapy (ALKYLATING drugs) is the cause of the highest risk of
infertility in men and women (lung cancer, hematologic malignancies
and neck tumors)
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Men: over 95% in US Prostate cancer treatment group had erection
problems
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Women (aromatase Inhibitors): vaginal dryness, pain during sexual,
activity, loss of sexual desire
Rates of sexual problem are close to 33% of childhood cancer
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Techniques of fertility preservation
Records of utilization of CRYOPRESERVED SEMEN in many large registries
continue to show typically 10% to 20% of man who retrieve their samples
for infertility treatments
Sexuality is rated as a high priority issue by a quarter to three-quarters of
survivors, and is ranked as an important unmet need during cancer
survivorship
In UK only 38% routinely provided written material on fertility preservation
to eligible patients
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Psychological distress
Deficits in a specific cognitive domains such as memory, attention,
executive functions and processing speed may profoundly affect quality of
life negatively affecting professional reintegration and interpersonal
relationship
Distress in cancer patients is often report to be above 30%.
The prevalence of depressive symptoms varies between 10% and 25%,
anxiety Symptoms varies from 10% to 30%.
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Cancer patients’ role to create a new
survivorship paradigm
European Commission’s Joint Action on Cancer Control
Work Package 8
WP leader: French National Cancer Institute.
ASSOCIATED PARTNERS INVOLVED IN THE WP:
• Cancer Society of Finland
• Istituto Tumori "Giovanni Paolo II" (Italy)
• Fondazione IRCCS Istituto Nazionale dei Tumori, INT (Italy)
• Norwegian University of Science and Technology
• Catalan Institute of Oncology, ICO
COLLABORATING PARTNERS :
• ECPC
• ECL
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Cancer patients’ role to create a new
survivorship paradigm
European Commission’s Joint Action on Cancer Control
Develops recommendations for high-quality survivorship care and
rehabilitation:
• a European framework for high-quality cancer survivorship care and
rehabilitation that could be promoted at EU level
• tools, a European "distress barometer", and personalised
rehabilitation and survivorship care plan.
The recommendations will:
- deal with all fields across the cancer control continuum from clinical
guidance to psychological and social rehabilitation
- take into account patients' status
- include subsequent policy recommendations, which take care of the
feasibility and acceptability of recommendations by all MS and
associated countries, and have a special focus on employment
issues.
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ASCO Cancer Survivorship Compendium
Providing patients with comprehensive care follow up
ASCO Treatment Summary and Survivorship Care Plan
General Information
Patient DOB:
Email:
Health Care Providers (Including Names, Institution)
Patient Name:
Patient phone:
Primary Care Provider:
Surgeon:
Radiation Oncologist:
Medical Oncologist:
Other Providers:
Treatment Summary
Diagnosis
Cancer Type/Location/Histology Subtype:
Stage: ☐I
☐II
☐III
Diagnosis Date (year):
☐Not applicable
Surgery ☐ Yes ☐No
Treatment
Surgery Date(s) (year):
Surgical procedure/location/findings:
Body area treated:
Radiation ☐ Yes ☐No
Systemic Therapy (chemotherapy, hormonal therapy, other) ☐ Yes ☐No
Names of Agents Used
End Date (year):
End Dates (year)
Persistent symptoms or side effects at completion of treatment: □ No □ Yes (enter type(s)) :
Familial Cancer Risk Assessment
Genetic/hereditary risk factor(s) or predisposing conditions:
Genetic counseling: □ Yes □ No
Genetic testing results:
Follow-up Care Plan
Need for ongoing (adjuvant) treatment for cancer ☐ Yes ☐ No
Additional treatment name
Planned duration
Possible Side effects
Schedule of clinical visits
Coordinating Provider
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When/How often
ASCO Cancer Survivorship Compendium
Providing patients with comprehensive care follow up
Coordinating Provider
Cancer surveillance or other recommended related tests
What/When/How Often
Please continue to see your primary care provider for all general health care recommended for a (man) (woman) your age, including cancer
screening tests. Any symptoms should be brought to the attention of your provider:
1.
Anything that represents a brand new symptom;
2.
Anything that represents a persistent symptom;
3.
Anything you are worried about that might be related to the cancer coming back.
Possible late- and long-term effects that someone with this type of cancer and treatment may experience:
Cancer survivors may experience issues with the areas listed below. If you have any concerns in these or other areas, please speak with your
doctors or nurses to find out how you can get help with them.
☐ Emotional and mental health
☐ Fatigue
☐ Weight changes
☐Stopping smoking
☐ Physical Functioning
☐ Insurance
☐ School/Work
☐Financial advice or assistance
☐ Memory or concentration loss
☐ Parenting
☐ Fertility
☐ Sexual functioning
☐ Other
A number of lifestyle/behaviors can affect your ongoing health, including the risk for the cancer coming back or developing another cancer.
Discuss these recommendations with your doctor or nurse:
☐Tobacco use/cessation
☐ Diet
☐Alcohol use
☐Sun screen use
☐Weight management (loss/gain)
☐Physical activity
Resources you may be interested in:
Other comments:
Prepared by:
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Delivered on:
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Cancer patients’ role:
Empowerment/Education of survivors
• The empowerment of patient and family should be
emphasized in survivorship
• More and better education and self-care programs,
particularly for underserved populations
• Training of health care professionals should include
communication skills next to medical
• Particular attention should be paid to the most deprived
populations education
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• Patient education research would be needed
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The role of researchers and clinicians
• Supportive care including palliative care and rehabilitation
should be integrated into the whole cancer pathway
• Follow-up period should begin with the elaboration of
survivorship care plan (SCP), with involvement of GPs
• Key health care worker (case management role) should
be assigned to the patients
• More data should be collected from large cohorts of
patients on follow-up and long-term survivorship.
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cost estimation of the different options
stratify patients according to the risk of recurrence and sequelae
Patient-reported outcomes
This is the only way to truly enhance knowledge!
• Biomarkers in survivorship settings: not only early
detection but also tertiary prevention/late effects
A fruitful collaboration
Patients and researchers/clinicians can be allies
• : prevention, early detection, improved treatments
through translational research
ECPC’s role: dissemination - from the lab to the patient
in collaboration with eCancer
• BIOBANKING
• ECPC produced a Biobanking glossary and
Frequently Asked Question
• In collaboration with
P. Riegman and M. Wilcox
• Publication launched in 2014–
AVAILABLE NOW on our website
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Biobanks and Patients
A mutually beneficial partnership
• Biobanks
• Crucial role in clinical research, including DNA
sequencing/diagnostics
• There is no safer place to store information on patients!
• BBMRI – ERIC is the future: added value of European
aggregated data!
• Patients
• Benefit of cancer research ran on biobanks data
• Patients have strong political voice
• Biobanks would not exist without patients’ donations
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Safeguarding the future of Clinical research
General Data Protection Regulation
A communication problem?
Public concerns about privacy
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more regulation
More regulation
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burdensome clinical
research
Burdensome clinical research
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late (or no) access to new treatments
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No innovation
General Data Protection Regulation
• Threatens to limit bio-banks and retrospective clinical
research in ways that could be detrimental to health
• The regulatory frameworks for medicinal products
and in-vitro diagnostics are insufficiently connected,
leading to missed opportunities. Predictive assays to
personalize treatment are currently insufficient
Data protection rules should facilitate access to
medical data that is crucial for both prospective and
retrospective medical research
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General Data Protection Regulation
Patients advocacy’s role
ECPC supported ESMO and the oncology community
(joint position paper in 2014)
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Risks derived from GDPR (articles 81 & 83)
Main consequence: slowing down or total block of
research based on population-based disease
registries
Patients believe in science!
Cancer patients advocates are fundamental partners
(civil society) to achieve results both in the lab and
within parliamentary assemblies (national and
Europeans)
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Creating an alliance with patients:
Giving back to the patient
Biobanking is not only about research!
Scientific community has to establish a dialogue to
inform and empower the patient on the advantages
related to the donation
HOW?
• New TRULY informed consent forms shall inform the
patient of the personal advantages of donating:
• Receive relevant information on the results of researches
made on their samples
• Need to share relevant information to the patient and their relatives!
• Be granted access to the sample
• The patients should have access to the sample in case of relapse
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Make patients your partners:
What patients organisations can do?
• Information campaigns on biobanking
• One example: Independent Cancer Patients’ Voice
• Patient-oriented UK charity, supporting the work of several
biobanks in the UK
• Provides key, patient-friendly information on biobanking
• Wins over the skeptical
• Leader: M. Wilcox (nurse)
• Influence the policies affecting biobanking
• European level
• National level
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• PATIENTS CAN DO A LOT IF THEY BECOME
TRUE PARTNERS
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Better involving patients in Clinical Trials
• The problem
• Innovation is slowly translated into new treatments
• Unmet clinical needs (pancreas) with no new treatments
• The cost of innovative treatments are becoming unsustainable
• Possible solutions: ealiER Dialogue
• Sponsors need to get patients, payers and HTAs involved in the
earliest phase of CTs design
• Use the knowledge developed (particularly biomarkers) to
design SMALLER trials with more specific patients cohorts, to
ensure results of the trials are valid AND cheaper
• Implement more pilot project to collect better real life data,
which can be used to assess new treatments
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• There are alternative models out there (SPECTA from
EORTC; FOCUS4 etc)
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From clinical trials to assessing value
A new model to include patients preferences
• Patients’ preferences must be taken in higher
consideration when assessing value of new treatments
• The current drug development and evaluation
processes are not harmonised to include patients’
preferences in a sufficient way
• Why?
• Fragmentation: there is one market authorisation authority
(EMA), but 96 local HTA bodies
• We lack a unified model to assess when and how specific
needs may be balanced against values at the public health
level
• EMA is a good model
• Patients involved in evaluation of new drugs
• ECPC collaborates at various levels with EMA
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Europe of Disparity in Cancer (EoDiC)
ECPC’s roadmap to tackle inequalities
• ECPC policy strategy, presented at ECC2015
• Covers all the inequalities in cancer patients’ journey, from early
detection to survivorship
• Patient-friendly,scientifically validated recommendations
to tackle inequalities in cancer care
• EoDiC is already making a difference!
• CanCon WP5 will use it as a starting point for their policy paper
on equity (2016)
• EoDiC’s principles are at the base of the Written Declaration
30/2015, supported by ECPC and promoted by 19 MEPs
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Take home messages
• Future translational research shall take into
consideration the new needs and rights of cancer
survivors and their families
• Getting back to a normal life shall be a priority for
translational research
• Cancer patients shall be considered coresearchers for their invaluable contribution &
collaboration
• Cancer patients believe in science and are partners
also in the policy efforts
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Thank for your attention
Francesco De Lorenzo
ECPC President
francesco.delorenzo@ecpc.org
@cancereu
European Cancer Patient Coalition
ECPCtv
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Nothing About Us Without Us