Transcript Belgrade, 29.10.2016

Neurocognitive and Psychosocial Issues
in childhood cancer survivors
Momcilo Jankovic, WPL
Fondazione MBBM, Monza (Italy)
Belgrade, 29.10.2016
The Survivorship Passport
• Riccardo Haupt
• Silvia Caruso
• Francesca Bagnasco
IGG
•
•
•
•
Giulia Stabile
Maurizio Ortali
Davide Saraceno
Roberta Amato
CINECA
• Sabine Karner
• Anita Kienesberger
ICCPO
All partners of:
ENCCA: WP 13
PanCareSurFup: WP6
2016 PanCare Meeting
What should be the passport?
• A template of a document to be given to the individual
patient at the moment of the elective end of therapies
containing cancer history and therapy information
• Paper and electronic based, written in a simple way,
potentially including images and other relevant medical
documents.
• To provide advice and guidance on patient-specific longterm follow-up of possible late effects
• All languages of the EU
Why is a survivorship passport necessary?
• To know the medical history
• Survivors might be not aware or not well informed about the risks of
potential late effects (or forget it)
• To know what to do after end of follow-up (check list what & when & why
to do)
• Education about their own illness (risks, why special screenings, etc.),
optimize prevention and care
• Those who understand the reasons will be more likely to continue followup care
• Transfer of information
• Tool for Survivors  empowerment
• So much information necessary??
YES!
The survivorship passport:
The prototype development (1)
• Definition of list of variables (ballot)
• Use common nomenclature (ICCC-3 and ICD-O, ATC)
• Tumor
• Tumor - Radiotherapy site
• Chemotherapy
• Data base creation
• Online tool for data entry and passport creation
The survivorship passport:
The prototype development (2)
• “Translation” into lay language of some medical
terms
• Linkage with clinical trials data bases to
automatically collect treatment information
• Linkage with guidelines of follow-up (in collaboration
with PanCareSurFup + harmonization)
• Data security and privacy issues
• Implementation on a national level
General outline of the survivorship passport:
Elective end of therapies
2nd Elective end of therapies
Survivorship Passport:
Quality and security Certifications
• ISO 9001:2008 quality certification for "Design,
development, creation, and distribution of
services and systems in the field of Information
and Communication Technology".
• ISO 27001:2005 security certification for
"Analysis, design, development, operation and
maintenance of Decision Support Systems and
Information System Infrastructures for
management, monitor and analysis of clinical
trials and epidemiological registries for health
services organizations".
Sustainability
One critical issue for the long-term sustainability of the
survivorship passport project is to limit the time needed for
clinicians to insert manually data on the system.
Some data entry simulations has demonstrated that, if not
properly organized within the healthcare delivery processes, it
may take a few hours to a clinician to gather all the documents
and data related to a patient and to insert them online into the
platform
It is key to integrate all existing data sources available at hospital
level related to the passport
The survivorship passport
Data integration options
 Integration with existing data flows through standard
format files
 Automatic or on-demand data import from local databases
to Passport central database
 Integration with Clinical Trials databases
 DB download for hospitals according to data access rules
 Possibility to develop specific web services for seamless
data integration
The survivorship passport data flow
Data Input
Passport
dedicated
database
Secure Web
Access rules
Clinical trials
databases
National/ Hospital
databases
Link to guidelines for follow-up
Guidelines development plan
Gannt chart for PanCareSurFup WP6 Topic Sub-groups
Before
SMN breast cancer
Cardiomyopathy
2013
January-June
July-December
2014
January-June
July-December
2015
January-July
Coronary/vascular disease
CV risk Metabolic syndrome
Models of care/transition
Male gonadal toxicity
Female gonadal toxicty
Neurocognitive deficits, fatigue
Growth hormone deficiency
CNS & other vasculopathy
Osteoporosis/osteonecrosis
Thyroid cancer/dysfunction
Other secondary neoplasms
Tubular/glomerular injury
Hearing disabilities
Miscellaneous Group 1 (see below)
IHG inititiative & members
EBM method
Miscellaneous Group 2 (see below)
Collaboration IHG & PCSF
EBM method
PCSF alone
"Pragmatic method focused on education"
Other secondary neoplasms - CNS (malignnat & benign), gastrointestinal, melanoma, other skin cancer, sarcoma
Miscellaneous Group 1 - gastrointestinal, hepatic, lower urinary tract, respiratory, spleen
Miscellaneous Group 2 - bone, craniofacial/dental, major surgery, radiotherapy/soft tissues, skin/alopecia, spine/scoliosis, visual
FINISHING FINAL DOCUMENTS
Grading system to formulate
recommendations
Clinical Recommendations
STRONG recommendation “is recommended ”
MODERATE recommendation “is reasonable “
WEAK recommendation “may be reasonable”
NOT TO DO recommendation “is not recommended”
Harmonizing Breast Cancer Surveillance
For Women Treated with Radiation for
Childhood Cancer
Definition of risk groups
• Providers and
• Breast cancer
• Breast cancer
women treated
surveillance is
surveillance may
with chest
reasonable for
be reasonable for
radiation should
women treated
women treated
be aware of
with 10-19 Gy
with 1-9 Gy
breast cancer risk.
chest radiation
based on clinical
• Breast cancer
based on clinical
judgment and
surveillance is
judgment and
considering
recommended for
considering
additional risk
women treated
additional risk
factors.
with > 20 Gy chest
factors.
radiation.
Frequency of Surveillance
• Annual breast
cancer surveillance
is recommended for
women treated
with chest radiation
for at least up to 50
years of age
• Additional breast cancer
surveillance (beyond that
recommended by national
health care systems) in
women older than 50 years
of age is reasonable based
on clinical judgment and
pending availability of
further data.
Surveillance modality: clinician exam
• Clinician exam may be reasonable in women
treated with chest radiation returning for
follow-up medical evaluations in countries
where breast cancer surveillance access is
through clinician referral.
Surveillance modality
• Breast cancer surveillance with mammography
and/ or MRI (as defined by health care systems)
is recommended for at risk women.
Comment: Screening with mammography and
MRI is superior to single modality in detection
of early breast cancer as has been demonstrated
in studies of younger women with hereditary
breast cancer risk.
Cardiomyopathy Surveillance
Harmonization:
Formulation of Recommendations
October 7, 2012
London
Definition of risk?
Risk
Group
Anthracycline
(mg/m2)
Radiation
(Gy)
Combined
Rx
High
> 250
> 35
Any
Moderate
100 to < 250
> 15 to < 35
--
Low
< 100
< 15
--
General recommendation
Survivors treated with anthracyclines and chest
radiation and their providers should be aware
of the risk of cardiomyopathy.
Who needs surveillance?
Anthracyclines
Cardiomyopathy surveillance is recommended
recommended for
for
survivors treated with high dose (> 250 mg/m2)
anthracyclines.
Cardiomyopathy surveillance is reasonable for
survivors treated with moderate dose (> 100 to < 250
mg/m2) anthracyclines.
Cardiomyopathy surveillance may be reasonable for
survivors treated with low dose (< 100 mg/m2)
anthracyclines.
Who needs surveillance?
Radiation fields including the heart
Cardiomyopathy surveillance is recommended for
survivors treated with high dose (> 35 Gy) chest
radiation.
Cardiomyopathy surveillance may be reasonable for
survivors treated with moderate dose (> 15 < 35 Gy)
chest radiation.
No recommendation can be formulated for cardiomyopathy
surveillance for survivors treated with low dose (< 15 Gy)
chest irradiation with conventional fractionation.
What surveillance modality
should be used?
Echocardiography is recommended as the primary
cardiomyopathy surveillance modality for
assessment of left ventricular systolic function in
survivors treated with anthracyclines and/or chest
radiation.
Radionuclide angiography may be reasonable for
cardiomyopathy surveillance in at risk survivors for
whom echocardiography is not technically
feasible/optimal.
What surveillance modality
should be used?
MRI is not recommended as the primary
cardiomyopathy surveillance modality for at risk
survivors.
Assessment of cardiac blood biomarkers (e.g.,
natriuretic peptides) is not recommended as the
primary cardiomyopathy surveillance in at risk survivors.
At what frequency should surveillance be
performed in Moderate/Low Risk Survivors?
Risk Group
Anthracycline (mg/m2)
Radiation (Gy)
Combined Rx
High
> 250
> 35
Any
Moderate
100 to < 250
> 15 to < 35
--
Low
< 100
< 15
--
Cardiomyopathy surveillance is reasonable for Moderate/Low
Risk survivors to begin no later than 2 years after completion
of cardiotoxic therapy, repeated at 5 years after diagnosis
and continue every 5 years thereafter.
More frequent cardiomyopathy surveillance may be
reasonable for Moderate/Low Risk survivors
Lifetime cardiomyopathy surveillance may be reasonable for
Moderate/Low Risk survivors
Conclusions
• The survivorship passport should be a standard of care in
the follow-up of childhood cancer survivors
• Guidelines development is an international long-term
plan
• The treatment summary may be long to be prepared
• Linkage among several data bases in which treatment
information has already been collected is highly
recommended
• Use of common languages
• … a challenging but a surely very useful enterprise!
The Statement
9.
The general public needs to be made aware of and
accept the reality of the cure of childhood cancer. The
society should insure that survivors have equal access
to education, jobs, insurance, and medical care.
10.
Inequalities of current treatment strategies and cure
rates, both within and between nations, remain a
challenge for the international community to address.