Neurocognitive and Psychosocial Issues in childhood cancer survivors Momcilo Jankovic, WPL

1. Neurocognitive and Psychosocial Issues in childhood cancer survivors Momcilo Jankovic, WPL Fondazione MBBM, Monza (Italy) Belgrade, 29.10.2016

6. The Survivorship Passport • Giulia Stabile • Maurizio Ortali • Davide Saraceno • Roberta Amato CINECA • Riccardo Haupt • Silvia Caruso • Francesca Bagnasco IGG • Sabine Karner • Anita Kienesberger ICCPO All partners of: ENCCA: WP 13 PanCareSurFup: WP6 2016 PanCare Meeting

7. 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 long-term follow-up of possible late effects • All languages of the EU

8. 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 follow-up care • Transfer of information • Tool for Survivors  empowerment • So much information necessary?? YES!

9. 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

10. 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

11. General outline of the survivorship passport: Elective end of therapies

12. 2nd Elective end of therapies

13. Survivorship Passport:Quality and security Certifications • ISO 9001:2008 qualitycertification for "Design, development, creation, and distribution of services and systems in the field of Information and Communication Technology". • ISO 27001:2005 securitycertificationfor "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".

14. Sustainability It is key to integrate all existing data sources available at hospital level related to the passport 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

15. 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

16. The survivorship passport data flow Data Input Passport dedicated database Secure Web Access rules Clinical trials databases National/ Hospital databases

17. Link to guidelines for follow-up

18. Guidelines development plan

19. Grading system to formulate recommendations

20. Clinical Recommendations STRONG recommendation “is recommended ” MODERATE recommendation “is reasonable “ WEAK recommendation “may be reasonable” NOT TO DO recommendation “is not recommended”

22. Harmonizing Breast Cancer Surveillance For Women Treated with Radiation for Childhood Cancer

23. Definition of risk groups • Providers and women treated with chest radiation should be aware of breast cancer risk. • Breast cancer surveillance is recommended for women treated with > 20 Gy chest radiation. • Breast cancer surveillance is reasonable for women treated with 10-19 Gy chest radiation based on clinical judgment and considering additional risk factors. • Breast cancer surveillance may be reasonable for women treated with 1-9 Gy based on clinical judgment and considering additional risk factors.

24. 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.

25. 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.

26. 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.

27. Cardiomyopathy Surveillance Harmonization: Formulation of Recommendations October 7, 2012 London

28. Definition of risk?

29. General recommendation Survivors treated with anthracyclines and chest radiation and their providers should be aware of the risk of cardiomyopathy.

30. Who needs surveillance? Anthracyclines Cardiomyopathy surveillance is recommended for survivors treated with high dose (> 250 mg/m2) anthracyclines. Cardiomyopathy surveillance is recommended 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.

31. 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.

32. 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.

33. 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.

34. At what frequency should surveillance be performed in Moderate/Low Risk Survivors? Cardiomyopathy surveillance isreasonable 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

35. 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!

37. 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. The Statement