Achievements in Implementing the SIOPE Strategic Plan

Cancer in young people is rare, but it is still a major health issue in Europe. Although the survival rates for this disease greatly improved in Europe over the past fifty years – thanks to the multidisciplinary treatments developed by the paediatric haemato-oncology research community – more than 6,000 young people still die of cancer every year. Moreover, survival rates have plateaued for some of these malignancies, other types of cancers still present a very poor prognosis, and the long-term side effects of treatment still (often severely) affect the lives of two thirds of the 300,000 childhood cancer survivors currently living in the region. Given this unacceptable situation, the European paediatric haemato-oncology community – represented by the European Society for Paediatric Oncology (SIOPE) – agreed that a consensus-based long-term plan would be needed to increase the cure rate and the quality of long term survival of children and young people with cancer by 2025. The Plan was officially launched on 18^th November 2015 at the European Parliament, during a key event hosted by MEP Alojz Peterle and co-organised by SIOPE and the ‘MEPs Against Cancer’ Group. On this occasion, more than 120 participants agreed that childhood cancer should always be a priority for the European Union, which should do more to save more children’s lives and reduce survivors’ adverse late-effects. A couple of months before, the European scientific community also welcomed the SIOPE Plan’s initiative during the SIOPE Session of the 2015 European Cancer Congress. Since the official launch of the Plan at the end of 2015, SIOPE took the lead in coordinating the implementation of the Strategic Plan. For instance, the SIOPE Board defined the leaders responsible for the implementation of each of the Plan’s objectives, and the society strengthened its partnerships with patients, parents and survivors’ advocates, adult oncologists, industry as well as paediatric oncologists from other continents. Most importantly, several cross-tumour platforms and projects were initiated to address the critical variables that could facilitate the Plan’s implementation.

Developments in 2016

In 2016, SIOPE focused on the next steps in the Plan’s implementation and made remarkable progresses carrying out several initiatives.

Plan’s Objective/Platform	Initiative
Obj. 4 - Equal Access	Successful application for a paediatric oncology European Reference Network (PaedCan-ERN): in December 2016, the Board of EU Member States officially approved the PaedCan-ERN developed within the ExPO-r-Net project. This ERN will establish a clear framework for European healthcare providers to provide cross-border healthcare for complex conditions requiring a concentration of expertise. This incredible result has been achievable thanks to the great team effort and the strong commitment of ExPO-r-Net partners during the assessment process.
Obj. 1 & 3 - Innovative Medicines & Tumour biology	European Parliament vote on the Resolution on the EU Regulation on Paediatric Medicines: this new Resolution is of utmost importance to the community, as it aims to influence the revision of the EU Paediatric Regulation (EC) No 1901/2006 and, thus, facilitate a better and faster access to innovative therapies for all children and adolescents will cancer in Europe. SIOPE and its partners (from Cancer Research UK, the MEPs against Cancer group of the European Parliament as well as from the Unite2Cure network of parent/patient advocates) took a leading role in contributing to this new Resolution, and this vote is the result of the intense work and advocacy campaign carried out within the ACCELERATE multi-stakeholder platform. Consolidation of the ACCELERATE Multistakeholder Platform: SIOPE partners have been working since 2013 with parents, patients and survivors as well as regulatory and industry experts in this unique platform to speed up life-saving innovation in paediatric oncology therapies. Over the past years, ACCELERATE partners managed to: Produce proposals to revise the already mentioned EU Paediatric Regulation to better address the needs of children and adolescents with cancer (proposals already reflected in the recently voted Resolution); Identify barriers and formulate possible solutions to set up drug prioritisation and enable drug development, propose new incentives for the development of specific paediatric drugs (and repurposing of existing drugs), as well as implement long-term follow up measures for new oncology drugs; Raise general interest on this theme thanks to the successful ACCELERATE Conferences (last edition: 4th CDDF – ITCC – SIOPE ACCELERATE Paediatric Oncology Conference, 20-21 January 2016, Brussels, BE).
Obj. 4 & 6 - Equal Access/Quality of Survivorship	Leadership of the Childhood Cancers’ Work Package of the Joint Action on Rare Cancers (JARC): SIOPE has been selected as the leader of the Work Package 9 (WP9) ‘Childhood Cancers’ of the Joint Action on Rare Cancers (JARC), an important initiative of the EU and Member States addressing the absence of rare cancers – including paediatric cancers – from national cancer and rare disease plans across Europe. Co-financed by Member States and the European Commission, the JARC has been officially launched on 7th November 2016 in Luxembourg. This initiative will generate recommendations to improve health outcomes for patients with rare cancers, undertake international research to concentrate their treatment of rare cancer patients in specialist multidisciplinary centres. More specifically, WP 9 will focus on: Access to essential medicines and innovative therapies; Extremely rare cancers; Models of healthcare for survivors.
Obj. 6 - Quality of Survivorship	Development of the Survivorship Passport: SIOPE is actively contributing to the development of the ‘Survivorship Passport’ initiative, included in the JARC as well as in the EU projects ExPO-r-Net and PanCareSurFup. The Passport addresses the general lack of information on the possible late effects stemming from having a tumour in the paediatric age, which can generate incorrect diagnosis and treatments. This online tool will provide access to the medical history of childhood cancer survivors, making both them and healthcare professionals aware of the potential risks or late effects. SIOPE is collaborating with the other Survivorship Passport partners to: Cross-check that the information available on the online platform is understandable and user-friendly; Develop recommendation brochures – translated in the main European languages – for an adequate follow-up depending on individual risk factors; Liaising with European Health ministries to ensure that this model will be effectively adopted and introduced into national health systems in Europe.
Platform on Radiotherapy Quality Assurance	Launch of the project QUARTET: on 20th May 2016, a group of European experts in paediatric cancer radiotherapy and imaging officially kicked-off the project QUARTET (Quality and Excellence in Radiotherapy and Imaging for Children and Adolescents with Cancer across Europe in Clinical Trials) in Brussels. High-quality radiotherapy in children and adolescents with cancer plays an essential role in achieving better patient outcomes, and this 5 years’ project aims to reduce the risk of local recurrence and long-term toxicity. Thanks to the collaboration between SIOPE and the European Organisation for Research on Treatment of Cancer (EORTC), and to the support of the Luxembourg Fondatioun Kriibskrank Kanner, QUARTET makes available a reviewing platform to ensure the quality of the radiation therapy and imaging provided in clinical trials for all paediatric malignancies. QUARTET enrolled its first patients: the first 2 patients have been already enrolled in the project and are currently under investigation. Moreover, several clinical trial groups within the SIOPE framework agreed to use the QUARTET platform and started to work together on radiotherapy quality assurance. The project currently covers patients treated for neuroblastoma, rhabdomyosarcoma, Wilms’ tumour and brain tumours as part of 9 European prospective clinical trials. It is to be expected that this project will be extended to even more – and maybe all – patients treated with radiotherapy in European paediatric oncology clinical trials.
Oncopolicy Project	Leading role in the revision of the EU Paediatric Regulation & in the JARC: in 2016 SIOPE was involved in several EU policy developments, as the only stakeholder to be consulted when European health and research policy initiatives related to paediatric cancers are being discussed. SIOPE effectively ensured that the needs of the paediatric haematology-oncology community were considered when these developments took place: The inclusion of paediatric cancers in the JARC initiative (WP on Paediatric Cancers and WP on Epidemiology), which will pave the way for the inclusion of the needs of paediatric cancer patients in each National Cancer Plan in Europe; The European Parliament vote on the Resolution on the EU Regulation on Paediatric Medicines on 15th December 2016, which is the result of an intense advocacy campaign carried out by SIOPE and its partners and benefitted from the support of several Members of the European Parliament; The successful application for a paediatric oncology European Reference Network (PaedCan-ERN), in the framework of the Cross-Border Healthcare Directive (2011/24/EU);
Platform on Epidemiology/Outcome Research	PICORET integrated into the JARC: the JARC Work Package on ‘Epidemiology’ will include some of the paediatric oncology needs identified by the project PICORET (Population Improvement in Childhood cancer Outcomes through Research, Evaluation and Training), which was previously submitted by SIOPE partners to the European Commission as a potential Horizon 2020 project. The aim is to use information from European registries and observational studies to monitor and evaluate progress in the survival of children and adolescents treated for cancer.
IT Platform	Ongoing IT Developments: the SIOPE IT partners from various EU-funded projects are currently developing different aspects of an integrated IT environment to implement the SIOPE Plan: Unique ID (EUPID) for Data Anonymisation: this pilot integrated IT structure will allow clinical trials groups to register patients with a unique ID so that their data can be anonymised and shared between different databases (e.g. registries, clinical trial databases) and users (such as researchers and analysts) across Europe; Virtual Tumour Board Case Consultation Systems: this online platform allows to have multidisciplinary experts around Europe exchanging advices on diagnosis and treatment for rare cancers. Already developed for patients with haepatoblastoma, this IT tool is further developed within the ExPO-rNet project for retinoblastoma and extremely rare paediatric tumours, and will eventually be adapted for other diseases within the Paediatric Oncology Europe Reference Network (PaedCan ERN). Survivorship Passport Database: the Survivorship Passport tool is linked to a database storing the medical history and the clinical data of the survivor, allowing both doctors and survivors to access this information via a secured website and a mobile app.
Platform “Clinical Trial Facilitation” (CTF)	First presentations from the CTF: at recent SIOPE events (e.g. the SIOPE General Assembly) the two leaders of this Platform have presented their first ideas on how to help institutions to set up international clinical trials in the framework of the new EU Clinical Trials Regulation (536/2014/ EU).
Education Platform	Educational Opportunities: SIOPE entered in several collaborative partnerships with other stakeholders to offer new and interesting education opportunities to its members and, thus, encourage the delivery of high quality paediatric oncology care and research: Partnership with ESMO: Activities linked to the ESMO-SIOPE Adolescents and Young Adults Working Group; Partnership with ESO: The organisation of the 6th SIOPE-ESO Masterclass in paediatric oncology; ESO-SIOPE e-sessions on Paediatric Oncology: SIOPE experts have been involved in delivering 3 online sessions on different aspects of childhood cancers. Moreover, two of the cases presented during the Masterclass – a case on adolescent sarcoma and one on refractory metastatic rhabdomyosarcoma – were uploaded on the ESO ePatCare platform for educational purposes, and are likely to be soon transformed in interactive. Partnership with ECCO: MCCR Workshop (former Flims): SIOPE contributes to the next edition of this Workshop on Clinical Cancer Research for young investigators; SIOPE Society Day: this unique one-day educational conference will take place on 27 January 2017, the first day of the European Cancer Congress (ECCO2017). This highly innovative programme for childhood cancer professionals which will illustrate the most effective approaches at the clinical and research levels.
Communication Platform	Several communication initiatives will be carried out in 2017 to mark the 10th anniversary since the establishment of the SIOPE permanent secretariat in Brussels, and to further increase the profile of SIOPE as main reference for paediatric haematology-oncology in Europe.

Conclusion & Next Steps These were just a few examples of the projects and structures created to address the needs identified in the SIOPE ‘European Cancer Plan for Children and Adolescents’. Since the launch of this ambitious Plan, SIOPE managed to unite the European community around the same objectives, raise awareness and generate action from all those who care for the future of childhood cancer patients and survivors. We would like to express our gratitude to all the SIOPE members and partners who essentially supported us in this endeavour and made possible what we have been able to achieve so far. However, there is still much to do. SIOPE is currently seeking the financial support of charities, companies, foundations as well as European and national grants to fund the complete implementation of this Plan. With a stronger financial support, more quality research would be funded and, thus, allow a better knowledge of paediatric cancers’ biology and genetics. This knowledge would be translated from bench to bedside into safer and more effective innovative treatments for young patients. Research would not only benefit patients, but it would also address the long-term consequences of cancer treatment and improve the quality of life of an increasing number of survivors. The Plan’s initiative would also contribute to reduce the existing inequalities in the quality and accessibility of the paediatric oncology care and treatment across Europe, and to integrate the specific needs of teenagers and young adults into standard care. Today, our priority is to make this ambitious document a reality, with the help of everyone. Donations could facilitate and speed up the multiple initiatives included in the Plan and, thus, save more children’s lives. You can contribute too to implement the SIOPE Strategic Plan via the following link www.siope.eu/donate.