Issue 8 – November 2016

UK EORTC LIAISON OFFICE

By Liz Flackett 1 – EORTC Liaison Officers and EORTC HQ team 2
1NIHR CRN: Cancer, University of Leeds, UK;
2EORTC HQ  International Policy  & Communication Offices, Brussels, BE

Edito

Dear colleagues,

EORTC has had a productive year in 2016, and I would like to take the opportunity via  this newsletter to report on progress towards our mission to provide patients with prolonged survival and improved quality of life.

Today our collaborations continue to deliver impactful research to address the challenges of cancer therapy, leaving no one behind, as established by the many important studies published this year, including:

The final results of a phase III study in partnership with GIMEMA Leukemia Groups and Pfizer to evaluate the efficacy and safety of Gemtuzumab Ozogamicin, which showed significantly improved overall survival as compared to BSC in elderly AML patients ineligible for intensive chemotherapy.

The EORTC CREATE study assessing the activity and safety of Crizotinib in 6 independent very rare tumor types with confirmed papillary Renal Cell Carcinoma type 1 and MET mutations achieved confirmed partial responses, opening the road for more explorations for these rare forms of cancer.

Three EORTC studies presented at the American Society of Clinical Oncology (ASCO) annual meeting exposing important findings in the treatment of rare brain tumors:

  • A Phase III trial sponsored by the Canadian Cancer Trials Group, reported at the Plenary Session, demonstrated the benefit of a shorter radiation schedule in combination with chemotherapy in elderly patients with glioblastoma, which increases two-year survival by about 10%, without affecting their quality of life.
  • The CATNON study established that chemotherapy after radiotherapy for patients with anaplastic glioma delays tumor progression and increases five-year survival rate from 44% to 56%.
  • And the EORTC 26101 phase III study explored the use of bevacizumab in combination with lomustine in patients recurrent glioblastoma, and while there was no improvement in the overall survival rate for those patients, tumor growth was delayed.

The MINDACT study, in partnership with BIG (Breast International Group) and published in the NEJM,  showed that 46% of women with early-stage breast cancer currently prescribed a course of adjuvant chemotherapy could consider foregoing this additional treatment, therefore avoiding its serious side-effects, with no difference in outcome

The EORTC 22033-26033, published in the Lancet, showed that there were no significant differences in Progression-Free Survival (PFS), Health-Related Quality of Life (HRQOL) and cognitive function in patients with low-grade glioma who were treated with either standard radiotherapy or primary chemotherapy.

The EORTC 18071 randomized, phase 3 trial involving patients with resected, high-risk stage III melanoma – published in NEJM and presented at the first Presidential Symposium at ESMO – which demonstrated that adjuvant treatment with the checkpoint inhibitor ipilimumab significantly improves overall survival, distant metastasis-free survival and recurrence- free survival compared with placebo.

With these achievements, which span across tumors – frequent and rare; varying populations including elderly; varying clinical situations early and advanced; and varying therapeutic modalities and their combination, EORTC confirms its premier leadership position in Europe as a multidisciplinary clinical research infrastructure.

With the collaboration of its network, EORTC’s portfolio continues to flourish:

  • 18 new studies opened in 2015, and probably as many in 2016
  • 48 studies currently open to patient entry
  • 14 studies in regulatory activation
  • 47 studies in development
  • Collaborations in 37 countries across Europe, Asia, North America

In addition, EORTC is growing its network, building new partnerships with professional societies, patient organisations and other stakeholders to broaden the reach and impact of our activities, including:

  • Partnership with IBBL and collaboration with Ignyta to further advance the SPECTA initiative and the development of precision medicine.
  • Partnership with SIOPe for quality assurance in pediatric radiotherapy.
  • Partnership with patient organisations and industry, under the IMI, for EUPATI, which aims to provide scientifically reliable, objective and comprehensive information to patients on medicines research and development.
  • Together with ESSO and JCOG, the SURCARE initiative aims to provide high-quality standards for prospective surgical clinical research.

Last but not least, two recent meetings:  “Navigating Safely through the Regulatory Triangle: Clinical Trials – In vitro Diagnostics – Data Protection”  and “Innovation and Biomarkers In Cancer Drug Development”(IBCD) highlighted important regulatory considerations to maintain an environment conducive to independent clinical research in Europe, and underlined the need for a coordinated, structured transition from biomarker science to more practical applications taking into account the interests and needs of all stakeholders.

With your important contribution as EORTC members and investigators, and the support of the national coordinators whose hard work ensures we can effectively open high-quality studies internationally, we are confident these activities will help address gaps in cancer clinical treatment and bring innovation to your patients. We thank you for your continued engagement as we work together to face a fast-changing environment with its assortment of challenges and opportunities.

Sincerely,

Denis Lacombe
EORTC Director General

Portraits of EORTC key opinion leaders


Dr  Mary O’Brien,
Consultant Medical Oncologist and Head of the Lung Unit
Royal Marsden Hospital – Sutton, Surrey

We had the opportunity to speak with Doctor Mary O’Brien, Consultant Medical Oncologist and Head of the Lung Unit at The Royal Marsden NHS Trust, in Sutton, Surrey,  a leading center for oncology research.

Specialised in lung and breast cancer including mesothelioma, Dr O’Brien is interested in all aspects of treatment development through clinical trials. In her early career, she worked on the development of a vaccine for lung cancer, but knowledge of the connections to the immune system was limited at the time. With today’s advances in technology and molecular science, Dr O’Brien sees further hope in the field: “I started off 25 years ago with this work, but at the time it didn’t work because we didn’t know how to activate a suppressed immune system. Today, we’ve come full circle, with new drugs that are actually designed to do this, and it is re-opening the perspective of development in that field.”

She was chair of the EORTC lung cancer group for 6 years and is Principal Investigator of a number of European trials including the PEARLS trial of adjuvant pembrolizumab in operable lung cancer, now recruiting in the UK and many other countries (link to study, EORTC 1416).

Why become a member of EORTC?

Being a member of the EORTC expands horizons and introduces you to people, places and ways of working that are not immediately obvious to an NHS clinician. The EORTC invests in young investigators, providing opportunities to attend and speak at group meetings and providing them with a reference senior oncologist to discuss ideas and approaches. In the lung research group, mature studies are usually allocated a young investigator to give them the opportunity to experience the trial throughout its development alongside more experienced investigators. They therefore have the chance to participate in the clinical study process at every stage, from concept to discussion, to following through with the implementation of the study. That is a tremendous start to their career.

 

What is your vision for the field of oncology in the EU

Oncology in the EU is at an exciting point – the developments are happening fast and furious. Immunotherapy is of course a notable area where lung cancer is benefitting greatly, and we are experiencing a paradigm shift in how lung cancers are managed.

The EORTC is at the forefront of the next generations of lung cancer treatment trials – one example is our trial in operable lung cancer (link to pembrolizumab study, EORTC 1416 here). These new technologies imply longer treatment regimens, potential new side effects and a new approach to disease management. The EORTC has identified these changes early on and is addressing them by following through with solid research.

Many countries will get left behind because of the cost of introducing these new treatments – let’s hope the UK will not be one of these. As an organization, the EORTC recognised a long time ago that research should not only evaluate whether a drug works, but how it brings value to the patient. The EORTC has Quality of Life tools that are very often used in oncology, but now health economics and cost benefit are factored into the research, to evaluate not only the overall benefit to the patient, but also to society.

Oncology research is multi-faceted: each area has a number of sub-topics that need to be addressed. The EORTC provides a structure in which these sub-questions are assessed, and these resources are open to all members.

UK EORTC Liaison office activity since May 2016

Leeds Liaison Office update

The Leeds Office continues to play a vital role in opening EORTC member studies in the UK and fully supports UK investigators and site study teams throughout the process.

  • New studies opened!
    Since the last edition of the newsletter in May 2016, the Liaison Office has opened two new EORTC studies across the UK in prostate and gastrointestinal stromal tumours:
    1321: ALT GIST: A randomised phase II trial of imatinib alternating with regorafenib compared to imatinib alone for the first line treatment of advanced gastrointestinal stromal tumour (GIST)
    1333: PEACE III: A Randomized multicenter phase III trial comparing enzalutamide vs. a combination of Ra223 and enzalutamide in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone.
    Both studies have been accepted onto the NIHR Clinical Research Network Portfolio of high-quality research studies in England. This brings the total number of open member studies in the UK to 16. A full list of studies under activation, recruiting or recently closed in the UK can be found below (please see “EORTC trials portfolio and recruitment status in the UK”).
  • HRA approval and EORTC studies
    The new HRA approval system was implemented on 1st April 2016 with the aim of simplifying and improving the approvals process for research in England. All new EORTC studies led from England are now processed via this route. This has been a busy time for the Liaison Office in order to navigate the new system and resolve queries from both the EORTC HQ and UK sites. The LO has now brought all relevant pre-HRA studies under the new system (only two approvals remain), in addition to setting up several new studies and supporting currently recruiting studies.

  • Patient/public/carer involvement in the review of EORTC trials concepts
    Building on the patient information and trial concept review, EORTC recently decided to go further and will form in the coming year a patient advisory panel that would provide regular advice on important elements of EORTC strategy. This panel will regularly report to the General Assembly of the organization, thus becoming an integral part of EORTC governance.
  • Relocation!
    The Leeds Liaison Office has moved to new premises! The Liaison Office now shares time between the NIHR Co-ordinating Centre team based in the centre of Leeds and the NIHR Specialty Cluster team located on campus at the University of Leeds.
  • Staff changes
    Our London-based Liaison Officer, Karen Heasley, left the organisation in August to take up a position at Cambridge University. We’d like to thank her for her valuable collaborative work and look forward to welcoming a new member of London staff  in October.

EORTC trials portfolio and recruitment status in the UK

List of studies under activation, recruiting or recently closed in the UK (cut-off date: 13/10/2016)

What type of assistance is provided by UK Liaison Offices?

Leeds Liaison Office (LO) – EORTC led studies regulatory support

The Leeds LO is the national contact point for UK investigators to provide guidance, practical information and assistance on all aspects of participation to EORTC studies. It mediates the collaboration and communication with EORTC HQ’s staff in charge of the study.

The Leeds Liaison Officer performs regulatory submissions via IRAS to the HRA for England and to REC and R&D for Wales, Scotland and Northern Ireland, as well as and any other regulatory requirements such as ARSAC, in collaboration with CI team and EORTC HQ. The LO, together with the CI verifies the quality of the translation of essential documents such as PIS-IC and protocol summary, and adapts the PIS-IC to UK requirements in collaboration with a dedicated volunteer patient/public panel from the NCRI Consumer Forum. The Leeds LO may assist UK sites in negotiations of contracts and site-specific documents collection. The LO may also provide guidance to new young UK investigators how to set-up the EORTC trials at their site.

Support to the investigators willing to apply for EORTC membership

EORTC membership enables the active participation in EORTC clinical trials and EORTC groups’ meetings, conferences and trainings. Candidates may apply directly through the Membership Committee (membership@eortc.be), or through the structures of the research groups (chairman or secretary).

The related information you can find here . The application forms are available from the EORTC Membership Coordinator (Ms Teodora Kirova) who should be contacted via general e-mail: membership@eortc.be.

Career opportunities for young investigators (physicians and statisticians)

EORTC always looks for young, active, talented people, who want to develop their skills under the supervision of EORTC. There are different opportunities available, the grants for 1 up to 3 years, when young people can design, construct and analyze different kind of data with the possibility to produce the final professional paper for publication or presentation at one of the world-famous scientific congresses. Everybody interested in the fellowship position at EORTC HQ   is welcome.
http://www.eortc.org/careers/

Agenda of Events

Full calendar of  EORTC scientific meetings, conferences and trainings  per category can  be found  here.
For direct access  to  information on EORTC Reserach group meetings calendar click here.

SAVE the DATE!

We highly recommend the following key conferences:

28th EORTC-NCI-AACR Symposium on “Molecular Targets and Cancer Therapeutics”
Venue: Munich, Germany (29/11-02/12/2016)

It is our great pleasure to announce that the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics will take place in Munich.  Hosted by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR), the 2016 Symposium will bring together around 2000 academics, scientists and pharmaceutical industry representatives from across the globe to discuss innovations in drug development, target selection and the impact of new discoveries in molecular biology.

This symposium is unique: it is THE scientific forum for developing drugs for the future! As a one-of-a-kind Symposium at the forefront of drug development, it will enable participants to apply the latest findings and knowledge in their work and practice. This edition will also build on the success of the previous symposium which was widely praised for the quality of its programme, inspirational contributions and exclusive insights.

More information on ENA 2016 website

EORTC Groups Annual Meeting -EGAM
Venue: Brussels, Belgium (09-10/03/2017)

 

This meeting, organized by the EORTC every two years provides an opportunity to get acquainted with the current activities of several research groups and  also to  share/exchange ideas  and  experience  about  the organization and conduct of  more complex smaller –scale clinical trials with strong  targeted  translational research component.

More information about the program will soon be available on the EORTC website: here

Our contact details are can be found on EORTC UK Liaison Office home page.

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