ETOP European Thoracic Oncology Platform c/o IBCSG Effingerstrasse Bern. Phone Fax

Transcription

1 Annual Report 2012

2 ETOP European Thoracic Oncology Platform c/o IBCSG Effingerstrasse Bern Phone Fax UBS AG Postfach CH-8098 Zürich Switzerland Account no: Q IBAN: CH Q SWIFT: UBSWCHZH80A 2 P a g e

3 Index Editorial 4 Key data 5 Ongoing projects and trials 5 Planned projects and trials 5-6 Publications / Abstracts Meetings / Activities ETOP collaboration with IBCSG 8 Group structure 8-10 Foundation Council Scientific Coordinator Financial statement 11 3 P a g e

4 Editorial January 2013 Dear Reader Since 2009 ETOP has continuously enlarged its membership and now comprises more than 40 collaborative groups and institutions from all over Europe, as well as two large and eminent institutions outside Europe, one in the United States (Roswell Park) and one in China (Shanghai Chest Hospital). During this year the ETOP Lungscape master protocol has been activated and the first study ETOP Lungscape 001 ALK has been concluded and was presented at ESMO 2012 in Vienna. Two ETOP-sponsored clinical studies, BELIEF and EMPHASIS-lung, have been activated. With this annual report we would like to provide you with an update on ETOP projects, studies and activities. We take this opportunity to thank you for your continued partnership and collaboration. Kind regards Prof. Rolf A. Stahel President, ETOP Foundation Council Dr. Solange Peters Scientific Coordinator 4 Page

5 Key Data Abstracts/presentations 6 Number of newly activated clinical trials 2 Number of participating patients In clinical trials 12 In observational studies ~ 2400 Ongoing projects and trials Lungscape Lungscape is a project to study the molecular epidemiology of lung cancer in Europe. Fifteen major cancer centers have created a decentralized biobank of tumor samples from 2400 patients who are fully documented with comprehensive demographic and clinical data. Several evaluations of specific biomolecular markers are in various stages of implementation. Lungscape 001 ALK This is a retrospective cohort study of ALK gene rearrangement: prevalence and clinical outcomes in patients with non-small cell lung cancer in Europe. The goals are to describe the expression of ALK and its clinical significance for the patients, their long-term outcome, the correlation of ALK with other biomolecular markers, and to determine the optimal method of ALK evaluation in clinical practice. The results have been presented at ESMO 2012 in Vienna and will be published soon. ETOP 2-11 BELIEF The first therapeutic trial sponsored by ETOP. BELIEF aims at determining the long-term outcome of patients with advanced non-small cell lung cancer and activating EGFR mutations treated with erlotiniband bevacizumab. The trial is being conducted in collaboration with the Spanish Lung Cancer Group, and about 50 hospitals in Europe are participating. ETOP 3-12 EMPHASIS-lung The predictive value of a blood based proteomic test is being assessed in this trial for patients with advanced squamous cell lung cancer. It is expected that the result of the test will allow choosing the more promising of two chemotherapeutic agents for these patients. The trial is currently being activated in about 60 hospitals across Europe. Planned projects and trials Lungscape 002 MET/PI3K/PTEN This is a retrospective cohort study of MET/PI3K/PTEN protein expression and MET/PI3K gene amplification for patients in the Lungscape study. The goals are to describe the expression and amplification of these three markers and their clinical significance. The tumor material secured from patients during the conduct of the ALK module is being used for this study. Lungscape 003 Multiplex Mutation Testing This is a retrospective cohort study of multiple biomarkers for patients in the Lungscape study. The goals are to study the prevalence of and interrelationship between selected cancer related mutations for patients with non-small cell lung cancer. The study is a unique opportunity to determine tumor characteristics which may lead to new treatment approaches. 5 P a g e

6 SPLENDOUR This will be a large trial for 1000 patients with advanced NSCLC and will evaluate the addition of an agent called denosumab to standard anticancer treatment. The drug is used to treat osteoporosis. Interesting results from lung cancer patients have shown that the drug may prolong the survival. This hypothesis will be tested in the SPLENDOUR trial in a systematic fashion. The trial will be conducted as a collaboration between ETOP and the European Organization for the Research and Treatment of Cancer EORTC. STIMULI The primary objective of the STIMULI trial is to evaluate if the survival of patients with limiteddisease small cell lung cancer treated with standard chemo-radiotherapy and prophylactic cranial irradiation can be improved by subsequent consolidation treatment with ipilimumab. This is an immune therapeutic which has shown activity in other types of cancer. The trial is in the development phase and is expected to be activated later this year. Publications / Abstracts Publications 2011 Gridelli C, Stahel R, Besse B, Ciardiello F, Felip E, Gasparini S, Graziano P, Rossi A, de Marinis F. Treatment decision-making for advanced non-small cell lung cancer and differences among European countries: 1st AIOT- ETOP meeting. Lung Cancer 74: Stahel R, Baas P, Faivre-Finn C, Dooms C, Passlick B, Mazières J, Cappuzzo F, Früh M, Sorensen JB, Blackhall F, Taron M, Gridelli C, O'Byrne K, Rosell R. Meeting report: 2nd meeting of the European Thoracic Oncology Platform (ETOP). Lung Cancer 68: Abstracts 2012 Peters S, Dafni O, Bubendorf L, Meldgaard P, O'Byrne KJ, Wrona A, Weder W, Canela M, Malatesta S, Vansteenkiste JF, Dingemans A-MC, Nicolson MC, Savic S, Baas P, Peck R, Lu S, Smit EF, Jantus-Lewintre E, Rosell R, Stahel RA on behalf of ETOP. The European Thoracic Oncology Platform Lungscape project. A way to bridge nonsmall cell lung cancer molecular characteristics and clinical data. Ann Oncol 23 (suppl 9):ix385 (presented at ES- MO 2012; Abstract 11790) Thunnissen E, Kerr KM, Bubendorf L, Nonaka D, Blackhall FH, Kammler R, Speel EJ, De Jong J, Martorell M, Stahel RA on behalf of ETOP. External quality assessment for ALK immunohistochemistry testing in lung adenocarcinoma within the European Thoracic Oncology Platform Lungscape project. Ann Oncol 23 (Suppl 9):ix80. (presented at ESMO 2012; Abstract 193P) Blackhall FH, Peters S, Kerr KM, O'Byrne KJ, Hager H, Sejda A, Soltermann A, Dooms C, Felip E, Marchetti A, Speel EJ, Price N, Savic S, De Jong J, Martorell M, Thunnissen E, Bubendorf L, Dafni O, Rosell R, Stahel RA on behalf of ETOP. Prevalence and clinical outcomes for patients with ALK gene rearrangement in Europe: Preliminary results from the European Thoracic Oncology Platform Lungscape project. Ann Oncol 23 (Suppl 9):ix73. (presented at ESMO 2012; Abstract 1670) 6 P a g e

7 Stahel RA. Lung Cancer: The European Thoracic Oncology Platform Ann Oncol 23 (Suppl 9):58 (presented at ESMO 2012) Normanno N, Patton S, Blackhall FH, Murray S, Kerr K, Dietel M, Filipits M, Benlloch S, Stahel RA, Thunnissen E. Results of the second pilot external quality assurance scheme for somatic EGFR mutation testing in non-small cell lung cancer (NSCLC). Ann Oncol 23 (Suppl 9):ix86. (presented at ESMO 2012; Abstract 213P) Stahel RA, Peters S, Blackhall F, Bubendorf L, Dafni O, Kerr K, Taron M, Thunnissen E, Weder W, Smit E, Rosell R. ETOP activity in the field of biomarkers and predictors. Lung Cancer 77 S1:S16-S17 Stahel RA, Blackhall F, Peters S, Bubendorf L, Dafni O, Kerr K, Taron M, Thunissen E, Weder W, Rosell R. The Lungscape project. Journal of Thorac Oncol 7(6):S13-S13 (presented at ELCC 2012) Peters S, Blackhall F, Taron M, Rosell R, Hiltbrunner A, Maibach R, King R, Stahel R. ETOP Data system: Combining the comprehensive Lungscape database with a clinical trails platform. Ann Oncol 23 (Suppl 1):i41. Meetings / Activities 2012 Several meetings with a high-level scientific exchange took place in Furthermore, various ETOP representatives participated to a number of meetings with pharmaceutical industry regarding further ETOP study options, website updates and general improvements. 5 th ETOP Annual Meeting in Dublin On November , 111 Participants from 14 countries attended the 5 th ETOP Annual Meeting in Dublin. Ongoing projects and trials, new ideas and concepts were presented and discussed either at the plenary meeting, in break-out sessions or working groups. On Friday evening, everyone enjoyed a wonderful dinner together. Foundation Council Meetings CIOT, Naples ETOP Meeting, Dublin Workshops st ETOP Residential Workshop, Lugano Meetings under auspices/in collaboration with ETOP BTOG Meeting 2012, Dublin nd Lung Cancer Network, Athens XIII. Central-European Lung Cancer Conference, Prague rd CIOT, Naples 7 P a g e

8 VI Educational Symposium SLCG, Alicante Educational and collaboration activities Slide decks from ASCO 2012 and ESMO 2012 Video News from ASCO Mutation testing meeting, Zurich LUNGSCAPE, BELIEF and EMPHASIS Investigator meetings in Geneva LUNGSCAPE presentations at ESMO IDMC Meeting, foundation of new committee, Vienna Help with foundation of a patient advocacy group in the field of lung cancer together with ESO (European School of Oncology) Meeting in Zurich Meeting in Geneva Meeting in Milan ETOP collaboration with IBCSG ETOP works in close collaboration with IBCSG and has appointed the IBCSG Coordinating Center with its long standing experience in clinical trials to take care of the organizational and logistical aspects of the ETOP trials. Group structure ETOP is a foundation with the purpose to promote exchange and research in the field of thoracic malignancies in Europe. It is a non-profit organization with its domicile in Bern, Switzerland. 8 P a g e

9 ETOP organization Foundation Council Prof. Rolf A. Stahel President, ETOP Foundation Council Laboratory of Molecular Oncology Clinic of Oncology University Hospital Zuerich Switzerland Paul Baas, MD, PhD Department of Thoracic Oncology The Netherlands Cancer Institute Amsterdam, The Netherlands Prof Kenneth O Byrne Consultant Medical Oncologist Clinical Director HOPE Directorate Haematology Oncology Day Care Centre St James s Hospital Dublin, Ireland Dr. Cesare Gridelli Director Division of Medical Oncology Director Department of Hematology-Oncology "S.G. Moscati" Hospital Avellino, Italy Rafael Rosell, MD Chief, Medical Oncology Service Scientific Director of Oncology Research Catalan Institute of Oncology Hospital Germans Trias i Pujol Badalona (Barcelona), Spain 9 Page

10 Suresh Senan MRCP, FRCR, PhD Professor of Clinical Experimental Radiotherapy Department of Radiation Oncology, VU University Medical Center, Amsterdam, The Netherlands Prof. Walter Weder Director, Division of Thoracic Surgery University Hospital Zurich Zurich, Switzerland Scientific Coordinator Dr. Solange Peters Scientific Coordinator Multidisciplinary Oncology Center Lausanne Cancer Center Centre Hospitalier Universitaire Vaudois Lausanne, Switzerland 10 P a g e

11 Financial statement 2012 (in thousand CHF) All ETOP trials with full academic independence from the pharmaceutical industry, even if sponsored wholly or in part by industry. Income Income from collaboration with industry Further research grants Total: Expenses Contributions to members, participating centers Pathology, translational research Production slide decks, training Website, internet Scientific exchange and coordination, travel expenses Personnel costs and external services (database, statistics, etc.) Start-up costs/insurance, consulting, financial audit Administrative costs Currency loss Total: P a g e