New strategies and designs in pancreatic cancer research: consensus guidelines report from a European expert panel |
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| Affiliation: | 1. Gastrointestinal Cancer Unit, Hôpital Erasme, Université Libre de Bruxelles, Brussels;2. Department of Hepatology, Universitair Ziekenhuis Gasthuisberg, Leuven, Belgium;3. Institut National de la Santé et de la Recherche Médicale, Marseille, France;4. Department of Gastroenterology and Endocrinology, University of Marburg, Marburg, Germany;5. Nancy University and Department of Medical Oncology, Centre Alexis Vautrin, Nancy;6. Digestive Surgery Department, Institut Mutualiste Montsouris, Paris;7. Gastroenterology Department, Hôpital Beaujon, Clichy;8. Medical Oncology Department, Institut Curie, Hôpital René-Huguenin, Saint-Cloud;9. Digestive Oncology Department, Institut G. Roussy, Villejuif, France;10. Medical Oncology Department, Hospital Vall d’Hebron, Barcelona, Spain;11. Department of Surgery, St Josef-Hospital, Ruhr-University, Bochum, Germany;12. Department of Radiation Oncology, Academic Medical Centre, Amsterdam, The Netherlands;13. Department of Gastroenterology, Hôpital Pitié Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France;14. Department of Gastroenterology and Hepato-Pancreatology, Gastrointestinal Cancer Unit, Hôpital Universitaire Erasme, Brussels;15. Department of Gastroenterology, Institut J. Bordet, Brussels;16. Department of Medical Imaging, Hôpital Erasme, Brussels, Belgium;17. Department of General and Visceral Surgery, J. W. Goethe University Medical Center, Frankfurt;18. Institute of Pathology, University Hospital Carl Gustav Carus, Dresden;19. Caritasklinik St Theresia, Saarbrücken, Germany;20. Department of Oncology, Universitair Ziekenhuis Antwerpen, Edegem;21. European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium;22. Department of Surgery, Clinic for Visceral and Transplantation Surgery, Hôpital Universitaire de Genève, Geneva, Switzerland;23. Department of Surgery, University of Liverpool, Liverpool, UK |
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| Abstract: | Although the treatment of pancreatic ductal adenocarcinoma (PDAC) remains a huge challenge, it is entering a new era with the development of new strategies and trial designs. Because there is an increasing number of novel therapeutic agents and potential combinations available to test in patients with PDAC, the identification of robust prognostic and predictive markers and of new targets and relevant pathways is a top priority as well as the design of adequate trials incorporating molecular-driven hypothesis. We presently report a consensus strategy for research in pancreatic cancer that was developed by a multidisciplinary panel of experts from different European institutions and collaborative groups involved in pancreatic cancer. The expert panel embraces the concept of exploratory early proof of concept studies, based on the prediction of response to novel agents and combinations, and randomised phase II studies permitting the selection of the best therapeutic approach to go forward into phase III, where the recommended primary end point remains overall survival. Trials should contain as many translational components as possible, relying on standardised tissue and blood processing and robust biobanking, and including dynamic imaging. Attention should not only be paid to the pancreatic cancer cells but also to microenvironmental factors and stem/stellate cells. |
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