title: New strategies and designs in pancreatic cancer research: consensus guidelines report from a European expert panel.
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.
authors.affiliation: Gastrointestinal Cancer Unit, Hôpital Erasme, Université Libre de Bruxelles, Brussels. Electronic address: jl.vanlaethem@erasme.ulb.ac.be.
authors.forename: J-L
authors.initials: JL
authors.lastname: Van Laethem
authors.affiliation: Department of Hepatology, Universitair Ziekenhuis Gasthuisberg, Leuven, Belgium.
authors.forename: C
authors.initials: C
authors.lastname: Verslype
authors.affiliation: Institut National de la Santé et de la Recherche Médicale, Marseille, France.
authors.forename: J L
authors.initials: JL
authors.lastname: Iovanna
authors.affiliation: Department of Gastroenterology and Endocrinology, University of Marburg, Marburg, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Michl
authors.affiliation: Nancy University and Department of Medical Oncology, Centre Alexis Vautrin, Nancy.
authors.forename: T
authors.initials: T
authors.lastname: Conroy
authors.affiliation: Digestive Surgery Department, Institut Mutualiste Montsouris, Paris.
authors.forename: C
authors.initials: C
authors.lastname: Louvet
authors.affiliation: Gastroenterology Department, Hôpital Beaujon, Clichy.
authors.forename: P
authors.initials: P
authors.lastname: Hammel
authors.affiliation: Medical Oncology Department, Institut Curie, Hôpital René-Huguenin, Saint-Cloud.
authors.forename: E
authors.initials: E
authors.lastname: Mitry
authors.affiliation: Digestive Oncology Department, Institut G. Roussy, Villejuif, France.
authors.forename: M
authors.initials: M
authors.lastname: Ducreux
authors.affiliation: Medical Oncology Department, Hospital Vall d'Hebron, Barcelona, Spain.
authors.forename: T
authors.initials: T
authors.lastname: Maraculla
authors.affiliation: Department of Surgery, St Josef-Hospital, Ruhr-University, Bochum, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Uhl
authors.affiliation: Department of Radiation Oncology, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: G
authors.initials: G
authors.lastname: Van Tienhoven
authors.affiliation: Department of Gastroenterology, Hôpital Pitié Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France.
authors.forename: J B
authors.initials: JB
authors.lastname: Bachet
authors.affiliation: Department of Gastroenterology and Hepato-Pancreatology, Gastrointestinal Cancer Unit, Hôpital Universitaire Erasme, Brussels.
authors.forename: R
authors.initials: R
authors.lastname: Maréchal
authors.affiliation: Department of Gastroenterology, Institut J. Bordet, Brussels.
authors.forename: A
authors.initials: A
authors.lastname: Hendlisz
authors.affiliation: Department of Medical Imaging, Hôpital Erasme, Brussels, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Bali
authors.affiliation: Gastrointestinal Cancer Unit, Hôpital Erasme, Université Libre de Bruxelles, Brussels.
authors.forename: P
authors.initials: P
authors.lastname: Demetter
authors.affiliation: Department of General and Visceral Surgery, J. W. Goethe University Medical Center, Frankfurt.
authors.forename: F
authors.initials: F
authors.lastname: Ulrich
authors.affiliation: Institute of Pathology, University Hospital Carl Gustav Carus, Dresden.
authors.forename: D
authors.initials: D
authors.lastname: Aust
authors.affiliation: Caritasklinik St Theresia, Saarbrücken, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Luttges
authors.affiliation: Department of Oncology, Universitair Ziekenhuis Antwerpen, Edegem.
authors.forename: M
authors.initials: M
authors.lastname: Peeters
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Mauer
authors.affiliation: Department of Surgery, Clinic for Visceral and Transplantation Surgery, Hôpital Universitaire de Genève, Geneva, Switzerland.
authors.forename: A
authors.initials: A
authors.lastname: Roth
authors.affiliation: Department of Surgery, University of Liverpool, Liverpool, UK.
authors.forename: J P
authors.initials: JP
authors.lastname: Neoptolemos
authors.affiliation: Caritasklinik St Theresia, Saarbrücken, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Lutz
mesh_terms: D000970:Antineoplastic Agents / Q000494:pharmacology; D021441:Carcinoma, Pancreatic Ductal / Q000188:drug therapy*; D005060:Europe; D006801:Humans; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design / Q000592:standards / Q000639:trends
chemical_list: D000970:Antineoplastic Agents