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1. Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials)

Author

Manfred B. Lutz, Roberto Labianca, Patrick Pessaux, Bert A. Bonsing, Benoist Chibaudel, David Malka, Claudio Bassi, Sophie Gourgou-Bourgade, Geertjan van Tienhoven, Pascal Hammel, Carine Bellera, Laeticia Dahan, Jean-Luc Van Laethem, Daniela Aust, Emmanuel Chamorey, Jean Robert Delpero, Josep Tabernero, Adelaide Dousseau, Teresa Macarulla, Franck Bonnetain, Julien Taieb, Karin Haustermans, Laurence Collette, Thomas Aparicio, François Lacaine, John P. Neoptolemos, Simone Mathoulin-Pélissier, Bengt Glimelius, Thierry Conroy, Paula Ghaneh, Alain Sauvanet, Erich Gerber, Christos Dervenis, Aurélien Latouche, Murielle Mauer, Michel Ducreux, Valérie Jooste, Virginie Berger, Jocelyn Gal, Alain Hendlisz, Aimery de Gramont, Emmanuel Mitry, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), UNICANCER, Leiden University Medical Center (LUMC), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), Université Victor Segalen - Bordeaux 2, CHU Bordeaux [Bordeaux], Uppsala Universitet [Uppsala], University Hospitals Leuven [Leuven], CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Erasme [Bruxelles] (ULB), Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Service de Gastro-entérologie [Avicenne], Université Paris 13 (UP13)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Avicenne [AP-HP], Carl Gustav Carus University (DRESDEN - CGCU), Technische Universität Dresden = Dresden University of Technology (TU Dresden), G.B. Rossi Hospital, Verona University, Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Service d'Oncologie Médicale [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Cooperator Multidisciplinary Oncology Group (GERCOR), Service d'oncologie digestive et hépato-gastro-entérologie [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Agia Olga Hospital [Athènes] (Konstantopoulio ), Oncologie digestive, Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Institut für Radioonkologie, Royal Liverpool University Hospital, University of Liverpool-Royal Liverpool and Broadgreen University Hospital NHS Trust, Service de Gastroentérologie [Hôpital Beaujon], Hôpital Beaujon [AP-HP], Institut Jules Bordet [Bruxelles], Registre Bourguignon des Cancers Digestifs, Lipides - Nutrition - Cancer (U866) (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon (ENSBANA)-Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon (ENSBANA)-Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon (ENSBANA), Azienda Ospedaleria Ospedali Riuniti di Bergamo, Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), CaritasKlinikum Saarbrücken, Vall d'Hebron University Hospital [Barcelona], European Organisation for Research and Treatment of Cancer [Bruxelles] (EORTC), European Cancer Organisation [Bruxelles] (ECCO), Institut Curie [Paris], CRLCC René Huguenin, L'Institut hospitalo-universitaire de Strasbourg (IHU Strasbourg), Institut National de Recherche en Informatique et en Automatique (Inria)-l'Institut de Recherche contre les Cancers de l'Appareil Digestif (IRCAD)-Les Hôpitaux Universitaires de Strasbourg (HUS)-La Fédération des Crédits Mutuels Centre Est (FCMCE)-L'Association pour la Recherche contre le Cancer (ARC)-La société Karl STORZ, Service d’Hépatologie [Hôpital Beaujon], Service de gastroenterologie [CHU HEGP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Academisch Medisch Centrum bij, Universiteit van Amsterdam (UvA), Institut de recherche en cancérologie de Montpellier (IRCM - U896 Inserm - UM1), Université Montpellier 1 (UM1)-CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Centre d'Investigation Clinique - Epidemiologie Clinique / Essais Cliniques Bordeaux, Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Bergonié [Bordeaux], Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Maladies chroniques, santé perçue, et processus d'adaptation. Approches épidémiologiques et psychologiques. ( APEMAC - EA 4360 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Université de Lorraine ( UL ), Institut de Cancérologie de Lorraine - Alexis Vautrin ( ICL ), CHU Tenon [APHP], Hôpital Erasme (Bruxelles), Université Paris 13 ( UP13 ) -Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Avicenne, Carl Gustav Carus University ( DRESDEN - CGCU ), Technische Universität Dresden ( TUD ), Institut de cancérologie de l'Ouest - Nantes ( ICO Nantes ), CRLCC Paul Papin-CRLCC René Gauducheau, CRLCC Antoine Lacassagne, Service d'Oncologie Médicale [CHU Saint -Antoine], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Saint-Antoine [APHP], Cooperator Multidisciplinary Oncology Group ( GERCOR ), Assistance Publique - Hôpitaux de Marseille ( APHM ) - Hôpital de la Timone [CHU - APHM] ( TIMONE ), Institut Paoli Calmettes, Agia Olga Hospital [Athènes] ( Konstantopoulio ), Institut Gustave Roussy ( IGR ) -Institut Gustave Roussy ( IGR ), Hôpital Beaujon, Institut Jules Bordet, Lipides - Nutrition - Cancer (U866) ( LNC ), Université de Bourgogne ( UB ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon ( ENSBANA ) -Université de Bourgogne ( UB ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon ( ENSBANA ) -Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ), Université de Bourgogne ( UB ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon ( ENSBANA ), Centre de recherche en épidémiologie et santé des populations ( CESP ), Université de Versailles Saint-Quentin-en-Yvelines ( UVSQ ) -Université Paris-Sud - Paris 11 ( UP11 ) -Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale ( INSERM ), European Organisation for Research and Treatment of Cancer [Bruxelles] ( EORTC ), European Cancer Organisation [Bruxelles] ( ECCO ), Institut Curie, L'Institut hospitalo-universitaire de Strasbourg ( IHU Strasbourg ), Institut National de Recherche en Informatique et en Automatique ( Inria ) -l'Institut de Recherche contre les Cancers de l'Appareil Digestif (IRCAD)-Les Hôpitaux Universitaires de Strasbourg (HUS)-La Fédération des Crédits Mutuels Centre Est (FCMCE)-L'Association pour la Recherche contre le Cancer (ARC)-La société Karl STORZ, Service de gastroenterologie [CHU Georges Pompidou], Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Européen Georges Pompidou [APHP] ( HEGP ), Universiteit van Amsterdam ( UvA ), Institut de recherche en cancérologie de Montpellier ( IRCM ), Université Montpellier 1 ( UM1 ) -CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Montpellier ( UM ), Institut National de la Santé et de la Recherche Médicale ( INSERM ), Institut Bergonié - CRLCC Bordeaux, Universiteit Leiden, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Università degli studi di Verona = University of Verona (UNIVR), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bourgogne (UB)-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon (ENSBANA)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bourgogne (UB)-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon (ENSBANA)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bourgogne (UB)-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon (ENSBANA)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), and CRLCC Val d'Aurelle - Paul Lamarque-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 1 (UM1)

Subjects
Oncology, Cancer Research, Pathology, Delphi Technique, MESH : Randomized Controlled Trials as Topic, MESH: Delphi Technique, MESH : Consensus, law.invention, Clinical trials, 0302 clinical medicine, Pancreatic cancer, Time to event end-point, Consensus, Guidelines, Methodology, Clinical trials, Randomized controlled trial, law, 030212 general & internal medicine, Time to event end-point, Randomized Controlled Trials as Topic, Event (probability theory), MESH: Endpoint Determination, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, 16. Peace & justice, 3. Good health, 030220 oncology & carcinogenesis, MESH : Disease-Free Survival, MESH : Endpoint Determination, MESH: Pancreatic Neoplasms, medicine.medical_specialty, Consensus, Endpoint Determination, Guidelines, Disease-Free Survival, 03 medical and health sciences, Internal medicine, Pancreatic cancer, medicine, Overall survival, Humans, MESH: Consensus, Distributed File System, neoplasms, MESH: Humans, End point, business.industry, MESH : Humans, Methodology, Cancer, medicine.disease, Pancreatic Neoplasms, Clinical trial, MESH: Randomized Controlled Trials as Topic, MESH : Delphi Technique, MESH: Disease-Free Survival, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, MESH : Pancreatic Neoplasms
Abstract

International audience; BACKGROUND:Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer.METHODS:Time-to-event end-points currently used were identified from a literature review of pancreatic RCT trials (2006-2009). Academic research groups were contacted for participation in order to select clinicians and methodologists to participate in the pilot and scoring groups (>30 experts). A consensus was built after 2 rounds of the modified Delphi formal consensus approach with the Rand scoring methodology (range: 1-9).RESULTS:For pancreatic cancer, 14 time to event end-points and 25 distinct event types applied to two settings (detectable disease and/or no detectable disease) were considered relevant and included in the questionnaire sent to 52 selected experts. Thirty experts answered both scoring rounds. A total of 204 events distributed over the 14 end-points were scored. After the first round, consensus was reached for 25 items; after the second consensus was reached for 156 items; and after the face-to-face meeting for 203 items.CONCLUSION:The formal consensus approach reached the elaboration of guidelines for standardised definitions of time-to-event end-points allowing cross-comparison of RCTs in pancreatic cancer.

Published
2014
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2. 18F-FLT and 18F-FDG positron emission tomography for the imaging of advanced well-differentiated gastro-entero-pancreatic endocrine tumours

Author

Francesco Giammarile, Valérie Hervieu, Didier Le Bars, Jean-Philippe Vuillez, Catherine Lombard-Bohas, Jean-Yves Scoazec, Catherine Cornu, Claire Houzard, Françoise Borson-Chazot, Claire Bournaud, Sandrine Masson, Thomas Walter, Marc Janier, Claire Billotey, Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Laboratoire de Physico-Chimie des Matériaux Luminescents (LPCML), Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, E04, Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Etude et de Recherche Multimodal Et Pluridisciplinaire en imagerie du vivant (CERMEP - imagerie du vivant), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-CHU Grenoble-Hospices Civils de Lyon (HCL)-CHU Saint-Etienne-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), DOCOMO Euro-Labs, DOCOMO Communications Laboratories Europe GmbH-DOCOMO Communications Laboratories Europe GmbH-Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Université de Lyon, Laboratoire Central d'Anatomie et de Cytologie Pathologiques [Hôpital Edouard Herriot - HCL], Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL)-Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL)-Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Radiopharmaceutiques biocliniques, Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM), Evaluation et modélisation des effets thérapeutiques, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), CIC CHU Lyon (inserm), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherche en Acquisition et Traitement de l'Image pour la Santé (CREATIS), Université Jean Monnet [Saint-Étienne] (UJM)-Hospices Civils de Lyon (HCL)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Lyon Sud [CHU - HCL] ( CHLS ), Hospices Civils de Lyon ( HCL ), Laboratoire de Physico-Chimie des Matériaux Luminescents ( LPCML ), Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique ( CNRS ), Centre de Recherche en Cancérologie de Lyon ( CRCL ), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ) -Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Centre d'Exploration et de Recherche Médicales par Émission de Positons ( CERMEP ), Université Joseph Fourier - Grenoble 1 ( UJF ) -Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-CHU Grenoble-Hospices Civils de Lyon ( HCL ) -CHU Saint-Etienne-Université Jean Monnet [Saint-Étienne] ( UJM ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), DOCOMO Communications Laboratories Europe GmbH-DOCOMO Communications Laboratories Europe GmbH-Centre de Recherche en Cancérologie de Lyon ( CRCL ), Hospices Civils de Lyon ( HCL ) -Hospices Civils de Lyon ( HCL ) -Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon ( HCL ) -Hospices Civils de Lyon ( HCL ) -Centre de Recherche en Cancérologie de Lyon ( CRCL ), Université Joseph Fourier - Grenoble 1 ( UJF ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Laboratoire de Biométrie et Biologie Evolutive ( LBBE ), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique ( Inria ) -Centre National de la Recherche Scientifique ( CNRS ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Centre de Recherche en Acquisition et Traitement de l'Image pour la Santé ( CREATIS ), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon ( INSA Lyon ), Université de Lyon-Institut National des Sciences Appliquées ( INSA ) -Institut National des Sciences Appliquées ( INSA ) -Hospices Civils de Lyon ( HCL ) -Université Jean Monnet [Saint-Étienne] ( UJM ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-CHU Grenoble-Hospices Civils de Lyon (HCL)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), and Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Male, MESH : Aged, Neuroendocrine tumors, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, 030218 nuclear medicine & medical imaging, 0302 clinical medicine, MESH: Fluorodeoxyglucose F18, MESH : Intestinal Neoplasms, MESH : Stomach Neoplasms, MESH : Neoplasm Staging, MESH : Female, Prospective cohort study, MESH: Aged, MESH: Middle Aged, medicine.diagnostic_test, Ultrasound, MESH : Neuroendocrine Tumors, Cell Differentiation, MESH: Stomach Neoplasms, MESH: Neoplasm Staging, General Medicine, MESH : Adult, Middle Aged, MESH: Positron-Emission Tomography, 3. Good health, Neuroendocrine Tumors, MESH: Dideoxynucleosides, Positron emission tomography, 030220 oncology & carcinogenesis, MESH : Dideoxynucleosides, Female, MESH: Pancreatic Neoplasms, Radiology, MESH : Cell Differentiation, Preclinical imaging, MESH: Cell Differentiation, Adult, medicine.medical_specialty, MESH: Neuroendocrine Tumors, MESH : Male, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, Fluorodeoxyglucose F18, Stomach Neoplasms, Intestinal Neoplasms, Brain positron emission tomography, medicine, Humans, Endocrine system, MESH : Middle Aged, Radiology, Nuclear Medicine and imaging, MESH: Intestinal Neoplasms, Aged, Neoplasm Staging, MESH: Humans, business.industry, MESH : Humans, MESH : Positron-Emission Tomography, MESH: Adult, MESH : Fluorodeoxyglucose F18, medicine.disease, MESH: Male, Dideoxynucleosides, Pancreatic Neoplasms, Positron-Emission Tomography, business, MESH: Female, MESH : Pancreatic Neoplasms, Progressive disease
Abstract

International audience; PURPOSE: Gastro-entero-pancreatic (GEP) endocrine tumours are a heterogenous group of tumours of variable localization and prognosis. It has been suggested that positron emission tomography (PET) using 2-[18F]fluoro-2-deoxy-D-glucose (18F-FDG) may have a prognostic value and help to identify patients at risk of progression. [18F]fluoro-3'-deoxy-3'-L-fluorothymidine (18F-FLT) has been recently developed as a PET proliferation tracer. At present, there are no studies investigating its role in GEP. The aim of this prospective study was to assess the value of 18F-FLT-PET for the evaluation of GEP. MATERIALS AND METHODS: Ten patients with biopsy-proven locally advanced or metastasized, well-differentiated GEP neuroendocrine tumours were prospectively enrolled and scheduled for 18F-FDG and 18F-FLT-PET. Images were compared with other conventional diagnostic procedures, namely computed tomography, ultrasound, somatostatin receptor scintigraphy and with clinical and diagnostic follow-up. RESULTS: Evaluation criteria were interpreted in terms of assumed presence of tumoral tissue. According to the patient's status, FDG was positive in five out of the seven patients with stable disease and in two out of the three patients with progressive disease. No positive case was identified by 18F-FLT in either the primary or the metastatic tumour site, whatever the status of patients, and this was probably a reflection of the slow proliferation rate of tumours. CONCLUSION: These preliminary data suggest that 18F-FLT-PET is not a suitable tracer for the evaluation of advanced well-differentiated GEP tumours. FDG showed good diagnostic performance but does not help to identify patients at risk of progression.

Published
2011
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3. Applying the Longitudinal Model from Item Response Theory to Assess Health-Related Quality of Life in the PRODIGE 4/ACCORD 11 Randomized Trial

Author

Beata Juzyna, Sophie Gourgou-Bourgade, Antoine Barbieri, Amélie Anota, Christian Lavergne, Franck Bonnetain, Thierry Conroy, Caroline Bascoul-Mollevi, Institut de recherche en cancérologie de Montpellier ( IRCM ), Université Montpellier 1 ( UM1 ) -CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Montpellier ( UM ), Institut Montpelliérain Alexander Grothendieck ( IMAG ), Université de Montpellier ( UM ) -Centre National de la Recherche Scientifique ( CNRS ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Plateforme Nationale Qualité de vie et Cancer, Institut de Cancérologie de Lorraine - Alexis Vautrin ( ICL ), Maladies chroniques, santé perçue, et processus d'adaptation. Approches épidémiologiques et psychologiques. ( APEMAC - EA 4360 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Université de Lorraine ( UL ), UNICANCER, Université Paul-Valéry - Montpellier 3 ( UM3 ), Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Institut Montpelliérain Alexander Grothendieck (IMAG), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), Université Paul-Valéry - Montpellier 3 (UPVM), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)

Subjects
Male, FOLFIRINOX, MESH : Antineoplastic Combined Chemotherapy Protocols, MESH : Aged, computer.software_genre, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Item response theory, Antineoplastic Combined Chemotherapy Protocols, Medicine, MESH : Female, 030212 general & internal medicine, Longitudinal Studies, Neoplasm Metastasis, MESH: Longitudinal Studies, MESH: Aged, MESH : Longitudinal Studies, MESH: Middle Aged, Health Policy, Contrast (statistics), [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, Middle Aged, MESH : Adult, humanities, 3. Good health, health-related quality of life, MESH: Antineoplastic Combined Chemotherapy Protocols, 030220 oncology & carcinogenesis, MESH : Neoplasm Metastasis, Female, Data mining, MESH: Pancreatic Neoplasms, Adult, medicine.medical_specialty, MESH : Male, Latent variable, Generalized linear mixed model, 03 medical and health sciences, Covariate, Humans, MESH : Middle Aged, Aged, MESH: Humans, business.industry, MESH : Humans, MESH: Quality of Life, item response theory, Polytomous Rasch model, MESH: Adult, EORTC QLQ-C30, longitudinal analysis, MESH : Quality of Life, MESH: Neoplasm Metastasis, MESH: Male, Pancreatic Neoplasms, generalized linear mixed model, Physical therapy, Quality of Life, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, computer, MESH: Female, MESH : Pancreatic Neoplasms
Abstract

Introduction. A new longitudinal statistical approach was compared to the classical methods currently used to analyze health-related quality-of-life (HRQoL) data. The comparison was made using data in patients with metastatic pancreatic cancer. Methods. Three hundred forty-two patients from the PRODIGE4/ACCORD 11 study were randomly assigned to FOLFIRINOX versus gemcitabine regimens. HRQoL was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. The classical analysis uses a linear mixed model (LMM), considering an HRQoL score as a good representation of the true value of the HRQoL, following EORTC recommendations. In contrast, built on the item response theory (IRT), our approach considered HRQoL as a latent variable directly estimated from the raw data. For polytomous items, we extended the partial credit model to a longitudinal analysis (longitudinal partial credit model [LPCM]), thereby modeling the latent trait as a function of time and other covariates. Results. Both models gave the same conclusions on 11 of 15 HRQoL dimensions. HRQoL evolution was similar between the 2 treatment arms, except for the symptoms of pain. Indeed, regarding the LPCM, pain perception was significantly less important in the FOLFIRINOX arm than in the gemcitabine arm. For most of the scales, HRQoL changes over time, and no difference was found between treatments in terms of HRQoL. Discussion. The use of LMM to study the HRQoL score does not seem appropriate. It is an easy-to-use model, but the basic statistical assumptions do not check. Our IRT model may be more complex but shows the same qualities and gives similar results. It has the additional advantage of being more precise and suitable because of its direct use of raw data.

Published
2015
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4. Cancer of the pancreas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Author

J.-L. Van Laethem, Dirk Arnold, Thomas Seufferlein, Caroline Caramella, A. Sa. Cuhna, Antoine Hollebecque, Michel Ducreux, Thierry Conroy, Diane Goéré, Karin Haustermans, Pascal Burtin, Université Paris-Sud 11 - Faculté de médecine ( UP11 UFR Médecine ), Oncologie digestive, Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy ( IGR ) -Institut Gustave Roussy ( IGR ), Hôpital Paul Brousse, Université Paris-Sud - Paris 11 ( UP11 ) -Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Paul Brousse, Imagerie diagnostique (radiologie / échographie), Département d'imagerie médicale [Gustave Roussy], Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy] ( DITEP ), Institut Gustave Roussy ( IGR ), Département de chirurgie générale [Gustave Roussy], Universitätsklinikum Ulm, University Hospitals Leuven [Leuven], Hôpital Erasme (Bruxelles), Institut de Cancérologie de Lorraine - Alexis Vautrin ( ICL ), Maladies chroniques, santé perçue, et processus d'adaptation. Approches épidémiologiques et psychologiques. ( APEMAC - EA 4360 ), Université de Lorraine ( UL ) -Université Paris Descartes - Paris 5 ( UPD5 ), Cervantes A, Pentheroudakis G, Pavlidis N, Stahel RA, Cardoso F, Senkus-Konefka E, Arnold D, Horwich A, Sessa C, Colombo N, Licitra L, Buske C, Ladetto M, Peters S, Blay JY, Keilholz U, Strasser F, Hassan AA, Herrstedt J, McGregor KH, Bramley C, Lamarre J, Wallace M, Galli A, Je S., Université Paris-Sud 11 - Faculté de médecine (UP11 UFR Médecine), Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Paul Brousse, Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy] (DITEP), Institut Gustave Roussy (IGR), Universitätsklinikum Ulm - University Hospital of Ulm, Institut de Cancérologie de Lorraine - Alexis Vautrin (ICL), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), Université Paris-Sud - Paris 11 - Faculté de médecine (UP11 UFR Médecine), Université Paris-Sud - Paris 11 (UP11), Hôpital Paul Brousse-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11), Hôpital Erasme [Bruxelles] (ULB), Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), and UNICANCER

Subjects
Oncology, medicine.medical_specialty, MESH: Combined Modality Therapy, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Pancreatic cancer, medicine, MESH : Pancreas, ComputingMilieux_MISCELLANEOUS, MESH: Humans, business.industry, General surgery, MESH : Humans, Cancer, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, Hematology, MESH: Pancreas, medicine.disease, Chemotherapy regimen, 3. Good health, Clinical Practice, medicine.anatomical_structure, Diagnosis treatment, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, MESH: Pancreatic Neoplasms, Pancreas, business, MESH : Combined Modality Therapy, MESH : Pancreatic Neoplasms
Abstract

International audience

Published
2015
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5. Gender-related differences in MEN1 lesion occurrence and diagnosis: a cohort study of 734 cases from the Groupe d'etude des Tumeurs Endocrines

Author

Guillaume Cadiot, Gérard Chabrier, Pierre Goudet, Catherine Cardot-Bauters, I. Guilhem, Claire Bonithon-Kopp, Philippe Bouchard, Olivier Chabre, Bruno Vergès, Françoise Borson-Chazot, Albert Beckers, Patricia Niccoli, P. Caron, Philippe Ruszniewski, A. Tabarin, H. Du Boullay, Fabrice Menegaux, Arnaud Murat, Centre d'épidémiologie des populations ( CEP ), Université de Bourgogne ( UB ) -Centre Régional de Lutte contre le cancer - Centre Georges-François Leclerc ( CRLCC - CGFL ), centre hospitalier universitaire de Nantes ( CHU Nantes ), Clinique d'endocrinologie, Service de gastro-entérologie et assistance nutritive, Assistance publique - Hôpitaux de Paris (AP-HP)-Université Paris Diderot - Paris 7 ( UPD7 ) -Hôpital Beaujon, Hôpital de la Timone [CHU - APHM] ( TIMONE ), Epidémiologie environnementale des cancers, Université Paris-Sud - Paris 11 ( UP11 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Centre de Recherche Astrophysique de Lyon ( CRAL ), École normale supérieure - Lyon ( ENS Lyon ) -Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Institut national des sciences de l'Univers ( INSU - CNRS ) -Centre National de la Recherche Scientifique ( CNRS ), Centre de Recherche en Cancérologie de Lyon ( CRCL ), Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Centre Léon Bérard [Lyon]-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], CHU Saint-Antoine [APHP], Hôpital Robert Debré, Service d'Hépato-gastroentérologie, 51092 Reims, France, affiliation inconnue, centre hospitalier universitaire de liège, Service d'endocrinologie clinique, ONERA - The French Aerospace Lab ( Palaiseau ), ONERA, Centre d'épidémiologie des populations (CEP), Université de Bourgogne (UB)-Centre Régional de Lutte contre le cancer - Centre Georges-François Leclerc (CRLCC - CGFL), centre hospitalier universitaire de Nantes (CHU Nantes), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon, Hôpital de la Timone [CHU - APHM] (TIMONE), Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherche Astrophysique de Lyon (CRAL), École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut national des sciences de l'Univers (INSU - CNRS)-Centre National de la Recherche Scientifique (CNRS), Centre de Recherche en Cancérologie de Lyon (CRCL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre Léon Bérard [Lyon]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), ONERA - The French Aerospace Lab [Palaiseau], Université de Bourgogne (UB)-Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER-UNICANCER, Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut national des sciences de l'Univers (INSU - CNRS), Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), ONERA-Université Paris Saclay (COmUE), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)

Subjects
Male, endocrine system diseases, MESH : Prevalence, Endocrinology, Diabetes and Metabolism, MESH : Thymus Neoplasms, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, Cohort Studies, 0302 clinical medicine, Endocrinology, Prevalence, MESH : Female, Family history, Multiple endocrine neoplasia, MESH: Cohort Studies, MESH: Middle Aged, General Medicine, Middle Aged, MESH : Adult, MESH : Pituitary Neoplasms, 030220 oncology & carcinogenesis, Female, France, MESH: Pancreatic Neoplasms, medicine.symptom, MESH : Multiple Endocrine Neoplasia Type 1, MESH: Thymus Neoplasms, Cohort study, Adult, medicine.medical_specialty, congenital, hereditary, and neonatal diseases and abnormalities, endocrine system, MESH : Sex Factors, MESH : Male, MESH: Multiple Endocrine Neoplasia Type 1, MESH : Cohort Studies, [SDV.CAN]Life Sciences [q-bio]/Cancer, 030209 endocrinology & metabolism, Context (language use), Lesion, 03 medical and health sciences, Sex Factors, MESH: Sex Factors, Internal medicine, Multiple Endocrine Neoplasia Type 1, medicine, Humans, Pituitary Neoplasms, MEN1, MESH : Middle Aged, MESH: Pituitary Neoplasms, MESH : France, MESH: Prevalence, Hyperparathyroidism, MESH: Humans, business.industry, Pituitary tumors, MESH : Humans, MESH: Adult, Thymus Neoplasms, MESH : Gastrinoma, medicine.disease, MESH: Male, Pancreatic Neoplasms, MESH: France, Gastrinoma, MESH: Gastrinoma, business, MESH: Female, MESH : Pancreatic Neoplasms
Abstract

ContextMultiple endocrine neoplasia type 1 (MEN1) disease is an autosomal dominant syndrome that is believed to equally affect men and women. This assumption has never been confirmed.ObjectiveThe aims of this study were to evaluate the impact of gender on the prevalence of MEN1 lesions, on their lifetime probability of occurrence, and on the diagnosis of MEN1.DesignData regarding a study of 734 cases of MEN1 from the multicenter ‘Groupe d'étude des Tumeurs Endocrines’ were analyzed.ResultsThere were 57.8% females. The prevalence and probability of pancreatic tumors were higher in males than in females (P=0.06, P=0.0004). This difference was due to gastrinomas. The prevalence and probability of developing pituitary tumors were significantly greater in females (PPP=0.02). In the case of pituitary tumor, the proportion of patients diagnosed with MEN1 at the time of the first lesion was lower in women (44.2%) than in men (67.3%).ConclusionThe phenotype expression of the MEN1 disease gene was different in males and females. In female patients, the possibility of MEN1 is not sufficiently taken into account. Any patient presenting a lesion that belongs to the MEN1 spectrum, such as a pituitary tumor, should be closely questioned about their family history and should be tested for hypercalcemia.

Published
2011
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6. Locally advanced unresectable pancreatic cancer: Induction chemoradiotherapy followed by maintenance gemcitabine versus gemcitabine alone: Definitive results of the 2000-2001 FFCD/SFRO phase III trial

Author

Barhoumi , M., Mornex , F., Bonnetain , Franck, Rougier , P., Mariette , C., Bouché , O., Bosset , J.-F., Aparicio , T., Mineur , L., Azzedine , A., Hammel , P., Butel , J., Stremsdoerfer , N., Maingon , P., Bedenne , L., Chauffert , B., Matrice extracellulaire et dynamique cellulaire - UMR 7369 (MEDyC), Université de Reims Champagne-Ardenne (URCA)-SFR CAP Santé (Champagne-Ardenne Picardie Santé), Université de Reims Champagne-Ardenne (URCA)-Université de Picardie Jules Verne (UPJV)-Université de Reims Champagne-Ardenne (URCA)-Université de Picardie Jules Verne (UPJV)-Centre National de la Recherche Scientifique (CNRS), Laboratoire d'Epidémiologie et d'Ecologie parasitaire, Institut Pasteur de Tunis, Institut Pasteur de Tunis, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP), Grand Accélérateur National d'Ions Lourds (GANIL), Centre National de la Recherche Scientifique (CNRS)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institut Pasteur de Tunis-Réseau International des Instituts Pasteur ( RIIP ), Grand Accélérateur National d'Ions Lourds ( GANIL ), Commissariat à l'énergie atomique et aux énergies alternatives ( CEA ) -Institut National de Physique Nucléaire et de Physique des Particules du CNRS ( IN2P3 ) -Centre National de la Recherche Scientifique ( CNRS ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), and Maquart, François-Xavier

Subjects
Male, MESH : Hematologic Diseases, MESH: Remission Induction, MESH: Combined Modality Therapy, Gastrointestinal Diseases, MESH : Antineoplastic Combined Chemotherapy Protocols, MESH : Aged, Kaplan-Meier Estimate, MESH : Gastrointestinal Diseases, Deoxycytidine, MESH : Radiotherapy, Conformal, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, MESH: Proportional Hazards Models, MESH: Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, MESH : Female, ComputingMilieux_MISCELLANEOUS, Aged, 80 and over, MESH: Aged, MESH : Carcinoma, Pancreatic Ductal, MESH: Antimetabolites, Antineoplastic, MESH: Middle Aged, MESH : Antimetabolites, Antineoplastic, Remission Induction, Middle Aged, MESH : Adult, MESH: Hematologic Diseases, Combined Modality Therapy, MESH: Antineoplastic Combined Chemotherapy Protocols, MESH: Radiotherapy, Conformal, Disease Progression, MESH : Fluorouracil, Female, MESH: Disease Progression, Fluorouracil, MESH: Pancreatic Neoplasms, Carcinoma, Pancreatic Ductal, Adult, Antimetabolites, Antineoplastic, MESH : Male, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH : Cisplatin, MESH : Kaplan-Meier Estimate, MESH : Deoxycytidine, Humans, MESH : Middle Aged, MESH : Aged, 80 and over, MESH: Gastrointestinal Diseases, MESH: Kaplan-Meier Estimate, Aged, Proportional Hazards Models, MESH : Remission Induction, MESH: Humans, MESH: Carcinoma, Pancreatic Ductal, MESH : Humans, MESH: Deoxycytidine, MESH: Adult, MESH : Disease Progression, MESH : Proportional Hazards Models, Hematologic Diseases, Gemcitabine, MESH: Male, Pancreatic Neoplasms, MESH: Cisplatin, Cisplatin, Radiotherapy, Conformal, MESH : Combined Modality Therapy, MESH: Female, MESH: Fluorouracil, MESH : Pancreatic Neoplasms
Abstract

International audience; PURPOSE: To compare chemoradiation with systemic chemotherapy to chemotherapy alone in locally advanced pancreatic cancer. PATIENTS AND METHODS: One hundred and nineteen patients with locally advanced pancreatic cancer, with World Health Organization performance status of zero to two were randomly assigned to either the induction chemoradiation group (60 Gy, 2 Gy/fraction; concomitant 5-fluoro-uracil infusion, 300 mg/m(2) per day, days 1-5 for 6 weeks; cisplatin, 20 mg/m(2) per day, days 1-5 during weeks 1 and 5) or the induction gemcitabine group (GEM: 1000 mg/m(2) weekly for 7 weeks). Maintenance gemcitabine (1000 mg/m(2) weekly, 3/4 weeks) was given in both arms until disease progression or toxicity. RESULTS: Overall survival was shorter in the chemoradiation than in the gemcitabine arm (median survival 8.6 [99% confidence interval 7.1-11.4] and 13 months [8,9,9-18], p=0.03). One-year survival was, respectively, 32 and 53%. These results were confirmed in a per-protocol analysis for patients who received 75% or more of the planned dose of radiotherapy. More overall grades 3-4 toxic effects were recorded in the chemoradiation arm, both during induction (36 versus 22%) and maintenance (32 versus 18%). CONCLUSION: This intensive induction schedule of chemoradiation was more toxic and less effective than gemcitabine alone.

Published
2011
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7. Well-differentiated pancreatic islet cell carcinoma: Is there reversibility in mTOR inhibitor resistance?

Author

Jean-Yves Scoazec, Julien Forestier, Jean-Alain Chayvialle, Catherine Lombard-Bohas, Christophe Couderc, Thomas Walter, Colette Roche, DOCOMO Euro-Labs, DOCOMO Communications Laboratories Europe GmbH, Centre de Recherche en Cancérologie de Lyon ( CRCL ), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Laboratoire Central d'Anatomie et de Cytologie Pathologiques [Hôpital Edouard Herriot - HCL], Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon ( HCL ) -Hospices Civils de Lyon ( HCL ), Hospices Civils de Lyon ( HCL ), Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), and Hospices Civils de Lyon (HCL)

Subjects
MESH : Carcinoma, Islet Cell, MESH : Antineoplastic Combined Chemotherapy Protocols, medicine.medical_treatment, Lanreotide, Gastroenterology, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, chemistry.chemical_compound, 0302 clinical medicine, Pancreatic tumor, MESH: Protein Kinase Inhibitors, MESH : Neoplasm Staging, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, MESH: Middle Aged, medicine.diagnostic_test, Sunitinib, MESH: Neoplasm Staging, Hematology, General Medicine, MESH: Drug Resistance, Neoplasm, 3. Good health, Portal vein thrombosis, MESH: Antineoplastic Combined Chemotherapy Protocols, MESH : Drug Resistance, Neoplasm, Oncology, 030220 oncology & carcinogenesis, MESH : TOR Serine-Threonine Kinases, MESH: Pancreatic Neoplasms, MESH : Cell Differentiation, medicine.drug, MESH: Cell Differentiation, medicine.medical_specialty, MESH : Male, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, Internal medicine, Biopsy, medicine, Carcinoma, Radiology, Nuclear Medicine and imaging, MESH : Middle Aged, MESH: TOR Serine-Threonine Kinases, Chemotherapy, MESH: Humans, Everolimus, business.industry, MESH : Humans, medicine.disease, MESH : Protein Kinase Inhibitors, MESH: Male, Surgery, chemistry, MESH: Carcinoma, Islet Cell, business, MESH : Pancreatic Neoplasms
Abstract

In 2000, a 48-year-old man presented with epigastralgia. Computed tomography scan revealed a hypervascular pancreatic tumor with multiple liver and mediastinal lymph node metastases. The diagnosis of metastatic well-differentiated pancreatic islet cell carcinoma (pNET) was made by biopsy of the liver lesions. The mitotic index was 3/10 HPF (x40); Ki67 index was 5%. Serum levels of digestive hormones were within normal limits and chromogranin A levels was 220 μg/l. Octreotide scintigraphy showed high-grade activity in liver and mediastinal metastases. The patient was successively treated with chemotherapy (six cycles of streptozotocin-doxorubicin); surgery (cephalic duo-denopancreatectomy in March 2002, due to the local risk of compression and presence segmental portal hypertension); without any treatment and stable disease until February 2004; alpha-interferon for 15 months; chemotherapy (ten cycles of Folfi ri); and everolimus in December 2006 (RADIANT 1 trial). The treatment resulted in a decrease in tumor size (34% using RECIST criteria) at four months; the dis-ease was controlled for 24 months. Because of occur-rence of two new liver metastases, the patient was then included in a phase 3 trial and received sunitinib throughout 12 months; sunitinib was stopped because of occurrence of portal vein thrombosis under enox-aparin; the disease was stable. The patient was then treated with lanreotide in order to maintain disease stabilization; however, new progression ( after a break in treatment or maybe induced by 10% among RECIST criteria and elevation of Chromogranin A from 1982 to 2932 μg/l) occurred three months later. In June 2010, as the patient refused cytotoxic chemo-therapy and because of the particular initial good response to the everolimus, it was decided to add everolimus in association with lanreotide. Three months after starting the treatment, the weight of the patient had increased by 3 kg, fatigue had disappeared and imaging studies showed a response of 23% on RECIST criteria. His disease remains stable six months after this combination started. To our knowledge, this is the fi rst case showing a second effi cacy of mTOR inhibitor for treatment of solid advanced cancer. It enables us to discuss the reversibility of resistance mechanisms of evero-limus, and potential interest of a combined therapy with somatostatin analogs. It has recently been shown that, in patients with pNET, sunitinib or everolimus signifi cantly increase progression-free survival [1,2]. However, even if a control of the disease is frequently achieved, objective responses, such as the one observed in our case, are rare. How can we explain the second effi cacy of everolimus in combination with somatostatin analogs 18 months after the end of the fi rst treatment, as reported here? Some hypotheses may be discussed: a) syner-getic antitumor effect between everolimus and somatostatin analogs; b) emergence of a predomi-nant tumor cell clone, responding to everolimus

Published
2011
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8. Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000-01 FFCD/SFRO study

Author

Ph. Rougier, Thomas Aparicio, Christophe Mariette, F. Mornex, J.-F. Bosset, O. Bouche, Franck Bonnetain, Laurent Mineur, A. Azzedine, Pascal Hammel, Bruno Chauffert, N. Stremsdoerfer, J. Butel, Philippe Maingon, Laurent Bedenne, Lipides - Nutrition - Cancer (U866) ( LNC ), Université de Bourgogne ( UB ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon ( ENSBANA ), Grand Accélérateur National d'Ions Lourds ( GANIL ), Commissariat à l'énergie atomique et aux énergies alternatives ( CEA ) -Institut National de Physique Nucléaire et de Physique des Particules du CNRS ( IN2P3 ) -Centre National de la Recherche Scientifique ( CNRS ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Lipides - Nutrition - Cancer (U866) (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon (ENSBANA), Grand Accélérateur National d'Ions Lourds (GANIL), Centre National de la Recherche Scientifique (CNRS)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Matrice extracellulaire et dynamique cellulaire - UMR 7369 (MEDyC), Université de Reims Champagne-Ardenne (URCA)-SFR CAP Santé (Champagne-Ardenne Picardie Santé), and Université de Reims Champagne-Ardenne (URCA)-Université de Picardie Jules Verne (UPJV)-Université de Reims Champagne-Ardenne (URCA)-Université de Picardie Jules Verne (UPJV)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Male, MESH: Remission Induction, MESH : Antineoplastic Combined Chemotherapy Protocols, medicine.medical_treatment, MESH : Aged, MESH: Risk Assessment, Deoxycytidine, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, MESH : Neoplasm Staging, ComputingMilieux_MISCELLANEOUS, MESH: Treatment Outcome, MESH: Middle Aged, Biopsy, Needle, Remission Induction, MESH : Infusions, Intravenous, MESH : Chemotherapy, Adjuvant, MESH: Follow-Up Studies, Immunohistochemistry, 3. Good health, MESH: Antineoplastic Combined Chemotherapy Protocols, Oncology, Fluorouracil, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, medicine.medical_specialty, MESH: Radiotherapy, Adjuvant, MESH: Probability, MESH : Drug Administration Schedule, Urology, MESH: Drug Administration Schedule, Antimetabolite, Risk Assessment, Drug Administration Schedule, MESH : Radiotherapy, Adjuvant, MESH : Cisplatin, 03 medical and health sciences, Humans, MESH : Middle Aged, Aged, MESH: Humans, Dose-Response Relationship, Drug, MESH: Deoxycytidine, MESH : Humans, MESH: Adult, MESH : Follow-Up Studies, Survival Analysis, Pancreatic Neoplasms, Concomitant, Cisplatin, MESH: Female, MESH: Fluorouracil, MESH : Pancreatic Neoplasms, MESH: Combined Modality Therapy, MESH : Immunohistochemistry, MESH : Dose-Response Relationship, Drug, MESH : Biopsy, Needle, MESH : Neoplasm Invasiveness, MESH: Dose-Response Relationship, Drug, MESH : Female, MESH : Risk Assessment, MESH: Radiotherapy Dosage, Infusions, Intravenous, MESH: Aged, MESH : Radiotherapy Dosage, Radiotherapy Dosage, Hematology, MESH: Neoplasm Staging, Middle Aged, MESH : Adult, Chemotherapy regimen, Combined Modality Therapy, Treatment Outcome, MESH: Chemotherapy, Adjuvant, Chemotherapy, Adjuvant, MESH: Survival Analysis, MESH : Fluorouracil, Female, MESH: Pancreatic Neoplasms, medicine.drug, Adult, MESH: Biopsy, Needle, medicine.drug_class, MESH : Male, MESH : Probability, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH : Treatment Outcome, MESH : Deoxycytidine, medicine, Neoplasm Invasiveness, MESH: Infusions, Intravenous, Neoplasm Staging, Probability, Chemotherapy, MESH : Remission Induction, Performance status, business.industry, MESH: Immunohistochemistry, MESH: Neoplasm Invasiveness, Gemcitabine, MESH: Male, Surgery, MESH: Cisplatin, Radiotherapy, Adjuvant, MESH : Survival Analysis, business, MESH : Combined Modality Therapy, Chemoradiotherapy, Follow-Up Studies
Abstract

International audience; BACKGROUND: The role of chemoradiation with systemic chemotherapy compared with chemotherapy alone in locally advanced pancreatic cancer (LAPC) is uncertain. PATIENTS AND METHODS: One hundred and nineteen patients with LAPC, World Health Organization performance status of zero to two were randomly assigned to either the induction CHRT group (60 Gy, 2 Gy/fraction; concomitant 5-fluorouracil infusion, 300 mg/m(2)/day, days 1-5 for 6 weeks; cisplatin, 20 mg/m(2)/day, days 1-5 during weeks 1 and 5) or the induction gemcitabine group (GEM: 1000 mg/m(2) weekly for 7 weeks). Maintenance gemcitabine (1000 mg/m(2) weekly, 3/4 weeks) was given in both arms until disease progression or toxicity. RESULTS: Overall survival was shorter in the CHRT than in GEM arm [median survival 8.6 (99% confidence interval 7.1-11.4) and 13 months (8.7-18.1), P = 0.03]. One-year survival was, respectively, 32% and 53%. These results were confirmed in a per-protocol analysis for patients who received 75% or more of the planned dose of radiotherapy. More overall grades 3-4 toxic effects were recorded in the CHRT arm, both during induction (36 versus 22%) and maintenance (32 versus 18%). CONCLUSION: This intensive induction schedule of CHRT was more toxic and less effective than gemcitabine alone.

Published
2008
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9. Lessons from Tarceva in pancreatic cancer: where are we now, and how should future trials be designed in pancreatic cancer?

Author

Julien Taieb, Pierre Laurent-Puig, Bases moléculaires de la réponse aux xénobiotiques (U775 (IFR95)), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Bases moléculaires de la réponse aux xénobiotiques ( U775 (IFR95) ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), and Hôpital Européen Georges Pompidou [APHP] ( HEGP )

Subjects
Cancer Research, MESH: Clinical Trials as Topic, medicine.medical_treatment, MESH: Receptor, Epidermal Growth Factor, Targeted therapy, 03 medical and health sciences, Erlotinib Hydrochloride, 0302 clinical medicine, MESH : Quinazolines, MESH : Receptor, Epidermal Growth Factor, Pancreatic cancer, medicine, MESH: Protein Kinase Inhibitors, Humans, [SDV.BBM]Life Sciences [q-bio]/Biochemistry, Molecular Biology, [ SDV.BBM ] Life Sciences [q-bio]/Biochemistry, Molecular Biology, Protein Kinase Inhibitors, 030304 developmental biology, 0303 health sciences, Clinical Trials as Topic, MESH: Humans, business.industry, MESH : Humans, MESH: Research Design, MESH : Protein Kinase Inhibitors, MESH : Research Design, medicine.disease, 3. Good health, MESH : Clinical Trials as Topic, ErbB Receptors, Pancreatic Neoplasms, MESH: Quinazolines, Oncology, Research Design, 030220 oncology & carcinogenesis, Immunology, Cancer research, Quinazolines, Pancreatic carcinogenesis, MESH: Pancreatic Neoplasms, business, MESH : Pancreatic Neoplasms
Abstract

PURPOSE OF REVIEW: The recent advances in the use of targeted therapy in pancreatic cancer are based on the knowledge of genetic alterations that occur during pancreatic carcinogenesis. We describe the repository of frequent alterations targeting tumour suppressor genes and oncogenes. We focus our attention on the epidermal growth factor receptor signalling pathway, which can be activated through different alterations and seems to play a central role in the cell transformation. Multiple targeted drugs have been developed against different partners of this network trying to improve the treatment of pancreatic cancer patients. RECENT FINDINGS: Tarceva has obtained approval in the USA and Europe for metastatic pancreatic cancer with a modest increase of median survival and a 6% increase in 1-year survival rates, suggesting that only a small fraction of patients truly benefit from it. The comparison with lung and colon cancer suggests that Kras mutations could be a predictive marker of resistance. Other promising drugs targeting different partners of the epidermal growth factor receptor signalling pathway could play a synergistic role with Tarceva as inhibitors of mTOR, mitogen-activated protein kinase kinase 1, and nuclear factor-kappaB or can directly turn down Ras. SUMMARY: The biology of the epidermal growth factor receptor, mitogen-activated protein kinase, PI3K/mTOR network suggests that a combination of drugs targeting simultaneously different partners should improve survival.

Published
2008
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