| Title: |
Oral presentations |
| Authors: |
Bonnetain, Franck; Dousseau, Adelaide; Bert, Bonsing; Bengt, Glimelius; Haustermans, Karin; Conroy, Thierry; Van Laethem, Jean Luc; Labianca, Roberto; Macarulla, Teresa; Tabernero, Josep; Lutz, Manfred; Neoptolemos, John P.; De Gramont, Aimery; Group, Datecan; Collette, Laurence; Richards, Donald; Muscarella, Peter; Bekaii-Saab, Tanios; Wilfong, Lalan; Rosemurgy, Alexander; Ross, Sharona; Raynov, Julian; Flynn, Patrick; Fisher, William; Whiting, Sam; Timcheva, Constanta; Harrell, Frank; Mercaldo, Nathaniel; Kosten, Scott; Speyer, Sue; Richman, Joni; Coeshott, Claire; Cohn, Allen; Ferraro, John; Rodell, Timothy; Apelian, David; Mitchell, Edith; Ocean, Allyson; Guarino, Michael; Pennington, Kenneth; Springett, Gregory; Gold, David; Tanio, Bekaii-saab; Wegener, William; Goldenberg, David; Horne, Heather; Montero, Alberto; Kauh, John; Sung, Max; Shroff, Rachna; Javle, Milind; Varadhachary, Gauri; Wolff, Robert; Fogelman, David; Bhosale, Priya; Wang, Xuemei; Overman, Michael; Sathyanarayanan, Sriram; Ayers, Mark; Mauro, David; Abbruzzese, James; Trouilloud, Isabelle; Dupont-Gossard, Anne Claire; Artru, Pascal; Lecomte, Thierry; Gauthier, Melanie; Aparicio, Thomas; Thirot-Bidault, Anne; Malka, David; Lobry, Celine; Asnacios, Amani; Lacombe, Sophie; Fein, Francine; Dubreuil, Olivier; Zaanan, Aziz; Rougier, Philippe; Taieb, Julien; Van Cutsem, Eric; Nowara, Elzbieta; Ciuleanu, Tudor; Aprile, Giuseppe; Moore, Malcolm; Federowicz, Irena; Hsu, Chiun; Ali, Sajid; Csutor, Zsuzsanna; Meng, Xianhua; Li, Chung-Pin; Ducreux, Michel; Davidenko, Irina; Propper, David; Cardellino, Giovanni Gerardo; Garin, Avgust; Bridgewater, John; Jain, Minesh; Kupcinskas, Limas; Safina, Sufiya; Fittipaldo, Alberto; Bordogna, Walter; Hillenbach, Carina; Klughammer, Barbara; Ryan, D.; Reddy, S.; Bahary, N.; Uronis, H.; Sigal, D.S.; Schelman, W.R.; Chiorean, E.G.; Rosen, P.J.; Ulrich, B.; Dragovich, T.; Del Prete, S.; Rarick, M.; Eng, C.; Kroll, S.; Porta, Camillo; Borbath, Ivan; Rimassa, Lorenza; Daniele, Bruno; Salvagni, Stefania; Van Vlieberghe, Hans; Trojan, Joerg; Kolligs, Frank; Gasbarrini, Antonio; Weiss, Alan; Lencioni, Monica; Abbadessa, Giovanni; Schwartz, Brian; Santoro, Armando; Oliner, Kelly; Tang, Rui; Anderson, Abraham; Lan, Yun; Iveson, Timothy; Donehower, Ross; Jiang, Yizhou; Dubey, Sarita; Loh, Elwyn; Hamamoto, Yasuo; Lee, Jeeyun; Ohtsu, Atsushi; Qin, Shukui; Price, Timothy; Xu, Rui-Hua; Song, Eun-Kee; Bi, Feng; Bouché, Olivier; Feliu, Alain; Nesheiwat, Tonia; Delaney, Rosemary; Chen, Joann; Costantini, Chiara; Rizvi, Syed; Sahmoud, Tarek; Doi, Tashiko; Heinemann, Volker; Laubender, Ruediger; Sartorius, Ute; Giessen, Clemens; Graser, Anno; Mansmann, Ulrich; Douillard, Jean-Yves; Peeters, Marc; Rong, Alan; Siena, Salvatore; Braun, Stephan; Sidhu, Roger; Köhne, Claus-Henning; Bokemeyer, Carsten; Schlichting, Michael; Heeger, Steffen; Folprecht, Gunnar; Taïeb, Julien; Maughan, Tim; Brodowicz, Thomas; Esser, Regina; Zemelka, Tomasz; Fountzilas, Georgios; Barone, Carlo; Eggleton, S. Peter; Srimuninnimit, Vichien; Hurwitz, Herbert; Tebbutt, Niall; Kabbinavar, Fairooz; Giantonio, Bruce; Guan, Zhong-Zhen; Mitchell, Lada; Waterkamp, Daniel; Michele-Celle, Boisdron; Capitain, Olivier; Metges, Jean-Philippe; Guerin-Meyer, Véronique; Faroux, Roger; Stampfli, Claire; Matysiak-Budnik, Tamara; Leguellec, Chantal; Gamelin, Erick; Morel, Alain; André, Thierry; Maria, Vieitez Jose; Bennouna, Jaafar; Sastre, Javier; Alonso-Orduna, Vicente; Arnold, Dirk; Österlund, Pia; Greil, Richard; von Moos, Roger; Reyes-Rivera, Irmarie; Makrutzki, Martina; Kubicka, Stefan; Vieitez, Jose Maria; Scherer, Stefan; Bendahmane, Belguendouz; Bendell, Johanna; Ervin, Thomas; Senzer, Neil; Firdaus, Irfan; Lockhart, A. Craig; Saleh, Mansoor; Sportelli, Peter; Gardner, Lesa; Eng, Cathy; Sobrero, Alberto; Grothey, Axel; Falcone, Alfredo; Ychou, Marc; Humblet, Yves; Mineur, Laurent; Adenis, Antoine; Yoshino, Takayuki; Lenz, Heinz Joseph; Goldberg, Richard; Sargent, Daniel; Cihon, Frank; Jeffers, Michael; Wagner, Andrea; Laurent, Dirk; Pericay, Carles; Saunders, Mark; Thomas, Anne; Roh, Jae Kyung; Lopez, Rafael; Höhler, Thomas; Kim, Jun Suk; Zilocchi, Chiara; Boëlle, Emmanuelle; Zalcberg, John; Salazar, Ramon; Rosenberg, Robert; Capdevila, Jaume; Moreno, Victor; Nitsche, Ulrich; Bachleitner-Hofmann, Thomas; Roepman, Paul; Gafa, Roberta; Lanza, Giovanni; Tian, Sun; Simon, Iris; Nickens, Dana; Ioka, Tatsuya; Richel, Dirk; Kim, Sinil; Wasan, Harpreet; Ricart, Alejandro; Pauly, Marc; Metzger, Brigitte; Mahon, Garry; Menzel, Alain; Weber, Bernard; Dicato, Mario; Mini, Enrico; Subtil, Fabien; Van Laethem, Jean-Luc; Thaler, Josef; Sanches, Evaristo; Petersen, Lone Nørgård; Praet, Michel; Girault, Cécile; Schneider, Martina; Squifflet, Pierre; Laurent-Puig, Pierre; Bedenne, Laurent; Lepage, Come; Sinicrope, Frank A.; Mahoney, Michelle R.; Smyrk, Thomas C.; Thibodeau, Stephen N.; Goldberg, Richard M.; Nelson, G.D.; Sargent, Daniel J.; Alberts, Steven R.; Nordlinger, Bernard; Sorbye, Halfdan; Glimelius, Bengt; John Poston, Graeme; Schlag, Peter M.; Bechstein, Wolf; Neil Primrose, John; Walpole, Euan Thomas; Finch-Jones, Meg; Jaeck, Daniel; Mirza, Darius; Parks, Rowan W.; Scheithauer, Werner; Mauer, Murielle E.; Gruenberger, Thomas |
| Publisher Information: |
Oxford University Press |
| Publication Year: |
2012 |
| Collection: |
HighWire Press (Stanford University) |
| Subject Terms: |
abstracts |
| Description: |
Introduction Variability in the definition of survival endpoints in oncology trials was identified. Lack of a formal consensus could cause this, which limits inter-trial comparisons. The DATECAN project aimed at obtaining a formal consensus recommendation for defining survival endpoints for randomized clinical trials (RCTs) in the following cancer sites: pancreas, sarcoma/GISTs, breast, colorectal, gastric/œsophagus, head and neck, kidney-bladder. We report results for pancreatic cancer. Methods Based on a literature review of RCTs (2006-2009), we identified survival endpoints and events currently used. A 2-round modified Delphi method using RAND scoring (range:1-9) was used to reach consensus. Academic research groups were contacted for participation in order to select clinicians and methodologists for Pilot and Scoring groups (>30 experts/localization). Results The Pilot group identified 14 endpoints that needed definition through consensus, such as progression free survival (PFS), time-to-treatment failure, and time to quality of life deterioration. Endpoint definitions were seeked by disease setting (detectable disease vs not). Amongst the 52 European experts contacted, 33 and 30 participated to the 1st and 2nd round respectively. The experts scored a total of 204 events; a consensus was reached for 25 (12%) at the 1st round and 156 (76%) at the 2nd round. As example PFS was defined as time interval between the date of randomization, and the day of first local, regional progression or occurrence of distant metastases (including liver or non-liver metastases) or occurrence of 2nd pancreatic cancer or death (all causes), whichever occurred first. The consensus was finalized during a face-to-face meeting organized during the ESMO 2011 congress and general rules were proposed for final ratification. Conclusion Based on this consensus, a European charter is being finalized and proposed for endorsement to all academic groups in order to harmonize results and to allow formal comparisons of pancreatic RCTs. The ... |
| Document Type: |
text |
| File Description: |
text/html |
| Language: |
English |
| Relation: |
http://annonc.oxfordjournals.org/cgi/content/short/23/suppl_4/iv5; http://dx.doi.org/10.1093/annonc/mds151 |
| DOI: |
10.1093/annonc/mds151 |
| Availability: |
http://annonc.oxfordjournals.org/cgi/content/short/23/suppl_4/iv5; https://doi.org/10.1093/annonc/mds151 |
| Rights: |
Copyright (C) 2012, European Society for Medical Oncology |
| Accession Number: |
edsbas.ACFEE4F6 |
| Database: |
BASE |