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dc.contributor.authorGoldberg, Richard M.-
dc.contributor.authorAdams, Richard-
dc.contributor.authorBUYSE, Marc-
dc.contributor.authorEng, Cathy-
dc.contributor.authorGrothey, Axel-
dc.contributor.authorAndre, Thierry-
dc.contributor.authorSobrero, Alberto F.-
dc.contributor.authorLichtman, Stuart M.-
dc.contributor.authorBenson, Al B.-
dc.contributor.authorPunt, Cornelis J. A.-
dc.contributor.authorMaughan, Tim-
dc.contributor.authorBURZYKOWSKI, Tomasz-
dc.contributor.authorSommeijer, Dirkje-
dc.contributor.authorSaad, Everardo D.-
dc.contributor.authorShi, Qian-
dc.contributor.authorCoart, Elisabeth-
dc.contributor.authorChibaudel, Benoist-
dc.contributor.authorKoopman, Miriam-
dc.contributor.authorSchmoll, Hans-Joachim-
dc.contributor.authorYoshino, Takayuki-
dc.contributor.authorTaieb, Julien-
dc.contributor.authorTebbutt, Niall C.-
dc.contributor.authorZalcberg, John-
dc.contributor.authorTabernero, Josep-
dc.contributor.authorVan Cutsem , Eric-
dc.contributor.authorMatheson, Alastair-
dc.contributor.authorde Gramont, Aimery-
dc.identifier.citationJNCI-Journal of the National Cancer Institute, 114 (6) , p. 819-828-
dc.description.abstractMeta-analysis based on individual participant data (IPD) is a powerful methodology for synthesizing evidence by combining information drawn from multiple trials. Hitherto, its principal application has been in questions of clinical management, but an increasingly important use is in clarifying trials methodology, for instance in the selection of endpoints, as discussed in this review. In oncology, the Aide et Recherche en Cancerologie Digestive (ARCAD) Metastatic Colorectal Cancer Database is a leader in the use of IPD-based meta-analysis in methodological research. The ARCAD database contains IPD from more than 38 000 patients enrolled in 46 studies and continues to collect phase III trial data. Here, we review the principal findings of the ARCAD project in respect of endpoint selection and examine their implications for cancer trials. Analysis of the database has confirmed that progression-free survival (PFS) is no longer a valid surrogate endpoint predictive of overall survival in the first-line treatment of colorectal cancer. Nonetheless, PFS remains an endpoint of choice for most first-line trials in metastatic colorectal cancer and other solid tumors. Only substantial PFS effects are likely to translate into clinically meaningful benefits, and accordingly, we advocate an oncology research model designed to identify highly effective treatments in carefully defined patient groups. We also review the use of the ARCAD database in assessing clinical response including novel response metrics and prognostic markers. These studies demonstrate the value of IPD as a tool for methodological studies and provide a reference point for the expansion of this approach within clinical cancer research.-
dc.description.sponsorshipSL was supported by the US National Cancer Institute Cancer Center Support Grant, award number: P30CA008748. AS was supported by AIRC, grant number IG2018. We thank our ARCAD colleagues Daniel G Haller, MD, for guidance and helpful revisions to the text, and Lama Sharara, PhD, Director General of ARCAD, for expertly coordinating this multi-author review. We also thank the many ARCAD members who commented on this article at the outline stage.-
dc.description.sponsorshipAIRCFondazione AIRC per la ricerca sul cancro [IG2018]-
dc.rightsThe Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please email: Free access-
dc.titleClinical Trial Endpoints in Metastatic Cancer: Using Individual Participant Data to Inform Future Trials Methodology-
dc.typeJournal Contribution-
dc.description.notesde Gramont, A (corresponding author), Hop Franco Britannique, 4 Rue Kleber, F-92300 Paris, France.-
local.publisher.placeJOURNALS DEPT, 2001 EVANS RD, CARY, NC 27513 USA-
dc.contributor.orcidAdams, Richard/0000-0003-3915-7243; Buyse, Marc/0000-0002-4559-0994;-
dc.contributor.orcidEng, Cathy/0000-0003-2335-0612; Grothey, Axel/0000-0002-9341-6499;-
dc.contributor.orcidMaughan, Timothy Stanley/0000-0002-0580-5065-
local.description.affiliation[Goldberg, Richard M.] West Virginia Univ, Inst Canc, Morgantown, WV 26506 USA.-
local.description.affiliation[Adams, Richard] Cardiff Univ, Cardiff, Wales.-
local.description.affiliation[Adams, Richard] Velindre UNHS Trust, Cardiff, Wales.-
local.description.affiliation[Buyse, Marc; Burzykowski, Tomasz; Saad, Everardo D.; Coart, Elisabeth] Int Drug Dev Inst, Louvain La Neuve, Belgium.-
local.description.affiliation[Buyse, Marc; Burzykowski, Tomasz] Hasselt Univ, Hasselt, Belgium.-
local.description.affiliation[Eng, Cathy] Vanderbilt Ingram Canc Ctr, Nashville, TN USA.-
local.description.affiliation[Grothey, Axel] West Canc Ctr & Res Inst, Germantown, TN USA.-
local.description.affiliation[Andre, Thierry] Hop St Antoine, Paris, France.-
local.description.affiliation[Sobrero, Alberto F.] Osped S Martin, Genoa, Italy.-
local.description.affiliation[Lichtman, Stuart M.] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA.-
local.description.affiliation[Benson, Al B.] Northwestern Univ, Robert H Lurie Comprehens Canc Ctr, Chicago, IL 60611 USA.-
local.description.affiliation[Punt, Cornelis J. A.; Koopman, Miriam] Univ Med Ctr Utrecht, Utrecht, Netherlands.-
local.description.affiliation[Maughan, Tim] Univ Oxford, Gray Inst Radiat Oncol & Biol, Oxford, England.-
local.description.affiliation[Sommeijer, Dirkje] Univ Amsterdam, Acad Med Ctr, Amsterdam, Netherlands.-
local.description.affiliation[Sommeijer, Dirkje] Flevohospital, Almere, Netherlands.-
local.description.affiliation[Saad, Everardo D.] Dendrix Res, Sao Paulo, Brazil.-
local.description.affiliation[Shi, Qian] Mayo Clin, Rochester, MN USA.-
local.description.affiliation[Chibaudel, Benoist; de Gramont, Aimery] Hop Franco Britannique, 4 Rue Kleber, F-92300 Paris, France.-
local.description.affiliation[Schmoll, Hans-Joachim] Martin Luther Univ Halle Wittenberg, Halle, Germany.-
local.description.affiliation[Yoshino, Takayuki] Natl Canc Ctr Hosp East, Kashiwa, Chiba, Japan.-
local.description.affiliation[Taieb, Julien] Georges Pompidou European Hosp, Paris, France.-
local.description.affiliation[Tebbutt, Niall C.] Austin Hlth, Heidelberg, Vic, Australia.-
local.description.affiliation[Zalcberg, John] Monash Univ, Sch Publ Hlth, Clayton, Vic, Australia.-
local.description.affiliation[Tabernero, Josep] Vall dHebron Hosp Campus & Inst Oncol VHIO, Barcelona, Spain.-
local.description.affiliation[Van Cutsem, Eric] Univ Hosp Gasthuisberg, Leuven, Belgium.-
local.description.affiliation[Matheson, Alastair; de Gramont, Aimery] Fdn ARCAD, Paris, France.-
item.accessRightsOpen Access-
item.fullcitationGoldberg, Richard M.; Adams, Richard; BUYSE, Marc; Eng, Cathy; Grothey, Axel; Andre, Thierry; Sobrero, Alberto F.; Lichtman, Stuart M.; Benson, Al B.; Punt, Cornelis J. A.; Maughan, Tim; BURZYKOWSKI, Tomasz; Sommeijer, Dirkje; Saad, Everardo D.; Shi, Qian; Coart, Elisabeth; Chibaudel, Benoist; Koopman, Miriam; Schmoll, Hans-Joachim; Yoshino, Takayuki; Taieb, Julien; Tebbutt, Niall C.; Zalcberg, John; Tabernero, Josep; Van Cutsem , Eric; Matheson, Alastair & de Gramont, Aimery (2022) Clinical Trial Endpoints in Metastatic Cancer: Using Individual Participant Data to Inform Future Trials Methodology. In: JNCI-Journal of the National Cancer Institute, 114 (6) , p. 819-828.-
item.contributorGoldberg, Richard M.-
item.contributorAdams, Richard-
item.contributorBUYSE, Marc-
item.contributorEng, Cathy-
item.contributorGrothey, Axel-
item.contributorAndre, Thierry-
item.contributorSobrero, Alberto F.-
item.contributorLichtman, Stuart M.-
item.contributorBenson, Al B.-
item.contributorPunt, Cornelis J. A.-
item.contributorMaughan, Tim-
item.contributorBURZYKOWSKI, Tomasz-
item.contributorSommeijer, Dirkje-
item.contributorSaad, Everardo D.-
item.contributorShi, Qian-
item.contributorCoart, Elisabeth-
item.contributorChibaudel, Benoist-
item.contributorKoopman, Miriam-
item.contributorSchmoll, Hans-Joachim-
item.contributorYoshino, Takayuki-
item.contributorTaieb, Julien-
item.contributorTebbutt, Niall C.-
item.contributorZalcberg, John-
item.contributorTabernero, Josep-
item.contributorVan Cutsem , Eric-
item.contributorMatheson, Alastair-
item.contributorde Gramont, Aimery-
item.validationecoom 2023-
item.fulltextWith Fulltext-
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