Please use this identifier to cite or link to this item:
|Title:||Clinical Trial Endpoints in Metastatic Cancer: Using Individual Participant Data to Inform Future Trials Methodology||Authors:||Goldberg, Richard M.
Sobrero, Alberto F.
Lichtman, Stuart M.
Benson, Al B.
Punt, Cornelis J. A.
Saad, Everardo D.
Tebbutt, Niall C.
Van Cutsem , Eric
de Gramont, Aimery
|Issue Date:||2021||Publisher:||OXFORD UNIV PRESS INC||Source:||JNCI-Journal of the National Cancer Institute,||Status:||Early view||Abstract:||Meta-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.||Notes:||de Gramont, A (corresponding author), Hop Franco Britannique, 4 Rue Kleber, F-92300 Paris, France.
|Document URI:||http://hdl.handle.net/1942/37076||ISSN:||0027-8874||e-ISSN:||1460-2105||DOI:||10.1093/jnci/djab218||ISI #:||WOS:000765949500001||Rights:||The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please email: email@example.com||Category:||A1||Type:||Journal Contribution|
|Appears in Collections:||Research publications|
Show full item record
WEB OF SCIENCETM
checked on Jan 30, 2023
checked on Sep 7, 2022
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.