biostudies-otherUnknown27Emma FairbanksJournal of clinical oncology : official journal of the American Society of Clinical Oncology4103-4108https://www.ebi.ac.uk/biostudies/studies/MODEL1708310001biostudies-other19636014Emma FairbanksfalseClaret2009 - Predicting phase III overall survival in colorectal cancer<notes xmlns="http://www.sbml.org/sbml/level3/version1/core"> <body xmlns="http://www.w3.org/1999/xhtml"> <div class="dc:title">Claret2009 - Predicting phase III overall survival in colorectal cancer</div><div class="dc:bibliographicCitation"> <p>This model is described in the article:</p> <div class="bibo:title"> <a href="http://identifiers.org/pubmed/19636014" title="Access to this publication">Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics.</a> </div> <div class="bibo:authorList">Claret L, Girard P, Hoff PM, Van Cutsem E, Zuideveld KP, Jorga K, Fagerberg J, Bruno R.</div> <div class="bibo:Journal">J. Clin. Oncol. 2009 Sep; 27(25): 4103-4108</div> <p>Abstract:</p> <div class="bibo:abstract"> <p>PURPOSE: We developed a drug-disease simulation model to predict antitumor response and overall survival in phase III studies from longitudinal tumor size data in phase II trials. METHODS: We developed a longitudinal exposure-response tumor-growth inhibition (TGI) model of drug effect (and resistance) using phase II data of capecitabine (n = 34) and historical phase III data of fluorouracil (FU; n = 252) in colorectal cancer (CRC); and we developed a parametric survival model that related change in tumor size and patient characteristics to survival time using historical phase III data (n = 245). The models were validated in simulation of antitumor response and survival in an independent phase III study (n = 1,000 replicates) of capecitabine versus FU in CRC. RESULTS: The TGI model provided a good fit of longitudinal tumor size data. A lognormal distribution best described the survival time, and baseline tumor size and change in tumor size from baseline at week 7 were predictors (P < .00001). Predicted change of tumor size and survival time distributions in the phase III study for both capecitabine and FU were consistent with observed values, for example, 431 days (90% prediction interval, 362 to 514 days) versus 401 days observed for survival in the capecitabine arm. A modest survival improvement of 39 days (90% prediction interval, -21 to 110 days) versus 35 days observed was predicted for capecitabine. CONCLUSION: The modeling framework successfully predicted survival in a phase III trial on the basis of capecitabine phase II data in CRC. It is a useful tool to support end-of-phase II decisions and design of phase III studies.</p> </div></div><div class="dc:publisher"> <p>This model is hosted on <a href="http://www.ebi.ac.uk/biomodels/">BioModels Database</a> and identified by: <a href="http://identifiers.org/biomodels.db/MODEL1708310001">MODEL1708310001</a>.</p> <p>To cite BioModels Database, please use: <a href="http://identifiers.org/pubmed/20587024" title="Latest BioModels Database publication">BioModels Database: An enhanced, curated and annotated resource for published quantitative kinetic models</a>.</p></div><div class="dc:license"> <p>To the extent possible under law, all copyright and related or neighbouring rights to this encoded model have been dedicated to the public domain worldwide. Please refer to <a href="http://creativecommons.org/publicdomain/zero/1.0/" title="Access to: CC0 1.0 Universal (CC0 1.0), Public Domain Dedication">CC0 Public Domain Dedication</a> for more information.</p></div></body> </notes>2017-08-31T00:00:00Z2025-07-14T17:54:04.258Z2025-03-30T22:40:51.34ZMODEL170831000119636014MAMO_0000046