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Status: Bibliographieeintrag

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Verfasst von:Ronellenfitsch, Ulrich [VerfasserIn]   i
 Jensen, Katrin [VerfasserIn]   i
 Seide, Svenja [VerfasserIn]   i
 Kieser, Meinhard [VerfasserIn]   i
Titel:Disease-free survival as a surrogate for overall survival in neoadjuvant trials of gastroesophageal adenocarcinoma
Titelzusatz:pooled analysis of individual patient data from randomised controlled trials
Verf.angabe:Ulrich Ronellenfitsch, Katrin Jensen, Svenja Seide, Meinhard Kieser, Matthias Schwarzbach, Tracy E. Slanger, Bryan Burmeister, David Kelsen, Donna Niedzwiecki, Guillaume Piessen, Christoph Schuhmacher, Susan Urba, Cornelis van de Velde, Marc Ychou, Ralf Hofheinz, Sylvie Lorenzen
E-Jahr:2019
Jahr:1 November 2019
Umfang:11 S.
Fussnoten:Gesehen am 16.01.2020
Titel Quelle:Enthalten in: European journal of cancer
Ort Quelle:Amsterdam [u.a.] : Elsevier, 1992
Jahr Quelle:2019
Band/Heft Quelle:123(2019), Seite 101-111
ISSN Quelle:1879-0852
Abstract:Introduction - Disease-free survival (DFS) is increasingly being used as surrogate end-point for overall survival (OS) in cancer trials. So far, there has been no validation of the surrogacy of DFS for OS for neoadjuvant treatment of gastroesophageal adenocarcinoma. - Methods - The study uses individual patient data (IPD) from eight randomised controlled trials (RCTs) (n = 1126 patients) comparing neoadjuvant therapy followed by surgery with surgery alone for gastroesophageal adenocarcinoma. Correlation between OS time and DFS time was calculated to evaluate individual-level surrogacy. For each trial, survival curves using the Kaplan-Meier method were plotted and hazard ratios (HRs) on the treatment effects were calculated for OS and DFS separately. Those HRs were pooled in a random-effects meta-analysis. Observed HRs were compared with predicted HRs for OS using results from an error-in-variables linear regression model accounting for the uncertainty about the estimated effect. The strength of the association was quantified by the coefficient of determination to assess trial-level surrogacy. The surrogate threshold effect was calculated to determine the minimum treatment effect on DFS necessary to predict a non-zero treatment effect on OS. - Results - A strong correlation between OS time and DFS time was observed, indicating a high individual-level surrogacy. For all RCTs, estimated HRs for OS and DFS were highly similar. In the meta-analysis, the overall HR for OS was virtually identical to that for DFS. The estimated coefficient of determination r2 for the association between HRs for OS and DFS was 0.912 (95% confidence interval: 0.75-1.0), indicating a very good fit of the regression model and thus a strong trial-level surrogacy between OS and DFS. The surrogate threshold effect based on the regression analysis was 0.79. - Discussion - Based on strong correlations between DFS and OS, as well as a strong correlation of the treatment effects of the two end-points in the error-in-variable regression, DFS seems an appropriate surrogate marker for OS in randomised trials of neoadjuvant chemotherapy or chemoradiotherapy for gastroesophageal adenocarcinoma.
DOI:doi:10.1016/j.ejca.2019.10.001
URL:Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.

Volltext: https://doi.org/10.1016/j.ejca.2019.10.001
 Verlag: http://www.sciencedirect.com/science/article/pii/S0959804919307488
 DOI: https://doi.org/10.1016/j.ejca.2019.10.001
Datenträger:Online-Ressource
Sprache:eng
Sach-SW:Disease-free survival
 Gastroesophageal adenocarcinoma
 Individual patient data meta-analysis
 Neoadjuvant chemoradiotherapy
 Neoadjuvant chemotherapy
 Overall survival
K10plus-PPN:1687546487
Verknüpfungen:→ Zeitschrift

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