SAVINA, Marion; LITIERE, Saskia; ITALIANO, Antoine; BURZYKOWSKI, Tomasz; BONNETAIN, Franck; GOURGOU, Sophie; RONDEAU, Virginie; BLAY, Jean Yves; COUSIN, Sophie; DUFFAUD, Florence; GELDERBLOM, Hans; GRONCHI, Alessandro; JUDSON, Ian; LE CESNE, Axel; LORIGAN, Paul; MAUREL, Joan; VAN DER GRAAF, Winette; VERWEIJ, Jaap; MATHOULIN-PELISSIER, Simone; BELLERA, Carine

doi:10.18632/oncotarget.26166

SAVINA, Marion
Bordeaux population health [BPH]

LITIERE, Saskia

ITALIANO, Antoine

Langue

Article de revue

Ce document a été publié dans

Oncotarget. 2018-10-02, vol. 9, n° 77, p. 34617-34627

Résumé en anglais

Background: Alternative endpoints to overall survival (OS) are frequently used to assess treatment efficacy in randomized controlled trials (RCT). Their properties in terms of surrogate outcomes for OS need to be assessed. We evaluated the surrogate properties of progression-free survival (PFS), time-to-progression (TTP) and time-to-treatment failure (TTF) in advanced soft tissue sarcomas (STS). Results: A total of 21 trials originally met the selection criteria and 14 RCTs (N = 2846) were included in the analysis. Individual-level associations were moderate (highest for 12-month PFS: Spearman's rho = 0.66; 95% CI [0.63; 0.68]). Trial-level associations were ranked as low for the three endpoints as per the IQWiG criterion. Materials and Methods: We performed a meta-analysis using individual-patient data (IPD). Phase II/III RCTs evaluating therapies for adults with advanced STS were eligible. We estimated the individual- and the trial-level associations between then candidate surrogates and OS. Statistical methods included weighted linear regression and the two-stage model introduced by Buyse and Burzykowski. The strength of the trial-level association was ranked according to the German Institute for Quality and Efficiency in Health Care (IQWiG) guidelines. Conclusions: Our results do not support strong surrogate properties of PFS, TTP and TTF for OS in advanced STS.< Réduire

Mots clés en anglais

Biostatistics

CIC1401

EPICENE

URI

https://oskar-bordeaux.fr/handle/20.500.12278/23641

DOI

http://dx.doi.org/10.18632/oncotarget.26166

Unités de recherche

Bordeaux Population Health Research Center (BPH) - UMR 1219

Voir/Ouvrir

Métadonnées

Partager cette publication !

Licence d’utilisation du document

Surrogate endpoints in advanced sarcoma trials: a meta-analysis

Langue

Ce document a été publié dans

Résumé en anglais

Mots clés en anglais

URI

DOI

Unités de recherche