Titre
Randomized Phase III Trial of Erlotinib versus Docetaxel in Patients with Advanced Squamous Cell Non-Small Cell Lung Cancer Failing First-Line Platinum-Based Doublet Chemotherapy Stratified by VeriStrat Good versus VeriStrat Poor. The European Thoracic Oncology Platform (ETOP) EMPHASIS-lung Trial.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Peters, S.
Auteure/Auteur
Stahel, R.A.
Auteure/Auteur
Dafni, U.
Auteure/Auteur
Ponce Aix, S.
Auteure/Auteur
Massutí, B.
Auteure/Auteur
Gautschi, O.
Auteure/Auteur
Coate, L.
Auteure/Auteur
López Martín, A.
Auteure/Auteur
van Heemst, R.
Auteure/Auteur
Berghmans, T.
Auteure/Auteur
Meldgaard, P.
Auteure/Auteur
Cobo Dols, M.
Auteure/Auteur
Garde Noguera, J.
Auteure/Auteur
Curioni-Fontecedro, A.
Auteure/Auteur
Rauch, D.
Auteure/Auteur
Mark, M.T.
Auteure/Auteur
Cuffe, S.
Auteure/Auteur
Biesma, B.
Auteure/Auteur
van Henten, AMJ
Auteure/Auteur
Juan Vidal, Ó.
Auteure/Auteur
Palmero Sanchez, R.
Auteure/Auteur
Villa Guzmán, J.C.
Auteure/Auteur
Collado Martin, R.
Auteure/Auteur
Peralta, S.
Auteure/Auteur
Insa, A.
Auteure/Auteur
Summers, Y.
Auteure/Auteur
Láng, I.
Auteure/Auteur
Horgan, A.
Auteure/Auteur
Ciardiello, F.
Auteure/Auteur
de Hosson, S.
Auteure/Auteur
Pieterman, R.
Auteure/Auteur
Groen, HJM
Auteure/Auteur
van den Berg, P.M.
Auteure/Auteur
Zielinski, C.C.
Auteure/Auteur
Chittazhathu Kurian Kuruvilla, Y.
Auteure/Auteur
Gasca-Ruchti, A.
Auteure/Auteur
Kassapian, M.
Auteure/Auteur
Novello, S.
Auteure/Auteur
Torri, V.
Auteure/Auteur
Tsourti, Z.
Auteure/Auteur
Gregorc, V.
Auteure/Auteur
Smit, E.F.
Auteure/Auteur
Groupes de travail
EMPHASIS-lung Collaborative Group
Liens vers les personnes
Liens vers les unités
ISSN
1556-1380
Statut éditorial
Publié
Date de publication
2017-04
Volume
12
Numéro
4
Première page
752
Dernière page/numéro d’article
762
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
Publication Status: ppublish
Publication Status: ppublish
Résumé
Docetaxel and erlotinib are registered second-line treatments for wild-type EGFR NSCLC. Previous studies suggested a predictive value of the VeriStrat test in second-line therapy of NSCLC, classifying patients as either VeriStrat good or VeriStrat poor. EMPHASIS-lung aimed at exploring this predictive effect in patients with squamous cell NSCLC. The trial closed prematurely because of low accrual and results from other trials. Our analysis includes an exploratory combined analysis with results from the PROSE trial.
EMPHASIS-lung was a randomized phase III multicenter trial exploring the differential effect of second-line erlotinib versus docetaxel on progression-free survival (PFS) in VeriStrat good versus VeriStrat poor patients with squamous cell NSCLC.
A total of 80 patients were randomized, with 72.5% categorized as VeriStrat good. Patient characteristics were balanced between VeriStrat status and treatment groups. The median PFS times with docetaxel and erlotinib treatment in the VeriStrat good cohort were 4.1 and 1.6 months, respectively, versus 1.9 and 2.1 months, respectively, in the VeriStrat poor cohort. The median overall survival (OS) times with docetaxel and erlotinib treatment in the VeriStrat good cohort were 7.8 and 8.4 months, respectively, and 4.4 and 5.2 months, respectively, in the VeriStrat poor cohort. An additional exploratory analysis was performed; in it, 47 patients from the squamous cell subgroup of PROSE were included in a combined analysis, contributing with 45 PFS and 41 OS events.
The final analysis of EMPHASIS-lung did not show a differential effect on PFS for erlotinib versus docetaxel stratified by VeriStrat status. Similarly, in the combined analysis, no significant treatment by VeriStrat status interaction was observed (interaction p = 0.24 for PFS and 0.45 for OS, stratified by study).
EMPHASIS-lung was a randomized phase III multicenter trial exploring the differential effect of second-line erlotinib versus docetaxel on progression-free survival (PFS) in VeriStrat good versus VeriStrat poor patients with squamous cell NSCLC.
A total of 80 patients were randomized, with 72.5% categorized as VeriStrat good. Patient characteristics were balanced between VeriStrat status and treatment groups. The median PFS times with docetaxel and erlotinib treatment in the VeriStrat good cohort were 4.1 and 1.6 months, respectively, versus 1.9 and 2.1 months, respectively, in the VeriStrat poor cohort. The median overall survival (OS) times with docetaxel and erlotinib treatment in the VeriStrat good cohort were 7.8 and 8.4 months, respectively, and 4.4 and 5.2 months, respectively, in the VeriStrat poor cohort. An additional exploratory analysis was performed; in it, 47 patients from the squamous cell subgroup of PROSE were included in a combined analysis, contributing with 45 PFS and 41 OS events.
The final analysis of EMPHASIS-lung did not show a differential effect on PFS for erlotinib versus docetaxel stratified by VeriStrat status. Similarly, in the combined analysis, no significant treatment by VeriStrat status interaction was observed (interaction p = 0.24 for PFS and 0.45 for OS, stratified by study).
Sujets
PID Serval
serval:BIB_D30A1C513C0C
PMID
Date de création
2017-01-03T18:09:15.627Z
Date de création dans IRIS
2025-05-21T03:33:53Z