RT Journal Article
T1 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.
A1 Peters, Solange
A1 Stahel, Rolf A
A1 Dafni, Urania
A1 Ponce Aix, Santiago
A1 Massutí, Bartomeu
A1 Gautschi, Oliver
A1 Coate, Linda
A1 López Martín, Ana
A1 van Heemst, Robbert
A1 Berghmans, Thierry
A1 Meldgaard, Peter
A1 Cobo Dols, Manuel
A1 Garde Noguera, Javier
A1 Curioni-Fontecedro, Alessandra
A1 Rauch, Daniel
A1 Mark, Michael T
A1 Cuffe, Sinead
A1 Biesma, Bonne
A1 van Henten, Arjen M J
A1 Juan Vidal, Óscar
A1 Palmero Sanchez, Ramón
A1 Villa Guzmán, José Carlos
A1 Collado Martin, Ricardo
A1 Peralta, Sergio
A1 Insa, Amelia
A1 Summers, Yvonne
A1 Láng, István
A1 Horgan, Anne
A1 Ciardiello, Fortunato
A1 de Hosson, Sander
A1 Pieterman, Remge
A1 Groen, Harry J M
A1 van den Berg, Paul M
A1 Zielinski, Christoph C
A1 Chittazhathu Kurian Kuruvilla, Yojena
A1 Gasca-Ruchti, Adriana
A1 Kassapian, Marie
A1 Novello, Silvia
A1 Torri, Valter
A1 Tsourti, Zoi
A1 Gregorc, Vanesa
A1 Smit, Egbert F
A1 EMPHASIS-lung Collaborative Group, 
K1 Docetaxel
K1 ETOP
K1 Erlotinib
K1 NSCLC
K1 Squamous
K1 VeriStrat
AB 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).
YR 2016
FD 2016-12-23
LK http://hdl.handle.net/10668/10713
UL http://hdl.handle.net/10668/10713
LA en
DS RISalud
RD Apr 8, 2025