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

Solange Peters*, Rolf A. Stahel, Urania Dafni, Santiago Ponce Aix, Bartomeu Massutí, Oliver Gautschi, Linda Coate, Ana López Martín, Robbert van Heemst, Thierry Berghmans, Peter Meldgaard, Manuel Cobo Dols, Javier Garde Noguera, Alessandra Curioni-Fontecedro, Daniel Rauch, Michael T. Mark, Sinead Cuffe, Bonne Biesma, Arjen M.J. van Henten, Óscar Juan VidalRamón Palmero Sanchez, José Carlos Villa Guzmán, Ricardo Collado Martin, Sergio Peralta, Amelia Insa, Yvonne Summers, István Láng, Anne Horgan, Fortunato Ciardiello, Sander de Hosson, Remge Pieterman, Harry J.M. Groen, Paul M. van den Berg, Christoph C. Zielinski, Yojena Chittazhathu Kurian Kuruvilla, Adriana Gasca-Ruchti, Marie Kassapian, Silvia Novello, Valter Torri, Zoi Tsourti, Vanesa Gregorc, Egbert F. Smit, EMPHASIS-lung Collaborative Group

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Introduction 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. Methods 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. Results 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. Conclusions 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).

Original languageEnglish
Pages (from-to)752-762
Number of pages11
JournalJournal of Thoracic Oncology
Issue number4
Publication statusPublished - 1 Apr 2017

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