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.

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 "poor". EMPHASIS-lung aimed at exploring this predictive effect in patients with squamous cell NSCLC. The trial closed prematurely due to low accrual and results from other trials. Our analysis includes an exploratory combined analysis with results from the PROSE trial. METHODS EMPHASIS-lung is a randomized phase III multicenter trial exploring the differential activity of second-line erlotinib versus docetaxel on progression-free survival (PFS) in Veristrat good versus 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. Median PFS under docetaxel and erlotinib in the Veristrat good cohort was 4.1 and 1.6 months respectively, and 1.9 and 2.1 months in the Veristrat poor cohort. Median overall survival (OS) under docetaxel and erlotinib in the Veristrat good cohort was 7.8 and 8.4 and 4.4 and 5.2 months in the Veristrat poor cohort. An additional exploratory analysis was performed, where 47 patients from the squamous cell subgroup of PROSE were included in a combined analysis contributing with 45 PFS and 41 OS events. CONCLUSION The final analysis of EMPHASIS-lung did not show differential activity 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)