Περίληψη:
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). © 2017 International Association for the Study of Lung Cancer
Συγγραφείς:
Peters, S.
Stahel, R.A.
Dafni, U.
Ponce Aix, S.
Massutí, B.
Gautschi, O.
Coate, L.
López Martín, A.
van Heemst, R.
Berghmans, T.
Meldgaard, P.
Cobo Dols, M.
Garde Noguera, J.
Curioni-Fontecedro, A.
Rauch, D.
Mark, M.T.
Cuffe, S.
Biesma, B.
van Henten, A.M.J.
Juan Vidal, Ó.
Palmero Sanchez, R.
Villa Guzmán, J.C.
Collado Martin, R.
Peralta, S.
Insa, A.
Summers, Y.
Láng, I.
Horgan, A.
Ciardiello, F.
de Hosson, S.
Pieterman, R.
Groen, H.J.M.
van den Berg, P.M.
Zielinski, C.C.
Chittazhathu Kurian Kuruvilla, Y.
Gasca-Ruchti, A.
Kassapian, M.
Novello, S.
Torri, V.
Tsourti, Z.
Gregorc, V.
Smit, E.F.
EMPHASIS-lung Collaborative Group
Λέξεις-κλειδιά:
docetaxel; erlotinib; antineoplastic agent; docetaxel; erlotinib; platinum; taxoid, aged; Article; cancer prognosis; controlled study; drug treatment failure; drug withdrawal; female; human; major clinical study; male; multicenter study; non small cell lung cancer; overall survival; phase 3 clinical trial; progression free survival; proteomics; randomized controlled trial; squamous cell non small cell lung cancer; squamous cell non small cell lung cancer; unspecified side effect; cancer staging; clinical trial; cohort analysis; follow up; lung tumor; non small cell lung cancer; pathology; prognosis; squamous cell carcinoma; survival rate, Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Cohort Studies; Erlotinib Hydrochloride; Female; Follow-Up Studies; Humans; Lung Neoplasms; Male; Neoplasm Staging; Platinum; Prognosis; Survival Rate; Taxoids
