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.

Détails

ID Serval
serval:BIB_D30A1C513C0C
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
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.
Périodique
Journal of thoracic oncology
Auteur(s)
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 AMJ, 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 HJM, 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.
Collaborateur(s)
EMPHASIS-lung Collaborative Group
ISSN
1556-1380 (Electronic)
ISSN-L
1556-0864
Statut éditorial
Publié
Date de publication
04/2017
Peer-reviewed
Oui
Volume
12
Numéro
4
Pages
752-762
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
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).

Mots-clé
Aged, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Carcinoma, Non-Small-Cell Lung/drug therapy, Carcinoma, Non-Small-Cell Lung/pathology, Carcinoma, Squamous Cell/drug therapy, Carcinoma, Squamous Cell/pathology, Cohort Studies, Erlotinib Hydrochloride/administration & dosage, Female, Follow-Up Studies, Humans, Lung Neoplasms/drug therapy, Lung Neoplasms/pathology, Male, Neoplasm Staging, Platinum/administration & dosage, Prognosis, Survival Rate, Taxoids/administration & dosage, Docetaxel, ETOP, Erlotinib, NSCLC, Squamous, VeriStrat
Pubmed
Web of science
Création de la notice
03/01/2017 20:09
Dernière modification de la notice
20/08/2019 16:53
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