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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
- Source :
- JOURNAL OF THORACIC ONCOLOGY, r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA, instname, Journal of Thoracic Oncology, 12(4), 752-762. International Association for the Study of Lung Cancer, 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 2017, ' 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 ', Journal of Thoracic Oncology, vol. 12, no. 4, pp. 752-762 . https://doi.org/10.1016/j.jtho.2016.12.017, 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 2017, ' 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 ', Journal of Thoracic Oncology, vol. 12, no. 4, pp. 752-762 . https://doi.org/10.1016/j.jtho.2016.12.017, Journal of Thoracic Oncology, 12(4), 752-762. ELSEVIER SCIENCE INC
- Publication Year :
- 2016
-
Abstract
- 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). (C) 2017 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
- Subjects :
- Oncology
Male
Lung Neoplasms
medicine.medical_treatment
Docetaxel
NSCLC
THERAPY
Squamous
Cohort Studies
RETROSPECTIVE ANALYSIS
0302 clinical medicine
Carcinoma, Non-Small-Cell Lung
3RD-LINE
Antineoplastic Combined Chemotherapy Protocols
VeriStrat
030212 general & internal medicine
Erlotinib Hydrochloride
ETOP
Prognosis
Survival Rate
Erlotinib
030220 oncology & carcinogenesis
Carcinoma, Squamous Cell
Female
Taxoids
Veristrat
2ND-LINE TREATMENT
medicine.drug
Pulmonary and Respiratory Medicine
medicine.medical_specialty
03 medical and health sciences
Internal medicine
Multicenter trial
medicine
TYROSINE KINASE INHIBITORS
Journal Article
Humans
Lung cancer
COMBINATION
Survival rate
neoplasms
METAANALYSIS
Aged
Neoplasm Staging
Platinum
Chemotherapy
business.industry
medicine.disease
respiratory tract diseases
business
GROWTH-FACTOR RECEPTOR
Follow-Up Studies
Subjects
Details
- ISSN :
- 15561380 and 15560864
- Volume :
- 12
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
- Accession number :
- edsair.doi.dedup.....ee1d367d8bc33b24edc27d000909d5bd
- Full Text :
- https://doi.org/10.1016/j.jtho.2016.12.017