title: 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.
abstract: 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).
authors.affiliation: University Hospital of Lausanne (CHUV), Lausanne, Switzerland. Electronic address: Solange.Peters@chuv.ch.
authors.forename: Solange
authors.initials: S
authors.lastname: Peters
authors.affiliation: University Hospital Zürich, Clinic of Oncology, Zürich, Switzerland.
authors.forename: Rolf A
authors.initials: RA
authors.lastname: Stahel
authors.affiliation: Frontier Science Foundation-Hellas and National and Kapodistrian University of Athens, Athens, Greece.
authors.forename: Urania
authors.initials: U
authors.lastname: Dafni
authors.affiliation: University Hospital 12 de Octubre, Madrid, Spain.
authors.forename: Santiago
authors.initials: S
authors.lastname: Ponce Aix
authors.affiliation: Alicante University Hospital, Alicante, Spain.
authors.forename: Bartomeu
authors.initials: B
authors.lastname: Massutí
authors.affiliation: Swiss Group for Clinical Cancer Research and Cantonal Hospital Lucerne, Switzerland.
authors.forename: Oliver
authors.initials: O
authors.lastname: Gautschi
authors.affiliation: Cancer Trials Ireland and Mid-Western Regional Hospital, Limerick, Ireland.
authors.forename: Linda
authors.initials: L
authors.lastname: Coate
authors.affiliation: University Hospital Severo Ochoa, Madrid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: López Martín
authors.affiliation: Deventer Hospital, Deventer, The Netherlands.
authors.forename: Robbert
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authors.lastname: van Heemst
authors.affiliation: Institute Jules Bordet, Brussels, Belgium.
authors.forename: Thierry
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authors.lastname: Berghmans
authors.affiliation: Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Peter
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authors.lastname: Meldgaard
authors.affiliation: University Hospital Virgen de la Victoria, Malaga, Spain.
authors.forename: Manuel
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authors.lastname: Cobo Dols
authors.affiliation: Hospital Arnau Vilanova, Valencia, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Garde Noguera
authors.affiliation: University Hospital Zürich, Clinic of Oncology, Zürich, Switzerland.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Curioni-Fontecedro
authors.affiliation: Cantonal Hospital, Thun, Switzerland.
authors.forename: Daniel
authors.initials: D
authors.lastname: Rauch
authors.affiliation: Cantonal Hospital, Chur, Switzerland.
authors.forename: Michael T
authors.initials: MT
authors.lastname: Mark
authors.affiliation: Cancer Trials Ireland and St. James's Hospital, Dublin, Ireland.
authors.forename: Sinead
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authors.lastname: Cuffe
authors.affiliation: Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
authors.forename: Bonne
authors.initials: B
authors.lastname: Biesma
authors.affiliation: Maxima Medical Centre, Eindhoven, The Netherlands.
authors.forename: Arjen M J
authors.initials: AMJ
authors.lastname: van Henten
authors.affiliation: Hospital La Fe, Valencia, Spain.
authors.forename: Óscar
authors.initials: Ó
authors.lastname: Juan Vidal
authors.affiliation: Hospital Duran i Reynalds, Barcelona, Spain.
authors.forename: Ramón
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authors.lastname: Palmero Sanchez
authors.affiliation: General University Hospital, Ciudad Real, Spain.
authors.forename: José Carlos
authors.initials: JC
authors.lastname: Villa Guzmán
authors.affiliation: Hospital San Pedro de Alcantara, Spain.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Collado Martin
authors.affiliation: Hospital Sant Joan de Reus, Spain.
authors.forename: Sergio
authors.initials: S
authors.lastname: Peralta
authors.affiliation: University Hospital, Valencia, Spain.
authors.forename: Amelia
authors.initials: A
authors.lastname: Insa
authors.affiliation: Christie Hospital Manchester, United Kingdom.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Summers
authors.affiliation: National Institute of Oncology, Budapest, Hungary.
authors.forename: István
authors.initials: I
authors.lastname: Láng
authors.affiliation: Cancer Trials Ireland and University Hospital Waterford, Ireland.
authors.forename: Anne
authors.initials: A
authors.lastname: Horgan
authors.affiliation: Second University of Naples, Naples, Italy.
authors.forename: Fortunato
authors.initials: F
authors.lastname: Ciardiello
authors.affiliation: Wilhelmina Hospital, Assen, The Netherlands.
authors.forename: Sander
authors.initials: S
authors.lastname: de Hosson
authors.affiliation: Ommelander Hospital Group, Winschoten, The Netherlands.
authors.forename: Remge
authors.initials: R
authors.lastname: Pieterman
authors.affiliation: University Medical Center Groningen, The Netherlands.
authors.forename: Harry J M
authors.initials: HJM
authors.lastname: Groen
authors.affiliation: Maasstad Hospital, Rotterdam, The Netherlands.
authors.forename: Paul M
authors.initials: PM
authors.lastname: van den Berg
authors.affiliation: Central European Cooperative Oncology Group and Comprehensive Cancer Center of the Medical University, Vienna, Austria.
authors.forename: Christoph C
authors.initials: CC
authors.lastname: Zielinski
authors.affiliation: European Thoracic Oncology Platform Coordinating Office, Bern, Switzerland.
authors.forename: Yojena
authors.initials: Y
authors.lastname: Chittazhathu Kurian Kuruvilla
authors.affiliation: European Thoracic Oncology Platform Coordinating Office, Bern, Switzerland.
authors.forename: Adriana
authors.initials: A
authors.lastname: Gasca-Ruchti
authors.affiliation: Frontier Science Foundation-Hellas, Athens, Greece.
authors.forename: Marie
authors.initials: M
authors.lastname: Kassapian
authors.affiliation: University of Turin, Department of Clinical and Biological Sciences, Turin, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Novello
authors.affiliation: Mario Negri Institute for Pharmacological Research, Milan, Italy.
authors.forename: Valter
authors.initials: V
authors.lastname: Torri
authors.affiliation: Frontier Science Foundation-Hellas, Athens, Greece.
authors.forename: Zoi
authors.initials: Z
authors.lastname: Tsourti
authors.affiliation: IRCCS Scientific Institute Ospedale San Raffaele, Milan, Italy.
authors.forename: Vanesa
authors.initials: V
authors.lastname: Gregorc
authors.affiliation: Cancer Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Egbert F
authors.initials: EF
authors.lastname: Smit
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D015331:Cohort Studies; D000077143:Docetaxel; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D010984:Platinum / Q000008:administration & dosage; D011379:Prognosis; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D010984:Platinum; D000069347:Erlotinib Hydrochloride
keywords: Docetaxel; ETOP; Erlotinib; NSCLC; Squamous; VeriStrat