Erlotinib versus chemotherapy (CT) in advanced non-small cell lung cancer (NSCLC) patients (p) with epidermal growth factor receptor (EGFR) mutations: Interim results of the European Erlotinib Versus Chemotherapy (EURTAC) phase III randomized trial. - PowerPoint PPT Presentation

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Erlotinib versus chemotherapy (CT) in advanced non-small cell lung cancer (NSCLC) patients (p) with epidermal growth factor receptor (EGFR) mutations: Interim results of the European Erlotinib Versus Chemotherapy (EURTAC) phase III randomized trial.

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Erlotinib versus chemotherapy (CT) in advanced non-small cell lung cancer (NSCLC) patients (p) with epidermal growth factor receptor (EGFR) mutations: Interim results ... – PowerPoint PPT presentation

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Title: Erlotinib versus chemotherapy (CT) in advanced non-small cell lung cancer (NSCLC) patients (p) with epidermal growth factor receptor (EGFR) mutations: Interim results of the European Erlotinib Versus Chemotherapy (EURTAC) phase III randomized trial.


1
Erlotinib versus chemotherapy (CT) in advanced
non-small cell lung cancer (NSCLC) patients (p)
with epidermal growth factor receptor (EGFR)
mutations Interim results of the European
Erlotinib Versus Chemotherapy (EURTAC) phase III
randomized trial.
  • AuthorsR. Rosell, R. Gervais, A. Vergnenegre, B.
    Massuti, E. Felip, F. Cardenal, R. Garcia Gomez,
    C. Pallares, J. Sanchez, R. Porta, M. Cobo, M. Di
    Seri, P. Garrido Lopez, A. Insa, F. De Marinis,
    R. Corre, M. Carreras, E. Carcereny, M. Taron, L.
    G. Paz-Ares, Spanish Lung Cancer Group
  • J Clin Oncol 29 2011 (suppl abstr 7503)
  • Reviewed by Charles Butts
  • Date posted June 2011

2
Thank you for downloading this update. Please
feel free to use it for educational purposes.
Please acknowledge OncologyEducation.ca and Dr.
Charles Butts when using these slides.
3
Study Design
  • Study Question
  • In a randomized, prospective, Phase III study
    comparing erlotinib to Platinum based doublet
    chemo as first line therapy EGFR mutation
    positive
  • Endpoints
  • Primary Endpoint
  • Progression free survival (PFS)
  • Secondary Endpoints
  • Overall survival (OS)
  • Objective Response Rate (ORR)
  • Study Population
  • Stage IIIB/IV NSCLC, ECOG 0-2, chemo-naïve, EGFR
    mutation positive (exon 19/21)

4
Study Design
N 174 Primary Outcome PFS
Erlotinib 150 mg daily until PD
R
Platinum doublet X 4 cycles
  • Stage IIIB/V
  • Chemo-naïve
  • Exon 19 del
  • Exon 21 L858R
  • ECOG 0-2
  • Patient
  • Population

5
Patient Characteristics
Erlotinib (n86) Chemo (n88)
Median age 65(24-82) 65 (29-82)
Gender Male Female 33 67 22 78
Smoking Current Former Never 31 55 14 34 52 14
Mutation Ex 19del Ex 21 sub 66 34 67 33
6
RESULTS
Treatment A Erlotinib Treatment B Chemo p-value
Response Rate () 58 15 NA
PFS (median, mos) 9.7 5.2 lt0.0001
OS (median, mos) NA NA
7
Study Commentary
  • 21 of patient samples tested were EGFR mutation
    positive
  • Overall survival no different but majority of
    patients crossed over at progression
  • No relevant safety concerns
  • First trial in western population to show
    erlotinib superior to chemo in terms of ORR and
    PFS in EGFR mutation positive patients.

8
Bottom Line for Canadian Medical Oncologists
  • This is the first study in Caucasian population
    of EGFR TKI versus chemo as first line therapy
  • Further support for EGFR mutation analysis in
    appropriate patients
  • Those with activating mutations should be
    considered for first line GFR TKI therapy
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