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.
Authors:R. 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
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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)
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Study Design
N= 174
Primary
Outcome: PFS
Erlotinib 150 mg daily until PD
R
•Stage IIIB/V
•Chemo-naïve
•Exon 19 del
•Exon 21 L858R
•ECOG 0-2
Platinum doublet
X 4 cycles
Population
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Patient Characteristics
Erlotinib
(n=86)
Chemo
(n=88)
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
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RESULTS
Treatment
A
Erlotinib
Treatment
B
Chemo
p-value
Response
Rate (%)
58
15
NA
PFS (median,
mos)
9.7
5.2
<0.0001
OS
(median,
mos)
NA
NA
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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.
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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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