1346 - Erlotinib role in pretreated EGFR wild type caucasian patients: a retrospective observational study

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer agents
Non-small-cell lung cancer
Biological therapy
Presenter Bruno Gori
Authors B. Gori1, E. Del Signore2, A. Fulvi3, S. Ricciardi2, M.R. Migliorino2, R. Belli2, S. Condò2, S. De Santis2, A.M. Colacchi2, F. De Marinis2
  • 1Pneumological Oncology, San Camillo High Specialization Hospital, 00151 - Rome/IT
  • 21st Oncological Pulmonary Unit, San Camillo High Specialization Hospital, 00151 - Rome/IT
  • 31st Oncological Pulmonary Unit, San Camillo High Specialization Hospital, Rome/IT



Erlotinib in UE was approved in unselected A-NSCLC patients (pts) (2nd/3rd line and switch maintenance) and in EGFR mutated pts.


We conducted a retrospective mono-institutional observational study (Jan 2007- May 2012) of Caucasian pts with A-NSCLC, all EGFR wild-type (WT), who received erlotinib in 2nd, 3rd, 4th, 5th line of therapy.191 pts with pretreated A-NSCLC were evaluated, including 108 (57%) treated with erlotinib as 2nd line and 83 (43%) as 3rd/4th/5th line. All pts were considered for survival, analyzing some different clinical characteristics for pts in 2nd line. All pts received a CT scan evaluation every two months of treatment.


Of 108 pts who received erlotinib in 2nd line the median PFS was 8,4 weeks(wks) with an Overall Survival(OS) of 16,8 wks, of which 59 pts (55%) with ECOG PS 1 had mPFS of 12,6 wks and mOS of 21 wks, compared with 49 pts (45%) with PS 2-3 who had 4,2 wks of mPFS and 8,4 wks of mOS. Selecting pts according to clinical prognostic/predictive factors we obtained different groups: the best one was represented by 19 pts (32%) female, adenocarcinoma, PS1, never/former smokers with a mPFS of 25,2 wks and mOS of 37,8 wks against the worst one defined by 7 pts (12%) male, squamous, current smokers with mPFS of 8,4 wks and mOS of 16,8 wks. In subsequent lines of therapy where the mPFS of 83 pts (43%) was 8.4 wks with a mOS of 21.0 wks, the PS played a decisive role: PS 1 63 pts (76%) showed respectively 12,6 wks and 25,2 wks of mPFS and mOS respect of 4,2 wks and 8,4 wks of 20 pts (24%) with PS 2-3.


90% of the Caucasian patients do not express the EGFR mutation, estimated to date in no more than 50-60% of patients diagnosed with A-NSCLC. Erlotinib is a standard treatment in 2nd / 3rd line, without adequate studies comparing with chemotherapy in wild-type population. This retrospective analysis, original for the assessment of EGFR mutational status and for the large number of cases, confirms the predictive/prognostic role of the PS 1 for the WT EGFR pts treated with erlotinib across all the lines ( p = .0001), limiting the advantage in the PS 2/3. Moreover, the results of the 2nd line shows that it is possible to identify a group of WT pts with positive predictive characteristics (PS 1, ADC, never / former smokers, female) to receive a greater benefit in survival (p= .03) with the use of erlotinib.


All authors have declared no conflicts of interest.