1323 - Study of the safety and efficacy of epidermal growth factor receptor tyrosine kinase inhibitors in 97 patients with epidermal growth factor receptor...

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer agents
Non-small-cell lung cancer
Translational Research
Basic Principles in the Management and Treatment (of cancer)
Biological therapy
Presenter Masayuki Ishibashi
Authors M. Ishibashi1, K. Ogawa2, S. Motizuki2, S. Hanada2, H. Uruga2, H. Takaya2, A. Miyamoto2, N. Morokawa2, T. Fujii3, K. Kishi2
  • 1Dept. Of Internal Medicine, Toranomon Hospital, 105-8470 - Tokyo/JP
  • 2Dept. Of Respiratory Medicine, Toranomon Hospital, 105-8470 - Tokyo/JP
  • 3Pathology, Troranomon Hospital, 105-8470 - tokyo/JP



Recent phase 3 trials have demonstrated that first-line epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) improved the progression-free survival (PFS) in good performance status (PS) patients with non-small cell lung cancer (NSCLC) harboring activating EGFR mutations. We aimed to study the safety and efficacy of EGFR TKIs in patients with activating EGFR mutation-positive NSCLC in a normal clinical setting.

Materials and methods

Between August 2006 and October 2011, 487 patients with NSCLC were examined for EGFR mutations by the peptide nucleic acid–locked nucleic acid polymerase chain reaction clamp method at Toranomon Hospital. One hundred and forty-two patients were tested positive for EGFR mutations: 82 patients had exon 19 deletions and 60 patients had L858R mutations in exon 21. Of these 142 patients, EGFR TKIs were administered in 97 patients (51 men and 46 women, with a median age of 68 years). We retrospectively studied the clinical data to determine the efficacy and toxicity of EGFR TKIs that were administered to these patients. The overall survival and PFS from the start date of EGFR TKI therapy were calculated using the Kaplan–Meier method.


Thirty-one patients were aged 75 or more. Fourteen patients had a poor PS of 3 or 4 and 57 patients had previously undergone chemotherapy. Gefitinib was administered to 76 patients, erlotinib to 56 patients, and both drugs to 35 patients. The response rate was 49%. The median PFS was 10.6 months and the median survival time was 26.4 months. The following grade 3 or 4 toxicities were observed: skin rash (n = 6), increased aminotransferase levels (n = 4), and interstitial lung disease (n = 6).


Although patients who are elderly, those with poor PS, and those who had previously undergone chemotherapy were included in this study, EGFR TKIs for 97 patients with EGFR mutation-positive NSCLC in clinical practice showed a median PFS of 10.6 months and a median survival time of 26.4 months without treatment-related death. The results of this study were consistent with those of the recent phase 3 trials.


All authors have declared no conflicts of interest.