1280P - A phase II study of erlotinib monotherpay in previously treated advanced non-small cell lung cancer (NSCLC) without EGFR gene mutation who have neve...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Presenter Makoto Maemondo
Authors M. Maemondo1, Y. Ishii2, Y. Demura3, K. Okudera4, K. Takamura5, N. Morikawa6, M. Harada7, O. Ishimoto8, K. Kobayashi9, Y. Saijo10
  • 1Respiratory Medicine, Miyagi Cancer Center, 981-1293 - Natori/JP
  • 2Pulmonary Medicine And Clinical Immmunolog, Dokkyo Medical University School of medicine, 321-0293 - Tochigi/JP
  • 3Respiratory Medicine, Ishikawa Prefectural Central Hospital, 920-8530 - Kanazawa/JP
  • 4Respiratory Medicine, Hirosaki Central Hospital, 036-8188 - Hirosaki/JP
  • 5Respiratory Medicine, Obihiro-Kousei General Hospital, 080-0016 - Obihiro/JP
  • 6Medical Oncology, TOHOKU KOUSEI-NENKIN Hospital, Sendai/JP
  • 7Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, Sapporo/JP
  • 8Respiratory Medicine, Sendai Kosei Hospital, Sendai/JP
  • 9Respiratory Medicine, Saitama International Medical Center, Saitama/JP
  • 10Medical Oncology, Niigata University Graduate School of Medical and Dental Sciences, Nigata/JP



Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) have dramatically improved clinical outcome in NSCLC harboring EGFR gene mutation. On the other hand, survival benefit from erlotinib was revealed even in the NSCLC patients with wild type (wt) EGFR gene by subset analyses of several phase III trials. Additionally, smoking status was identified as one of predictive factors of erlotinib efficacy. This study aimed to evaluate the efficacy of erlotinib in Japanese NSCLC patients with wt-EGFR and to find a biomarker that predicts the efficacy of erlotinib except EGFR gene mutation.


The primary endpoint was an objective response rate. Secondary endpoints included disease control rate, overall survival, safety, and a biomarker finding. Advanced NSCLC patients without EGFR gene mutation who had received one to three prior chemotherapy regimens and who had never or light smoked were eligible in this study. EGFR gene status was evaluated by the PNA-LNA PCR clamp method. Erlotinib was administered daily (150mg/day) until disease progression or unacceptable toxicities.


Forty seven patients were enrolled between March 2010 and November 2011. One patient was excluded for evaluation because having activating EGFR mutation. Efficacy and safety were evaluated among 46 patients. Best responses were PR 7 (15.2%), SD 12 (26.1%), PD 26 (46.4%), and NE 1 (2.2%). Response rate and disease control rate were 15.2% (95%CI: 4.9-25.5%) and 41.3 % (95%CI 27.1-55.5%) respectively. Median PFS were 1.5 months and 5 (11%) cases received erlotinib for more than 6 months. Grade 3 or 4 adverse events were anorexia (4), skin rash (2), neutropenia (1), leukopenia (1), anemia (2), elevation of AST/ALT (1), rectal ulcer (1), and cerebral infarction (1).Two patients suffered grade 3 interstitial lung disease.


This is the first report to evaluate erlotinib efficacy in NSCLC selected by EGFR mutation negative and smoking status. This study elucidated that erlotinib has appreciable effect on some EGFR-wild cases without severe toxicities. Finding of predictive marker became more important. Biomarker analysis is ongoing.


M. Maemondo: M. Maemondo received honoraria for lecture fees from Chugai.

All other authors have declared no conflicts of interest.