122P - Icotinib as first-line treatment for elderly patients with EGFR 19 or 21 mutation in advanced NSCLC: A phase-IV, open-label, single-arm study

Date 17 April 2015
Event ELCC 2015
Session Poster lunch
Topics Anti-Cancer Agents & Biologic Therapy
Geriatric Oncology
Non-Small-Cell Lung Cancer, Metastatic
Presenter Baohui Han
Citation Annals of Oncology (2015) 26 (suppl_1): 29-44. 10.1093/annonc/mdv050
Authors B. Han1, C. Shi2, J. Qian2, R. Li2
  • 1Department Of Pulmonary, Shanghai Chest Hospital, 200030 - Shanghai/CN
  • 2Department Of Pulmonary, Shanghai Chest Hospital, Shanghai/CN



The number of elderly patients with non-small cell lung cancer (NSCLC) continues to increase. Icotinib, an oral EGFR tyrosine kinase inhibitor, had shown antitumour activity and favourable toxicity in the phase-III ICOGEN trial. This phase-IV study aimed to investigate the efficacy and safety of icotinib as first-line treatment for elderly patients with advanced NSCLC harboring EGFR 19 or 21 mutation.


Chemotherapy-naive patients aged 70 years or older with stage IIIB or IV NSCLC harboring EGFR mutations (exon 19 del or L858R) were enrolled and treated with 125 mg of icotinib three times daily until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival. Secondary endpoints were safety, response rate (RR), disease control rate (DCR) and overall survival (OS).


Between Oct 12, 2012 and Jan 2, 2014, 35 eligible patients were enrolled. The median age was 76 years (range: 70-82 years). Baseline characteristics included: female/male 17/18; stage IIIB/IV 9/26; adenocarcinoma/non-adenocarcinoma 30/5; never smoker/smoker 22/13; exon 19 del/L858R 16/19. Overall response rate was 62.9% and DCR was 97.1% (CR/PR/SD/PD 0/22/12/1). The most common adverse events were rash (65.7%), diarrhea (45.7%) and anorexia (14.39%). Grade 3 skin rash occurred in 1 patient. None of the 35 patients experienced lung toxicities. Median PFS was 19.5 months (95% CI: 12.3- .) and median OS has not been attained yet.


First-line icotinib showed efficacy and tolerable toxicity in elderly patients with EGFR mutations.

Clinical trial identification NCT01646450 July 17, 2012


All authors have declared no conflicts of interest.