1289P - Higher dose icotinib in treating non-small cell lung cancer patients who progressed with conventional dose of icotinib

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Non-Small Cell Lung Cancer
Biological Therapy
Presenter Xiaoqing Liu
Citation Annals of Oncology (2014) 25 (suppl_4): iv426-iv470. 10.1093/annonc/mdu349
Authors X. Liu1, W. Wang1, C. Tang1, X. Li1, J. Li1, W. Guo1, H. Qin1, L. Qu1, H. Gao1, X. Yuan2
  • 1Cancer Center, 307 Hospital of the Academy of Military Medical Sciences, 100071 - Beijing/CN
  • 2Beijing R & D Center, Betta Pharma Inc., 100176 - Beijing/CN



Icotinib is an oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) for treating non- small-cell lung cancer (NSCLC). Icotinib showed non-inferior efficacy to gefitinib in the phase III ICOGEN study, and improved efficacy was seen as the dose of icotinib increased in the phase I study. The present study was aimed to explore the safety and efficacy of higher dose icotinib (250 mg or 375 mg three times per day) in treating patients who failed with normal dose icotinib.


Patients who progressed (according to RECIST version 1.1) after conventional dose of icotinib (125mg tid) were administered with icotinib 250mg tid, until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS), secondary endpoints include objective response rates (ORR), disease control rates (DCR) and safety. This study was registered on the clinicaltrial.gov with an ID of NCT01465243.


A total of 29 patients were enrolled in this study, most patients were with stage IV disease (26/29), ECOG score 0-1 (29/29), adenocarcinoma (26/29) and non-smokers (18/29). All patients received icotinib 125 mg tid before progression with a median PFS of 4.4 months (3.4-6.7 months), and then received icotinib 250 mg tid. A total of 29 patients were evaluable for tumour response. The median PFS for 250 mg-treatment stage was 2.1 months (95%CI 1.1-3.1 months). Six patients received icotinib of 375mg tid after progression with icotinib of 250 mg tid, for whom the median PFS was 2.4 months (95%CI 1.1-3.9 months). The ORR and DCR were 6.9% (2/29) and 58.6% (17/29) respectively. Patients with over-three-months PFS when treated with 125mg icotinib have more benefits when treated with 250mg icotinib, compared with patients with PFS less-than-three months (3.0 vs 1.4 months, long-rank P = 0.0093). 51.9% of patients suffered drug-related adverse events (AE), and 1 serious adverse event (urinary tract infection) was reported. The most frequent AEs were rash and diarrhea, with incidence of 25.9% and 11.1%, respectively. No ILD or treatment-related death was reported.


Icotinib was well tolerated with 250 mg tid or 375 mg tid. NSCLC patients continued to benefit from higher dose icotinib after progression with routine dose, especially in patients with a median PFS exceeding 3 months at the 125 mg dose level.


X. Yuan is a salaried employee of Betta Pharma Inc., no other potential conflict of interest relevant to this article was reported. X. Yuan worked as assistant of Xiaoqing Liu for study directing in this study, and was involved in writing and revision of this abstract. All authors have declared no conflicts of interest.