title: The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study.
abstract: BACKGROUND
  Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.
  
  
  METHODS
  Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125 mg tablet, three times per day). The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety.
  
  
  RESULTS
  From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9-6.6 m) and 5.4 months (95%CI 3.1-7.9 m), respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA) according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127), diarrhea (12.6%, 16/127) and elevation of transaminase (15.7%, 20/127).
  
  
  CONCLUSIONS
  In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02486354.
authors.affiliation: Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China.
authors.forename: Xingsheng
authors.initials: X
authors.lastname: Hu
authors.affiliation: Sun Yat-Sen University Cancer Center, Guangzhou, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China.
authors.forename: Yuankai
authors.initials: Y
authors.lastname: Shi
authors.affiliation: Shanghai Pulmonary Hospital, Tongji University, Shanghai, China.
authors.forename: Caicun
authors.initials: C
authors.lastname: Zhou
authors.affiliation: Department of Pulmonary Oncology, 307 Hospital of the Academy of Military Medical Sciences, Cancer Center, Beijing, China.
authors.forename: Xiaoqing
authors.initials: X
authors.lastname: Liu
authors.affiliation: Third Affiliated Hospital, The Third Military Medical University of People's Liberation Army, Chongqing, China.
authors.forename: Dong
authors.initials: D
authors.lastname: Wang
authors.affiliation: Nanjing Military General Hospital, Nanjing, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Song
authors.affiliation: Changhai Hospital, The Second Military Medical University, Shanghai, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Li
authors.affiliation: Jiangsu Province Cancer Hospital, Nanjing, China.
authors.forename: Jifeng
authors.initials: J
authors.lastname: Feng
authors.affiliation: Nanjing Bayi Hospital of People's Liberation Army, Nanjing, China.
authors.forename: Shukui
authors.initials: S
authors.lastname: Qin
authors.affiliation: The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, China.
authors.forename: Nong
authors.initials: N
authors.lastname: Xv
authors.affiliation: The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, China.
authors.forename: Jianying
authors.initials: J
authors.lastname: Zhou
authors.affiliation: Peking Union Medical College Hospital, Beijing, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.affiliation: The Second Xiangya Hospital, Changsha, China.
authors.forename: Chunhong
authors.initials: C
authors.lastname: Hu
authors.affiliation: Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China.
authors.forename: Shucai
authors.initials: S
authors.lastname: Zhang
authors.affiliation: Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Rongcheng
authors.initials: R
authors.lastname: Luo
authors.affiliation: Beijing Cancer Hospital, Beijing, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Wang
authors.affiliation: Betta Pharmaceuticals Co, Ltd, Hangzhou, China.
authors.forename: Fenlai
authors.initials: F
authors.lastname: Tan
authors.affiliation: Betta Pharmaceuticals Co, Ltd, Hangzhou, China.
authors.forename: Yinxiang
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Betta Pharmaceuticals Co, Ltd, Hangzhou, China.
authors.forename: Lieming
authors.initials: L
authors.lastname: Ding
authors.affiliation: Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Sun
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D043844:Crown Ethers / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009154:Mutation; D011799:Quinazolines / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043844:Crown Ethers; D011799:Quinazolines; C531470:icotinib