title: A single-arm, multicenter, safety-monitoring, phase IV study of icotinib in treating advanced non-small cell lung cancer (NSCLC).
abstract: BACKGROUND
  The phase 3 ICOGEN trial established the non-inferiority of icotinib to gefitinib in terms of progression-free survival (PFS) in non-small cell lung cancer (NSCLC) patients, and this led to the approval of icotinib for NSCLC by the China Food and Drug Administration. A phase 4 study was conducted to assess the safety and efficacy of icotinib in a broad range of patients with advanced NSCLC across China.
  
  
  METHODS
  This study retrospectively analyzed data from unresectable, recurrent, and/or advanced NSCLC patients who received oral icotinib 125 mg three times per day. The primary endpoint was safety. The secondary endpoints included objective response rate (ORR) and disease control rate (DCR), which were investigated overall and in subgroups such as patients with an EGFR mutation and elderly patients.
  
  
  RESULTS
  Between August, 2011 and August, 2012, a total of 6087 advanced NSCLC patients were registered in this study, of which 5549 were evaluable for safety and tumor response. The median age was 63 years (range 21-95 years), and 1571 (28.3%) patients were over the age of 70. The majority of patients were non-smokers, and had adenocarcinoma and stage IV disease. The overall incidence of adverse drug reactions (ADRs) of any grade was 31.5%. The most common ADRs included rash (17.4%) and diarrhea (8.5%), and three patients experienced interstitial lung disease (ILD). The ORR and DCR were 30.0% and 80.6%, respectively, for the overall population, and 33.4% and 81.2%, 30.3% and 80.3%, and 30.4% and 89.3%, for first-line, second-line, and third-line or multiple line subsets, respectively. In 665 EGFR-mutated patients who were evaluable for tumor response, the ORR and DCR were 49.2% (327/665) and 92.3% (614/665), respectively.
  
  
  CONCLUSIONS
  The data from over 6000 patients was consistent with the results of the ICOGEN study. Icotinib demonstrated a favorable toxicity profile and efficacy in the routine clinical setting.
authors.affiliation: Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & 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: Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.
authors.forename: Baohui
authors.initials: B
authors.lastname: Han
authors.affiliation: Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.
authors.forename: Aiqin
authors.initials: A
authors.lastname: Gu
authors.affiliation: Department of Chemotherapy, Zhejiang Cancer Hospital, Key Laboratory Diagnosis and Treatment Technology on Thoracic Oncology, Hangzhou, China.
authors.forename: Yiping
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: General Hospital of People's Liberation Army, Beijing, China.
authors.forename: Shun Chang
authors.initials: SC
authors.lastname: Jiao
authors.affiliation: Department of Lung Cancer, Cancer Institute and Hospital, Tianjin Medical University, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.
authors.forename: Chang-Li
authors.initials: CL
authors.lastname: Wang
authors.affiliation: Sichuan Cancer Hospital and Institute, Chengdu, China.
authors.forename: Jintao
authors.initials: J
authors.lastname: He
authors.affiliation: Baoding Hengxing Medicine Integrative Hospital, Baoding, China.
authors.forename: Xueke
authors.initials: X
authors.lastname: Jia
authors.affiliation: Department of Respiratory Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Department of Medical Oncology, Zhongshan City Pepole's Hospital, Zhongshan, China.
authors.forename: Jiewen
authors.initials: J
authors.lastname: Peng
authors.affiliation: Department of Thoracic Medical Oncology Peking University School of Oncology, Beijing Cancer Hospital & Institute, Beijing, China.
authors.forename: Meina
authors.initials: M
authors.lastname: Wu
authors.affiliation: Zhejiang Sir Run Run Shaw Hospital, Department of Medicine, Zhejiang University, Hangzhou, China.
authors.forename: Kejing
authors.initials: K
authors.lastname: Ying
authors.affiliation: State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, China.
authors.forename: Junye
authors.initials: J
authors.lastname: Wang
authors.affiliation: Cancer Center of the First Hospital of Jilin University, Changchun, China.
authors.forename: Kewei
authors.initials: K
authors.lastname: Ma
authors.affiliation: Beijing Key Laboratory of Drug Resistance Tuberculosis Research, 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: Department of Medical Oncology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Changxuan
authors.initials: C
authors.lastname: You
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/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China. Electronic address: suny@csco.org.cn.
authors.forename: Yan
authors.initials: Y
authors.lastname: Sun
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology*; D043844:Crown Ethers / Q000009:adverse effects / Q000627:therapeutic use*; D066246:ErbB Receptors / Q000235:genetics; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009154:Mutation; D009367:Neoplasm Staging; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D019233:Retreatment; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D043844:Crown Ethers; D011799:Quinazolines; C531470:icotinib; D066246:ErbB Receptors
keywords: EGFR TKIs; Icotinib; Non-small-cell lung cancer; Phase IV; efficacy; real-world study; safety