title: Efficacy of erlotinib in previously treated patients with advanced non-small cell lung cancer: analysis of the Chinese subpopulation in the TRUST study.
abstract: OBJECTIVE
  This study is to analyze the data of Chinese subpopulation in the Tarceva Lung Cancer Survival Treatment Study (TRUST-China) which was a global Phase IV study designed to provide erlotinib to previously treated patients with Stage IIIB/IV non-small cell lung cancer.
  
  
  METHODS
  Patients with pathologically confirmed, unresectable Stage IIIB/IV non-small cell lung cancer who were previously failed on or unsuitable for chemotherapy or radiotherapy were given erlotinib (150 mg/day, oral) until disease progression, intolerable toxicity or death. Efficacy and toxicity of the agent were evaluated.
  
  
  RESULTS
  In total, 519 patients Chinese patients were analyzed. The TRUST-China had similar baseline characteristics to TRUST-Global except the greater percentage of adenocarcinoma and non-smoker cases. The response rate and disease control rate were 24.7 and 75.3%, respectively. Median progression-free survival and overall survival were 6.4 and 15.4 months in the general Chinese population in the TRUST, and 10.2 and 18.9 months in non-smokers with adenocarcinoma (n = 254). Median progression-free survival and overall survival were significantly longer in non-smokers with adenocarcinoma than those in other groups (P ≤ 0.0001 and P ≤ 0.0001, respectively). Eastern Cooperative Oncology Group Performance Status (≥ 2 vs. ≤ 1, hazard ratio = 1.746, P < 0.0001) and histology (squamous cell carcinoma vs. adenocarcinoma, hazard ratio = 1.595, P = 0.0008) were independent risk factors that affected survival according to Cox regression multivariate analysis.
  
  
  CONCLUSIONS
  We confirmed the efficacy and safety of erlotinib in Chinese patients. Non-smoking patients with adenocarcinoma histology had the best clinical benefits. (NCT00949910).
authors: Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangdong Province.
authors: Yisheng
authors: Y
authors: Huang
authors: Cancer Center of Sun Yat-Sen University, Guangdong Province.
authors: Li
authors: L
authors: Zhang
authors: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing.
authors: Yuankai
authors: Y
authors: Shi
authors: Hangzhou First People's Hospital, Zhejiang Province.
authors: Shenglin
authors: S
authors: Ma
authors: Lung Tumor Clinical Medicine Center, Shanghai Chest Hospital, Shanghai.
authors: Meilin
authors: M
authors: Liao
authors: Department of Pulmonary Medicine, Zhongshan Hospital Affiliated with Fudan University, Shanghai.
authors: Chunxue
authors: C
authors: Bai
authors: Department of Medical Oncology, Tumor Hospital of Harbin Medical University, Helongjiang Province.
authors: Qingyuan
authors: Q
authors: Zhang
authors: Tianjin Tumor Hospital, Tianjin.
authors: Changli
authors: C
authors: Wang
authors: Department of Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Sichuan Province.
authors: Feng
authors: F
authors: Luo
authors: Tongji Medical College, Huazhong University of Science and Technology, Hubei Province.
authors: Shiying
authors: S
authors: Yu
authors: Nanjing Eight One Hospital, Jiangsu Province.
authors: Shukui
authors: S
authors: Qin
authors: Beijing Lung Cancer Center, Capital Medical University, Beijing.
authors: Xiuyi
authors: X
authors: Zhi
authors: Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, PR China caicunzhoudr@163.com.
authors: Caicun
authors: C
authors: Zhou
mesh_terms: D000230:Adenocarcinoma; D000077192:Adenocarcinoma of Lung; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D044466:Asian People / Q000706:statistics & numerical data*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000037:antagonists & inhibitors*; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D007391:International Cooperation; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011799:Quinazolines / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; C512478:EGFR protein, human; D066246:ErbB Receptors
keywords: EGFR mutation; TRUST study; adenocarcinoma; erlotinib; non-small cell lung cancer