Yisheng Huang1, Li Zhang2, Yuankai Shi3, Shenglin Ma4, Meilin Liao5, Chunxue Bai6, Qingyuan Zhang7, Changli Wang8, Feng Luo9, Shiying Yu10, Shukui Qin11, Xiuyi Zhi12, Caicun Zhou13. 1. Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangdong Province. 2. Cancer Center of Sun Yat-Sen University, Guangdong Province. 3. Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing. 4. Hangzhou First People's Hospital, Zhejiang Province. 5. Lung Tumor Clinical Medicine Center, Shanghai Chest Hospital, Shanghai. 6. Department of Pulmonary Medicine, Zhongshan Hospital Affiliated with Fudan University, Shanghai. 7. Department of Medical Oncology, Tumor Hospital of Harbin Medical University, Helongjiang Province. 8. Tianjin Tumor Hospital, Tianjin. 9. Department of Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Sichuan Province. 10. Tongji Medical College, Huazhong University of Science and Technology, Hubei Province. 11. Nanjing Eight One Hospital, Jiangsu Province. 12. Beijing Lung Cancer Center, Capital Medical University, Beijing. 13. Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, PR China caicunzhoudr@163.com.
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).
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).