Efficacy of erlotinib in previously treated patients with advanced non-small cell lung cancer: analysis of the Chinese subpopulation in the TRUST study.

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).