Efficacy of Erlotinib on Advanced Non-small Cell Lung Cancer

BACKGROUND OBJECTIVE: Erlotinib is a selective inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase, and has been used in treating advanced non-small cell lung cancer (NSCLC). This study was to evaluate the efficacy of erlotinib on advanced NSCLC, and observe the adverse events. METHODS: An open labeled, expanded access program (EAP) was conducted on 44 pathologically confirmed advanced NSCLC patients who had received at least one regimen. Erlotinib (150 mg) was orally administered daily till disease progression or intolerable adverse events developed. The efficacy was evaluated according to RECIS criteria; the adverse events were evaluated according to NCI criteria. RESULTS: In the 44 patients, the objective response rate was 27.3%, and the disease control rate was 65.9%; the median progression-free survival time was 4.5 months (0.9-8.1 months), and the median survival time was 13.7 months (9.2-18.2 months). Adverse events were generally mild (grade Ⅰ or Ⅱ), including skin rash (81.8%) and diarrhea (56.8%). One (2.3%) patient developed grade Ⅲ elevation of serum glutamate pyruvate transaminase (SGPT). No grade Ⅳ drug-related adverse event occurred. CONCLUSION: Erlotinib is effective and safe for locally advanced or metastatic NSCLC patients who have failed previous chemotherapy.