Phase II clinical trial of chemotherapy-naive patients≥ 70 years of age treated with erlotinib for advanced non–small-cell lung cancer

摘要: Purpose This is a phase II, multicenter, open-label study of chemotherapy-naïve patients with non–small-cell lung cancer (NSCLC) and age ≥ 70 years who were treated with erlotinib and evaluated to determine the median, 1-year, and 2-year survival. The secondary end points include radiographic response rate, time to progression (TTP), toxicity, and symptom improvement. Patients and Methods Eligible patients with NSCLC were treated with erlotinib 150 mg/d until disease progression or significant toxicity. Tumor response was assessed every 8 weeks by computed tomography scan using Response Evaluation Criteria in Solid Tumors. Tumor samples were analyzed for the presence of somatic mutations in EGFR and KRAS. Results Eighty eligible patients initiated erlotinib therapy between March 2003 and May 2005. There were eight partial responses (10%), and …