A Phase II Trial of Erlotinib As Front-Line Treatment in Clinically Selected Patients With Non-Small-Cell Lung Cancer

摘要: Abstract Background The purpose of this study was to evaluate the efficacy erlotinib as front-line treatment in clinically selected patients with non–small-cell lung cancer (NSCLC). Patients and Methods Forty-nine previously untreated white who had stage IIIB/IV pulmonary adenocarcinoma or bronchoalveolar carcinoma were nonsmokers former light smokers treated 150 mg daily, irrespective EGFR mutation status. Results In an intention-to-treat analysis, overall response rate (ORR) 24.5%. median progression-free survival (PFS) 6.7 months, (OS) 15.5 1-year 61.3%. Among 36 for whom tumor material available, 9 (25%) activating mutations. ORR 66.7% mutations 14.8% wild-type (2 P = .006). mutations, OS has not been reached, whereas it 12.9 months wild type .045). Twenty-four a PFS > 6 months; 11 (45.8%) them 7 (29.1%) mutation. Conclusions selection -directed tyrosine kinase inhibitors (TKIs) should be based on testing. However use clinical (smoking status) pathologic (adenocarcinoma) criteria may identify subgroup advanced/metastatic NSCLC can benefit from when testing is feasible.