Southwest Oncology Group Phase II Trial (S0341) of Erlotinib (OSI-774) in Patients with Advanced Non-small Cell Lung Cancer and a Performance Status of 2

In chemotherapy-naive patients with advanced NSCLC and a PS of 2, single agent erlotinib resulted in an acceptable but significant level of treatment-related side effects. With an overall DCR of 42% and median survival of 5 months, results are comparable to those achieved with chemotherapy in this population. Development of an epidermal growth factor receptor-directed biomarker selection strategy may optimize use of erlotinib in PS 2 patients.