Impact of EGFR and KRAS genotype on outcomes in a clinical trial registry of NSCLC patients initially treated with erlotinib or gefitinib

8035 Background: There is increasing interest in the impact of EGFR and KRAS genotype on patterns of response and resistance NSCLC pts treated with gefitinib or erlotinib. We created a mutation registry to track protocol-based clinical outcomes with specific mutations in NSCLC pts initially treated with an EGFR-TKI. Methods: To date, 5 clinical trials performed in the US and Europe have been included in this registry. These include: 1) erlotinib in pts age > 70 yrs; 2) erlotinib in unselected NSCLC pts; 3) gefitinib in pts with known EGFR mutations; 4) erlotinib in pts with bronchioloalveolar carcinoma (BAC) or adenocarcinoma with BAC features; and 5) erlotinib for women with adenocarcinoma who were former or never smokers. The registry includes only chemo-naive pts, to assess the impact of EGFR-TKI’s on tumors that have not been exposed to the effects of cytotoxic chemotherapy. Results: 290 previously untreated pts have been enrolled and treated in these 5 trials from 2003 until the present. 277 chemo-na...