Long survival of never smoking non-small cell lung cancer (NSCLC) patients (pts) treated with erlotinib HCI (OSI-774) and chemotherapy: Sub-group analysis of TRIBUTE

7061 Background: Erlotinib (Tarceva) is a potent HER1/EGFR tyrosine kinase inhibitor (TKI). Monotherapy trials of EGFR-TKIs have suggested never smokers and pts with bronchioloalveolar cell carcinoma (Shah, Proc ASCO 2003 #2524; Miller, Proc ASCO 2003 #2491) are more likely to benefit from these agents. TRIBUTE was a placebo-controlled study randomizing pts with previously untreated advanced NSCLC to receive erlotinib, 150 mg/d, or placebo (PBO) with 6 cycles of carboplatin/paclitaxel (CP) followed by maintenance monotherapy. Methods: Pts with performance status (PS) of 0 or 1 were eligible. Randomization was stratified by stage, >5% weight loss (WL) prior 6 mos., measurable disease (MD), and study site. The primary endpoint was overall survival (OS). Other endpoints included time to progression (TTP), objective response (OR) and duration of response. Results: 1059 pts randomized/treated (526 erlotinib; 533 PBO). No difference was observed in OS (p=0.95), OR (p=0.36) or TTP (p=0.36) with erlotinib and CP ...