Adjuvant Erlotinib (E) Versus Placebo (P) In Non-Small Cell Lung Cancer (Nsclc) Patients (Pts) With Tumors Carrying Egfr-Sensitizing Mutations From The Radiant Trial.

7513 Background: E, anEGFR TKI, prolongs survival in pts with advanced NSCLC. Pts with tumors carrying EGFR exon 19 del or 21 L858R mutations are particularly sensitive to EGFR TKIs. Methods: RADIANT was a randomized trial of postoperative E v P in pts with completely resected stage IB-IIIA NSCLC. Pts were stratified by histology (adenocarcinoma, other), stage (IB, II, IIIA), adjuvant chemotherapy (yes, no), smoking history (never, current/former), EGFR FISH (positive, negative/undetermined) and country. Pts were randomized 2:1 to receive E 150mg/day or P for up to 2 yr. Among 973 randomized pts, EGFR mutation status was determined for 921 (95%); 161 (17%) had mutations (55% exon 19 del, 45% exon 21 L858R). These pts form the basis of this report. Results: Pts with mutations were more frequently female (65%) and non-smokers (63%); 47% had stage IB, 29% stage II, 22% stage IIIA; 49% received adjuvant chemotherapy; 47% were Asian. Some imbalances were observed (E: less chemo and lower stage; P: smaller tumo...