The RADIANT study was a randomized, double-blind, phase 3 trial comparing adjuvant erlotinib (E) versus placebo (PBO) following complete tumor resection (with or without adjuvant chemotherapy) in patients with stage IB-IIIA EGFR-positive NSCLC (Kelly K, et al. ASCO 2014. Abstract 7501). In RADIANT, 973 patients with completely resected stage IB-IIIA NSCLC were randomized 2:1 to receive E or PBO for 2 years. Patients were stratified according to stage (IB, 51%; II, 33%; IIIA, 16%), histology (59% adenocarcinoma), prior adjuvant chemotherapy (53%), smoking status (20% never smoked), EGFR status (16.5% EGFR-mutant [mut]), and country of origin (17% Asian). The primary endpoint of the study was progression-free survival, with secondary endpoints of overall survival (OS) and disease-free survival (DFS) and OS in the EGFR-mut subset. At a median follow-up of 47 months, no significant differences in median DFS or OS were observed between the E and PBO groups. Median DFS was 50.5 months in the E group and 48.2 months in the PBO group (P = .3235). Median OS had not been reached in either group. However, in the EGFR-mut subset, median DFS was 46.4 months in the E group and 28.5 months in the PBO group (P = .0391). In this subset, median OS had not been reached. While adjuvant E did not prolong DFS in the overall population, further consideration of this agent is warranted in EGFR-mut patients in this setting.
