• Multicenter Phase II study (N = 36) of 2 years of adjuvant erlotinib in Stage IA to IIIA EGFR-mutant NSCLC
• Two-year DFS of 94% with all but 1 relapse occurring off treatment
• Grade 3 AEs (mostly rash) were uncommon, with no Grade 4 AEs observed, and 69% of patients completed >90% of therapy

This study is relevant in that it establishes the feasibility — from a tolerability standpoint — of using erlotinib in the adjuvant setting because most patients were able to receive the planned 2 years of treatment. The efficacy data are clearly preliminary but intriguing nonetheless and perhaps reminiscent of the static-like effect seen during treatment with, for example, imatinib in gastrointestinal stromal tumors. Prospective Phase III trials will be required to determine whether patients with EGFR tumor mutations will gain an advantage from treatment with an EGFR tyrosine kinase inhibitor in the adjuvant setting rather than starting therapy upon relapse, and currently investigators almost universally agree that this strategy should be used only as part of a clinical trial. In that regard, cooperative group studies are finally being implemented and should accrue quickly — perhaps like adjuvant trastuzumab trials in breast cancer a decade ago.