• Phase II study (N = 60) of neoadjuvant erlotinib x 3 weeks
• Pathologic examination showed >50% necrosis in 23% of the overall and 34% of the enriched population
• Low rates of toxicity, primarily skin rash and diarrhea, with only 12% of patients stopping treatment prematurely

Across all of oncology there is considerable interest in evaluating neoadjuvant treatment with novel agents for patients with targetable mutations, and this study establishes that neoadjuvant erlotinib is safe and does not prevent NSCLC patients in an unselected population from going on to surgery. Of particular interest, 3 of the 7 patients in this pilot initiative with EGFR mutations experienced partial responses to erlotinib prior to resection. A similar neoadjuvant strategy is soon to be studied in the cooperative groups for patients with locally advanced disease about to receive combined chemoradiation therapy.