Lapatinib is a tyrosine kinase inhibitor of both EGFT and ErbB2, both of which are overexpressed in up to 90% and 40% of patients with SCCHN. This was the final analysis of a randomized, double-blind, clinical trial involving 688 patients with resected stage II-IVA SCCHN who were at high risk for recurrence (surgical margin <5 mm and/or extracapsular extension), who were randomized to receive cisplatin-based chemotherapy + radiation therapy (CT-RT), plus placebo or lapatinib for 1 week prior, during, and for up to 12 months post CT-RT as maintenance therapy (Harrington KJ, et al. ASCO 2014. Abstract 6005). Patients were stratified by nodal status, primary tumor location, and ErbB1 expression. At the time of unblinding, there were no statistically significant differences among the treatment groups or prespecified subgroups in disease-free survival (DFS) or overall survival. This trial suggests that adding lapatinib to standard CT-RT provides no benefit in DFS to patients with resected SCCHN at high risk for recurrence. One caveat to the data in this trial is that DFS in both treatment arms exceeded historical randomized data for CT-RT.
