The Study: In LUX-Head & Neck 2, patients with unfavorable risk (basically everything but favorable risk oropharyngeal cancer), locally advanced (stage III-IV) H&N cancer undergoing platinum-based chemoradiation were randomized to receive adjuvant placebo versus the irreversible ERBB-family inhibitor afatinib x 18 months. The rationale here was, because the ERBB-family of receptors play important roles in H&N cancer, their inhibition should improve outcomes. What was that? Alarm bells? Over 600 patients were enrolled with the majority having oropharyngeal primaries, advanced nodal disease, and unknown p16-status. The trial was shut down after an interim analysis demonstrated a low likelihood afatinib would improve median disease-free survival. In fact, the subset of patients with N0-N2a disease hadworse disease-free survival with afatinib, and there was no association between ERBB-expression levels and afatinib efficacy. What’s more, these unfortunate outcomes came at the added cost of worse toxicity and reduced quality of life.
TBL: Adjuvant afatinib has no benefit for patients with locally advanced H&N cancer receiving chemoradiation. | Burtness, JAMA Oncol 2019