Effects of lapatinib monotherapy: Results of a randomised phase II study in therapy-naive patients with locally advanced squamous cell carcinoma of the head and neck
British Journal of Cancer,  Clinical Article

del Campo JM et al. –Short-term lapatinib monotherapy did not demonstrate apoptotic changes, but provided evidence of clinical activity in locally advanced SCCHN, and warrants further investigation in this disease.


  • 107 therapy-naive patients with locally advanced SCCHN were randomised (2?:?1) to receive lapatinib or placebo for 2–6 weeks before chemoradiation therapy (CRT)
  • Endpoints included apoptosis and proliferation rates, clinical response, and toxicity

  • Versus placebo, lapatinib monotherapy did not significantly increase apoptosis detected by terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate-biotin nick-end labelling or caspase-3 assays
  • Statistically significant decrease in proliferation using Ki67 assay was observed (P=0.030)
  • In subset of 40 patients that received 4 weeks of lapatinib or placebo, ORR was 17% (n=4/24) vs 0% (n=0/16)
  • In lapatinib single-agent responders, all had EGFR overexpression, 50% had EGFR amplification, and 50% had HER2 expression by immunohistochemistry (including one patient with HER2 amplification)
  • These patients showed variable modulation of apoptosis, proliferation, and phosphorylated EGFR on drug treatment
  • Following CRT, there was statistically non-significant difference in ORR between lapatinib (70%) and placebo (53%)
  • No clear correlation between changes in apoptosis or proliferation and response to chemoradiation
  • Mucosal inflammation, asthenia, odynophagia, and dysphagia were most commonly reported AEs with lapatinib

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