Clinical aspects and perspectives of erlotinib in the treatment of patients with biliary tract cancer.

INTRODUCTION: Patients with non-resectable biliary tract cancer have a poor prognosis even if treated with systemic chemotherapy. One hope for improving treatment is through molecular biology and the characterization of specific cancer driving alterations followed by the design of targeted drugs. The epidermal growth factor receptor system is upregulated in many cancers and can be targeted by the protein kinase inhibitor erlotinib. Erlotinib has demonstrated a clinically applicable effect in pancreatic and lung cancer Areas covered: In this review, the author presents the published clinical data about erlotinib in biliary tract cancer. The data is interpreted with respect to its clinical value and in regards to its future development. EXPERT OPINION: Erlotinib has low activity as a monotherapy, but has shown synergistic effects when combined with bevacizumab. The only phase III trial with erlotinib was negative, but suggested improved progression free survival in cholangiocarcinoma patients when added to gemcitabine and oxaliplatin. There is no clinical, radiological or molecular marker to guide therapy, but genomic profiling and basket or umbrella trials may be useful in identifying the subset of patients benefitting from erlotinib. Until this subgroup has been defined, erlotinib has no value to biliary tract cancer patients in the daily clinic.