Abstract
In biliary tract cancer, systemic chemotherapy should be indicated for unresectable disease, and patients with good performance status have the survival benefit of chemotherapy. Recently, phase II studies of gemcitabine and tegafur/gimeracil/oteracil potassium (S-1) were conducted in Japan, and they showed promising activity against advanced biliary tract cancer. As a result, gemcitabine and S-1 have been approved for biliary tract cancer. Based on retrospective analyses and pooled analyses of phase II trials, gemcitabine and cisplatin are expected to be effective for unresectable biliary tract cancer. Furthermore, combination chemotherapy are being investigated, and randomized clinical trials between monotherapy using gemcitabine or S-1 vs. combination chemotherapy, e.g., gemcitabine+cisplatin or gemcitabine+S-1, has been under investigation. In foreign countries, combination of gemcitabine and cisplatin or gemcitabine and capecitabin. As adjuvant therapy after surgery, gemcitabine or capecitabine is applied in randomized clinical trials. Based on some randomized clinical trials, a standard chemotherapy will be established in biliary tract cancer soon.