AB026. S5A-2. The role of TS-1 in cholangiocarcinoma

Abstract

: Gemcitabine plus platinum, notably cisplatin, is conceived as the standard regimen for advanced biliary tract cancer (ABTC). S-1 consists of tegafur and two biomodulators that maintain high serum 5-flurouracil concentrations while reducing gastrointestinal toxicity. A phase II study, JCOG0805 showed that gemcitabine plus S-1 was more promising than S-1 alone in ABTC, and a recently phase III JCOG1113 (FUGA-BT) showed gemcitabine plus S-1 (GS) is non-inferiority to gemcitabine plus cisplatin (GC) in overall survival (OS) benefit. Our TCOG T1308 trial also demonstrated that modified GS is an active regimen with excellent safety profiles as the first-line treatment in patients with ABTCs. For the triplet regimen, KHBO1002 trial, a single-arm phase II study of GC plus S-1 combination therapy (GCS), demonstrated a favorable survival benefit in ABTC patients. Recently, KHBO1401 trial was aimed to confirm the superiority of GCS to GC in terms of survival in patients with ABTC. This phase III study demonstrated the significant survival benefits of GCS treatment over GC treatment (13.5 versus 12.6 months, P=0.046), indicating that GCS could be a new standard treatment for patients with advanced BTC in Japan. In this talk, I will briefly introduce above clinical trials and share our experience of S-1 application in the treatment of ABTCs.