title: Feasibility and efficacy of gemcitabine plus cisplatin combination therapy after curative resection for biliary tract cancer.
abstract: BACKGROUND
  The aim of this multi-institutional study was to assess the feasibility and the efficacy of gemcitabine plus cisplatin (CDDP) combination therapy (GC therapy) for biliary tract cancer (BTC) in the adjuvant setting.
  
  
  METHODS
  Eligible patients identified between January 2008 and January 2013 were enrolled. GC therapy at 1,000 mg/m(2) of gemcitabine and 25 mg/m(2) of CDDP on days 1 and 8 repeated every 3 weeks was performed for 6 months. The primary endpoint was the feasibility and the adverse events, and the secondary endpoint was recurrence-free survival (RFS) and overall survival (OS).
  
  
  RESULTS
  Among 29 evaluable patients, the protocol was completed in 21 (72%) patients. Relative dose intensity (RDI) of gemcitabine and CDDP was 77% and 81%, respectively. There was no difference in the completion rate and the RDI between patients who underwent resection with vs. without major hepatectomy. Grade 3-4 toxicities included leukopenia (14%) and neutropenia (27%). Two-year RFS and 2-year OS was 59% and 90%, respectively.
  
  
  CONCLUSIONS
  Standard dose of GC therapy is tolerable in patients with BTC who underwent curative resection either with or without major hepatectomy. The survival effect of this regimen is promising, but further comparative study is needed.
authors.affiliation: Department of Gastroenterological Surgery, Chiba Cancer Center, 666-2 Nitona, Chuo-ku, Chiba, 260-8717, Japan. okainuma@chiba-cc.jp.
authors.forename: Osamu
authors.initials: O
authors.lastname: Kainuma
authors.affiliation: Department of Surgery, Tokyo University School of Medicine, Tokyo, Japan.
authors.forename: Fumihiko
authors.initials: F
authors.lastname: Miura
authors.affiliation: Department of Surgery, Tokai University School of Medicine, Isehara, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Furukawa
authors.affiliation: Department of Gastroenterological Surgery, Chiba Cancer Center, 666-2 Nitona, Chuo-ku, Chiba, 260-8717, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yamamoto
authors.affiliation: Department of Gastroenterological Surgery, Chiba Cancer Center, 666-2 Nitona, Chuo-ku, Chiba, 260-8717, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Cho
authors.affiliation: Department of Surgery, Tokyo University School of Medicine, Tokyo, Japan.
authors.forename: Keiji
authors.initials: K
authors.lastname: Sano
authors.affiliation: Department of Surgery, Tokai University School of Medicine, Isehara, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Nakagohri
authors.affiliation: Department of Surgery, National Hospital Organization Chiba-East Hospital, Chiba, Japan.
authors.forename: Takehide
authors.initials: T
authors.lastname: Asano
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001650:Bile Duct Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000601:surgery; D017734:Bile Ducts, Extrahepatic / Q000187:drug effects / Q000601:surgery; D001653:Bile Ducts, Intrahepatic / Q000187:drug effects / Q000601:surgery; D001661:Biliary Tract Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000601:surgery; D001662:Biliary Tract Surgical Procedures / Q000379:methods; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine
keywords: Adjuvant chemotherapy; Biliary tract cancer; Cisplatin; Gemcitabine