title: A multi-institution phase II study of gemcitabine/S-1 combination chemotherapy for patients with advanced biliary tract cancer.
abstract: OBJECTIVE
  We aimed to evaluate the efficacy and safety of gemcitabine/S-1 combination chemotherapy for the treatment of patients with advanced biliary tract cancer.
  
  
  METHODS
  Patients with histologically or cytologically confirmed unresectable or recurrent biliary tract cancer were eligible for inclusion. The primary endpoint was overall survival. Gemcitabine was administered intravenously at a dose of 1,000 mg/m(2) over 30 min on days 1 and 8, and oral S-1 was administered daily at a dose of 60 mg/m(2) on days 1-14. This schedule was repeated every 3 weeks until disease progression or patient refusal.
  
  
  RESULTS
  Twenty-five patients were enrolled between October 2007 and January 2009. Eleven patients (44%) had extrahepatic bile duct cancer, 5 (20%) had intrahepatic bile duct cancer, 8 had gallbladder cancer (32%), and 1 (4%) had ampulla of Vater cancer. The median overall survival time was 12.7 months (95% CI, 8.4-23.5 months), and the 1-year survival rate was 52.0% (95% CI, 31.2-69.2%). Of the 23 patients with evaluable target regions, seven patients experienced a partial response, and an overall response rate was 30.4%. The following grade 3-4 hematological toxicities occurred: neutropenia (56%), leukopenia (24%), anemia (8%) and thrombocytopenia (4%). In spite of the high incidence of grade 3-4 neutropenia, no patients developed febrile neutropenia in the present study. The major grade 3-4 non-hematological toxicities were fatigue (8%), anorexia (8%) and diarrhea (4%).
  
  
  CONCLUSIONS
  Gemcitabine/S-1 combination chemotherapy offered a promising survival benefit with acceptable toxicity in patients with advanced biliary tract cancer.
authors.affiliation: Outpatient Oncology Unit, Kyoto University Hospital, 54 Shogoin-Kawahara-cho Sakyo-ku, Kyoto, Japan. kanai@kuhp.kyoto-u.ac.jp
authors.forename: Masashi
authors.initials: M
authors.lastname: Kanai
authors.forename: Kenichi
authors.initials: K
authors.lastname: Yoshimura
authors.forename: Takehiko
authors.initials: T
authors.lastname: Tsumura
authors.forename: Masanori
authors.initials: M
authors.lastname: Asada
authors.forename: Chihiro
authors.initials: C
authors.lastname: Suzuki
authors.forename: Miyuki
authors.initials: M
authors.lastname: Niimi
authors.forename: Shigemi
authors.initials: S
authors.lastname: Matsumoto
authors.forename: Takafumi
authors.initials: T
authors.lastname: Nishimura
authors.forename: Takashi
authors.initials: T
authors.lastname: Nitta
authors.forename: Kentaro
authors.initials: K
authors.lastname: Yasuchika
authors.forename: Kojiro
authors.initials: K
authors.lastname: Taura
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Mori
authors.forename: Akihiko
authors.initials: A
authors.lastname: Hamada
authors.forename: Naoya
authors.initials: N
authors.lastname: Inoue
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Tada
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yanagihara
authors.forename: Shujiro
authors.initials: S
authors.lastname: Yazumi
authors.forename: Yukio
authors.initials: Y
authors.lastname: Osaki
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Chiba
authors.forename: Iwao
authors.initials: I
authors.lastname: Ikai
authors.forename: Masanori
authors.initials: M
authors.lastname: Fukushima
authors.forename: Shinji
authors.initials: S
authors.lastname: Uemoto
authors.forename: Etsuro
authors.initials: E
authors.lastname: Hatano
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D010094:Oxonic Acid / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000093542:Gemcitabine