title: Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: a Korean Cancer Study Group phase II trial.
abstract: OBJECTIVE
  Chemotherapy represents a palliative treatment, with poor response rates and a median survival of less than 6 months in patients with biliary tract cancers (BTCs). The aim of this study was to evaluate the efficacy and safety of the combination chemotherapy with gemcitabine and oxaliplatin (GEMOX) in patients with BTCs including gall bladder cancer.
  
  
  METHODS
  We carried out a nationwide multicenter phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTCs received gemcitabine 1,000 mg/m(2) (day 1 and 8) and oxaliplatin 100 mg/m(2) (day 1), every 3 weeks.
  
  
  RESULTS
  Fifty-three patients were evaluated, 60% had cholangiocarcinoma and the remaining 40% gall bladder cancer; the objective response rate was 18.9% (10/53 patients including 1 Complete response) [14.9%; 95% confidence interval (CI), 7.4-25.7%] in the treated population. Stable disease were observed in 27/53 (50.9%) patients, disease control rate was achieved in 69.8% of all patients. Median progression-free survival was 4.8 months (3.1-6.5, 95% CI) and median overall survival was 8.3 months (5.8-10.8, 95% CI). Grade 3/4 toxicities included neutropenia (33.9% of patients) and thrombocytopenia (7.6%).
  
  
  CONCLUSIONS
  The GEMOX regimen demonstrated a modest antitumor activity and is well tolerated in patients with advanced BTCs.
authors: Division of Hematology/Oncology, Department of Internal Medicine, Chung-Ang University College of Medicine, 224 Heukseok-dong, Dongjak-gu, Seoul, 156-755, Republic of Korea. alsaba@daum.net
authors: Joung-Soon
authors: JS
authors: Jang
authors: Ho Yeong
authors: HY
authors: Lim
authors: In Gyu
authors: IG
authors: Hwang
authors: Hong Suk
authors: HS
authors: Song
authors: NaeChoon
authors: N
authors: Yoo
authors: SoYoung
authors: S
authors: Yoon
authors: Yeul Hong
authors: YH
authors: Kim
authors: Eunsik
authors: E
authors: Park
authors: Jae Ho
authors: JH
authors: Byun
authors: Myung Ah
authors: MA
authors: Lee
authors: Suk Joong
authors: SJ
authors: Oh
authors: Kyung Hee
authors: KH
authors: Lee
authors: Bong Seog
authors: BS
authors: Kim
authors: Sang Cheul
authors: SC
authors: Oh
authors: Sam Yong
authors: SY
authors: Kim
authors: Sang Jae
authors: SJ
authors: Lee
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; 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 / Q000009:adverse effects / Q000031:analogs & derivatives; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D005260:Female; D005706:Gallbladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000093542:Gemcitabine