title: Gemcitabine plus cisplatin versus capecitabine plus cisplatin as first-line chemotherapy for advanced biliary tract cancer: a retrospective cohort study.
abstract: OBJECTIVE
  Gemcitabine plus cisplatin (GP) is a standard chemotherapy option for patients with advanced biliary tract cancer (BTC). We compared the efficacy and safety of capecitabine plus cisplatin (XP) versus GP in advanced BTC.
  
  
  METHODS
  The records of all patients treated with GP or XP chemotherapy for unresectable, metastatic, or recurrent BTC at the National Cancer Center between December 2001 and August 2012 were reviewed retrospectively. Patients with histologically confirmed intrahepatic cholangiocarcinoma, gallbladder cancer, or extrahepatic cholangiocarcinoma were enrolled.
  
  
  RESULTS
  Of the 344 patients enrolled, 127 received GP and 217 received XP. At a median follow-up time of 8.9 months, the median time to progression was longer in the GP group than in the XP group (5.6 vs. 4.7 months), but the difference was not statistically significant (p = 0.081). The median overall survival (OS) was 8.4 months (95% CI 6.2-10.7) in the GP group and 7.6 months (95% CI 6.8-8.7) in the XP group (p = 0.024), with statistical significance retained following multivariate analysis (HR 0.72; 95% CI 0.527-0.987; p = 0.004). Grade 3/4 toxicities were significantly more frequent in the GP group than in the XP group (40.9 vs. 24.9%, p = 0.002).
  
  
  CONCLUSIONS
  GP was superior to XP in prolonging OS, despite increasing the rate of grade 3/4 adverse events.
authors.affiliation: Center for Liver Cancer, National Cancer Center, Goyang, Republic of Korea.
authors.forename: Sang Myung
authors.initials: SM
authors.lastname: Woo
authors.forename: Woo Jin
authors.initials: WJ
authors.lastname: Lee
authors.forename: Ji Hun
authors.initials: JH
authors.lastname: Kim
authors.forename: Dong Hwan
authors.initials: DH
authors.lastname: Kim
authors.forename: Sung-Sik
authors.initials: SS
authors.lastname: Han
authors.forename: Sang-Jae
authors.initials: SJ
authors.lastname: Park
authors.forename: Tae Hyun
authors.initials: TH
authors.lastname: Kim
authors.forename: Ju Hee
authors.initials: JH
authors.lastname: Lee
authors.forename: Young Hwan
authors.initials: YH
authors.lastname: Koh
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Hong
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000209:etiology; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000069287:Capecitabine; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007970:Leukopenia / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000209:etiology; D009367:Neoplasm Staging; D012189:Retrospective Studies; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine