title: Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma.
abstract: BACKGROUND
  Biliary tract carcinoma is an aggressive cancer, with median survival rarely exceeding 6 months. There is currently no established palliative standard of care. A Phase II trial was conducted to study a combination of oral capecitabine and gemcitabine (CapGem) as first-line therapy in patients with advanced and/or metastatic biliary carcinoma.
  
  
  METHODS
  Patients with unresectable or metastatic intrahepatic or extrahepatic biliary duct carcinoma and gallbladder carcinoma were enrolled. Eligible patients had histologically or cytologically confirmed, measurable adenocarcinoma and had not received prior therapy with capecitabine or gemcitabine. Treatment consisted of intravenous (i.v.) gemcitabine (1000 mg/m(2) on Days 1 and 8) plus oral capecitabine (650 mg/m(2) twice daily on Days 1-14) every 3 weeks for up to 6 cycles. Tumor response, survival, and safety were determined.
  
  
  RESULTS
  A total of 44 patients were evaluable. Primary tumor sites were: intrahepatic (n = 14) and extrahepatic biliary duct (n = 16); gallbladder (n = 7); and ampulla (n = 7). Fourteen (32%) patients had a partial response and 15 (34%) patients had stable disease. Median time to disease progression and overall survival were 6.0 (range, 3.8-8.1) and 14 (range, 11.4-16.6) months, respectively. The 1-year survival rate was 58%. No Grade 4 adverse events were seen. Transient Grade 3 neutropenia/thrombocytopenia and manageable (almost invariably Grade 2) nausea, diarrhea, and hand-foot syndrome were the most common adverse events.
  
  
  CONCLUSIONS
  CapGem is an active and well tolerated first-line combination chemotherapy regimen for patients with advanced/metastatic biliary tract carcinoma that offers a convenient home-based therapy.
authors.affiliation: Department of Internal Medicine, Yongdong Severance Hospital Pancreatobiliary Clinic, Yonsei University College of Medicine, Seoul, South Korea. chojy@yumc.yonsei.ac.kr
authors.forename: Jae Yong
authors.initials: JY
authors.lastname: Cho
authors.forename: Yong Han
authors.initials: YH
authors.lastname: Paik
authors.forename: Yoon Soo
authors.initials: YS
authors.lastname: Chang
authors.forename: Se Joon
authors.initials: SJ
authors.lastname: Lee
authors.forename: Dong-Ki
authors.initials: DK
authors.lastname: Lee
authors.forename: Si Young
authors.initials: SY
authors.lastname: Song
authors.forename: Jae Bock
authors.initials: JB
authors.lastname: Chung
authors.forename: Mi-Suk
authors.initials: MS
authors.lastname: Park
authors.forename: Jeong-Sik
authors.initials: JS
authors.lastname: Yu
authors.forename: Dong-Sup
authors.initials: DS
authors.lastname: Yoon
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D001707:Biopsy, Needle; D001859:Bone Neoplasms / Q000556:secondary; D000069287:Capecitabine; D044584:Carcinoma, Ductal / Q000188:drug therapy* / Q000556:secondary*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D007150:Immunohistochemistry; D008113:Liver Neoplasms / Q000556:secondary; D008175:Lung Neoplasms / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine