title: Phase II trial of combination chemotherapy with gemcitabine, 5-fluorouracil and cisplatin for advanced cancers of the bile duct, gallbladder, and ampulla of Vater.
abstract: OBJECTIVE
  For advanced cancers of the bile duct, gallbladder and ampulla of Vater, there are only a few treatment options. We explored the efficacy of the combination of gemcitabine, 5-fluorouracil and cisplatin for advanced biliary cancers.
  
  
  METHODS
  From September 2003 to April 2010, 28 patients with recurrent or metastatic biliary tract cancer were enrolled. A treatment regimen consisting of gemcitabine (800 mg/m² at a fixed dose rate on days 1 and 8), 5-fluorouracil (1 g/m²/day continuous infusion for 4 days) and cisplatin (60 mg/m² on day 2) was repeated every 3 weeks.
  
  
  RESULTS
  One (3.6%) patient showed complete response, 8 (28.6%) partial response, 14 (50%) stable disease and 5 (17.9%) disease progression. Overall, the objective response rate was 32.1% (95% CI, 17.9-50.6%) and the disease control rate was 82.1% (95% CI, 64.4-92.1%). Median progression-free survival and overall survival were 7.6 months (95% CI, 5.5-9.7) and 11.2 months (95% CI, 6.8-15.5), respectively. G3/4 neutropenia was observed in 44 (24.3%) of 181 cycles and G3/4 thrombocytopenia in 48 (26.5%) of 181 cycles. There was no treatment-related mortality.
  
  
  CONCLUSIONS
  The combined regimen of gemcitabine, 5-fluorouracil and cisplatin has comparable activity for patients with advanced cancer of the bile duct, gallbladder and ampulla of Vater. Toxicity was tolerable but substantial.
authors.affiliation: Department of Internal Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.
authors.forename: Byeong Seok
authors.initials: BS
authors.lastname: Sohn
authors.forename: Young Jin
authors.initials: YJ
authors.lastname: Yuh
authors.forename: Ki-Hwan
authors.initials: KH
authors.lastname: Kim
authors.forename: Tae Joo
authors.initials: TJ
authors.lastname: Jeon
authors.forename: Nam Sun
authors.initials: NS
authors.lastname: Kim
authors.forename: Sung Rok
authors.initials: SR
authors.lastname: Kim
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D014670:Ampulla of Vater; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D001650:Bile Duct Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003138:Common Bile Duct Neoplasms / Q000188:drug therapy; D003404:Creatinine / Q000097:blood; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D004357:Drug Synergism; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced* / Q000453:epidemiology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005706:Gallbladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006785:Hospitals, University; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D056910:Republic of Korea / Q000453:epidemiology; D012720:Severity of Illness Index; D013280:Stomatitis / Q000139:chemically induced; D013921:Thrombocytopenia / Q000139:chemically induced; D014839:Vomiting / Q000139:chemically induced; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D003404:Creatinine; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine