title: Outcome of infusional 5-fluorouracil, doxorubicin, and mitomycin-C (iFAM) chemotherapy and analysis of prognostic factors in patients with refractory advanced biliary tract cancer.
abstract: OBJECTIVE
  The purpose of this study was to determine the efficacy and safety of infusional 5-fluorouracil (5-FU), doxorubicin, and mitomycin-C (iFAM) as salvage chemotherapy in biliary tract cancer (BTC) and to identify prognostic factors.
  
  
  METHODS
  Fifty patients received 5-FU 800 mg/m(2) over 10 h on days 1-5, doxorubicin 30 mg/m(2) on day 1 and mitomycin-C 8 mg/m(2) on day 1, every 4 weeks. The primary endpoint was the overall survival (OS) rate at 6 months.
  
  
  RESULTS
  The responses to iFAM were as follows: partial response in 2 patients (4.2%) and stable disease in 9 patients (18.7%). The median progression-free survival and OS were 2.2 months and 5.6 months, respectively. The 6-month OS rate was 48%. Grade 3/4 adverse events included neutropenia (10%), thrombocytopenia (8%), and anemia (2%). Based on multivariate analysis, Eastern Cooperative Oncology Group (ECOG) performance status, serum albumin, and response to previous chemotherapy were significantly associated with OS. Three risk groups based on the number of 3 poor prognostic factors (0 vs. 1 vs. 2-3) were well correlated to OS (8.7 vs. 5.5 vs. 2.4 months, respectively; p = 0.0002).
  
  
  CONCLUSIONS
  iFAM as salvage regimen has modest effect and tolerable toxicity in advanced BTC. The described risk group classification may help guide treatment plans.
authors: Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors: Kyu-Hyoung
authors: KH
authors: Lim
authors: Sae-Won
authors: SW
authors: Han
authors: Do-Youn
authors: DY
authors: Oh
authors: Seock-Ah
authors: SA
authors: Im
authors: Tae-You
authors: TY
authors: Kim
authors: Yung-Jue
authors: YJ
authors: Bang
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D015999:Multivariate Analysis; D009503:Neutropenia / Q000139:chemically induced; D011379:Prognosis; D012709:Serum Albumin / Q000032:analysis; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D012709:Serum Albumin; D016685:Mitomycin; D004317:Doxorubicin; D005472:Fluorouracil