title: Efficacy of infusional 5-fluorouracil, doxorubicin, and mitomycin-C (iFAM) in the treatment of patients with gemcitabine-pretreated pancreatic cancer and analysis of prognostic factors in a salvage setting.
abstract: OBJECTIVE
  In gemcitabine-pretreated pancreatic cancer, salvage chemotherapy has not been established, and the prognostic factors are not completely known. The purpose of this study was to determine the efficacy and safety of infusional 5-fluorouracil (5-FU), doxorubicin, and mitomycin-C (iFAM) in patients with gemcitabine-pretreated pancreatic cancer and to elucidate the prognostic factors.
  
  
  METHODS
  Study eligibility was as follows: (1) 18-75 years of age; (2) relapse within 6 months after adjuvant gemcitabine-based chemotherapy (GBC) or previously treated with palliative GBC; and (3) an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. iFAM consisted of a 5-FU (800 mg/m(2)) infusion 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.
  
  
  RESULTS
  Sixty patients were enrolled. The responses to iFAM included a partial response in 6 patients (10.0%) and stable disease in 8 patients (13.3%). The median progression-free survival (PFS) and overall survival (OS) were 2.4 months (95% confidence interval [CI], 2.0-2.8 months) and 6.1 months (95% CI, 4.2-8.0 months), respectively. The 6- and 12-month survival rates were 50.4 and 26.4%, respectively. Grade 3/4 hematologic toxicities included neutropenia (3.3%) and thrombocytopenia (3.3%). The ECOG PS was a significant prognostic factor for PFS (P < 0.001) and OS (P = 0.022). An elevated CA 19-9 at the time of initiating iFAM (P = 0.011) was a poor prognostic factor for OS.
  
  
  CONCLUSIONS
  iFAM is an effective and well-tolerated in patients with gemcitabine-pretreated pancreatic cancer, even patients with an ECOG PS of 2. ECOG PS and CA 19-9 were shown to be significant prognostic factors in this salvage setting.
authors.affiliation: Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 28 Yongon dong, Chongno-gu, Seoul, 110-744, Korea.
authors.forename: Kyu-Hyoung
authors.initials: KH
authors.lastname: Lim
authors.forename: Tae-Yong
authors.initials: TY
authors.lastname: Kim
authors.forename: Kyung-Hun
authors.initials: KH
authors.lastname: Lee
authors.forename: Sae-Won
authors.initials: SW
authors.lastname: Han
authors.forename: Do-Youn
authors.initials: DY
authors.lastname: Oh
authors.forename: Seock-Ah
authors.initials: SA
authors.lastname: Im
authors.forename: Tae-You
authors.initials: TY
authors.lastname: Kim
authors.forename: Yung-Jue
authors.initials: YJ
authors.lastname: Bang
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018395:CA-19-9 Antigen / Q000097:blood; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006305:Health Status Indicators; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D009364:Neoplasm Recurrence, Local; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011379:Prognosis; D016879:Salvage Therapy / Q000379:methods; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D018395:CA-19-9 Antigen; D003841:Deoxycytidine; D016685:Mitomycin; D004317:Doxorubicin; D005472:Fluorouracil; D000093542:Gemcitabine