title: Adjuvant intra-arterial 5-fluoruracil, leucovorin, epirubicin and carboplatin with or without systemic gemcitabine after curative resection for pancreatic adenocarcinoma.
abstract: BACKGROUND
  The role of adjuvant therapy in pancreatic cancer remains controversial. Gemcitabine given systemically seems to be effective; intra-arterial chemotherapy (IAC) has a deep rationale.
  
  
  METHODS
  The goal was to evaluate the impact of postoperative IAC followed or not by systemic gemcitabine in patients after curative resection for pancreatic adenocarcinoma. 5-fluoruracil 750 mg sq m(-1), leucovorin 75 mg sq m(-1), epirubicin 45 mg sq m(-1), carboplatin 225 mg sq m(-1) were administered every 3 weeks into celiac axis for three cycles (FLEC regimen), then gemcitabine at the dosage of 1 g sq m(-1) on days 1, 8 and 15 every 4 weeks for 3 months (FLECG regimen).
  
  
  RESULTS
  Forty-seven patients entered the study. The first 24 received only IAC (FLEC regimen), the other 23 received the same intra-arterial regimen followed by systemic gemcitabine (FLECG regimen). After a median follow-up of 16.9 months, 29 patients recurred (61.7%). Median disease free survival (DFS) was 18 months and median overall survival (OS) was 29.7 months. One-year DFS was 59.4% and 1-year OS was 75.5%. Main grade 3 toxicity related to IAC was only nausea/vomiting in 4%; regarding gemcitabine, grade 3 toxicities were anaemia 8%, leukopenia 8%, thrombocitopenia 17%, nausea/vomiting 4%.
  
  
  CONCLUSIONS
  FLEC regimen with or without gemcitabine is active with a very mild toxicity and results are very encouraging in an adjuvant setting.
authors.affiliation: Department of Oncology, General City Hospital, Massa Carrara, Italy. maurizio.cantore@us11.toscana.it
authors.forename: Maurizio
authors.initials: M
authors.lastname: Cantore
authors.forename: Giovanni
authors.initials: G
authors.lastname: Serio
authors.forename: Paolo
authors.initials: P
authors.lastname: Pederzoli
authors.forename: Andrea
authors.initials: A
authors.lastname: Mambrini
authors.forename: Calogero
authors.initials: C
authors.lastname: Iacono
authors.forename: Coriolano
authors.initials: C
authors.lastname: Pulica
authors.forename: Paola
authors.initials: P
authors.lastname: Capelli
authors.forename: Mirko
authors.initials: M
authors.lastname: Lombardi
authors.forename: Tito
authors.initials: T
authors.lastname: Torri
authors.forename: Paola
authors.initials: P
authors.lastname: Pacetti
authors.forename: Mauro
authors.initials: M
authors.lastname: Pagani
authors.forename: Giammaria
authors.initials: G
authors.lastname: Fiorentini
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007261:Infusions, Intra-Arterial; D017567:Karnofsky Performance Status; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D015251:Epirubicin; D016190:Carboplatin; D002955:Leucovorin; D005472:Fluorouracil; D000093542:Gemcitabine