title: Precision hepatic arterial irinotecan therapy in the treatment of unresectable intrahepatic cholangiocellular carcinoma: optimal tolerance and prolonged overall survival.
abstract: BACKGROUND
  Unresectable intrahepatic cholangiocellular carcinoma (ICC) carries a poor prognosis, and there are few chemotherapeutic treatments to prolong survival. The purpose of this study was to assess the efficacy of drug-eluting bead (DEB) therapy by transarterial infusion for unresectable ICC.
  
  
  METHODS
  A prospective multicenter study of ICC patients who received hepatic arterial DEB therapy.
  
  
  RESULTS
  Twenty-four patients with unresectable ICC were treated with DEB. Ten patients (41.6%) had recurrent ICC after prior radiofrequency ablation (n = 3) or hepatectomy (n = 7). Twenty patients (80%) had received prior chemotherapy, mostly of gemcitabine (n = 8) or Eloxatin (n = 6). The percent of overall liver involvement was < 25% (n = 8), 26% to 50% (n = 11), and > 50% (n = 4). Ten patients (40%) had sites of extrahepatic disease located at lymph nodes (n = 5), bone (n = 2), peritoneum (n = 1), lung (n = 1), and mouth (n = 1). A total of 42 DEB treatments were administered. Eight were administered in combination with systemic chemotherapy of FOLFOX (n = 4) or Gemzar (n = 4). Twelve patients (48%) received a second treatment, and 4 patients (16%) received a third treatment. The median length of stay was 23 h (23-72 h). Eleven adverse reactions (26.2%) were reported. Of these, 7 (63.6%) were minor (less than grade 3). One patient died from hepatorenal syndrome. The disease of one patient was downstaged to resection. After a median follow-up of 13.6 months, the median overall survival of a multitherapeutic regimen with DEB therapy was significantly greater than chemotherapy alone (17.5 vs. 7.4 months; P = 0.02).
  
  
  CONCLUSIONS
  Bead therapy is safe and effective in patients with unresectable ICC. There is a marked survival benefit when DEB therapy is used as adjunctive therapy.
authors.affiliation: Department of Surgery, James Graham Brown Cancer Center, University of Louisville, Louisville, KY, USA.
authors.forename: Suzanne C
authors.initials: SC
authors.lastname: Schiffman
authors.forename: Tiffany
authors.initials: T
authors.lastname: Metzger
authors.forename: Gregory
authors.initials: G
authors.lastname: Dubel
authors.forename: Tomas
authors.initials: T
authors.lastname: Andrasina
authors.forename: Ivan
authors.initials: I
authors.lastname: Kralj
authors.forename: Cliff
authors.initials: C
authors.lastname: Tatum
authors.forename: Kelly M
authors.initials: KM
authors.lastname: McMasters
authors.forename: Charles R
authors.initials: CR
authors.lastname: Scoggins
authors.forename: Robert C G
authors.initials: RC
authors.lastname: Martin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D001650:Bile Duct Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D001653:Bile Ducts, Intrahepatic / Q000187:drug effects* / Q000601:surgery; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018281:Cholangiocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006499:Hepatic Artery; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D011355:Prodrugs; D011446:Prospective Studies; D016879:Salvage Therapy; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D011355:Prodrugs; D000077146:Irinotecan; D002166:Camptothecin