title: Hepatic intra-arterial injection of drug-eluting bead, irinotecan (DEBIRI) in unresectable colorectal liver metastases refractory to systemic chemotherapy: results of multi-institutional study.
abstract: BACKGROUND
  Response rates and overall outcome for patients who have failed first-line and in some cases second-line chemotherapy are as low as 12% and 7 months, respectively. The aim of this study is to evaluate the efficacy of hepatic arterial sulfonate hydrogel microsphere (drug-eluting beads), irinotecan preloaded therapy (DEBIRI) in metastatic colorectal cancer refractory to systemic chemotherapy.
  
  
  METHODS
  This was a multicenter multinational single-arm study of metastatic colorectal cancer patients who received DEBIRI after failing systemic chemotherapy from 10/2006 to 8/2008. Primary endpoints were safety, tolerance, tumor response rates, and overall survival.
  
  
  RESULTS
  Fifty-five patients who had received prior systemic chemotherapy and who underwent a total of 99 DEBIRI treatments were reviewed. The median number of DEBIRI treatments was 2 (range 1-5), median treatment dose was 100 mg (range 100-200 mg), with total hepatic treatment of 200 mg (range 200-650 mg), with 86% of treatments performed as lobar infusion and 30% of patients treated with concurrent simultaneous chemotherapy. Adverse events occurred in 28% of patients with median grade of 2 (range 1-3) with no deaths at 30 days post procedure. Response rates were 66% at 6 months and 75% at 12 months. Overall survival in these patients was 19 months, with progression-free survival of 11 months.
  
  
  CONCLUSIONS
  Hepatic arterial drug-eluting bead, irinotecan (DEBIRI) was safe and effective in treatment of metastatic colorectal cancer (MCC) refractory to multiple lines of systemic chemotherapy. DEBIRI is an acceptable therapy for treatment of metastatic colorectal cancer to the liver.
authors.affiliation: Division of Surgical Oncology, University of Louisville School of Medicine, Louisville, KY, USA. Robert.Martin@louisville.edu
authors.forename: Robert C G
authors.initials: RC
authors.lastname: Martin
authors.forename: Jonathan
authors.initials: J
authors.lastname: Joshi
authors.forename: Ken
authors.initials: K
authors.lastname: Robbins
authors.forename: Dana
authors.initials: D
authors.lastname: Tomalty
authors.forename: Petar
authors.initials: P
authors.lastname: Bosnjakovik
authors.forename: Milous
authors.initials: M
authors.lastname: Derner
authors.forename: Radek
authors.initials: R
authors.lastname: Padr
authors.forename: Miloslav
authors.initials: M
authors.lastname: Rocek
authors.forename: Alexander
authors.initials: A
authors.lastname: Scupchenko
authors.forename: Cliff
authors.initials: C
authors.lastname: Tatum
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016503:Drug Delivery Systems; D005240:Feasibility Studies; D005260:Female; D006499:Hepatic Artery; D006801:Humans; D007261:Infusions, Intra-Arterial; D000077146:Irinotecan; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016879:Salvage Therapy; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000077146:Irinotecan; D002166:Camptothecin