title: Trans-arterial chemoembolization of metastatic colorectal carcinoma to the liver adopting DC Bead®, drug-eluting bead loaded with irinotecan: results of a phase II clinical study.
abstract: Trans-arterial chemoembolization (TACE) is a promising locoregional therapy for the treatment of primary hepatic tumors and liver metastases. The aim of the study was to define the activity and outcome of using DC Bead, drug-eluting bead, a spherical embolic device capable of being loaded with irinotecan.
  
  
  METHODS
  We conducted a double institutional, single arm, phase II clinical study to evaluate TACE adopting this device in 82 patients presenting with metastatic colorectal carcinoma to the liver after failing chemotherapy. The primary endpoints were tumor shrinkage, safety, feasibility, compliance, and overall survival. RECIST criteria were used to assess responses. Quality of life (QoL) was addressed using Edmonton SAS improvement scale.
  
  
  RESULTS
  Out of 103 patients considered, 82 were enrolled and underwent a total of 185 treatments of TACE. The median number of TACE was 2.2 (1-4). A post-embolization syndrome was frequently observed. Adverse observed effects were: right upper quadrant pain (40%), fever (80%), nausea (27%) and increased transaminases (70%). The median follow-up was 29 months. Within one month after treatment, each patient received a computed tomograpic scan. It showed reduction of metastatic contrast enhancement in all patients. Responses were 78% at 3 months. After the first treatment, 75 out 82 patients declared an improvement of their well being lasting more than 18 weeks. The median duration of response was 6 (range 3-10) months; the median follow up was 29 (range 7-48) months. The median survival was 25 (range 6-34) months, with progression free survival at 8 (range 4-16) months.
  
  
  CONCLUSIONS
  We suggest that TACE adopting DC Bead®, drug-eluting bead loaded with irinotecan could be proposed as palliative therapy for unresectable and chemotherapy resistant liver metastases from CRC.
authors.affiliation: Unit of Oncological Interventional Radiology, IOV (IRCCS), Padova, Italy. camillo.aliberti@ioveneto.it
authors.forename: Camillo
authors.initials: C
authors.lastname: Aliberti
authors.forename: Giammaria
authors.initials: G
authors.lastname: Fiorentini
authors.forename: Pier Carlo
authors.initials: PC
authors.lastname: Muzzio
authors.forename: Fabio
authors.initials: F
authors.lastname: Pomerri
authors.forename: Massimo
authors.initials: M
authors.lastname: Tilli
authors.forename: Sergio
authors.initials: S
authors.lastname: Dallara
authors.forename: Giorgio
authors.initials: G
authors.lastname: Benea
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001158:Arteries / Q000473:pathology; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010166:Palliative Care; D011446:Prospective Studies; D011788:Quality of Life; D014057:Tomography, X-Ray Computed / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000077146:Irinotecan; D002166:Camptothecin