title: Surgical downstaging and neo-adjuvant therapy in metastatic colorectal carcinoma with irinotecan drug-eluting beads: a multi-institutional study.
abstract: BACKGROUND
  Neoadjuvant chemotherapy for potentially resectable metastatic colorectal cancer (MCC) is becoming a more common treatment algorithm. The aim of the present study was to evaluate the efficacy of precision hepatic arterial Irinotecan therapy in unresectable MCC.
  
  
  METHODS
  An open-label, multi-centre, multi-national single arm study of MCC patients, who received hepatic arterial irinotecan. Primary endpoints were safety, tolerance and metastatic tumour resection.
  
  
  RESULTS
  Fifty-five patients with metastatic colorectal to the liver underwent a total of 90 hepatic arterial irinotecan treatments. The extent of liver involvement was < 25% in 75% of the patients (n= 41), between 26 and 50% in 15% of the patients (n= 11) and >50% in 10% of the patients (n= 24). The median number of hepatic lesions was four (range 1-20), with a median total size of all target lesions of 9 cm (range 5.5-28 cm) with 50% of patients having bilobar tumour distribution. The median number of irinotecan treatments was two (range 1-5). The median treatment dose was 100 mg (range 100-200) with a median total hepatic treatment of 200 mg (range 200-650). The majority of treatments (86%) were performed as lobar infusion treatments, and 30% of patients were treated with concurrent simultaneous chemotherapy. Eleven (20%) patients demonstrated significant response and downstage of their disease or demonstrated stable disease without extra-hepatic disease progression allowing resection, ablation or resection and ablation. There were no post-operative deaths. Post-operative complications morbidity occurred in 18% of patients, with none of them hepatic related. Non-tumorous liver resected demonstrated no evidence of steatohepatitis from the irinotecan arterial infusion.
  
  
  CONCLUSIONS
  Hepatic arterial infusion irinotecan drug-eluting beads is safe and effective in pre-surgical therapy and helpful in evaluating the biology of metastatic colorectal cancer to the liver prior to planned hepatic resection.
authors.affiliation: Division of Surgical Oncology, Department of Surgery, University of Louisville School of Medicine, Louisville, KY 40292, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Bower
authors.forename: Tiffany
authors.initials: T
authors.lastname: Metzger
authors.forename: Ken
authors.initials: K
authors.lastname: Robbins
authors.forename: Dana
authors.initials: D
authors.lastname: Tomalty
authors.forename: Vlatimil
authors.initials: V
authors.lastname: Válek
authors.forename: Jean
authors.initials: J
authors.lastname: Boudný
authors.forename: Tomas
authors.initials: T
authors.lastname: Andrasina
authors.forename: Cliff
authors.initials: C
authors.lastname: Tatum
authors.forename: Robert C G
authors.initials: RC
authors.lastname: Martin
mesh_terms: D000328:Adult; D000368:Aged; D000407:Alabama; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002277:Carcinoma / Q000175:diagnosis / Q000556:secondary / Q000601:surgery / Q000628:therapy*; D017115:Catheter Ablation / Q000009:adverse effects; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant; D016009:Chi-Square Distribution; D015179:Colorectal Neoplasms / Q000473:pathology / Q000628:therapy*; D018153:Czech Republic; D005260:Female; D006498:Hepatectomy / Q000009:adverse effects; D006499:Hepatic Artery; D006801:Humans; D007261:Infusions, Intra-Arterial; D000077146:Irinotecan; D007629:Kentucky; D008113:Liver Neoplasms / Q000175:diagnosis / Q000556:secondary / Q000601:surgery / Q000628:therapy*; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D049268:Positron-Emission Tomography; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012042:Registries; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D002166:Camptothecin