title: Multicenter pilot study of 5-fluorouracil, folinic acid, interferon alpha-2b and degradable starch microspheres via hepatic arterial infusion in patients with nonresectable colorectal liver metastases.
abstract: BACKGROUND
  It is necessary to establish therapeutic regimens for patients with nonresectable hepatic metastases of colorectal carcinoma. A new regional chemotherapy regimen was tested in a prospective study in three centers.
  
  
  METHODS
  An arterial port system was implanted in 95 patients. From January 1994 to March 1999, intra-arterial treatment was applied via the hepatic artery using 450 mg starch microspheres with 5 million IU recombinant interferon-alpha 2B, 500 mg/m2 folinic acid and 600 mg/m2 5-FU body surface for 5 days with a 14-day interval.
  
  
  RESULTS
  The tumor response rate was 70%. Median disease progression was 17 months, median survival 24 months. The subgroup analysis shows a significant advantage (p<0.00001) for patients with a liver tumor involvement of <25% and a median survival of 39 months compared to a tumor involvement of 25-50% (24 months) and >50% (14 months). Major toxicity problems were observed in 11%. However, there was no termination of therapy on account of these problems.
  
  
  CONCLUSIONS
  Intra-arterial chemotherapy with our new regimen was useful in patients with colorectal liver metastases who had only an intrahepatic tumor burden of <50%.
authors.affiliation: Department of Surgery, Charité, Universitaetsmedizin Berlin, Campus Benjamin Franklin, Germany. SU1110@aol.com
authors.forename: U
authors.initials: U
authors.lastname: Pohlen
authors.forename: U
authors.initials: U
authors.lastname: Mansmann
authors.forename: G
authors.initials: G
authors.lastname: Berger
authors.forename: C T
authors.initials: CT
authors.lastname: Germer
authors.forename: U
authors.initials: U
authors.lastname: Gallkowski
authors.forename: J
authors.initials: J
authors.lastname: Boese-Landgraf
authors.forename: H J
authors.initials: HJ
authors.lastname: Buhr
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002408:Catheters, Indwelling / Q000009:adverse effects; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006499:Hepatic Artery; D006801:Humans; D007261:Infusions, Intra-Arterial; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D002955:Leucovorin / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011994:Recombinant Proteins; D013213:Starch / Q000008:administration & dosage
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; C083286:degradable starch microspheres; D013213:Starch; D002955:Leucovorin; D005472:Fluorouracil