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.
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%.
Pohlen
U
U
Department of Surgery, Charité, Universitaetsmedizin Berlin, Campus Benjamin Franklin, Germany. SU1110@aol.com
Mansmann
U
U
Berger
G
G
Germer
C T
CT
Gallkowski
U
U
Boese-Landgraf
J
J
Buhr
H J
HJ
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
D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; C083286:degradable starch microspheres; D013213:Starch; D002955:Leucovorin; D005472:Fluorouracil