Phase II study of hepatic arterial floxuridine, leucovorin, and dexamethasone for unresectable liver metastases from colorectal carcinoma.
OBJECTIVE
To determine the toxicity, response rate, and survival of a regimen of hepatic arterial floxuridine (FUDR) with leucovorin (LV) and dexamethasone (Dec) for the treatment of unresectable hepatic metastases from colorectal carcinoma.


METHODS
Sixty-two patients with hepatic metastases (33 previously untreated with chemotherapy) were treated with FUDR (0.30 mg/kg/d) and LV (15 mg/m2/d) and Dec (20 mg total dose) as a 14-day hepatic arterial infusion via an implantable pump alternating with 2 weeks of saline.


RESULTS
The complete response (CR) plus partial response (PR) rate was 78% in previously untreated patients, with a median survival duration of 24.8 months; 1- and 2-year survival rates were 91% and 57%, respectively. In the previously treated group, the response rate was 52%, with a median survival duration of 13.5 months. Only 3% of patients (two of 62) developed biliary sclerosis; this was significantly lower than the 21% biliary sclerosis rate observed in our previous trial of hepatic arterial FUDR and LV without Dec (P = .002).


CONCLUSIONS
The addition of Dec to hepatic arterial FUDR and LV reduces biliary toxicity while maintaining an excellent response rate and survival. We recommend that this treatment be studied further.
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021.
N
N
Kemeny
J A
JA
Conti
A
A
Cohen
P
P
Campana
Y
Y
Huang
W J
WJ
Shi
J
J
Botet
S
S
Pulliam
J R
JR
Bertino
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001663:Bilirubin / Q000378:metabolism; D015179:Colorectal Neoplasms / Q000473:pathology*; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage; D006801:Humans; D007261:Infusions, Intra-Arterial; D002955:Leucovorin / Q000008:administration & dosage; D008111:Liver Function Tests; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis
D005467:Floxuridine; D003907:Dexamethasone; D002955:Leucovorin; D001663:Bilirubin