Journal of Clinical Oncology, Vol 7, 1646-1654, Copyright © 1989 by American Society of Clinical Oncology
A randomized trial of continuous intravenous versus hepatic intraarterial floxuridine in patients with colorectal cancer metastatic to the liver: the Northern California Oncology Group trial
DC Hohn, RJ Stagg, MA Friedman, JF Hannigan Jr, A Rayner, RJ Ignoffo, P Acord and BJ Lewis
Cancer Research Institute, University of California, San Francisco.
In 1983, the Northern California Oncology Group (NCOG) instituted a
randomized trial of intravenous (IV) versus intraarterial (IA) floxuridine
(FUDR) administered via an implantable pump for patients with colorectal
cancer metastatic to the liver. The study objectives were to compare the
hepatic response rate, time to hepatic progression, and toxicity for the
two treatment arms. The study design, which allowed patients failing IV
FUDR to crossover to the IA arm, prevents a meaningful comparative analysis
of survival. Patients with liver-only metastases (N = 143) were randomized,
76 to the IV arm and 67 to the IA arm, and 115 patients (65 IV, 50 IA) were
fully evaluable. Of the 65 patients in the IV arm, 28 crossed over to IA
treatment after failing IV FUDR. The dose-limiting toxicity of IV FUDR was
diarrhea, whereas biliary toxicity limited both the dose and duration of IA
FUDR therapy. Of the first 25 patients treated with IA FUDR at a dose of .3
mg/kg/day, 10 developed radiographically evident biliary strictures, and
three developed permanent jaundice. With reduction of the initial IA FUDR
dose to .2 mg/kg/day, and adoption of a policy of early dosage reduction,
treatment interruption, or termination of therapy for persistent elevations
in alkaline phosphatase, only two further cases of serious biliary toxicity
occurred. However, 26 of the 50 IA FUDR patients ultimately had therapy
terminated because of drug toxicity rather than disease progression. When
compared with systemic infusion, infusion into the hepatic artery greatly
enhanced the antitumor activity of FUDR against colorectal liver
metastases. Although biliary toxicity is the most serious limitation of
this form of therapy, biliary stricture and jaundice usually can be averted
through careful monitoring of liver enzymes and early dosage reduction.
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