A clinical trial involving 93 patients with biopsy-proven colorectal cancer metastatic to the liver was conducted to evaluate the effectiveness of hepatic arterial infusion of 5-fluorodeoxyuridine (FUDR). The patient group consisted of 52 men and 41 women, with a median age of 60 years. Among them, 42 patients had previously failed systemic chemotherapy. Treatment involved the operative placement of catheters, with multiple catheters used as necessary to ensure perfusion of the entire liver. The FUDR was delivered via a totally implanted INFUSAID model 400 pump, with patients receiving cyclic therapy of 2 weeks of 0.3 mg/kg/d FUDR alternating with 2 weeks of saline. For patients with extrahepatic tumor or those whose hepatic tumor did not respond to FUDR, an additional treatment of a 30-minute intraarterial infusion of mitomycin C, 15 mg/m2, every 6 to 8 weeks was administered.
Results showed that 50 out of the 93 evaluable patients had metastatic tumor confined to the liver. Among these, 83% experienced a significant reduction in tumor size, with a median duration of response of 13 months and a median survival of 25 months from the diagnosis of liver metastases. Twenty-four of these patients remain alive. In contrast, 43 patients presented with extrahepatic metastases in addition to their liver tumor, with 74% responding to treatment, a median duration of response of 6 months, and a median survival of 14 months. Only six of these patients remain alive. Notably, none of the 93 patients died solely of uncontrolled liver tumor, and only nine died from uncontrolled liver metastases and disseminated extrahepatic tumor. The study concluded that in patients with metastatic colorectal cancer involving only the liver, hepatic arterial FUDR alone and with the addition of mitomycin C provided excellent control of hepatic tumor and appeared to prolong survival.
