Abstract: |
Previously untreated patients with only liver metastases from CRC were randomized to either intrahepatic (H) or systemic (S) infusion of fluorodeoxyuridine (FUDR). The dose was 0.3 and 0.125 mg/kg/day for 14 days per month in the H and S groups, respectively. All patients underwent exploratory laparotomy to evaluate the extent of liver involvement and to assure the absence of extrahepatic disease. In the H group, the Infusaid pump was connected to hepatic artery; in the S group, the pump was connected to a venous catheter, while the hepatic artery catheter was connected to an infus-a-port, thereby allowing crossover to H therapy if disease progressed on S therapy. Of 178 patients referred to entry into the study, 63 did not have pumps placed because of extrahepatic disease (n = 33), resectable disease (n = 25), no tumor (n = 4), and infection (n = 1). Of the remaining 99 patients, 48 were randomized to H, and 51 to S. The two groups were well-matched for all variables including PS, percentage of liver involvement, and baseline LDH. Partial remissions (>50% reduction in measurable disease) were seen in 24/45 (50%) evaluable patients on H therapy, vs 10/48 (20%) on S. Extrahepatic progression occurred in 27/48 of H and 18/51 of S patients. Toxicity included ulcer disease or gastritis in 25%, bilirubin > 3 mg/dl in 19%, and biliary sclerosis in 8% of patients in the H group. The dose limiting toxicity for the S group was diarrhea (70%). More than half of the S group underwent a crossover to H, and 58% of crossovers had a response or stabilization of disease on H after tumor progression on S. Median survivals are presently 17 and 12 months in H and S groups, respectively. If the systemic group is divided into those who crossed over to H and versus those who did not have a crossover (usually for mechanical reasons), the median survivals are presently 18 and 8 months, respectively. This study suggests that intrahepatic therapy increases response rate and appears to be a more effective way of treating hepatic metastases from colorectal carcinoma. © 1987. |