Results of a prospective randomized trial of continuous regional chemotherapy and hepatic resection as treatment of hepatic metastases from colorectal primaries.

One hundred patients were entered on a randomized prospective protocol to evaluate the effectiveness of hepatic resection of single as well as multiple hepatic metastases from colorectal primaries in combination with continuous hepatic artery infusion (CHAI) of fluorodeoxyuridine (FUDR) via the implantable pump (Infusaid, Intermedics Infusaid Inc., Norwood, MA). The eight patients with single metastases were randomized to hepatic resection alone (three patients) or hepatic resection plus CHAI (five patients). The 22 patients with resectable multiple metastases were randomized between receiving CHAI only (12) or CHAI after resection of all metastases (10). Patients who had positive portal lymph nodes (14) were all treated with CHAI. Patients with unresectable metastases (31) were randomized between intravenous 5-fluorouracil or CHAI of FUDR. FUDR was alternately infused every 2 weeks at a dose of 0.1 mg/kg/24 hour escalated to .3 mg/kg/24 hour with heparinized saline as the alternative infusate. The median follow-up of all patients was 20 months. All patients with multiple resectable metastases had at least a partial response (PR) to the CHAI (PR defined as greater than or equal to 50% decrease of the sum of the products of the diameters of the lesions measured on computerized axial tomography scans), and four patients given CHAI only had no metastases in the liver on relaparotomy. Patients with resection and CHAI had a better survival than patients with CHAI only; however, the difference was not significant. Patients with positive portal nodes and CHAI had a lower PR (36%) than patients with unresectable disease treated with CHAI (52%). Patients with positive portal nodes or metastatic disease outside of the liver did significantly worse than patients with unresectable disease treated with CHAI.

Preoperative staging with computerized axial tomography and biochemical laboratory tests in patients with hepatic metastases.

Preoperative biochemical liver function tests and computerized axial tomographic (CAT) scans were performed on 100 patients as part of a prospective randomized study of treatments for liver metastases from colorectal cancer. The CAT scans reliably reflected the presence of disease in most patients but only accurately demonstrated the number and location of metastases in 43% of the patients. Extrahepatic metastases were present in 35 patients but were only seen on the CAT scans in three of these patients. The biochemical tests, which were useful for detecting hepatic metastases, were alkaline phosphatase (AP), lactic dehydrogenase (LDH), and carcinoembryonic antigen (CEA). When hepatic disease was minimal, these tests were less likely to be elevated than when there was extensive disease. Even with the combination of late generation CAT scans and biochemical tests, the accurate quantification and location of hepatic metastases and extrahepatic disease require a surgical assessment.