TREATMENT OF LIVER METASTASES FROM COLORECTAL-CANCER WITH HEPATIC-ARTERY OCCLUSION, INTRAPORTAL 5-FLUOROURACIL INFUSION, AND ORAL ALLOPURINOL - A RANDOMIZED CLINICAL-TRIAL

Background. Regional therapy for colorectal liver metastases aimed at prolonging survival has not been tested fully in a randomized trial wi th untreated control subjects. This study explored the efficacy of tem porary hepatic artery occlusion followed by intraportal infusion of 5- fluorouracil (5-FU) and oral allopurinol as biochemical modulators in prolonging the survival of patients with nonresectable liver metastase s and no extrahepatic cancer. Methods. Eighty-four patients were consi dered for randomization, of whom 24 were excluded at laparotomy becaus e of extrahepatic cancer (n = 17) or resectable lesions (n = 5). In tw o patients, no cancer was identified in the liver. Thirty-two patients were allocated to receive treatment, and 28 were allocated to receive no regional or systemic treatment. Six patients were excluded after r andomization because of major protocol violations. Results. The median survival time for patients was 17 months (range, 0-66), and for contr ol subjects, the median was 8 months (range, 0-31). Log rank analysis demonstrated a significant survival benefit for treatment versus no tr eatment (P = 0.0039). (In two patients, early death was due to toxicit y from the wrong dose of 5-FU and the wrong route of administration, r espectively; the mean and median survival were reduced by 1 month). Co nclusion. This study identified a treatment modality that prolongs sur vival in patients with nonresectable liver metastases and no extrahepa tic metastases from colorectal cancer, suggesting that control subject s receiving no therapy may not be necessary in future randomized trial s.