Superselective intra-arterial chemotherapy with mitomycin C in liver and gallbladder cancer.

This phase 2 study was undertaken to evaluate the feasibility and efficiency of superselective intra-arterial chemotherapy with mitomycin C (SIAC) in patients with liver and gallbladder cancer and compare them to hepatic artery ligation (HAL) and regional chemotherapy with 5-fluorouracil (5-FU). Survival time was related to the percent hepatic replacement (PHR) of the tumour (P less than 0.01) in all patients. SIAC had no advantage over HAL +/- 5-FU as chemotherapy regimen for unresectable liver cancer. The overall response rate of SIAC was 42% (15/36), 27% (3/11) for primary liver cancer, 40% (8/20) for hepatic metastases from colorectal cancer and 60% (3/5) for carcinoma of the gallbladder. The patients who responded to SIAC survived significantly longer (P less than 0.005). The survival rate for responders at 1 year was 68% and for non-responders 26%. Chemotherapy toxicity after SIAC occurred in 16 (44%) patients requiring cessation of therapy in 6 (16%) patients. We conclude that the results of this phase 2 clinical trial were not encouraging. There is an urgent need for reliable means of predicting tumour response to chemotherapy and for a more careful patient selection.