Background: This randomized controlled study was objectively designed to evaluate the utility cisplatin (50 mg) in transcatheter arterial embolization (TAE) for treatment of hepatocellular carcinoma (HCC).
Methods: From May 1991 to July 1993, 46 patients were included in the study. All had a pathologic verification of HCC. Clinically, all of the patients were considered inoperable. However, these patients satisfied eligibility criteria for TAE. The patients were divided into two groups by random sampling. In group I, 22 patients received TAE with the regimen of cisplatin (50 mg) mixed with Lipiodol 5-15 ml followed by gelfoam pieces. In group II, 24 patients, as a controlled group, used the regimen of Lipiodol and gelfoam (Spongostan Film, Ferrosan, Denmark) pieces only, without adding any anticancer drug. The two groups were evaluated by a series of imaging studies and various clinical examinations before and after TAE. Subsequently, TAE was performed every 2 or 3 months for all patients until there was no visible tumor, or the patient could not sustain further TAE, or the patient died.
Results: In group I, TAE was administered 61 times (average 28 times for each patient), and in group II, 73 times (average 3 times for each patient). The 1-year and 2-year survival rates of group I were 52.5% and 26.2%, and group II were 72.5% and 39.5%. Statistically, there was no significant difference in survival curves and survival rates between these two groups. Tumor response rate of group I was 68% (15/22) and group II was 67% (16/24). There was no significant difference in tumor response between these two groups. The liver and renal function studies after TAE also showed no significant difference between these two groups.
Conclusions: Based on this controlled study, the authors conclude that the addition of cisplatin does not enhance the therapeutic effect of TAE for treatment of HCC.