TRANSCATHETER ARTERIAL EMBOLIZATION WITH OR WITHOUT CISPLATIN TREATMENT OF HEPATOCELLULAR-CARCINOMA - A RANDOMIZED CONTROLLED-STUDY

Background. This randomized controlled study was objectively designed to evaluate the utility cisplatin (50 mg) in transcatheter arterial em bolization (TAE) for treatment of hepatocellular carcinoma (HCC). Meth ods. From May 1991 to July 1993, 46 patients were included in the stud y. All had a pathologic verification of HCC. Clinically, all of the pa tients were considered inoperable. However, these patients satisfied e ligibility criteria for TAE. The patients were divided into two groups by random sampling. In group I, 22 patients received TAE with the reg imen of cisplatin (50 mg) mixed with Lipiodol 5-15 ml followed by gelf oam pieces. In group II, 24 patients, as a controlled group, used the regimen of Lipiodol and gelfoam (Spongostan Film, Ferrosan, Denmark) p ieces only, without adding any anticancer drug. The two groups were ev aluated by a series of imaging studies and various clinical examinatio ns before and after TAE. Subsequently, TAE was performed every 2 or 3 months for all patients until there was no visible tumor, or the patie nt could not sustain further TAE, or the patient died. Results. In gro up I, TAE was administered 61 times (average 2 8 times for each patien t), 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 gr oups. 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 bet ween these two groups. The liver and renal function studies after TAE also showed no significant difference between these two groups. Conclu sions. Based on this controlled study, the authors conclude that the a ddition of cisplatin does not enhance the therapeutic effect of TAE fo r treatment of HCC.