1Department of Internal Medicine, Korea Cancer Center Hospital. 2Department of Radiology, Korea Cancer Center Hospital. 3Department of Statistics, Hankuk University of Foreign Studies, Seoul, Korea.
ABSTRACT
PURPOSE: Although transarterial chemoembolization (TACE) has been widely used for the treatment of unresectable hepatocellular carcinoma, it has not been determined yet which chemotherapeutic agents were best for TACE. To determine the best chemotherapeutic regimen for TACE, we performed a prospective randomized study comparing 3 chemo- therapeutic regimen (adriamycin alone vs. cisplatin alone vs. adriamycin + cisplatin).
MATERIALS AND METHODS: The patients with unresectable hepatocellular carcinoma were eligible for this study and were randomly assigned to three treatment groups (A: adriamycin 30 mg/m(2), B: cisplatin 60 mg/m(2), C: adriamycin 30 mg/m(2) + cisplatin 60 mg/m(2)). The TACE were performed by administering the mixture of lipiodol and the assigned chemotherapeutic drugs through the hepatic artery, followed by embolization with gelfoam powder. The treatment was planned to be repeated every 4 weeks.
RESULTS: After 40 patients (14 in group A, 16 in group B, 10 in group C) entered, the study was stopped prematurely because of serious treatment-related complications including 15% of local complications, 18% of hepatic encephalopathy, and 8% of deaths. Because TACE could result in necrosis without reduction of mass size, the response could not be evaluated by the change of mass size, but by the change of serum alpha-fetoprotein level. Of 25 patients who had elevated serum alpha-fetoprotein and were assessable for response, there were one complete response (CR) and 5 partial responses (PR) out of 10 in group A, 5 PRs out of 10 in group B, and 2 PRs out of 5 in group C. There was no difference in response rates among the 3 treatment groups (p > 0.05). The response rate in patients treated with gelform embolization was higher than patients without embolization (63% (12/19) vs 19% (1/6): p<0.05). The median survival (OS) was 23 weeks for all 40 patients, 15 weeks for group A, 42 weeks for group B and 24 weeks for group C. The difference of OS between group A and B was statistically significant (p=0.02). However, the OS was not associated with any prognostic factors including treatment group in multivariate analysis.
CONCLUSION: Although cisplatin seemed to be more effective in TACE than adriamycin, no firm conclusion could be drawn from this prematurely ended study. However, we could conclude that the TACE with gelform powder is so toxic that it could not be given safely to the patients with unresectable hepatocellular carcinoma
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