Combination therapy with transcatheter arterial chemoembolization and percutaneous ethanol injection compared with percutaneous ethanol injection alone for patients with small hepatocellular carcinoma - A randomized control study

BACKGROUND. To assess whether the effectiveness of a combination of transca theter arterial chemoembolization (TACE) and percutaneous ethanol injection (PEI) is superior to PEI alone in the treatment of patients with small hep atocellular carcinoma (HCC), a randomized controlled study was performed. METHODS. Fifty-two patients with one to three HCC tumors measuring < than 3 cm. in greatest dimension were enrolled and underwent the combination TACE -PEI therapy (26 patients with 31 nodules) or PEI alone (26 patients with 3 4 nodules). There were no significant differences in background between the two groups. The mean follow-up was 30.1 months +/- 17.5 months. RESULTS. The cumulative detection rates of local residual disease in the TA CE-PEI group (3.7% at 1 year and 19.3% at 3 years) were significantly lower compared with the detection rates in the PEI alone group (34.2% and 39.3%, respectively, P = 0.013). The cumulative new nodular recurrence rates in t he TACE-PEI group (8.7% at 1 year and 19.3% at 3 years) tended to be lower compared,vith the recurrence rates in the PEI alone group (26.9% and 80.1%, respectively, P = 0.057). The cumulative survival rates were not significa ntly different between the two groups (TACE-PEI group: 100%, 80.8%, and 40. 4% at 1 year, 3 years, and 5 years, respectively; PEI alone group: 91.3%, 6 5.9%, and 37.7%, respectively; P = 0.458). However, among the patients from each group with HCC tumors measuring < 2 cm, the survival rates in the TAC E-PEI group were improved compared with the survival rates in the PEI alone group (P < 0.01) in addition to the detection rates of local residual dise ase and the new nodular recurrence rates (P < 0.01 and P = 0.047, respectiv ely). The frequency of short-term and long-term adverse effects was not sig nificantly different between the groups. However, only two major complicati ons (biloma and ascites with pleural effusion) were observed, both of which occurred in patients in the TACE-PEI group. CONCLUSIONS. Combination therapy with TACE-PEI was superior to PEI alone in the treatment of patients with small HCC tumors, especially for patients w ith HCC tumors measuring < 2 cm in greatest dimension. (C) 2001 American Ca ncer Society.