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 transcatheter arterial chemoembolization (TACE) and percutaneous ethanol injection (PEI) is superior to PEI alone in the treatment of patients with small hepatocellular 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 34 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 TACE-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 the TACE-PEI group (8.7% at 1 year and 19.3% at 3 years) tended to be lower compared with the recurrence rates in the PEI alone group (26.9% and 80.1%, respectively; P = 0.057). The cumulative survival rates were not significantly 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%, 65.9%, 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 TACE-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 disease and the new nodular recurrence rates (P < 0.01 and P = 0.047, respectively). The frequency of short-term and long-term adverse effects was not significantly different between the groups. However, only two major complications (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 with HCC tumors measuring < 2 cm in greatest dimension.