Ann Surg Treat Res.  2018 Feb;94(2):74-82. 10.4174/astr.2018.94.2.74.

A prospective randomized study comparing radiofrequency ablation and hepatic resection for hepatocellular carcinoma

• Lee HW
• Lee JM
• Yoon JH
• Kim YJ
• Park JW
• Park SJ
• Kim SH
• Yi NJ
• Suh KS

• KMID: 2402849
• DOI: http://doi.org/10.4174/astr.2018.94.2.74

Abstract

PURPOSE
Although there are several prospective clinical studies comparing radiofrequency ablation (RFA) and hepatic resection (HR) for the treatment of hepatocellular carcinoma, there are few trials that have been performed in strictly homogeneous patients.
METHODS
Patients who were newly diagnosed with a solitary hepatocellular carcinoma were randomized to the HR or RFA group. Inclusion criteria were as follows: age ≥ 20 years but ≤ 70 years, Child-Pugh class A, maximal diameter of the tumor ≥ 2 cm but ≤ 4 cm, no previous treatment history, and platelet count > 80,000/mm3.
RESULTS
Although the study was early terminated, 29 and 34 patients were enrolled in the HR and RFA groups, respectively, and prospectively followed on an intention-to-treat basis. The 5-year overall survival rates were 83.4% and 86.2% in the HR and RFA groups, respectively, which were not significantly different (P = 0.812 by log-rank, P = 0.990 by Breslow). The 3- and 5-year disease-free survival rates in the HR group were significantly superior to those in the RFA group (66.7%, 44.4% vs. 44.1%, 31.2%, P = 0.071 by log-rank, P = 0.023 by Breslow). Intrahepatic local recurrence tended to develop more frequently in the RFA group (P = 0.042), while the frequency of intrahepatic distant and extrahepatic recurrence was similar bet ween the 2 groups. There were no significant differences in the frequency and severity of complications between the 2 groups.
CONCLUSION
HR was significantly superior to RFA in terms of disease-free survival; however, the overall survival was excellent in both groups.

Keyword

Hepatocellular carcinoma; Hepatectomy; Catheter ablation; Randomized controlled trial; Disease-free survival

MeSH Terms

Carcinoma, Hepatocellular*
Catheter Ablation*
Disease-Free Survival
Hepatectomy
Humans
Platelet Count
Prospective Studies*
Recurrence
Survival Rate

Figure

• 

  Fig. 1 The number of patients included in the ITT, PP, and PT an alyses. Excluding protocol violations, 26 and 29 patients of the HR and RFA groups, respectively, were included in the PP an alysis. The final PT analysis was performed in 31 and 32 pa tients of the HR and RFA groups, respectively, according to actual treatment modalities and not the assigned modalities. HR, hepatic resection; RFA, radiofrequency ablation; ITT, intention-to-treat; PP, per-protocol; PT, per-treatment.

• 

  Fig. 2 Overall survival based on the intention-to-treat analysis. The 5-year overall survival rate was 83.4% in the HR group and 86.2% in the RFA group; however, this difference was not statistically significant. HR, hepatic resection; RFA, radiofrequency ablation.

• 

  Fig. 3 Disease-free survival based on the intention-to-treat analysis. On the ITT basis, the 5-year disease-free survival rate was 42.9% in the HR group and 31.2% in the RFA group (P = 0.084 by log-rank test, 0.030 by Breslow test). HR, hepatic resection; RFA, radiofrequency ablation.

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