Radiofrequency ablation (RFA) is considered a curative treatment option for
hepatocellular carcinoma (HCC). Growing data have demonstrated that
cryoablation represents a safe and effective alternative
therapy for HCC, but no randomized controlled trial (RCT) has been reported to compare
cryoablation with RFA in HCC treatment. The present study was a multicenter RCT aimed to compare the outcomes of percutaneous
cryoablation with RFA for the treatment of HCC. In all, 360 patients with Child-Pugh class A or B
cirrhosis and one or two HCC lesions ≤ 4 cm, treatment-naïve, without
metastasis were randomly assigned to
cryoablation (n = 180) or RFA (n = 180). The primary endpoints were local
tumor progression at 3 years
after treatment and safety. Local
tumor progression rates at 1, 2, and 3 years were 3%, 7%, and 7% for
cryoablation and 9%, 11%, and 11% for RFA, respectively (P = 0.043). For lesions >3 cm in diameter, the local
tumor progression rate was significantly lower in the
cryoablation group versus the RFA group (7.7% versus 18.2%, P = 0.041). The 1-, 3-, and 5-year overall survival rates were 97%, 67%, and 40% for
cryoablation and 97%, 66%, and 38% for RFA, respectively (P = 0.747). The 1-, 3-, and 5-year
tumor-free survival rates were 89%, 54%, and 35% in the
cryoablation group and 84%, 50%, and 34% in the RFA group, respectively (P = 0.628). Multivariate analyses demonstrated that Child-Pugh class B and distant intrahepatic recurrence were significant negative predictors for overall survival. Major complications occurred in seven patients (3.9%) following
cryoablation and in six patients (3.3%) following RFA (P = 0.776).
CONCLUSION: