The aim of this prospective observational trial was to evaluate the efficacy, toxicity and quality of life after stereotactic body radiation therapy SBRT in patients with hepatocellular carcinoma HCC and to assess the results of this treatment in comparison to trans-arterial chemoembolization TACE. The primary endpoint was feasibility; secondary endpoints were toxicity, quality of life QOL , local progression LP and overall survival OS. The median follow-up was 31 months. The QOL remained stable before and after treatment and was comparable in both treatment groups.
The incidence and mortality of hepatocellular carcinoma HCC is rising worldwide due to the rise of viral hepatitis and non-alcoholic steatohepatitis NASH 1. According to the current Barcelona Clinic Liver Cancer BCLC classification for patients who are not eligible for resection or liver transplantation, treatment options include local non-surgical methods such as RFA, trans-arterial chemoembolization TACE , and systemic therapy 3.
For these patients, SBRT could be offered as an alternative local ablative therapy with high rates of local control 4 , while maintaining a good quality of life 5 , 6. The aim of this study was to assess the feasibility of SBRT in everyday clinical practice, in patients with HCC, prior to a randomized trial.
The primary objective of this trial was to investigate the feasibility of SBRT in everyday clinical practice, prior to a randomized trial. The active recruitment time was 12 months. For patients where TACE or systemic treatment were not deemed suitable either due to exclusion criteria Supplementary Table 1 or for any other reason such as patient preference, SBRT was offered as an alternative.
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The procedure involved gaining percutaneous trans-arterial access by the Seldinger technique to the hepatic artery with an arterial sheath, usually by puncturing the common femoral artery in the right groin and passing a catheter guided by a wire through the abdominal aorta, through the celiac trunk and common hepatic artery, and finally into the branch of the proper hepatic artery supplying the tumor.
