Abstract
OBJECTIVE: The objective of this study was to investigate the safety of robotic stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma (HCC) patients and its related factors. METHODS: A total of 74 HCC patients with Child-Turcotte-Pugh (CTP) Class A were included in a multi-institutional, single-arm Phase II trial (NCT 02363218) between February 2013 and August 2016. All patients received SBRT treatment at a dose of 45 Gy/3f. The liver function was compared before and after SBRT treatment by the analysis of adverse hepatic reactions and changes in CTP classification. RESULTS: After SBRT treatment, eight patients presented with decreases in CTP classification and 13 patients presented with ≥ grade 2 hepatic adverse reactions. For patients presenting with ≥ grade 2 hepatic adverse reactions, the total liver volume of ≤1,162 mL and a normal liver volume (total liver volume - gross tumor volume [GTV]) of ≤1,148 mL were found to be independent risk factors and statistically significant (P<0.05). CONCLUSION: The total liver volume and normal liver volume are associated with the occurrence of ≥ grade 2 hepatic adverse reactions after SBRT treatment on HCC patients. Therefore, if the fractionated scheme of 45 Gy/3f is applied in SBRT for HCC patients, a total liver volume >1,162 mL and a normal liver volume >1,148 mL should be ensured to improve therapeutic safety.