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Abstract
BACKGROUND:
Although several prospective studies have reported the efficacy of stereotactic body radiotherapy (SBRT) for hepatocellular carcinoma (HCC), treatment-related toxicity varies and has not been determined. Therefore, the authors evaluated the safety and efficacy of SBRT for patients with HCC in a hepatitis B virus-endemic area.

METHODS:
This multicenter phase 2 trial enrolled patients with unresectable HCC. Patients received SBRT with 45 to 60 Gy in 3 fractions. To evaluate gastroduodenal toxicity, esophagogastroduodenoscopy (EGD) was performed before and 2 months after SBRT. The primary endpoint was treatment-related severe toxicity at 1 year after SBRT. The secondary endpoints were the 2-year local control, progression-free survival, and overall survival rates.

RESULTS:
In total, 74 patients were enrolled between January 2012 and April 2015, and 65 eligible patients were analyzed. One patient experienced radiation-induced liver disease with acute grade ≥3 toxicity 1 month after SBRT. In addition, 1 patient had a grade 3 esophageal ulcer with stenosis 5 months after SBRT. The actuarial rate of treatment-related severe toxicity at 1 year was 3%. The pre-SBRT and post-SBRT EGD findings were not significantly different among the 57 evaluable patients who underwent EGD. The 2-year and 3-year local control rates were 97% and 95%, respectively. The progression-free and overall survival rates were 48% and 84% at 2 years, respectively, and 36% and 76% at 3 years, respectively.

CONCLUSIONS:
With a median follow-up of 41 months, this prospective multicenter study demonstrated that SBRT for patients with HCC is well tolerated and is an effective treatment modality.

Author information

Jang WI1, Bae SH2, Kim MS1, Han CJ3, Park SC3, Kim SB4, Cho EH4, Choi CW5, Kim KS5, Hwang S6, Kim JH7, Chang AR8, Park Y8, Kim ES9, Kim WC10, Jo S11, Park HJ12.
1
Department of Radiation Oncology, Korea Institute of Radiological and Medical Sciences, Seoul, Korea.
2
Department of Radiation Oncology, Soonchunhyang University College of Medicine, Bucheon, Korea.
3
Department of Internal Medicine, Korea Institute of Radiological and Medical Sciences, Seoul, Korea.
4
Department of General Surgery, Korea Institute of Radiological and Medical Sciences, Seoul, Korea.
5
Department of Radiation Oncology, Dongnam Institute of Radiological and Medical Sciences, Busan, Korea.
6
Department of Internal Medicine, Dongnam Institute of Radiological and Medical Sciences, Busan, Korea.
7
Department of Radiation Oncology, Seoul National University College of Medicine, Seoul, Korea.
8
Department of Radiation Oncology, Soonchunhyang University College of Medicine, Seoul, Korea.
9
Department of Radiation Oncology, Soonchunhyang University College of Medicine, Cheonan, Korea.
10
Department of Radiation Oncology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.
11
Department of Radiation Oncology, Haeundae Paik Hospital, Inje University School of Medicine, Busan, Korea.
12
Department of Radiation Oncology, Hanyang University Hospital, Seoul, Korea.