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A phase 2 multicenter study of stereotactic body radiotherapy for hepatocellular carcinoma: Safety and efficacy

Authors
Jang, Won IlBae, Sun HyunKim, Mi-SookHan, Chul JuPark, Su CheolKim, Sang BumCho, Eung-HoChoi, Chul WonKim, Kyung SuHwang, SangyounKim, Jin HoChang, A. RamPark, YoungheeKim, Eun SeogKim, Woo ChulJo, SunmiPark, Hae Jin
Issue Date
15-Jan-2020
Publisher
John Wiley & Sons Inc.
Keywords
endoscopy; hepatocellular carcinoma; stereotactic body radiotherapy; toxicity
Citation
Cancer, v.126, no.2, pp 363 - 372
Pages
10
Journal Title
Cancer
Volume
126
Number
2
Start Page
363
End Page
372
URI
https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/3174
DOI
10.1002/cncr.32502
ISSN
0008-543X
1097-0142
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.
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