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

被引:105
作者
Jang, Won Il [1 ]
Bae, Sun Hyun [2 ]
Kim, Mi-Sook [1 ]
Han, Chul Ju [3 ,5 ]
Park, Su Cheol [3 ,5 ]
Kim, Sang Bum [4 ,6 ]
Cho, Eung-Ho [4 ]
Choi, Chul Won
Kim, Kyung Su
Hwang, Sangyoun
Kim, Jin Ho [7 ]
Chang, A. Ram [2 ,8 ]
Park, Younghee [2 ,8 ]
Kim, Eun Seog [2 ,9 ]
Kim, Woo Chul [10 ]
Jo, Sunmi [11 ]
Park, Hae Jin [12 ]
机构
[1] Korea Inst Radiol & Med Sci, Dept Radiat Oncol, 75Nowon Ro, Seoul 01812, South Korea
[2] Soonchunhyang Univ, Dept Radiat Oncol, Coll Med, Bucheon, South Korea
[3] Korea Inst Radiol & Med Sci, Dept Internal Med, Seoul, South Korea
[4] Korea Inst Radiol & Med Sci, Dept Gen Surg, Seoul, South Korea
[5] Dongnam Inst Radiol & Med Sci, Dept Radiat Oncol, Busan, South Korea
[6] Dongnam Inst Radiol & Med Sci, Dept Internal Med, Busan, South Korea
[7] Seoul Natl Univ, Dept Radiat Oncol, Coll Med, Seoul, South Korea
[8] Soonchunhyang Univ, Dept Radiat Oncol, Coll Med, Seoul, South Korea
[9] Soonchunhyang Univ, Coll Med, Dept Radiat Oncol, Cheonan, South Korea
[10] Inha Univ, Inha Univ Hosp, Dept Radiat Oncol, Sch Med, Incheon, South Korea
[11] Inje Univ, Haeundae Paik Hosp, Sch Med, Dept Radiat Oncol, Busan, South Korea
[12] Hanyang Univ Hosp, Dept Radiat Oncol, Seoul, South Korea
关键词
endoscopy; hepatocellular carcinoma; stereotactic body radiotherapy; toxicity; RADIATION-THERAPY; GASTRODUODENAL TOXICITY; PROTON-BEAM; TRIAL;
D O I
10.1002/cncr.32502
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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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页码:363 / 372
页数:10
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