肝细胞癌立体定向放射疗法的2期多中心研究：安全性和有效

StephenW

Cancer. 2019 Nov 20. doi: 10.1002/cncr.32502. [Epub ahead of print]
A phase 2 multicenter study of stereotactic body radiotherapy for hepatocellular carcinoma: Safety and efficacy.
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.
Author information

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.

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.

© 2019 American Cancer Society.
KEYWORDS:

endoscopy; hepatocellular carcinoma; stereotactic body radiotherapy; toxicity

PMID:
    31747476
DOI:
    10.1002/cncr.32502

StephenW

癌症。 2019年11月20日.doi：10.1002 / cncr.32502。 [Epub提前发布]
肝细胞癌立体定向放射疗法的2期多中心研究：安全性和有效性。
张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 。
作者信息

1个
    韩国首尔市韩国放射医学科学院放射肿瘤学系。
2
    朝鲜春川大学医学院放射肿瘤学系，韩国富川市。
3
    韩国首尔市韩国放射医学科学院内科。
4
    韩国首尔，韩国放射医学医学研究所普通外科。
5
    韩国釜山市放射医学医学研究所放射肿瘤学系。
6
    韩国釜山市东南放射医学研究所内科。
7
    首尔国立大学医学院放射肿瘤学系，韩国首尔。
8
    韩国首尔淳淳大学医学院放射肿瘤学系。
9
    淳春市大学医学院放射肿瘤学系，韩国天安市。
10
    韩国仁川仁荷大学医学院附属仁荷大学医院放射肿瘤科。
11
    韩国釜山仁济大学医学院海云台白医院放疗科。
12
    韩国首尔市汉阳大学医院放射肿瘤科。

抽象
背景：

尽管一些前瞻性研究报告了立体定向放射疗法（SBRT）对肝细胞癌（HCC）的疗效，但与治疗相关的毒性有所不同，尚未确定。因此，作者评估了SBRT对乙型肝炎病毒流行地区的HCC患者的安全性和有效性。
方法：

该多中心2期试验招募了无法切除的HCC患者。患者分3步接受45至60 Gy的SBRT。为了评估胃十二指肠毒性，在SBRT之前和之后2个月进行了食管胃十二指肠镜检查（EGD）。主要终点是SBRT后1年与治疗相关的严重毒性反应。次要终点是2年局部控制，无进展生存期和总生存率。
结果：

在2012年1月至2015年4月之间，总共招募了74位患者，并对65位合格患者进行了分析。一名患者在SBRT治疗1个月后经历了放射性诱发的肝病，急性毒性≥3级。此外，1例患者在SBRT后5个月出现3级食管溃疡并狭窄。 1年时与治疗相关的严重毒性反应的精算率为3％。在接受EGD的57例可评估患者中，SBRT之前和SBRT之后的EGD结果无显着差异。 2年和3年本地控制率分别为97％和95％。无进展生存率和总生存率在2年时分别为48％和84％，在3年时分别为36％和76％。
结论：

这项前瞻性多中心研究的中位随访期为41个月，表明SBRT对HCC患者的耐受性良好，是一种有效的治疗方式。

©2019美国癌症协会。
关键字：

内窥镜检查肝细胞癌；立体定向身体放疗；毒性

PMID：
    31747476
DOI：
    10.1002 / cncr.32502