无法手术切除的胆管细胞癌经体部立体定向放射治疗的效果及安全性分析

赵晓芳; 张爱民; 李文刚; 孙静; 常小云; 张弢; 何卫平; 段学章

doi:10.3969/j.issn.1001-5256.2023.11.021

无法手术切除的胆管细胞癌经体部立体定向放射治疗的效果及安全性分析

DOI: 10.3969/j.issn.1001-5256.2023.11.021

赵晓芳¹,
张爱民²,
李文刚²,
孙静²,
常小云²,
张弢²,
何卫平²,
段学章^{1, 2, , ,}

1.
中国人民解放军医学院，北京 100039
2.
中国人民解放军总医院第五医学中心肿瘤放射治疗科，北京 100039

基金项目:

国家自然科学基金面上项目 (81972856)

伦理学声明：本研究方案于2019年3月12日经由解放军总医院第五医学中心医学伦理委员会审批，批号：2019-083D，患者均签署知情同意书。

利益冲突声明：本文不存在任何利益冲突。

作者贡献声明：赵晓芳负责起草及撰写文章；张爱民、孙静负责采集数据并统计分析；李文刚、常小云、张弢、何卫平参与分析解释数据；段学章负责总体修改文章。

详细信息

通信作者:
段学章， duanxuezhang2006@163.com （ORCID： 0000-0002-1941-9317）

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出版历程
- 收稿日期: 2023-01-02
- 录用日期: 2023-04-11
- 出版日期: 2023-11-28

Efficacy and safety of stereotactic body radiation therapy in treatment of patients with unresectable cholangiocarcinoma

1.
Chinese PLA Medical College，Beijing 100039，China
2.
Department of Oncology and Radiotherapy，The Fifth Medical Center of Chinese PLA General Hospital，Beijing 100039，China

Research funding:

National Natural Science Foundation of China (81972856)

More Information

Corresponding author: DUAN Xuezhang， duanxuezhang2006@163.com （ORCID： 0000-0002-1941-9317）

摘要

摘要: 目的观察体部立体定向放疗治疗无法手术切除的胆管细胞癌患者的生存情况及不良反应。方法选取2012年2月—2020年7月于解放军总医院第五医学中心行体部立体定向放射治疗的27例无法手术切除的单发无转移的胆管细胞癌患者。计划靶区（PTV）处方剂量42～60 Gy，分5～8次，5～11 Gy/次。其中有5例联合肝动脉化疗栓塞术（TACE）和化疗治疗。以6个月、12个月、18个月和24个月的总生存率、无进展生存率和局部控制率作为疗效评价指标。使用不良事件通用术语标准（CTCAE）v.4.03评估不良反应。采用Kaplan-Meier法计算总生存率、无进展生存率和局部控制率。结果中位随访时间17个月。27例患者的6个月、12个月、18个月和24个月的总生存率分别为100%、88%、57.5%和47.9%，无进展生存率分别为74.1%、58.6%、47.9%和35.9%，局部控制率分别为96.3%、91.9%、84.8%和76.4%。未出现3级及以上毒性反应。5例患者诊断为放射性肝损伤，无因放射性肝损伤死亡病例。结论体部立体定向放疗治疗不可切除胆管细胞癌安全、有效，具有较高的生存率、无进展生存率和局部控制率，且毒性反应低，可作为不适合手术治疗的胆管癌的替代治疗。
- 胆管上皮癌 /
- 放射外科手术 /
- 治疗结果
Abstract: Objective To investigate the survival and adverse reactions of patients with unresectable cholangiocarcinoma after stereotactic body radiation therapy （SBRT）. Methods A total of 27 patients with unresectable solitary cholangiocarcinoma without metastasis who underwent SBRT in The Fifth Medical Center of Chinese PLA General Hospital from February 2012 to July 2020 were enrolled. The prescribed dose to planning target volume was 42-60 Gy in 5-8 fractions， with 5-11 Gy/fraction. Among these patients， five patients were also treated with chemotherapy and transcatheter arterial chemoembolization. The 6-， 12-， 18-， and 24-month overall survival （OS） rates， progression-free survival （PFS） rates， and local control （LC） rates were used as the assessment indices for treatment outcome； Common Terminology Criteria for Adverse Events v.4.03 was used to evaluate adverse reactions； the Kaplan-Meier method was used to calculate OS， PFS， and LC rates. Results The median follow-up time was 17 months. For all 27 patients， the 6-， 12-， 18-， and 24-month OS rates were 100%， 88%， 57.5%， and 47.9%， respectively； the 6-， 12-， 18-， and 24-month PFS rates were 74.1%， 58.6%， 47.9%， and 35.9%， respectively； the 6-， 12-， 18-， and 24-month LC rates were 96.3%， 91.9%， 84.8%， and 76.4%， respectively. No grade 3 or above toxic reactions were observed. Five patients were diagnosed with radiation-induced liver injury， but there was no death due to radiation-induced liver injury. Conclusion SBRT is safe and effective in the treatment of unresectable cholangiocarcinoma， with relatively high survival rate， PFS rate， and LC rate and low toxicity， and therefore， SBRT can be used as an alternative treatment method for patients with cholangiocarcinoma who are not candidates for surgery.
- Cholangiocarcinoma /
- Radiosurgery /
- Treatment Outcome

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图 1 27例患者总生存率

Figure 1. Overall survival of 27 patients

下载: 全尺寸图片幻灯片

图 2 27例患者无进展生存率

Figure 2. Progression-free survival of 27 patients

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图 3 27例患者局部控制率

Figure 3. Local control rate of 27 patients

下载: 全尺寸图片幻灯片

表 1 27例患者一般临床资料

Table 1. The characteristics of 27 patients

特征	数值
性别［例（%）］
男	19（70.4）
女	8（29.6）
年龄（岁）	64（52～68）
肿瘤位置［例（%）］
肝内	14（51.9）
肝门	13（48.1）
肿瘤大小（cm）	4.5（2.6～5.1）
肿瘤标志物
AFP（ng/mL）	2.85（1.51～5.80）
CA19-9（U/mL）	129.65（28.69～521.98）
合并梗阻性黄疸［例（%）］
有	15（55.6）
无	12（44.4）
ECOG PS评分［例（%）］
0分	5（18.5）
1分	22（81.5）
Child-Pugh分级［例（%）］
A级	15（55.6）
B级	12（44.4）
治疗方案［例（%）］
单用SBRT	22（81.5）
SBRT+替吉奥	4（14.8）
SBRT+TACE+替吉奥	1（3.7）
放疗计划
总剂量（Gy）	50（42～60）
单次剂量（Gy）	10（5～11）
分割次数（次）	5（5～8）
BED	83.0（71.4～115.0）
注：BED，生物有效剂量。

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