CalliSpheres载药栓塞微球治疗中晚期肝癌临床效果评价

doi:10.3877/cma.j.issn.2095-5782.2017.03.013

目的：

探讨CalliSpheres载药栓塞微球治疗中晚期肝癌的临床效果和安全性。

方法：

对25例中晚期肝癌患者行导管肝动脉化疗栓塞术（TACE），并使用CalliSpheres载药栓塞微球进行栓塞，采用改良实体瘤疗效评价标准（mRECIST）评价治疗效果，比较患者治疗前后肝功能变化，记录不良反应及并发症发生情况。

结果：

本组25例患者均顺利接受CalliSpheres载药栓塞微球治疗，技术成功率为100%；25例患者随访6个月，根据mRECIST标准，3个月疾病缓解率（CR+PR）为80%，疾病控制率（CR+PR+SD）为88%，6个月疾病缓解率（CR+PR）为72%，疾病控制率（CR+PR+SD）为80%。术后3 d，肝功能变化主要表现为谷丙转氨酶（ALT）、谷草转氨酶（AST）及总胆红素升高，与术前差异有统计学意义，白蛋白变化不明显，与术前差异无统计学意义，术后3个月，肝功能基本恢复正常水平，与术前比较差异无统计学意义，所有患者均未出现胆汁漏并发感染、肝脓肿、肿瘤破裂出血及消化道出血等严重并发症。

结论：

对中晚期肝癌患者，应用CalliSpheres载药栓塞微球是一个新的选择，近期临床疗效及安全性良好，远期疗效尚待进一步观察。

关键词: 肝动脉化疗栓塞术, 肝癌, 可载药栓塞微球, CalliSpheres

Objective:

To evaluate the safety and clinical short-term efficacy of interventional embolization with CalliSpheres-loaded microspheres in treating advanced hepatocellular carcinoma.

Methods:

A total of 25 patients with advanced hepatocellular carcinoma underwent transcatheter arterial chemoembolization (TACE) plus using CalliSpheres-loaded microspheres treatment. The clinical and imaging data, complications of interventional treatment and prognosis were summarized and analyzed by modified response evaluation criteria in solid tumors (mRECIST); follow-up was performed on all patients.

Results:

The follow-up lasted 6 months. According to mRECIST, the 3-month objective response rate (CR+PR) was 80% and disease control rate (CR+PR+SD) was 88%; the 6-month objective response rate (CR+PR) was 72% and disease control rate (CR+PR+SD) was 80%. At day 3 after the procedure, the levels of ALT, AST and TBIL were increased, with a statistical significance compared with those before the operation. However, there was no significant difference in the level of albumin. At 3 months postoperatively, the indications of liver function returned to the normal level. And there was no significant difference between pre- and post-operation. No severe complications, such as bile leak with infection, liver abscess, abdominal hemorrhage, bleeding due to tumor rupture and gastrointestinal bleeding occurred in these patients.

Conclusion:

TACE performed with CalliSpheres-loaded microspheres is a novel and safe option for patients with advanced hepatocellular carcinoma. Its clinical short-term efficacy was satisfied, yet its long-term efficacy needs further studies.

Key words: Transcatheter arterial chemoembolization, Hepatocellular carcinoma, Drug-loaded microspheres, CalliSpheres

表1 患者术前资料

临床病理特征		例数	临床病理特征		例数
病因		?	BCLC分期		?
?	乙肝	22	?	A期	0
?	未知	5	?	B期	21
肝硬化		?	?	C期	4
?	有	21	肿瘤范围		?
?	无	4	?	单叶	16
Child-Pugh分级		?	?	双叶	9
?	A级	21	肿瘤数量		?
?	B级	4	?	1个	12
ECOG评分		?	?	2～3个	5
?	0分	20	?	>3个	8
?	1分	5	?	?	?

表1 患者术前资料

临床病理特征		例数	临床病理特征		例数
病因		?	BCLC分期		?
?	乙肝	22	?	A期	0
?	未知	5	?	B期	21
肝硬化		?	?	C期	4
?	有	21	肿瘤范围		?
?	无	4	?	单叶	16
Child-Pugh分级		?	?	双叶	9
?	A级	21	肿瘤数量		?
?	B级	4	?	1个	12
ECOG评分		?	?	2～3个	5
?	0分	20	?	>3个	8
?	1分	5	?	?	?

表2 术后不同时间的随访结果　例（%）

术后时间	CR	PR	SD	PD	CR+PR	CR+PR+SD
3个月	2(8%)	18(72%)	2(8%)	3(12%)	20(80%)	22(88%)
6个月	1(4%)	17(68%)	2(8%)	5(20%)	18(72%)	20(80%)

表2 术后不同时间的随访结果　例（%）

术后时间	CR	PR	SD	PD	CR+PR	CR+PR+SD
3个月	2(8%)	18(72%)	2(8%)	3(12%)	20(80%)	22(88%)
6个月	1(4%)	17(68%)	2(8%)	5(20%)	18(72%)	20(80%)

图1 典型病例手术前后CT及造影图

表3 患者治疗前后肝功能变化比较　（±s）

时间	白蛋白（g/L）	ALT（U/L）	AST（U/L）	总胆红素（μmol/L）
术前	40.0±3.0	31.5±12.0	39.0±17.0	13.5±4.5
术后3 d	37.0±5.6	86.0±53.0^a	132.0±82.0^a	19.0±7.7^a
术后3个月	38.0±4.6	33.5±10.0	42.0±15.5	14.5±6.5
F	0.64	6.37*	15.54*	9.75*

表3 患者治疗前后肝功能变化比较　（±s）

时间	白蛋白（g/L）	ALT（U/L）	AST（U/L）	总胆红素（μmol/L）
术前	40.0±3.0	31.5±12.0	39.0±17.0	13.5±4.5
术后3 d	37.0±5.6	86.0±53.0^a	132.0±82.0^a	19.0±7.7^a
术后3个月	38.0±4.6	33.5±10.0	42.0±15.5	14.5±6.5
F	0.64	6.37*	15.54*	9.75*

1	Aliberti C, Tilli M, Benea G, et al. Trans-arterial chemoembolization (TACE) of liver metastases from colorectal cancer using irinotecan-eluting beads: preliminary results[J]. Anticancer Res, 2006,26:3793-3795.
2	Thirion P, Michiels S, Pignon JP, et al. Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: an updated metaanalysis[J]. J Clin Oncol, 2004, 22:3766-3775.doi: 10.1200/JCO.2004.03.104.
3	Rees M, Tekkis PP, Welsh FK, et al. Evaluation of longterm survival after hepatic resection for metastatic colorectal cancer: a multifactorial model of 929 patients[J]. Ann Surg, 2008, 247:125-135. doi: 10.1097/SLA.0b013e31815aa2c2.
4	Smith MD, McCall JL. Systematic review of tumour number and outcome after radical treatment of colorectal liver metastases[J]. Br J Surg, 2009, 96:1101-1113. doi: 10.1002/bjs.6735.
5	Bhattacharjya S, Aggarwal R, Davidson BR. Intensive follow-up after liver resection for colorectal liver metastases: results of combined serial tumour marker estimations and computed tomography of the chest and abdomen—a prospective study[J]. Br J Cancer, 2006, 95:21-26.doi: 10.1038/sj.bjc.6603219.
6	Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer[J]. N Engl J Med, 2004, 350:2335-2342.doi: 10.1016/j.clcc.2016.07.013.
7	Tang Y, Taylor RR, Gonzalez MV, et al. Evaluation of irinotecan drug-eluting beads: a new drug-device combination product for the chemoembolization of hepatic metastases[J]. J Control Release, 2006, 116:e55-e56. doi:10.1016/j.jconrel.2006.09.047.
8	Sobrero AF, Maurel J, Fehrenbacher L, et al. EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer[J]. J Clin Oncol, 2008, 26: 2311-2319. doi: 10.1200/JCO.2007.13.1193.
9	赵艳，韩国宏，白苇，等．药物缓释微球肝动脉化疗栓塞治疗肝癌研究进展[J].介入放射学杂志，2012，21(1):79-83．doi:10.3969/j.issn.1008-794X.2012.01.020
10	Jordan O, Denys A, de Baere T, et al. Comparative study of chemoembolization loadable beads: in vitro drug release and，physical properties of DC bead and hepasphere loaded with doxorubicin and irinotecan[J]. J Vasc Interv Radiol, 2010, 21:1084-1090.doi: 10.1016/j.jvir.2010.02.042.
11	邵海波，张曦彤，李红,等．栓塞微球在肝癌介入治疗中的应用[J]．介入放射学杂志，2008，17:776-778．doi:10.3969/j.issn.1008-794X.2008.11.005.
12	Malagari K, Pomoni M, Moschouris H, et al. Chemoembolization of hepatocellular carcinoma with HepaSphere 30-60 μm. Safety and efficacy study[J]. Cardiovasc Intervent Radiol, 2014, 37: 165-175.doi: 10.1007/s00270-013-0777-x.
13	段峰，阎洁羽，刘凤永，等．装载阿霉素的DC- Beads经导管化疗栓塞治疗不可切除性原发性肝癌的初步经验[J]．中华肿瘤杂志，2014，36: 314-315．doi:10.3760/cma.j.issn.0253-3766.2014.04.016.
14	Golfieri R, Giampalma E, Renzulli M, et al. Randomised controlled trial of doxorubicin- eluting beads vs conventional chemoembolisation，for hepatocellular carcinoma [J]. Br J Cancer, 2014,111: 255-264.doi: 10.1038/bjc.2014.199.
15	Malagari K, Pomoni M, Spyridopoulos TN, et al. Safety profile of，sequential transcatheter chemoembolization with DC Bead:，results of 237 hepatocellular carcinoma （HCC ） patients [J]. Cardiovasc Intervent Radiol, 2011, 34: 774-785.doi: 10.1007/s00270-010-0044-3.

[1]	唐梅, 周丽, 牛岑月, 周小童, 王倩. ICG荧光导航的腹腔镜肝切除术临床意义[J/OL]. 中华普外科手术学杂志(电子版), 2024, 18(06): 655-658.
[2]	高金红, 陈玉梅, 郭韵. 基于King互动达标理论的心理疏导在腹腔镜肝癌切除术患者的应用效果分析[J/OL]. 中华普外科手术学杂志(电子版), 2024, 18(05): 517-520.
[3]	林巧, 周丽. RFA联合LAH术治疗原发性肝癌并门静脉癌栓的临床效果分析[J/OL]. 中华普外科手术学杂志(电子版), 2024, 18(05): 521-524.
[4]	曾繁利, 齐秩凯, 杨贺庆. 两种经Glisson蒂鞘解剖路径肝切除术治疗原发性肝癌的肿瘤学疗效及风险比对[J/OL]. 中华普外科手术学杂志(电子版), 2024, 18(05): 525-527.
[5]	马立伟, 贾志强, 陈午盛, 邵明亮, 刘琼, 段玉松. CalliSpheres载药微球联合碘化油治疗肝癌的临床研究[J/OL]. 中华普外科手术学杂志(电子版), 2024, 18(04): 369-372.
[6]	胡宁宁, 赵延荣, 王栋, 王胜亮, 郭源. FMNL3与肝细胞癌肝移植受者预后的相关性研究[J/OL]. 中华移植杂志(电子版), 2024, 18(05): 283-288.
[7]	王飞, 陈政, 余德才, 曹亚娟. 原发性肝癌合并门静脉高压症的微创手术治疗[J/OL]. 中华腔镜外科杂志(电子版), 2024, 17(05): 306-310.
[8]	张敏, 朱建华, 缪雅芳, 郭锦荣. 菝葜皂苷元对肝癌HepG2细胞抑制作用的机制研究[J/OL]. 中华细胞与干细胞杂志(电子版), 2024, 14(06): 328-335.
[9]	曾聿理, 雷发容, 肖慧, 邱德亮, 谢静, 吴寻. 氯普鲁卡因通过调控circRNA-ZKSCAN1表达抑制肝癌Huh-7细胞体外生长和转移的研究[J/OL]. 中华细胞与干细胞杂志(电子版), 2024, 14(04): 220-228.
[10]	袁雨涵, 杨盛力. 体液和组织蛋白质组学分析在肝癌早期分子诊断中的研究进展[J/OL]. 中华肝脏外科手术学电子杂志, 2024, 13(06): 883-888.
[11]	吴警, 吐尔洪江·吐逊, 温浩. 肝切除术前肝功能评估新进展[J/OL]. 中华肝脏外科手术学电子杂志, 2024, 13(06): 889-893.
[12]	鲍乐, 刘颖, 王友彬, 陈龙, 朱玉芝, 梁爽, 权鹤太, 李鹏飞. 还阳通络灸在原发性肝癌介入治疗中的临床应用研究[J/OL]. 中华消化病与影像杂志(电子版), 2024, 14(03): 197-202.
[13]	广东省护士协会介入护士分会, 广东省医师协会介入医师分会. 原发性肝癌低血糖患者护理规范管理专家共识[J/OL]. 中华临床医师杂志(电子版), 2024, 18(08): 709-714.
[14]	韦巧玲, 黄妍, 赵昌, 宋庆峰, 陈祖毅, 黄莹, 蒙嫦, 黄靖. 肝癌微波消融术后中重度疼痛风险预测列线图模型构建及验证[J/OL]. 中华临床医师杂志(电子版), 2024, 18(08): 715-721.
[15]	蔡晓雯, 李慧景, 丘婕, 杨翼帆, 吴素贤, 林玉彤, 何秋娜. 肝癌患者肝动脉化疗栓塞术后疼痛风险预测模型的构建及验证[J/OL]. 中华临床医师杂志(电子版), 2024, 18(08): 722-728.

阅读次数

全文

摘要

选择文件类型/文献管理软件名称

选择包含的内容

Interventional chemoembolization with CalliSpheres-loaded microspheres for the treatment of advanced hepatocellular carcinoma

模态框（Modal）标题

选择文件类型/文献管理软件名称

选择包含的内容

Interventional chemoembolization with CalliSpheres-loaded microspheres for the treatment of advanced hepatocellular carcinoma