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电化学治疗不可切除结直肠癌肝转移患者的安全性和可行性:一项初步研究。

Safety and feasibility of electrochemotherapy in patients with unresectable colorectal liver metastases: A pilot study.

机构信息

Hepatobiliary Surgery and Liver Transplantation, University of Pisa Medical School Hospital, Via Paradisa 2, I-56124, Pisa, Italy.

Department of Radiology, University of Pisa Medical School Hospital, Via Paradisa 2, I-56124, Pisa, Italy.

出版信息

Int J Surg. 2017 Aug;44:26-32. doi: 10.1016/j.ijsu.2017.06.033. Epub 2017 Jun 15.

DOI:10.1016/j.ijsu.2017.06.033
PMID:28624558
Abstract

BACKGROUND AND OBJECTIVES

Electrochemotherapy is a novel ablation technique combining chemotherapeutic agents with reversible cell membrane electroporation. Previous experiences have shown its efficacy for cutaneous tumors. Its application for deep-seated malignancies is under investigation. We performed a prospective, pilot study to evaluate the feasibility, safety, and efficacy of intraoperative electrochemotherapy for otherwise unresectable colorectal liver metastases.

METHODS

Electrochemotherapy with bleomycin was combined with open liver resection and performed with linear or hexagonal needle electrodes according to an individualized pretreatment plan. The primary endpoints were: feasibility, as ratio of completed to planned treatments; safety, and efficacy, as per response assessed at 30 days with MRI and according to RECIST. The secondary endpoint was overall and progression-free survival at month 6.

RESULTS

A total of 9 colorectal liver metastases were treated in 5 patients with 20 electrode applications. No intraoperative complications were observed. At day 30, complete response was 55.5% and stable disease 45.5%. All (5) patients reached a 6 months overall survival, and 4 out of 5 patients had 6 months progression free survival.

CONCLUSIONS

Electrochemotherapy is a feasible and safe adjunct to open surgery for treatment of unresectable colorectal liver metastases. Larger studies and longer follow-ups are favored to better define its role in the treatment of secondary liver malignancies.

摘要

背景与目的

电化疗是一种将化疗药物与可逆细胞膜电穿孔相结合的新型消融技术。先前的经验表明其对皮肤肿瘤有效。其在深部恶性肿瘤中的应用正在研究中。我们进行了一项前瞻性、初步研究,以评估术中电化疗治疗无法切除的结直肠肝转移的可行性、安全性和疗效。

方法

电化疗采用博来霉素,与开放性肝切除术相结合,并根据个体化预处理计划使用线性或六边型针电极进行治疗。主要终点为:可行性,以实际完成与计划治疗的比例表示;安全性和疗效,以 30 天时 MRI 评估的反应和 RECIST 标准表示。次要终点为 6 个月时的总生存率和无进展生存率。

结果

5 例患者共治疗 9 个结直肠肝转移灶,共进行了 20 次电极治疗。术中未观察到并发症。在第 30 天,完全缓解率为 55.5%,稳定疾病率为 45.5%。所有(5)例患者均达到 6 个月的总生存率,5 例中有 4 例达到 6 个月的无进展生存率。

结论

电化疗是治疗无法切除的结直肠肝转移的开放性手术的一种可行且安全的辅助手段。倾向于开展更大规模的研究和更长时间的随访,以更好地确定其在治疗继发性肝恶性肿瘤中的作用。

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Int J Surg. 2017 Aug;44:26-32. doi: 10.1016/j.ijsu.2017.06.033. Epub 2017 Jun 15.
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