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钙电穿孔治疗复发性头颈癌:一项临床I期研究。

Calcium electroporation for recurrent head and neck cancer: A clinical phase I study.

作者信息

Plaschke Christina Caroline, Gehl Julie, Johannesen Helle Hjorth, Fischer Barbara Malene, Kjaer Andreas, Lomholt Anne Fog, Wessel Irene

机构信息

Department of Otorhinolaryngology, Head & Neck Surgery and Audiology Copenhagen University Hospital Rigshospitalet Copenhagen Denmark.

Department of Clinical Medicine Copenhagen University Hospital Rigshospitalet Copenhagen Denmark.

出版信息

Laryngoscope Investig Otolaryngol. 2019 Jan 3;4(1):49-56. doi: 10.1002/lio2.233. eCollection 2019 Feb.

Abstract

BACKGROUND

Calcium electroporation is a novel cancer treatment, which combines temporary cell permeability from electroporation with a high influx of calcium intracellularly resulting in cancer cell necrosis.

METHODS

A phase I trial performing calcium electroporation on 6 patients suffering from recurrent head and neck cancer. In general anesthesia, intratumoral calcium injections were followed by electroporation. Safety was monitored by adverse events registration, serum Ca, ECG, and pain scores. Tumor response was measured on PET/MRI scans.

RESULTS

Procedures were performed without complications. No serious adverse events, signs of hypercalcemia, or cardiac arrhythmias were observed. Two months post-treatment tumor responses on MRI: three partial responses, one stable disease, and two progression. Responses on PET: one partial metabolic disease, four with stable metabolic disease, and one not evaluable. One patient was without clinical evidence of disease after 12 months of observation.

CONCLUSION

Calcium electroporation is feasible and safe in head and neck tumors. Clinical responses were observed in three of six patients, warranting further studies.

LEVEL OF EVIDENCE

Level 4.

摘要

背景

钙电穿孔是一种新型癌症治疗方法,它将电穿孔引起的细胞短暂通透性与细胞内大量钙流入相结合,导致癌细胞坏死。

方法

一项I期试验对6例复发性头颈癌患者进行钙电穿孔治疗。在全身麻醉下,瘤内注射钙后进行电穿孔。通过不良事件登记、血清钙、心电图和疼痛评分监测安全性。通过PET/MRI扫描测量肿瘤反应。

结果

手术过程无并发症。未观察到严重不良事件、高钙血症迹象或心律失常。治疗后两个月MRI上的肿瘤反应:3例部分缓解,1例疾病稳定,2例进展。PET上的反应:1例部分代谢缓解,4例代谢稳定,1例不可评估。1例患者在观察12个月后无疾病临床证据。

结论

钙电穿孔在头颈肿瘤中可行且安全。6例患者中有3例观察到临床反应,值得进一步研究。

证据水平

4级。

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