Calcium electroporation in cutaneous metastases- A non- randomised phase II multicentre clinical trial

被引：8

作者：

Vissing, Mille ^{[1
,2
]}

Pervan, Mascha ^{[3
]}

Ploen, John ^{[4
]}

Schnefeldt, Mazen ^{[5
]}

Rafaelsen, Soren Rafael ^{[5
]}

Jensen, Lars Henrik ^{[4
]}

Rody, Achim

Gehl, Julie ^{[1
,2
,6
]}

机构：

[1] Zealand Univ Hosp, Ctr Expt Drug & Gene Electrotransfer C EDGE, Dept Clin Oncol & Palliat Care, Roskilde, Denmark

[2] Univ Copenhagen, Fac Hlth & Med Sci, Dept Clin Med, Blegdamsvej 3B, DK-2200 Copenhagen, Denmark

[3] Univ Hosp Schleswig Holstein, Dept Gynaecol & Obstet, Campus Lubeck,Ratzeburger Allee 160, D-23538 Lubeck, Germany

[4] Univ Hosp Southern Denmark, Dept Oncol, Beriderbakken 4, DK-7100 Vejle, Denmark

[5] Univ Hosp Southern Denmark, Dept Radiol, Beriderbakken 4, DK-7100 Vejle, Denmark

[6] Zealand Univ Hosp, Dept Clin Oncol & Palliat Care, Sygehusvej 10, DK-4000 Roskilde, Denmark

来源：

EJSO | 2023年 / 49卷 / 09期

关键词：

CANCER; ELECTROCHEMOTHERAPY; TUMORS; CELLS;

D O I：

10.1016/j.ejso.2023.04.024

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: Cutaneous metastases can cause distressing symptoms and be challenging to treat. Local therapies are essential in management. Calcium electroporation uses calcium and electrical pulses to selectively kill cancer cells. This multicentre study aimed to define response in cutaneous metastases across different cancer types. Methods: Patients with tumours <= 3 cm of any histology were included (stable or progressing on current therapy >= 2 months), at three centres. Tumours were treated with 220 mM calcium chloride injection and manual application of eight 0.1 ms pulses with 1 kV/cm and 1Hz with a handheld electrode, in local or general anaesthesia. Clinical response was evaluated after 1, 2, 3, 4, 5, 6, and 12 months. Primary endpoint was response at two months. The overall response rate (ORR) was partial- and complete responses of treated tumours. MR-imaging and qualitative interviews were performed in respective subsets. Results: Nineteen patients with disseminated cancer (breast n = 4, lung n = 5, pancreatic n = 1, colorectal n = 2, gastric n = 1, and endometrial cancer n = 1) were enrolled, and 58 metastases were treated (50 once, 8 retreated). The ORR was 36% (95% CI 22-53) after two months. Best ORR was 51% (CR 42%; PR 9%). Previous irradiation improved outcomes (p = 0.0004). Adverse events were minimal. Median pain score was reduced after two months (p = 0.017). Treatment may relieve symptoms according to qualitative interviews. MRI showed restriction in treated tissue. Conclusion: The majority of tumours were treated only once with calcium electroporation, achieving an ORR of 36% after two months and best ORR of 51%. Efficacy, symptom-relief and safety support calcium electroporation as a palliative treatment option for cutaneous metastases. (c) 2023 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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