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Open AccessArticle

Evaluation of Calcium Electroporation for the Treatment of Cutaneous Metastases: A Double Blinded Randomised Controlled Phase II Trial

1
Department of Dermatology and Allergology, University of Szeged, 6720 Szeged, Hungary
2
Department of Oral and Maxillofacial Surgery, University of Szeged, 6720 Szeged, Hungary
3
Center for Experimental Drug and Gene Electrotransfer (C*EDGE), Department of Clinical Oncology and Palliative Care, Zealand University Hospital, 4000 Roskilde, Denmark
4
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark
5
Department of Oncotherapy, University of Szeged, 6720 Szeged, Hungary
*
Author to whom correspondence should be addressed.
Cancers 2020, 12(1), 179; https://doi.org/10.3390/cancers12010179
Received: 22 December 2019 / Revised: 5 January 2020 / Accepted: 8 January 2020 / Published: 10 January 2020
Calcium electroporation (Ca-EP) is a new anticancer treatment providing similar features to electrochemotherapy (ECT). The aim of our study is to compare the efficacy of Ca-EP with bleomycin-based ECT. This double-blinded randomized controlled phase II study was conducted at the Medical University of Szeged, Hungary. During this once only treatment up to ten measurable cutaneous metastases per patient were separately block randomized for intratumoral delivery of either calcium or bleomycin, which was followed by reversible electroporation. Tumour response was evaluated clinically and histologically six months after treatment. (ClinicalTrials.gov: NCT03628417, closed). Seven patients with 44 metastases (34 from malignant melanoma, 10 from breast cancer) were included in the study. Eleven metastases were taken for biopsies, and 33 metastases were randomised and treated once. The objective response rates were 33% (6/18) for Ca-EP and 53% (8/15) for bleomycin-based ECT, with 22% (4/18) and 40% (6/15) complete response rates, respectively. The CR was confirmed histologically in both arms. Serious adverse events were not registered. Ulceration and hyperpigmentation, both CTCA criteria grade I side effects, were observed more frequently after bleomycin-based ECT than for Ca-EP. Ca-EP was non-inferior to ECT, therefore, it should be considered as a feasible, effective and safe treatment option. View Full-Text
Keywords: calcium electroporation; bleomycin-based electrochemotherapy; cutaneous metastases; melanoma malignum; breast cancer; randomization; biopsy; non-inferiority calcium electroporation; bleomycin-based electrochemotherapy; cutaneous metastases; melanoma malignum; breast cancer; randomization; biopsy; non-inferiority
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Ágoston, D.; Baltás, E.; Ócsai, H.; Rátkai, S.; Lázár, P.G.; Korom, I.; Varga, E.; Németh, I.B.; Dósa-Rácz Viharosné, É.; Gehl, J.; Oláh, J.; Kemény, L.; Kis, E.G. Evaluation of Calcium Electroporation for the Treatment of Cutaneous Metastases: A Double Blinded Randomised Controlled Phase II Trial. Cancers 2020, 12, 179.

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