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.