Abstract
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.
Highlights
Bleomycin-based ECT is a widely used method for the treatment of cutaneous tumours from all histologies [1,2,3,4,5,6]
The primary endpoint of the study was to compare the tumour response of cutaneous metastases after application of Calcium electroporation (Ca-EP) and ECT with the administration of intratumoral bleomycin
The results of the first clinical trials suggested that Ca-EP is safe and efficient at the local level for tumours of different types, including cutaneous metastases from breast cancer and malignant melanoma and recurrent head and neck cancer [11,20]
Summary
Bleomycin-based ECT is a widely used method for the treatment of cutaneous tumours from all histologies [1,2,3,4,5,6]. During ECT, a chemotherapeutic drug, usually bleomycin, is electroporated into the Cancers 2020, 12, 179; doi:10.3390/cancers12010179 www.mdpi.com/journal/cancers. A recent meta-analysis of ECT in a palliative setting found a complete response (CR) rate of 46.6% and objective response rates (ORR) of 82.2%, regardless of the tumour type. ECT is a repeatable and minimally invasive intervention that reduces symptom burden [7]. With the goal of reducing the risk of possible adverse events, the chemotherapeutic drug (bleomycin) is replaced with calcium in calcium electroporation (Ca-EP). Calcium might be an effective option in cases where the administration of a chemotherapeutic drug is contraindicated
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
