Evaluation of calcium electroporation for the treatment of cutaneous metastases: A double blinded randomised controlled phase II trial

Dóra Ágoston, Eszter Baltás, Henriette Ócsai, Sándor Rátkai, Péter Gy Lázár, Irma Korom, Erika Varga, István Balázs Németh, Éva Dósa Rácz Viharosné, Julie Gehl, Judit Oláh, Lajos Kemény, Erika Gabriella Kis

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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.

Original languageEnglish
Article number179
JournalCancers
Volume12
Issue number1
DOIs
Publication statusPublished - Jan 2020

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Keywords

  • Biopsy
  • Bleomycin-based electrochemotherapy
  • Breast cancer
  • Calcium electroporation
  • Cutaneous metastases
  • Melanoma malignum
  • Non-inferiority
  • Randomization

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Ágoston, D., Baltás, E., Ócsai, H., Rátkai, S., Lázár, P. G., Korom, I., Varga, E., Németh, I. B., Viharosné, É. D. R., Gehl, J., Oláh, J., Kemény, L., & Kis, E. G. (2020). Evaluation of calcium electroporation for the treatment of cutaneous metastases: A double blinded randomised controlled phase II trial. Cancers, 12(1), [179]. https://doi.org/10.3390/cancers12010179