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Evaluation of Calcium Electroporation for the Treatment of Cutaneous Metastases: A Double Blinded Randomised Controlled Phase II Trial
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 o...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7017133/ https://www.ncbi.nlm.nih.gov/pubmed/31936897 http://dx.doi.org/10.3390/cancers12010179 |
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author | Ágoston, Dóra Baltás, Eszter Ócsai, Henriette Rátkai, Sándor Lázár, Péter Gy Korom, Irma Varga, Erika Németh, István Balázs Dósa-Rácz Viharosné, Éva Gehl, Julie Oláh, Judit Kemény, Lajos Kis, Erika Gabriella |
author_facet | Ágoston, Dóra Baltás, Eszter Ócsai, Henriette Rátkai, Sándor Lázár, Péter Gy Korom, Irma Varga, Erika Németh, István Balázs Dósa-Rácz Viharosné, Éva Gehl, Julie Oláh, Judit Kemény, Lajos Kis, Erika Gabriella |
author_sort | Ágoston, Dóra |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7017133 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-70171332020-02-28 Evaluation of Calcium Electroporation for the Treatment of Cutaneous Metastases: A Double Blinded Randomised Controlled Phase II Trial Ágoston, Dóra Baltás, Eszter Ócsai, Henriette Rátkai, Sándor Lázár, Péter Gy Korom, Irma Varga, Erika Németh, István Balázs Dósa-Rácz Viharosné, Éva Gehl, Julie Oláh, Judit Kemény, Lajos Kis, Erika Gabriella Cancers (Basel) Article 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. MDPI 2020-01-10 /pmc/articles/PMC7017133/ /pubmed/31936897 http://dx.doi.org/10.3390/cancers12010179 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Ágoston, Dóra Baltás, Eszter Ócsai, Henriette Rátkai, Sándor Lázár, Péter Gy Korom, Irma Varga, Erika Németh, István Balázs Dósa-Rácz Viharosné, Éva Gehl, Julie Oláh, Judit Kemény, Lajos Kis, Erika Gabriella Evaluation of Calcium Electroporation for the Treatment of Cutaneous Metastases: A Double Blinded Randomised Controlled Phase II Trial |
title | Evaluation of Calcium Electroporation for the Treatment of Cutaneous Metastases: A Double Blinded Randomised Controlled Phase II Trial |
title_full | Evaluation of Calcium Electroporation for the Treatment of Cutaneous Metastases: A Double Blinded Randomised Controlled Phase II Trial |
title_fullStr | Evaluation of Calcium Electroporation for the Treatment of Cutaneous Metastases: A Double Blinded Randomised Controlled Phase II Trial |
title_full_unstemmed | Evaluation of Calcium Electroporation for the Treatment of Cutaneous Metastases: A Double Blinded Randomised Controlled Phase II Trial |
title_short | Evaluation of Calcium Electroporation for the Treatment of Cutaneous Metastases: A Double Blinded Randomised Controlled Phase II Trial |
title_sort | evaluation of calcium electroporation for the treatment of cutaneous metastases: a double blinded randomised controlled phase ii trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7017133/ https://www.ncbi.nlm.nih.gov/pubmed/31936897 http://dx.doi.org/10.3390/cancers12010179 |
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