Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
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
_version_ 1783497132862341120
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
work_keys_str_mv AT agostondora evaluationofcalciumelectroporationforthetreatmentofcutaneousmetastasesadoubleblindedrandomisedcontrolledphaseiitrial
AT baltaseszter evaluationofcalciumelectroporationforthetreatmentofcutaneousmetastasesadoubleblindedrandomisedcontrolledphaseiitrial
AT ocsaihenriette evaluationofcalciumelectroporationforthetreatmentofcutaneousmetastasesadoubleblindedrandomisedcontrolledphaseiitrial
AT ratkaisandor evaluationofcalciumelectroporationforthetreatmentofcutaneousmetastasesadoubleblindedrandomisedcontrolledphaseiitrial
AT lazarpetergy evaluationofcalciumelectroporationforthetreatmentofcutaneousmetastasesadoubleblindedrandomisedcontrolledphaseiitrial
AT koromirma evaluationofcalciumelectroporationforthetreatmentofcutaneousmetastasesadoubleblindedrandomisedcontrolledphaseiitrial
AT vargaerika evaluationofcalciumelectroporationforthetreatmentofcutaneousmetastasesadoubleblindedrandomisedcontrolledphaseiitrial
AT nemethistvanbalazs evaluationofcalciumelectroporationforthetreatmentofcutaneousmetastasesadoubleblindedrandomisedcontrolledphaseiitrial
AT dosaraczviharosneeva evaluationofcalciumelectroporationforthetreatmentofcutaneousmetastasesadoubleblindedrandomisedcontrolledphaseiitrial
AT gehljulie evaluationofcalciumelectroporationforthetreatmentofcutaneousmetastasesadoubleblindedrandomisedcontrolledphaseiitrial
AT olahjudit evaluationofcalciumelectroporationforthetreatmentofcutaneousmetastasesadoubleblindedrandomisedcontrolledphaseiitrial
AT kemenylajos evaluationofcalciumelectroporationforthetreatmentofcutaneousmetastasesadoubleblindedrandomisedcontrolledphaseiitrial
AT kiserikagabriella evaluationofcalciumelectroporationforthetreatmentofcutaneousmetastasesadoubleblindedrandomisedcontrolledphaseiitrial