TY - JOUR

T1 - Evaluation of Calcium Electroporation for the Treatment of Cutaneous Metastases

T2 - A Double Blinded Randomised Controlled Phase II Trial

AU - Ágoston, Dóra

AU - Baltás, Eszter

AU - Ócsai, Henriette

AU - Rátkai, Sándor

AU - Lázár, Péter Gy

AU - Korom, Irma

AU - Varga, Erika

AU - Németh, István Balázs

AU - Viharosné, Éva Dósa Rácz

AU - Gehl, Julie

AU - Oláh, Judit

AU - Kemény, Lajos

AU - Kis, Erika Gabriella

PY - 2020/1

Y1 - 2020/1

N2 - 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.

AB - 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.

KW - Biopsy

KW - Bleomycin-based electrochemotherapy

KW - Breast cancer

KW - Calcium electroporation

KW - Cutaneous metastases

KW - Melanoma malignum

KW - Non-inferiority

KW - Randomization

U2 - 10.3390/cancers12010179

DO - 10.3390/cancers12010179

M3 - Journal article

C2 - 31936897

AN - SCOPUS:85078275240

VL - 12

JO - Cancers

JF - Cancers

SN - 2072-6694

IS - 1

M1 - 179

ER -