TY - JOUR
T1 - Calcium electroporation for treatment of cutaneous metastases; a randomized double-blinded phase II study, comparing the effect of calcium electroporation with electrochemotherapy
AU - Falk, H
AU - Matthiessen, L W
AU - Wooler, G
AU - Gehl, J
PY - 2018/3/4
Y1 - 2018/3/4
N2 - BACKGROUND: Calcium electroporation is a novel anticancer treatment, which utilizes high voltage pulses to permeabilize cell membranes and expose the cell to supraphysiological doses of calcium. Preclinical studies on calcium electroporation have shown strikingly high tumor response with cell necrosis. Calcium electroporation builds on the treatment electrochemotherapy, where chemotherapeutic drugs, mostly bleomycin, are internalized by electroporation. This double-blinded randomized study compared calcium electroporation to electrochemotherapy in terms of objective response measured 6 months after treatment.METHODS: Seven patients with a total of 47 cutaneous metastases from breast cancer and malignant melanoma were included in the protocol. A total of 37 metastases were randomized and evaluated for response, another 10 metastases were used for biopsy. This was a non-inferiority trial and metastases were randomized individually in each patient to either intratumoral calcium or bleomycin followed by application of electric pulses to tumor site. All metastases were treated once, and after 6-months of follow-up, the randomization code was revealed.RESULTS: Objective response of calcium electroporation was 72% (13/18) with complete response in 66% (12/18). For electrochemotherapy, objective response was 84% (16/19) with complete response in 68% (13/19). There was no statistically significant difference between the two treatments (p = 0.5). After 1 year, only three out of 25 metastases had relapsed. Ulceration, itching and exudation were reported slightly more frequently in metastases treated with bleomycin, and hyperpigmentation was only seen in metastases treated with bleomycin.CONCLUSION: This study shows that calcium electroporation is feasible and effective in patients with cutaneous metastases.
AB - BACKGROUND: Calcium electroporation is a novel anticancer treatment, which utilizes high voltage pulses to permeabilize cell membranes and expose the cell to supraphysiological doses of calcium. Preclinical studies on calcium electroporation have shown strikingly high tumor response with cell necrosis. Calcium electroporation builds on the treatment electrochemotherapy, where chemotherapeutic drugs, mostly bleomycin, are internalized by electroporation. This double-blinded randomized study compared calcium electroporation to electrochemotherapy in terms of objective response measured 6 months after treatment.METHODS: Seven patients with a total of 47 cutaneous metastases from breast cancer and malignant melanoma were included in the protocol. A total of 37 metastases were randomized and evaluated for response, another 10 metastases were used for biopsy. This was a non-inferiority trial and metastases were randomized individually in each patient to either intratumoral calcium or bleomycin followed by application of electric pulses to tumor site. All metastases were treated once, and after 6-months of follow-up, the randomization code was revealed.RESULTS: Objective response of calcium electroporation was 72% (13/18) with complete response in 66% (12/18). For electrochemotherapy, objective response was 84% (16/19) with complete response in 68% (13/19). There was no statistically significant difference between the two treatments (p = 0.5). After 1 year, only three out of 25 metastases had relapsed. Ulceration, itching and exudation were reported slightly more frequently in metastases treated with bleomycin, and hyperpigmentation was only seen in metastases treated with bleomycin.CONCLUSION: This study shows that calcium electroporation is feasible and effective in patients with cutaneous metastases.
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Agents/administration & dosage
KW - Bleomycin/administration & dosage
KW - Breast Neoplasms/drug therapy
KW - Calcium/administration & dosage
KW - Double-Blind Method
KW - Electrochemotherapy/adverse effects
KW - Female
KW - Humans
KW - Melanoma/drug therapy
KW - Middle Aged
KW - Skin Neoplasms/drug therapy
U2 - 10.1080/0284186X.2017.1355109
DO - 10.1080/0284186X.2017.1355109
M3 - Journal article
C2 - 28816072
SN - 1100-1704
VL - 57
SP - 311
EP - 319
JO - Acta Oncologica, Supplement
JF - Acta Oncologica, Supplement
IS - 3
ER -
