Electro-Chemo-Therapy (ECT) for metastatic Melanoma

Electro-Chemo-Therapy (ECT) for metastatic Melanoma

Update on Electro-Chemo-Therapy in Bristol Antonio Orlando Department of Plastic Surgery Southmead Hospital North Bristol Trust SWAG Skin SSG meeting, 17th May 2016 Electroporation of the cellular membrane: The application of electric pulses induces cells to form a transient pore in the cell membrane Cell membrane before electroporation Pores formation

Low dosage chemotherapeutic drug can enter the cell e.g. Bleomycin / Cisplatin (non/ poorly permeable anticancer drug possessing a high intrinsic cytotoxicity). ELECTROCHEMOTHERAPY TUMOR RESPONSE The efficacy of bleomycin in the treatment of melanoma is increased by over 100% when associated with electroporation MEDICAL DEVICE AND CHEMOTHERAPEUTIC DRUG COMBINATION: LOCALLY ENHANCED CHEMOTHERAPY CLINIPORATOR

EPSO2, ECT, CE Mark, Class IIa Elettric field amplitude: 1000V/cm Electric field distribution: omogeneous Pulse number: 8 Pulse lenght: 100s STANDARD OPERATING PROCEDUReS CLINIPORATOR ELECTRODES PLATE: P-30-8B HEXAGONAL NEEDLE:

FINGER ELECTRODE: N10/20/30-HG F05/10-LG LINEAR NEEDLE: N-10/20/30-HG FINGER ELECTRODE: Handles F05/10-OR Adjustable leght exagonal electrode

Indications ECT is an effective treatment of neoplastic lesions located in the skin or subcutaneous tissue, both primary and metastatic, regardless of the histological type of the neoplasm or previous treatments. It can be used as an adjunct to normal treatment options or as an additional option for patients unresponsive or unfit for normal treatment regimes Indications melanoma basal cell carcinoma squamous cell carcinoma kaposi sarcoma

local recurrences or cutaneous metastases from breast cancer, head and neck cancers STANDARD STANDARD OPERATING OPERATING PROCEDURES: PROCEDURES: DRUG DRUG ADMINISTRATION ADMINISTRATION Intra-tumoral administration: BLM and CDDP Volume ab2/ 6 V < 0.5 cm3

0.5 cm3 < V < 1 cm3 V > 1 cm3 BLM 1000IU/ml 1ml/cm3 (> 0,1ml) 0.5ml/cm3 0,25 ml/cm3 0.5ml (1

mg)/cm3 0,25 ml (0.5mg)/cm3 CDDP 2mg/ml 1ml (2 mg)/cm3 Intravenous administration: Bleomycin Standard dose 15.000 IU/m2 in bolus; Electric pulses delivered after 8 minutes of administration to allow optimized diffusion; Window timing for electric pulses: 30-40 minutes. the drug

ECT centres in Europe 4 7 12 28 3 5 Country Centres

Italy 28 Germany 12 Austria 1 Portugal 1

Spain 3 Sweden 3 Greece 5 Great Britain 7 (6*)

Hungary 1 Poland 1 The Netherlands 1 Lithuania

1 ESOPE 4 Research 12 Total 80 * A further 6 UK Trusts have applied for new CLINIPORATOR set up

ECT in North Bristol Trust Total of 70 ECT procedures on 52 patients January 2012 May 2016 (see bar chart) Most commonly used for melanoma (pie chart), but also successfully used for breast cancer, SCC, BCC (including 2 Gorlins cases), Merkel cell, angiosarcoma and T-cell lymphoma ECT Southmead experience 52 patients: 30 females, 22 males Age range: 29-98yrs Mean age: 73.7yrs Median age: 77.5yrs Diagnosis

Melanoma BCC (incl. Gorlin's) SCC Breast Ca Angiosarcoma Merkel cell T-cell lymphoma Annual Breakdown 25 20 15 10 5 0

2012 2013 2014 2015 2016 ECT Pathway - Referral to the SSMDT - Consultation with plastic surgeon - Lung function test/pre op assessment for GA

- Oncology referral - Day case GA - Follow up 6/weeks - Re-treat not before 8-12 weeks ECT +Lesional Excision Lesional excision % ECT cases Yes 56% No

44% Thank you

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