Brussels, 18 Nov 2005
The EU-funded ESOPE project has developed a new treatment based on electrochemotherapy which is highly effective for cutaneous or sub-cutaneous tumours resistant to conventional cancer therapies.
In addition, the project has produced new low-cost apparatus and operational procedures that make this technique available for immediate application throughout Europe. It is already being used in several hospitals in Italy and Spain, as well as in the clinics participating in the project itself.
Electrochemotherapy (ECT) is a method whereby a drug is administered while the tumour cells' membranes are made porous through the application of a series of short, strong electrical pulses. This technique is called electroporation and, while the principle of ECT has been known in cell cultures since 1988, the project team has developed, and shown the effectiveness of, apparatus and standard operating procedures for administering the treatment.
The project carried out studies involving 110 patients with cancers such as Kaposi sarcoma or malignant melanoma for whom no other treatment was available, having exhausted conventional surgery, radio- and chemotherapy options. Of the 170 tumour nodules treated, 74 percent disappeared completely, while a further 11 percent partially regressed, giving an 85 per cent objective response rate.
Speaking at the Communicating European Research 2005 (CER 2005) conference in Brussels, project coordinator Dr Lluis Mir of the French National Centre for Scientific Research (CNRS) said: 'We found that the therapy could immediately stop bleeding in melanomas, with the nodules healing in 10 weeks, while Kaposi sarcoma nodules would disappear after two months'.
The drugs used in the studies were Bleomycin, administered both intravenously and through local injections, and Cisplatin injected directly into tumour nodules. Dr Mir explained that the dose of Cisplatin was too small to cause side effects, while Bleomycin is a long-established drug known to have no side effects. Indeed, the project team observed no important side effects at all during the study's two year duration.
Bleomycin has been known as a chemotherapy molecule since 1977, went on Dr Mir, and while it effectively attacks the tumour DNA once inside the cell, its difficulty in entering the cell severely reduces its effectiveness, making it next to useless in the cases under study in normal circumstances. The ECT technique applies a rapid series of eight electrical pulses to the skin, each of between 800 and 1,000 volts and of 100 microseconds duration. This disrupts the lipid bilayer of the cell wall, forming 'pores' that make it permeable enough for the drug to enter.
The study found ECT to be appropriate for any cutaneous or sub-cutaneous metastasis, or secondary tumour, as well as melanoma and in transit melanoma metastasis. Furthermore, it could be used for localised breast cancer recurrences and basal cell carcinomas.
Igea, a small enterprise based in Italy, has developed apparatus that is very cost effective in comparison with other therapies; indeed costs are low enough for it to have great potential for use in developing countries. Dr Ruggero Cadossi from the company explained that the 'Cliniporator' machine would be available for 45,000 euro, while the electrodes necessary for the treatment cost around 700 euro for each patient. He compared this with radiotherapy machines that cost in the region of one million euro with each treatment typically costing 12,000 euro.
ESOPE was funded under the 'Quality of Life' section of the EU's Fifth Framework Programme for research (FP5), and Dr Mir emphasised the role of this support in transforming European science into an effective treatment and common operating procedure for its use. The apparatus is CE marked for use throughout the European Union and the project has produced a European Standard Operating Procedure for Electrochemotherapy. These can be performed on an out-patient basis and are already being used in several hospitals around Europe, including Denmark, Ireland, Italy and Spain.
The project has shown that the treatment can save organs and their function, improve quality of life, and that it can be repeated. It is also applicable to areas that have previously been irradiated or where surgery is difficult. Dr Mir explained that the next stage for research would be to see if ECT could be used on cancers elsewhere, including primary tumours on internal organs.