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Clinical Trials and Data
Clinical Trials and Statistics: The studies performed have all shown that this is an effective treatment in many patients. Between 79% and 85% of patients benefit from the treatment, and in about two out of three patients the cancer nodule disappears altogether. These results were obtained after a single outpatient treatment in most cases. The technique of Electrochemotherapy has been extensively studied with published results in 297 patients in which 1292 cancer lesions were treated. The studies include a multi-centre trial that has been performed between five hospitals in Europe and America. Pre – Clinical Trials: In vitro: the cyto-toxicity of Bleomycin or Cysplatin is increased by 1.000 to 10.000 times when the cultures are subject to electroporation (1-3). In vivo: the growth control of mice implanted tumours was significantly higher when treatment with Bleomycin or Cysplatin was associated with electroporation (4- 6) The efficacy of Electrochemotherapy in controlling the growth of experimental tumoral lesion is documented by numerous publications. References
The first clinical experience with Electrochemotherapy for the treatment of cutaneous and subcutaneous tumours was performed first in the 1990's, by Dr. Lluis Mir. The first positive clinical results were subsequently confirmed by further research. The European Community has sponsored and promoted a large clinical study aiming at the definition of the: European Standard Operating Procedure for ElectroChemoTherapy. (ESOPE V FP Quality of Life and Management of Living Resources Programme). The results of ESOPE project have precisely defined the indications and modalities for the use of Electrochemotherapy in clinical practice. The clinical experiences were carried out with the use of both Bleomycin and Cysplatin in local or general anaesthesia. The study was led at 4 European Oncological institutes Clinical Results Clinical Results of the ESOPE project brought two main results; The ESOPE (European Standard Operating Procedure for Electrochemotherapy) project has been recently published in a dedicated supplement of the European Journal of Cancer totally devoted to Electrochemotherapy (Electrochemotherapy. EJC Supplements, Volume 4, No. 11, Elsevier, November 2006. Guest Editor: Lluis M.Mir D.Sc). The ESOPE project brought t- Description and validation of the standard operating procedure for ECT for the local treatment of cutaneous and subcutaneous tumours independently of their histology. Standard operating procedures of the Electrochemotherapy: Instructions for the use of bleomycin or cisplatin administered either systemically or locally and electric pulses delivered by the CliniporatorTM by means of invasive or non-invasive electrodes Lluis M. Mir et al., EJC SUPPLEMENTS 4(2006) 14-25 Confirmation that Electrochemotherapy with The Cliniporator is easy to perform, safe, and highly effective. A positive response was obtained in 85% of the treated nodules (73.7% of complete response). Electrochemotherapy – An easy, highly effective and safe treatment of cutaneous and subcutaneous metastases: Results of ESOPE (European Standard Operating Procedures of Electrochemotherapy) study Michel Marty et al., EJC SUPPLEMENTS 4 (2006) 3-13 For more information: www.cliniporator.com |