Electroporation Clinical Data
Following extensive preclinical studies on electroporation using either bleomycin or cisplatin, the first clinical study on electrochemotherapy with bleomycin was performed by a team at the Institut Gustave-Roussy in Paris lead by Dr. Lluis Mir. The trial demonstrated good antitumor effectiveness on cutaneous metastases of head and neck carcinoma patients. The procedure was established to be extremely potent with reproducible antitumor effects observed. The first positive clinical results were subsequently confirmed by further research in both Europe and the USA. After the initial study, several clinical trials on electrochemotherapy using bleomycin and cisplatin administered locally or systemically were initiated for the treatment of various types of cancer malignancies. All together the results from over 1100 tumours in more than 350 cancer patients have been published. The overall results of these studies show that electrochemotherapy is an effective and well-tolerated treatment providing numerous benefits (publications below).
The European Community subsequently sponsored and promoted a large clinical study aiming at the optimising the delivery of chemotherapy drugs (bleomycin or cisplatin) using electroporation: The European Standard Operating Procedure for Electro-chemotherapy. (ESOPE). The results of ESOPE project have precisely defined the indications and modalities for the use of Electrochemotherapy in clinical practice. The study was led at 4 European Oncological institutes including the Cork Cancer Research Centre where the EndoVE® system was developed.
The results of the ESOPE project have been 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). This article provides a description and validation of the standard operating procedure for electrochemotherapy 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 cliniporator by means of invasive or non-invasive electrodes. Lluis M. Mir et al., EJC SUPPLEMENTS 4(2006) 14-25, provides confirmation that electrochemotherapy is easy to perform, safe, and highly effective. A positive response was obtained in 85% of the treated nodules (73.7% of tumours showed a complete response with a single treatment).
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
Hampton T. Electric pulses help with chemotherapy, may open new paths for other agents. JAMA. 2011 Feb 9;305(6):549-51
Edhemovic I, Gadzijev EM, Brecelj E, Miklavcic D, Kos B, et al., Electrochemotherapy: a new technological approach in treatment of metastases in the liver. Technol Cancer Res Treat. 2011 Oct;10(5):475-85.
Testori A, Faries MB, Thompson JF, Pennacchioli E, Deroose JP, van Geel AN, et al., Local and intralesional therapy of in-transit melanoma metastases. J Surg Oncol. 2011 Sep;104(4):391-6. doi: 10.1002/jso.22029. Review.
Sersa G, Cufer T, Paulin SM, Cemazar M, Snoj M. Electrochemotherapy of chest wall breast cancer recurrence. Cancer Treat Rev. 2011 Aug 17.
Curatolo P, Quaglino P, Marenco F, Mancini M, Nardò T, et al., Electrochemotherapy in the Treatment of Kaposi Sarcoma Cutaneous Lesions: A Two-Center Prospective Phase II Trial. Ann Surg Oncol. 2011
Agerholm-Larsen B, Iversen HK, Ibsen P, Moller JM, Mahmood F, Jensen KS, Gehl J. Preclinical validation of electrochemotherapy as an effective treatment for brain tumors. Cancer Res. 2011 Jun 1;71(11):3753-62.
Larkin JO, Collins CG, Aarons S, Tangney M, Whelan M, Soden DM, et al. Electrochemotherapy: aspects of preclinical development and early clinical experience. Ann Surg2007 Mar;245(3):469-79.
Gargiulo M, Moio M, Monda G, Parascandolo S, Cubicciotti G. Electrochemotherapy: actual considerations and clinical experience in head and neck cancers. Ann Surg2010 Apr;251(4):773.
Quaglino P, Mortera C, Osella-Abate S, Barberis M, Illengo M, Rissone M, et al. Electrochemotherapy with intravenous bleomycin in the local treatment of skin melanoma metastases. Ann Surg Oncol2008 Aug;15(8):2215-22.
Gothelf A, Mir LM, Gehl J. Electrochemotherapy: results of cancer treatment using enhanced delivery of bleomycin by electroporation. Cancer Treat Rev2003 Oct;29(5):371-87.
Mir LM, Belehradek M, Domenge C, Orlowski S, Poddevin B, Belehradek J, Jr., et al. [Electrochemotherapy, a new antitumor treatment: first clinical trial]. C R Acad Sci III1991;313(13):613-8.
Gaudy C, Richard MA, Folchetti G, Bonerandi JJ, Grob JJ. Randomized controlled study of electrochemotherapy in the local treatment of skin metastases of melanoma. J Cutan Med Surg2006 May-Jun;10(3):115-21.
Heller R, Jaroszeski MJ, Reintgen DS, Puleo CA, DeConti RC, Gilbert RA, et al. Treatment of cutaneous and subcutaneous tumors with electrochemotherapy using intralesional bleomycin. Cancer1998 Jul 1;83(1):148-57.
Glass LF, Pepine ML, Fenske NA, Jaroszeski M, Reintgen DS, Heller R. Bleomycin-mediated electrochemotherapy of metastatic melanoma. Arch Dermatol1996 Nov;132(11):1353-7.
Byrne CM, Thompson JF, Johnston H, Hersey P, Quinn MJ, Michael Hughes T, et al. Treatment of metastatic melanoma using electroporation therapy with bleomycin (electrochemotherapy). Melanoma Res 2005 Feb;15(1):45-51.
Campana LG, Mocellin S, Basso M, Puccetti O, De Salvo GL, Chiarion-Sileni V, et al. Bleomycin-based electrochemotherapy: clinical outcome from a single institution's experience with 52 patients. Ann Surg Oncol2009 Jan;16(1):191-9.
Rols MP, Bachaud JM, Giraud P, Chevreau C, Roche H, Teissie J. Electrochemotherapy of cutaneous metastases in malignant melanoma. Melanoma Res2000 Oct;10(5):468-74.
Allegretti JP, Panje WR. Electroporation therapy for head and neck cancer including carotid artery involvement. Laryngoscope2001 Jan;111(1):52-6.
Tijink BM, De Bree R, Van Dongen GA, Leemans CR. How we do it: Chemo-electroporation in the head and neck for otherwise untreatable patients. Clin Otolaryngol2006 Oct;31(5):447-51.
Panje WR, Hier MP, Garman GR, Harrell E, Goldman A, Bloch I. Electroporation therapy of head and neck cancer. Ann Otol Rhinol Laryngol1998 Sep;107(9 Pt 1):779-85.
Bloom DC, Goldfarb PM. The role of intratumour therapy with electroporation and bleomycin in the management of advanced squamous cell carcinoma of the head and neck. Eur J Surg Oncol2005 Nov;31(9):1029-35.
Burian M, Formanek M, Regele H. Electroporation therapy in head and neck cancer. Acta Otolaryngol2003 Jan;123(2):264-8.
Mir LM, Gehl J, Sersa G, Collins CG, Garbay JR, Billard V, et al. 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. European Journal of Cancer, Supplement2006;4(11):14-25.
Marty M, Sersa G, Garbay JR, Gehl J, Collins CG, Snoj M, et al. Electrochemotherapy - An easy, highly effective and safe treatment of cutaneous and subcutaneous metastases: Results of ESOPE (European Standard Operating Procedures of Electrochemotherapy) study. European Journal of Cancer, Supplement2006;4(11):3-13.
Jarm T, Cemazar M, Miklavcic D, Sersa G. Antivascular effects of electrochemotherapy: implications in treatment of bleeding metastases. Expert Rev Anticancer Ther May;10(5):729-46.