Electrochemotherapy -: An easy, highly effective and safe treatment of cutaneous and subcutaneous metastases:: Results of ESOPE (European Standard Operating Procedures of Electrochemotherapy) study

Purpose: To evaluate and confirm efficacy and safety of electrochemotherapy with bleomy 19 August 2006 cin or cisplatin on cutaneous and subcutaneous tumour nodules of patients with malig in revised form nant melanoma and other malignancies in a multicenter study. Patients and methods: This was a two year long prospective non-randomised study on 41 Accepted 23 August 2006 patients evaluable for response to treatment and 61 evaluable for toxicity. Four cancer centers enrolled patients with progressive cutaneous and subcutaneous metastases of any histologically proven cancer. The skin lesions were treated by electrochemotherapy, using application of electric pulses to the tumours for increased bleomycin or cisplatin delivery Melanoma into turnout cells. The treatment was performed using intravenous or intratumoural drug Cutaneous metastases injection, followed by application of electric pulses generated by a Cliniporator (TM) using plate Recurrent breast cancer or needle electrodes. Tumour response to electrochemotherapy as well as possible side effects with respect to the treatment approach, tumour histology and location of the Cisplatin tumour nodules and electrode type were evaluated. Results: An objective response rate of 85% (73.7% complete response rate) was achieved on Complete response the electrochemotherapy treated tumour nodules, regardless of tumour histology, and drug used or route of its administration. At 150 days after the treatment (median follow up was 133 days and range 60-380 days) local tumour control rate for electrochemotherapy was 88% with bleomycin given intravenously, 73% with bleomycin given intratumourally and 75% with cisplatin given intratumourally, demonstrating that all three approaches were similarly effective in local tumour treatment. Furthermore, electrochemotherapy was equally effective regardless of the tumour type and size of the nodules treated. Side-effects of electrochemotherapy were minor and acceptable, as reported by the patients. Conclusion: We demonstrated that electrochemotherapy is an easy, highly effective, safe and cost-effective approach for the treatment of cutaneous and subcutaneous tumour nodules of different malignancies. Electrochemotherapy can provide immediate clinical benefit in patients with advanced cutaneous and subcutaneous metastases. (c) 2006 Elsevier Ltd. All rights reserved.