Results of the ESOPE (European Standard Operating Procedures on Electrochemotherapy) study: Efficient, highly tolerable and simple palliative treatment of cutaneous and subcutaneous metastases from cancers of any histology
8047 Background: By applying brief, electric pulses, cell membranes can be transiently permeabilised (electroporation). This can be applied focally to tumors, enhancing the uptake of certain chemotherapeutic agents dramatically (electrochemotherapy). Methods: From 2003 to 2005, patients with cancer of any histological diagnosis and symptomatic metastases to skin or subcutis were accrued in four cancer centers. Patients had been offered standard treatment options previously. Primary endpoint was response. One treatment was performed in either general anesthesia or local anesthesia, depending on anatomical site, size and number of tumors. The Cliniporator (IGEA, Italy) was used to deliver electric pulses, with 3 different electrode types: 1) Plate electrodes, 2) Linear array needle electrodes 3) Hexagonal needle electrodes. Eight pulses of 100 μs were applied using 1) 1300 V/cm, 2 and 3) 1000 V/cm. Either intravenous bleomycin 15000 IU/M-2, or intratumoral injections of either bleomycin or cisplatinum, were administered prior to application of electric pulses to the tumors. Responses were documented through direct tumor measurement and digital photography. Results: 41 patients, with altogether 171 cutaneous metastases of malignant melanoma (98 nodules, 57 %), carcinoma or sarcoma were treated. Overall, 145 (84.8%) of the treated nodules responded (CR or PR), with CR in 126 of the nodules (73.7%). Negative response was observed in very low percentage of the treated nodules being either NC (10.5%) or PD (4.7%). Treatment of melanoma and non-melanoma nodules was equally successful. Treatment time per session (one or more nodules) was median 25 min (range 6–60). Intravenous and intratumoral administration of bleomycin, or cisplatinum yielded similar results. No significant toxicity was found, and 96% of patients reported they would agree to another treatment if indicated. Conclusions: Electrochemotherapy is an efficient, safe and simple palliative treatment of cutaneous and subcutaneous metastases of cancers of various histologies. Patient acceptance of treatment was excellent and 73.7% of nodules were in CR after one single treatment. No significant financial relationships to disclose.