Electrochemotherapy treatment regimen

ECT treatment of cSCC lesions was performed according to the European Standard Operating procedures of Electrochemotherapy (ESOPE) [8, 11]. In 2006, the multicenter ESOPE project has defined and validated the standard operating procedures to safely and effectively treat patients with cutaneous and subcutaneous tumor nodules with ECT, thus providing the necessary guidelines for the use of ECT in clinical practice [8]. The primary endpoint of the study was to evaluate the efficacy of ECT in the treatment of cSCC. Treatment outcome was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST-Guidelines) [13]. The term “complete response” means clearance lesions on later visits when compared with the first lesions on admission. “Partial response” equals at least 30% decrease in diameter of target lesions whereas “stable disease” involves less than 30% decrease. The terms complete and partial response as well as stable disease implicate the absence of new lesions or of progressive lesions. The electric pulse generator used in this study was the CE certified medical device Cliniporator_ (IGEAS.p.A., Carpi, Modena, Italy). The delivery devices were N-20-4B linear needle electrodes for head and neck lesions and N-20 HG needle electrodes for all other, which were inserted at subcutaneous level directly into deep tumor tissues and surrounding areas up to 2 cm of safe margin, so that the entire tumor tissue could lie within the electric field. Electric pulses were administered in a time interval of 8–28 min after intravenous injection of bleomycin at the dose of 15,000 IU/m², in bolus, in a time interval of about 40–45 s, under general anesthesia. The patients were followed up at 1 and 4 weeks after the treatment and thereafter at monthly interval. The treatment was repeated in those patients who complete response was not achieved at a first ECT application.