Electrochemotherapy consists of
chemotherapy followed by local application of electric pulses to the
tumor to increase
drug delivery into the cells. The aim of this Phase II clinical study was to evaluate the antitumor effectiveness of electrochemotherapy using intratumoral
cisplatin administration on cutaneous
tumor nodules in
malignant melanoma patients. In 10 patients, 133
tumor nodules of different sizes were treated: (a) 82
tumor nodules were treated with electrochemotherapy; (b) 27
tumor nodules were treated with
cisplatin; (c) 2
tumor nodules were treated with electric pulses; and (d) 22
tumor nodules were untreated. Four weeks after
therapy, 78% objective responses were obtained in the electrochemotherapy group, and 38% objective responses were obtained in the
cisplatin group. Exposure of
tumor nodules to electric pulses without
cisplatin treatment had no effect on
tumor growth. Electrochemotherapy was well tolerated by all patients, and a good cosmetic effect was obtained, with only minimal
scarring and a slight depigmentation of the skin. At 124 weeks of follow-up, a 77% control rate of the
tumor nodules treated by electrochemotherapy was observed, compared to 19% for those that were treated with
cisplatin only (P < 0.0001). Our results clearly demonstrate that electrochemotherapy with
cisplatin is a highly effective approach for treatment of
cutaneous malignant melanoma nodules. The advantages of this
therapy include its simplicity, the short
duration of treatment sessions, low
cisplatin doses, and insignificant side effects, as well as the fact that it can be done on an outpatient basis.