Background: Electrochemotherapy (ECT) is currently used to treat cutaneous and subcutaneous tumors of different histotypes. ECT combines cytotoxic drugs and the application of high-intensity electric pulses to increase cell permeability. In 2006, a multicenter European project (ESOPE, European Standard Operating Procedures of Electrochemotherapy) defined the guidelines for ECT application. To date, a revision of the first SOP is required. The International Network for Sharing Practices on Electrochemotherapy (InspECT) database was established to improve the clinical application of ECT. The objective of this study was to evaluate the effectiveness of ECT using reduced dosages of i.v. bleomycin (BLM). Methods: Lowering of the dose of BLM is advised e.g. in patients with impaired renal function. As patients treated with ECT were registered prospectively in a common database (InspECT registry) we decided to investigate efficacy and side effects when a lower dose of BLM was used. 57 patients, uploaded by 7 European centres, were treated by ECT with respectively 7.500, 10.000 and 13.500 IU/m2 of BLM, instead of the standard 15.000 IU/m2, because of renal dysfunction. Results: We enrolled 57 patients with 147 skin lesions. Diagnosis distribution of primary tumour was: 38.6% melanoma, 22.8% squamous cell carcinoma, 17.5% basal cell carcinoma, 7% breast cancer, 7% Kaposi sarcoma, 7.1% other. Per-tumor response at 60 days was as follows: CR, 70.1%, PR, 16.3%. Per-patient response was as follows: CR, 57.9%, PR, 21.1%. Only 2 patients (4%) experienced flu-like symptoms, 1 patient (2%) nausea and 22 patients (39%) referred pain, mostly mild. Conclusions: According to the data of this pilot study, the use of dose of BLM lower than those recommended by SOP, seems to be effective. Our results suggest that also patients with renal failure may benefit from ECT treatment with a reduced BLM dose. These findings need prospective confirmations on wider cohorts of patients.
Prospective pilot study evaluating the effectiveness of electrochemotherapy using reduced dosages of intravenous bleomycin
CAMPANA, LUCA GIOVANNI;
2017
Abstract
Background: Electrochemotherapy (ECT) is currently used to treat cutaneous and subcutaneous tumors of different histotypes. ECT combines cytotoxic drugs and the application of high-intensity electric pulses to increase cell permeability. In 2006, a multicenter European project (ESOPE, European Standard Operating Procedures of Electrochemotherapy) defined the guidelines for ECT application. To date, a revision of the first SOP is required. The International Network for Sharing Practices on Electrochemotherapy (InspECT) database was established to improve the clinical application of ECT. The objective of this study was to evaluate the effectiveness of ECT using reduced dosages of i.v. bleomycin (BLM). Methods: Lowering of the dose of BLM is advised e.g. in patients with impaired renal function. As patients treated with ECT were registered prospectively in a common database (InspECT registry) we decided to investigate efficacy and side effects when a lower dose of BLM was used. 57 patients, uploaded by 7 European centres, were treated by ECT with respectively 7.500, 10.000 and 13.500 IU/m2 of BLM, instead of the standard 15.000 IU/m2, because of renal dysfunction. Results: We enrolled 57 patients with 147 skin lesions. Diagnosis distribution of primary tumour was: 38.6% melanoma, 22.8% squamous cell carcinoma, 17.5% basal cell carcinoma, 7% breast cancer, 7% Kaposi sarcoma, 7.1% other. Per-tumor response at 60 days was as follows: CR, 70.1%, PR, 16.3%. Per-patient response was as follows: CR, 57.9%, PR, 21.1%. Only 2 patients (4%) experienced flu-like symptoms, 1 patient (2%) nausea and 22 patients (39%) referred pain, mostly mild. Conclusions: According to the data of this pilot study, the use of dose of BLM lower than those recommended by SOP, seems to be effective. Our results suggest that also patients with renal failure may benefit from ECT treatment with a reduced BLM dose. These findings need prospective confirmations on wider cohorts of patients.Pubblicazioni consigliate
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