Abstract
BackgroundIrreversible electroporation (IRE) has recently been added as an additional therapeutic ablative option in patients with locally advanced cancers (LAC) involving vital structures. IRE delivers localized electric current by peri-tumoral discrete probes to attain irreversible changes in cell membrane leading to cell death. The aim of this study was to evaluate the long-term effects of IRE in the treatment of locally advanced tumors.MethodsA prospective IRB approved evaluation of 107 consecutive patients from 7 institutions with tumors that had vascular invasion treated with IRE from 5/2010 to 1/2012. LAC was defined as primary tumor with <5 mm from major vascular structure based on pre-operative dynamic imaging or intra-operative criteria.ResultsIRE as utilized in LAC in the liver (N = 42, 40%) and pancreas (N = 37, 35%), with a median number of lesions being 2 with a mean target size of 3 cm. IRE attributable morbidity rate was 13.3% (total 29.3%) with high-grade complications seen in 4.19% (total 12.6%). No significant vascular complications were seen, and of the high-grade complications, bleeding (2), biliary complications (3) and DVT/PE (3) were the most common. Complications were more likely with pancreatic lesions (p = 0.0001) and open surgery (p = 0.001). Calculated local recurrence free survival (LRFS) was 12.7 months with a median follow up of 26 months censured at last follow up. The tumor target size was inversely associated with recurrence free survival (b = 0.81, 95% CI: 1.6 to 4.7, p value = 0.02) but this did not have a significant overall survival impact.ConclusionsIRE represents a novel therapeutic option in patients with LAC involving vital structures that are not amenable to surgical resection. Acceptable to high local disease control and the long LRFS can be achieved with this therapy in combination with other multi-disciplinary therapies.
Highlights
Irreversible electroporation (IRE) has recently been added as an additional therapeutic ablative option in patients with locally advanced cancers (LAC) involving vital structures
We present our multi-center experience with the single largest study of 107 patients who underwent IRE of soft tissue tumors with vascular invasion that were not amenable to surgical resection, thermal ablation and/or had failed radiation therapy
The tumor target size was inversely associated with recurrence free survival (b = 0.81, 95% CI: 1.6 to 4.7, p value = 0.02) but this did not have a significant overall survival impact
Summary
Irreversible electroporation (IRE) has recently been added as an additional therapeutic ablative option in patients with locally advanced cancers (LAC) involving vital structures. Electroporation is a phenomenon by which cell membrane integrity is compromised by inducing nanopores using trans-membrane electrical distortion This was initially used to increase the permeability of the cells to therapeutic compounds and gene transfer in a reversible fashion [1]. It was used as an independent modality to achieve permanent cell destruction We and other authors have recently demonstrated the safety of the use of IRE around vascular and ductile structures on chronic large animal models [4,5,6] Subsequent to those studies we have recently published organ specific safety and efficacy data with the use of IRE in liver and pancreas [7,8,9]. We present our multi-center experience with the single largest study of 107 patients who underwent IRE of soft tissue tumors with vascular invasion that were not amenable to surgical resection, thermal ablation and/or had failed radiation therapy
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