Letter to the Editor Concerning “Irreversible Electroporation (IRE) Fails to Demonstrate Efficacy in a Prospective Multicenter Phase II Trial on Lung Malignancies: The ALICE Trial” by Ricke et al. 2015 (doi:10.1007/s00270-014-1049-0)
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We would like to compliment the authors for the first controlled prospective human trial to determine the safety and efficacy of irreversible electroporation (IRE) in lung malignancies that was stopped prematurely because of a high rate of treatment failure (69 %) . We would like to supplement the discussion of IRE treatment failure by reflecting the actual discrepancy between the approval of IRE, the theoretical basis of mechanism, the current knowledge in clinical tumor studies, and the potential efficacies of IRE in different tissues. Up to now, there is only one clinical IRE system available on the market (NanoKnife® System; AngioDynamics Inc., Latham, NY). In 2007, the NanoKnife®has received a 510(k) clearance for surgical ablation of soft tissue by the US FDA and is approved for commercialization in the E.U. (CE mark for medical devices 93/42/EWG), although it has not been cleared for the treatment of any specific disease or condition, and the treatment...
KeywordsBile Duct Transitional Cell Carcinoma Angiosarcoma Tissue Ablation Lung Malignancy
AngioDynamics Inc. (NY, USA) supports the current IRENE study (www.ClinicalTrials.gov: NCT01967407) by providing the NanoKnife electroporator device and technical maintenance. The company has had no involvement in devising, writing or editing a protocol, and study conduct and will have no contentual input in presenting the results in conferences, congresses, and/or papers.
Conflict of interest
The authors Wendler Johann Jakob, Porsch Markus, Fischbach Frank, Pech Maciej, Schostak Martin, and Liehr Uwe-Bernd declare that they have no conflict of interest.
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