Zusammenfassung
Hintergrund
Die irreversible Elektroporation (IRE) stellt ein seit 2007 verfügbares, neuartiges Gewebeablationsverfahren dar, das mit seinen postulierten Eigenschaften, allen voran die fehlende, thermoablativ wirkende Hitzewirkung, die Anforderungen einer idealen fokalen Therapie (FT) erfüllen könnte. Bisher liegen keine ausreichenden tumorentitätsspezifischen Wirksamkeitsnachweise vor. Die klinische Anwendung beschränkt sich bislang auf sehr kleine Patientenkohorten. Dies gilt auch für das Prostatakarzinom (PCA). Trotzdem erfolgt aktuell zunehmend eine Anwendung außerhalb von Studien. Nicht zuletzt durch aktive Werbung für das Verfahren in der Laienpresse.
Ziel der Arbeit
In dieser Arbeit wird die aktuelle Diskrepanz zwischen der bisherigen klinischen Anwendung und Studienlage und der Zulassung bzw. Marktimplementierung des Verfahrens aufgezeigt und die Mediendarstellung der IRE, insbesondere im Hinblick auf die FT des PCA, aus unterschiedlichen Blickwinkeln diskutiert. Gefolgt von einer abschließenden klinischen Bewertung der IRE mittels NanoKnife®-System.
Diskussion
Bei der Neuzulassung eines Medikaments gelten strengste Anforderungen. Der Nachweis eines Zusatznutzens zur bestehenden Therapie ist durch Vergleichsstudien nach Arzneimittelgesetz (AMG) zu erbringen. Bei medizinisch-technischen Behandlungsverfahren werden solche Ansprüche durch Studien nach Medizinproduktgesetz (MPG) nicht eingefordert. Seit der Markteinführung des NanoKnife®-Systems wird die IRE-Anwendung auch außerhalb von Studien aktiv beworben. Dies hat in den letzten 2 Jahren zu einer Zunahme der unkontrollierten IRE-Behandlungen des PCA geführt. Die Patienten müssen in diesen Fällen die hohen Behandlungskosten selbst zahlen. Werben zusätzlich Laienpresseartikel mit vielversprechenden, aber ungeprüften Inhalten, werden aktuell unberechtigte Hoffnungen bei den Betroffenen geweckt. Fatal, wenn dies zur Verzögerung tatsächlich wirksamer Therapieoptionen führt.
Schlussfolgerung
Grundsätzlich besitzt die IRE auch weiterhin ein hohes Potential für die Therapie von Malignomen. Ob sie tatsächlich als FT einsetzbar ist, bleibt aufgrund fehlender Daten unklar. Dies gilt auch für die Therapie des PCA. Nur wissenschaftliche Fragestellungen mit adäquater Studiendurchführung können die bislang ungeklärten Fragen zur IRE des PCA auflösen. Die dringend benötigte Entwicklung allgemeingültiger geprüfter Behandlungsstandards für die IRE wird durch wirtschaftlich gelenkte Patientenströme unnötig erschwert.
Abstract
Background
Irreversible electroporation (IRE), a new tissue ablation procedure available since 2007, could meet the requirements for ideal focal therapy (FT) with its postulated features, especially the absence of a thermal ablative effect. Thus far, there is no adequate tumor-entity-specific proof of its effectiveness, and its clinical application has hitherto been confined to very small patient cohorts. This also holds true for prostate cancer (PCA). Nevertheless, it is now being increasingly applied outside clinical trials—to a certain extent due to active advertising in the lay press.
Aim of the study
In this study, current discrepancies between the clinical application and study situation and the approval and market implementation of the procedure are described. The media portrayal of IRE is discussed from different perspectives, particularly with reference to the FT of PCA. This is followed by a final clinical assessment of IRE using the NanoKnife® system.
Discussion
Strict requirements govern new drug approvals. According to the German Drug Act (AMG), evidence of additional benefit over existing therapy must be provided through comparative clinical trials. For medicotechnical treatment procedures, on the other hand, such trial-based proof is not required according to the Medical Devices Act (MPG). The use of IRE even outside clinical trials has been actively promoted since the NanoKnife® system was put on the market. This has led to an increase in the number of uncontrolled IRE treatments of PCA in the last 2 years. The patients have to cover the high treatment costs themselves in these cases. If articles in the lay press advertise the procedure with promising but unverified contents, false hopes are raised in those concerned. This is disastrous if it delays the use of truly effective treatment options.
Conclusion
IRE basically still has high potential for the treatment of malignancies; however, whether it can really be used for FT remains unclear due to the lack of data. This also holds true for the treatment of PCA. Only carefully conducted scientific research studies can clarify the unresolved issues regarding IRE of PCA. The urgently needed development of universally valid treatment standards for IRE is unnecessarily hampered by the flow commercially driven patients.
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Interessenkonflikt. J.J. Wendler, R. Ganzer, B. Hadaschik, A. Blana, T. Henkel, K.U. Köhrmann, S. Machtens, A. Roosen, G. Salomon, L. Sentker, U. Witzsch, H.P. Schlemmer, D. Baumunk, J. Köllermann, M. Schostak und U.B. Liehr geben an, dass kein Interessenkonflikt besteht. Dieser Beitrag beinhaltet keine Studien an Menschen oder Tieren.
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Wendler, J., Ganzer, R., Hadaschik, B. et al. Irreversible Elektroporation. Urologe 54, 854–862 (2015). https://doi.org/10.1007/s00120-015-3864-6
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DOI: https://doi.org/10.1007/s00120-015-3864-6