gms | German Medical Science

59th Annual Meeting of the German Society of Neurosurgery (DGNC)
3rd Joint Meeting with the Italian Neurosurgical Society (SINch)

German Society of Neurosurgery (DGNC)

1 - 4 June 2008, Würzburg

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Disruption of cancer cell replication by alternating electric fields – a phase 3 clinical study in recurrent glioblastoma multiforme

Störung der Krebszellenteilung durch elektrische Wechselstromfelder – eine Phase-3 klinische Studie bei rezidivierenden Glioblastomen

Meeting Abstract

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  • corresponding author N.G. Rainov - Department of Neurosurgery, Klinikum Augsburg, Germany
  • E. Kirson - NovoCure Ltd., Haifa, Israel
  • S. Al-Qadhi - Department of Neurosurgery, Klinikum Augsburg, Germany
  • V. Heidecke - Department of Neurosurgery, Klinikum Augsburg, Germany

Deutsche Gesellschaft für Neurochirurgie. Società Italiana di Neurochirurgia. 59. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie e.V. (DGNC), 3. Joint Meeting mit der Italienischen Gesellschaft für Neurochirurgie (SINch). Würzburg, 01.-04.06.2008. Düsseldorf: German Medical Science GMS Publishing House; 2008. DocDI.06.06

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/dgnc2008/08dgnc187.shtml

Published: May 30, 2008

© 2008 Rainov et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

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Objective: Low-intensity, intermediate-frequency (100-300 kHz), alternating electric fields (tumor-treating fields, TTF-100) delivered by insulated electrodes have a profound inhibitory effect on the growth rate of a variety of human and rodent tumor cell lines and malignant tumors in animals. This effect, shown to be non-thermal, selectively affects dividing cells, while quiescent cells are left intact. TTF-100 act by two simultaneous mechanisms: arrest of cell proliferation and destruction of cells undergoing mitosis. The potential applicability of TTF-100 as a novel therapeutic modality was tested in adult patients with primary and recurrent glioblastoma.

Methods: In a completed phase 1 study, a total of 18 patients were treated with TTF-100 and compared with controls undergone standard treatments. Currently, a pivotal phase 3 randomized and controlled prospective trial is underway. It was designed to test the efficacy and safety of the new medical device, NovoTTF-100. The trial is expected to enroll a total of 236 patients in multiple centers in the USA and in Europe. Patients enrolled in the trial are randomized to one of two groups, treatment vs. control, and undergo continuous (24 hours/7 days a week) treatment for as long as their disease is stable or regressing. During the treatment, patients are able to maintain normal daily activity.

Results: Two of 10 treated patients have not progressed for more than two years after initiating TTF-100 treatment. One of these patients showed complete regression of tumor on MRI scans. Treated patients demonstrated doubling of the median survival time compared to the patients with best standard treatment. Unlike chemotherapy or radiation, the NovoTTF-100 device has exhibited no significant side effects. Some patients have only experienced mild skin irritation beneath the electrodes.

Conclusions: The data from the phase 1 trial suggest that NovoTTF-100 treatment may significantly increase progression-free and overall survival of patients with recurrent or progressive GBM. No data from the phase 3 trial are currently available, but an interim analysis will be carried out after enrolling 50% of the planned patient population.