NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality
Roger Stupp, Eric T Wong, Andrew A Kanner, David Steinberg, Herbert Engelhard, Volkmar Heidecke, Eilon D Kirson, Sophie Taillibert, Frank Liebermann, Vladimir Dbalý, Zvi Ram, J Lee Villano, Nikolai Rainov, Uri Weinberg, David Schiff, Lara Kunschner, Jeffrey Raizer, Jerome Honnorat, Andrew Sloan, Mark Malkin, Joseph C Landolfi, Franz Payer, Maximilian Mehdorn, Robert J Weil, Susan C Pannullo, Manfred Westphal, Martin Smrcka, Lawrence Chin, Herwig Kostron, Silvia Hofer, Jeffrey Bruce, Rees Cosgrove, Nina Paleologous, Yoram Palti, Philip H Gutin, Roger Stupp, Eric T Wong, Andrew A Kanner, David Steinberg, Herbert Engelhard, Volkmar Heidecke, Eilon D Kirson, Sophie Taillibert, Frank Liebermann, Vladimir Dbalý, Zvi Ram, J Lee Villano, Nikolai Rainov, Uri Weinberg, David Schiff, Lara Kunschner, Jeffrey Raizer, Jerome Honnorat, Andrew Sloan, Mark Malkin, Joseph C Landolfi, Franz Payer, Maximilian Mehdorn, Robert J Weil, Susan C Pannullo, Manfred Westphal, Martin Smrcka, Lawrence Chin, Herwig Kostron, Silvia Hofer, Jeffrey Bruce, Rees Cosgrove, Nina Paleologous, Yoram Palti, Philip H Gutin
Abstract
Purpose: NovoTTF-100A is a portable device delivering low-intensity, intermediate frequency electric fields via non-invasive, transducer arrays. Tumour Treatment Fields (TTF), a completely new therapeutic modality in cancer treatment, physically interfere with cell division.
Methods: Phase III trial of chemotherapy-free treatment of NovoTTF (20-24h/day) versus active chemotherapy in the treatment of patients with recurrent glioblastoma. Primary end-point was improvement of overall survival.
Results: Patients (median age 54 years (range 23-80), Karnofsky performance status 80% (range 50-100) were randomised to TTF alone (n=120) or active chemotherapy control (n=117). Number of prior treatments was two (range 1-6). Median survival was 6.6 versus 6.0 months (hazard ratio 0.86 [95% CI 0.66-1.12]; p=0.27), 1-year survival rate was 20% and 20%, progression-free survival rate at 6 months was 21.4% and 15.1% (p=0.13), respectively in TTF and active control patients. Responses were more common in the TTF arm (14% versus 9.6%, p=0.19). The TTF-related adverse events were mild (14%) to moderate (2%) skin rash beneath the transducer arrays. Severe adverse events occurred in 6% and 16% (p=0.022) of patients treated with TTF and chemotherapy, respectively. Quality of life analyses favoured TTF therapy in most domains.
Conclusions: This is the first controlled trial evaluating an entirely novel cancer treatment modality delivering electric fields rather than chemotherapy. No improvement in overall survival was demonstrated, however efficacy and activity with this chemotherapy-free treatment device appears comparable to chemotherapy regimens that are commonly used for recurrent glioblastoma. Toxicity and quality of life clearly favoured TTF.
Trial registration: ClinicalTrials.gov NCT00379470.
Copyright © 2012 Elsevier Ltd. All rights reserved.
Source: PubMed