NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: A randomised phase III trial of a novel treatment modality Journal Article
| Authors: | Stupp, R.; Wong, E. T.; Kanner, A. A.; Steinberg, D.; Engelhard, H.; Heidecke, V.; Kirson, E. D.; Taillibert, S.; Liebermann, F.; Dbaly, V.; Ram, Z.; Villano, J. L.; Rainov, N.; Weinberg, U.; Schiff, D.; Kunschner, L.; Raizer, J.; Honnorat, J.; Sloan, A.; Malkin, M.; Landolfi, J. C.; Payer, F.; Mehdorn, M.; Weil, R. J.; Pannullo, S. C.; Westphal, M.; Smrcka, M.; Chin, L.; Kostron, H.; Hofer, S.; Bruce, J.; Cosgrove, R.; Paleologous, N.; Palti, Y.; Gutin, P. H. |
| Article Title: | NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: A randomised phase III trial of a novel treatment modality |
| 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 (20-24 h/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. © 2012 Elsevier Ltd. All rights reserved. |
| Keywords: | adult; cancer survival; controlled study; aged; survival rate; major clinical study; overall survival; neutropenia; diarrhea; hypertension; cancer patient; cancer radiotherapy; chemotherapy; recurrent cancer; cell division; progression free survival; quality of life; leukopenia; randomized controlled trial; thrombocytopenia; deep vein thrombosis; abdominal pain; rash; lung embolism; malaise; glioblastoma; patient safety; mental disease; nausea and vomiting; cognitive defect; dermatitis; clinical effectiveness; headache; phase 3 clinical trial; urogenital tract disease; metabolic disorder; hemiparesis; musculoskeletal disease; brain edema; respiratory tract disease; transducer; convulsion; brain tumour; randomised trial; device safety; dysphasia; hemianopia; nutritional disorder; tumor treatment field therapy |
| Journal Title: | European Journal of Cancer |
| Volume: | 48 |
| Issue: | 14 |
| ISSN: | 0959-8049 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2012-09-01 |
| Start Page: | 2192 |
| End Page: | 2202 |
| Language: | English |
| DOI: | 10.1016/j.ejca.2012.04.011 |
| PROVIDER: | scopus |
| PUBMED: | 22608262 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 1 October 2012" - "CODEN: EJCAE" - "Source: Scopus" |
