Results of the first randomized controlled trial to compare a novel cancer treatment modality delivering Tumor Treating Fields (TTFields) therapy versus chemotherapy in patients with recurrent glioblastoma (GBM) were published in the European Journal of Cancer (Stupp R. et al., NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: A randomized phase III trial of a novel treatment modality, Eur J Cancer(2012), http://dx.doi.org/10.1016/j.ejca.2012.04.011). The study showed that NovoTTF™ therapy was comparable to active chemotherapy in extending overall survival, with minimal side effects and far better quality of life.
Novocure™, a commercial stage private oncology company, manufactures the device, NovoTTF™-100A, a wearable device that delivers TTFields, or alternating electrical fields, specifically tuned to disrupt the uncontrolled division of cancer cells, resulting in cell death.
This is the first publication in a peer reviewed journal of the Phase 3 trial of chemotherapy-free treatment with NovoTTF monotherapy (20-24h/day) versus active chemotherapy in the treatment of patients with recurrent GBM. The primary endpoint of the trial was overall survival. The secondary endpoints were progression-free survival at six months, 1-year survival rate, and quality of life.
Patients enrolled in the Phase 3 trial had a median age of 54 years (range 23-80) with a Karnofsky performance status of 80% (range 50-100). Patients were randomized to NovoTTF alone.
The most common NovoTTF-related adverse events were principally mild (14%) to moderate (2%) skin rash beneath the device's transducer arrays. Severe adverse events occurred in 6% of patients treated with NovoTTF vs 16% for those treated with chemotherapy.