Glioblastoma multiforme (GBM) is one of the most aggressive forms of cancer known to mankind and patients with recurrent glioblastoma only survive for months. As we reported back in 2007, Israeli company NovoCure has developed the NovoTTF-100A, a portable, battery operated device that produces low intensity alternating electric fields (TTFields) delivered through electrodes attached to the scalp, that disrupt cancer cell proliferation and tumor growth. Last Saturday, results of the first Phase III clinical trial of the device in patients with recurrent, late-stage GBM were presented at the annual meeting of the American Society of Clinical Oncology. In an international randomized controlled trial NovoTTF (n=120) was compared with standard chemotherapy (n=117). Based on intention-to-treat analysis, the overall survival was around 6 months for both treatment groups, and one-year survival rates also did not differ significantly. Side effects of the NovoTTF were limited to skin rashes while in chemotherapy group hematological and other toxicities occurred. Interestingly, if you look at the per protocol analysis, in which only data is used of patients who completed at least one treatment session in the group they were assigned to, the data even shows a better median survival for patients with the NovoTTF (7.8 vs 6.1 months). Also curious is that even though overall survival improved, an objective response to treatment was still only observed in 12% of patients (versus 6% with chemotherapy). It is not yet known why only some patients respond well to treatment while most others do not. Overall these results show great potential for the device as a novel cancer treatment option and we expect more studies to follow.
Video: CBS item showing the first patient who was treated with the NovoTTF…
Press release: Successful Phase III Clinical Trial Results Reported for NovoCure’s Novel Medical Device for Treatment of Recurrent Glioblastoma…
Study abstract: A prospective, randomized, open-label, phase III clinical trial of NovoTTF-100A versus best standard of care chemotherapy in patients with recurrent glioblastoma…