(Added 10/29/14) Supplement to "Seminars in Oncology" devoted to NovoTTF-100A. This is a set of 4 research papers and an introduction. This is the publication of the registry data mentioned below. It goes into more details on the analysis of how the treatment works in patients and patterns of response. It shows that in about 50% o the patients who respond, the first MRI looks worse, and it takes about 5 months for the MRIs to start to look better - so be aware and do not give up too soon.
A prospective, randomized, open-label, phase III clinical trial of NovoTTF-100A versus best standard of care chemotherapy in patients with recurrent glioblastoma. An abstract presented at the 2010 ASCO (American Society of Clinical Oncology) meeting discusses a trial in which the device alone was tested against the best of whatever treatments were available. Many in the control group used Avastin, vaccines, other clinical trials, targeted drugs, and alternate schedules of temodar or other therapies. The result was that overall, there was a small improvement in progression free survival and overall survival with the Novo TTF device, but there were no significant side effects whereas there were many in the control group. My impression is that this means the device has an effect, and it is at least as good as anything else available, with no side effects.
Subgroup and quality of life analyses of the phase III clinical trial ofNovoTTF-100A versus best standard chemotherapy for recurrent glioblastoma. An abstract presented at the 2010 SNO (Society of Neuro-oncology) annual meeting - discusses subgroup analysis of the recurrent gbm trial mentioned above. Basically if you take the people who were in relatively good shape and under 60 years old, the Novo TTF device did much better the control group (which was the best of available treatments): 1-year survival was 35% vs. 20% and PFS6 was 25.6% vs. 7.7%. The way I interpret this is that some of the older patients in the trial were unable to correctly utilize the device or it was too late for anything to help. Patients who were able to use it correctly did well with it.
Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Full article from the Proceedings of the National Academy Of Sciences: talks about the first human GBM trial of the device. They tried the device on 10 patients with recurrent gbms. They reported a median overall survival of 62 weeks, with 3 of the patients alive at the end of the trial. This is about double that expected of historical controls. A recent (Jan 2011) follow up communication with the author reveals that 2 of these patients are still alive now, over 6 years since starting the trial.
Chemotherapeutic treatment efficacy and sensitivity are increased by adjuvant alternating electric fields (TTFields). Full journal article from BMC Medical Physics Shows how the Novo TTF device enhances the effectiveness of chemotherapy in the lab, and also discusses 2 human trials: 10 newly diagnosed and 10 recurrent glioblastoma multiforme. (The recurrent group is the same trial mentioned above). For the newly diagnosed group, they used the device in combination with the standard treatments and the progression free survival and overall survival reported was over 300% longer than expected from historical controls. Follow up communication with the authors in December 2012 reveal that 4 of the 10 newly diagnosed glioblastoma patients are still alive today - over 4-6 years from when they started the trial.
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