Scientific Publications about Optune™
The abbreviation TTF means "Tumor Treating Fields" - which is what the Novocure Optune™ System delivers
- Final results for OptimalTTF-1: Optimizing Tumor Treating Fields with targeted skull remodeling surgery for first recurrence glioblastoma: Phase 1 trial
This interesting study looked at what would happen if you remove small parts of the skull using burr holes to allow the tumor treating fields better access to the tumor. There was no control group to compare but they reported pretty good results with overall survival of 15 months (after start of trial - which is for recurrent glioblastoma). I love these studies that look at ways to make current treatments better. Now they have to build upon these results and try other combinations. (Added 04/27/2020)
- EF-19 - A post-approval registry study of TTFields for the treatment of recurrent glioblastoma (GBM)
This study shows a small improvement with Optune by itself compared to standard tretments. Enough to show Optune does have a positive effect but not enough to use Optune by itself for recurrent Glioblastoma (or to use the standard treatments either). Further study is needed combining Optune with other treatments to make meaningful gains in survival.(Added 04/27/2020)
- High compliance with Optune linked to greatest survival benefit for glioblastoma 29% 5 year survival in high compliance group compared to 4.5% in control group.(Added 1/26/19)
- 'Out-of-the-Box' Approach Plus Temozolomide Extends Survival in Glioblastoma 5 year survival rate more than double the standard of care! (added 5/10/17)
- Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma This may become the new standard of care for Glioblastoma multiforme! (added 12/15/15)
- Added 11/15/2014 Results of Optune trial for newly diagnosed gbm - This is the most important article
- (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.
- (ADDED 7/4/2014) NovoTTF-100A- Report on Patient Registry Data (PRiDe)
This is a report on the first 457 patients with recurrent glioblastoma to use the NovoTTF-100A system since it was FDA approved. Very impressive results.
- (ADDED 5/14/2014) NovoTTF-100A alternating electric fields therapy for recurrent glioblastoma: An analysis of patient registry data. Retrospective look at how the first 457 patients did using the device. Pretty good results.
- (Added6/1/2013) Overcoming cell size escape from tumor treating fields using a varying frequency treatment paradigm in vitro. Fascinating article on how cells might become resistent to TTF and a simple way to fix that. (Simple in theory - but not yet available. I am sure they are working on it).
- (Added 6/1/2013)Response assessment of novoTTF-100A versus best physician's choice chemotherapy in recurrent glioblastoma. An update on the trial for recurrent GBM. A little better result than originally reported last year. Still not good enough but it is the best of approved treatments.
- (Added 6/1/2013) Safety analysis of bevacizumab plus NovoTTF-100A in patients with recurrent malignant gliomas. They found it is safe to mix Avastin and TTF but it did not do better than either alone. However, this was a very small study - only 6 patients had Avastin and TTF at the same time so it is hard to know how they would have done without any treatment.
- (Added 6/1/2013) Effect of tumor-treating fields on DNA repair in cancer cell lines. This shows that adding TTF to radiation may result in a big increase in the effectiveness of the radiation. However, this was only in the test tube and on renal cell cancer and not brain cancer so more work needs to be done before we can say it is good to use with brain tumor radiation.
- (Added 6/1/2013) Meta-analysis of cancer cell lines genomes based on their response to ttfields. They found a link between some genes and the tumor's response to TTF. This may open the door to find out why it works so well on some people and not at all on others. Perhaps this may lead to a screening test to determine if it is worth even trying or better yet to adding a drug that will allow TTF to work for everyone. Exciting concept.
- (Added 1/14/2012) Delayed response and survival from NovoTTF-100A in recurrent GBM . A case report of a patient from the trial for recurrent GBMs, who has been on the device and doing well for 6 years. Of note is his initial MRI after sterting the device looked worse. This shows that the device takes time to work and some people have been stopping too soon.
- Noninvasive Application of Alternating
Electric Fields in Glioblastoma : A Fourth
Cancer Treatment Modality. Overview of how the device works!
- NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastom: a randomized phase 3 trial of a novel treatment modality. This is the report on the large trial that let to the FDA approval of the Novocure device!
- SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) All of the data from the animal studies and clinical trials.
- Device for Glioblastoma May Offer Advantage Over Chemo from Internal Medicine News - gives nice non technical overview
- 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.
- Disruption of Cancer Cell Replication by Alternating Electric Fields. Full article from 2004 Cancer Research - pre-clinical research - pretty technical but explains how it works on mice and in the lab.
- 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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Disclosure: the Novocure company is a sponsor of our organization!