The latest news:

• Novocure Announces the EF-14 Phase III Clinical Trial of Tumor Treating Fields in Patients with Newly Diagnosed Glioblastoma has been Terminated at the Interim Analysis due to Early Success        

  This is historic.  As far as I know, and I have been involved with brain tumors for 22 years, this is the first time a GBM trial was ever stopped early because it actually worked!  Optune – the new name for the FDA approved Novocure tumor treating field device, has finally shown what it can do.   This was a large phase 3 randomized trial comparing the standard “Stupp Protocol” to the standard + the Optune device.  There are many ways to look at the results (see the article for the rest)  but keep in mind the numbers given are from the time the trial started, not from the date of diagnosis. The trial started around 3.8 months after diagnosis.  There was an increase of about 50% in the number of patients alive at 2 years after starting treatment ( about 27.8 months after diagnosis) ,  from 29% in the Temodar group to 43% in the Optune group.  Overall survival increased by about 3 months, from 16.6 to 19.9 months after trial started ( or about 20.4 to 23.7 after diagnosis).   

  Dr Stupp presented the data and then said "a new standard of care for patients with GBM has been established", and  "A new cancer treatment modality has been born".  He called it a paradigm shift.

  The last time the standard of care changed was in 2005  when Dr Stupp presented his data on using Temodar at the same time as radiation, in addition to the old way of using Temodar.  That resulted in a gain of 2.5 months, from 12.1 months to 14.6 months from diagnosis.

  My opinion is that this is a big step forward, with very little downside. This is the first non-toxic therapy ever to succeed in a phase III trial for newly diagnosed cancer patients.  I agree it should be the new standard of care.  Of course a lot more work needs to be done but we have to go with the best we have at the time and this is it. I hope to see more trials combining other treatments with Optune – hopefully also with no or low toxicities.  This brings us a step closer to our goal of a cure.

  Talking to many of the doctors present at the meeting, there were still a few who said they wouldn’t use it. The main objection now is that it may interfere with clinical trials.   I would suggest designing trials to allow for the use of Optune just as they had to do when the standard of care changed 9 years ago.  I am a huge supporter of clinical trials but if there is a choice between using Optune and having minimal or no additional side effects with a known average benefit of a 50% better chance of living at least 2 years, vs. a clinical trial which has unknown side effect profile and unknown benefit in survival, I would probably choose the Optune. 

   If you decide that you want to try this treatment, ask your doctor about it but if they seem resistant to the idea, go to http://optune.com to find a doctor in your area that is trained to use it and get another opinion. This treatment has been FDA approved for recurrent glioblastoma, but it can be prescribed off label for newly diagnosed. Clearly the earlier you start it the better the outcome.  Hopefully the FDA will approve it for newly diagnosed GBM soon!

   

       Disclaimer: Novocure is a sponsor of the Musella Foundation but I have never personally received anything of value from them.
  




• Electrical Scalp Device Can Slow Progression of Deadly Brain Tumors         The NY Times picked up the story of the Optune (Novocure Device)!   I love the response of the patient  when told she could stop!  
  

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