NovoTTF Therapy for recurrent glioblastoma - PRiDe (Patient Registry Dataset) When the NovoTTF Therapy was approved by the FDA, they required the company to track the patients who use the treatment. This is the report on the first 457 patients to use it commercially (outside of the trials). It gives a feel for how it works in the real world.
Keep in mind that it does not report on any other treatments patients did. Since it was outside of the trial, patients are allowed to do anything they want in addition to the NovoTTF therapy. There also was no control group to directly compare it to and they did not show historical controls.
The results are remarkable. Usually reports of patients using a treatment in the real world are much worse than those in the trials. In this case the results in the real world are much better than in the trial. I think it may have to do with compliance. If you are paying for it, you have more of a tendency to use it. In the trial, there were many patients who didn't even use it for a month.
Some highlights: 30% of patients survived over 2 years (after recurrence of GBM), and average survival was 9.6 months. It is hard to compare patients directly, but in general most other studies report an average survival of 3-6 months. The large study used to get FDA approval for Avastin for recurrent GBM reported an average of 6 months survival and about a 15% survival at 90 weeks (almost 2 years.)
They broke down the results by compliance - what % of the time the patient actually used the treatment. If used less than 75% of the time, average survival was only 4 months. However, if used over 75% of the time, average survival was 13.5 months.
