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Saturday, June 10, 2017 8:18:57 AM
It is true that disease eventing eventually naturally slows down over the course of time, but let's think about what a current and slowing 2 OS per month means for the entire group in this trial.
1. 100 patients still alive is an amazing 30% of this ITT trial population.
2. #1 is true even though half the patients were enrolled 3.2 to 9 years ago.
3. If you tried to get to the point where 25% of all patients were still alive at the current rate, you'd have to wait until March 2018; however, because the event rate is slowing, you'd likely be waiting until September 2018 to reach 248 OS events, and that is for the entire ITT group. By September 2018, all patients would have been enrolled three to ten years ago, and this is a group without most normally very long lived "confirmed" psPD, and it is for the entire ITT group. Had it been standard of care instead with no crossover and very few psPD, I'd suggest by September 2018, there would be no one alive in a SOC group in a patient population such as this. -- 0%.
4. Perhaps, at this late stage in the trial, #3 would be a good reason for researchers to possibly give control patients who chose not to crossover after eventing the information to potentially rethink their decision.... Particularly since we already reached the primary endpoint date.
5. Just stop for a second and take stock. This is a GBM trial that would likely have had to wait until all ITT patients had been enrolled ranging from 3 to 10 years to reach 25% survival. Unheard of. Completely unprecedented. Even more so because they excluded most long lived pspD from the start. Good thing those that designed the trial resizing four years ago concluded only 233 OS events were required instead of 248. -- flip
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