Really good post explaining the most likely scenario as to why the data was presented as it was and why JAMA Oncology supported the methods and conclusions. I see exwannabe has no response; ). Best wishes.
Ex, no, it doesn’t fail badly. I don’t think the censors for the first two years were discarded, what I think is they were not included in the JAMA publication because they were all part of the 99 arm and none of the 232 arm.
So 13 of the 13 early OS censors just happened to be in the SOC arm? Wow. What are the odds. Try ..00000014738810721990. Any RA would have a field day with that one.
Other of the key points is for example the read at 12 months of 77%, because the earlier the censor effect occurs, the higher the effect. Regarding my 35% read vs. your 36% read it is your eye and word against mine and others can decide who to believe. But in any case, that 1% difference doesn’t allow for 8 or 9 censors as you mention.
The 1% difference can explain 13 censors in theory. Censors only effect the step size after them. So if most censors have few events after them they have little effect.
As you can see from the notes below the chart, there were 81 events in the 99 patients arm. That means there were 18 patients ( 99 – 81 ) that were part of the 99 that arm, but were not PFS events. So they are censors for PFS analysis. I think that the majority if not all of those patients were censored because they were pseudoprogressors, that being initially thought to be progressors, received DCVax after pseudoprogression as part of the crossover design of the trial. As a consequence of that, these patients were not included in the 64 patients rGBM arm, because they were not real progressors when they crossed over.
So they could detect the psPD in the 99 but not the psPD in the 232. Sure.
That [my assertion that they would a 232vs99 win would be huge] is not a fact at all. I think it is exactly the opposite: The reality is that the less statistically significant the difference between the OS for the 232 arm and the 99 arm, the better the results for DCVax.
And now you are off the deep end. Anybody with the slightest clue knows that the the original OS of 232 vs 99 would be a huge.
Well Doc, if GermanCol is correct and among the subgroup of 35 there were 17 who progressed and 18 who were never counted as having officially progressed because they were thought to have pseudoprogressed, why then did Dr. Liau during one of the Q+A sessions, reveal that this group of 35 (of whom 29 remained in the trial) had such a dismal mOS? This low survival capability strikes me as very strange especially if most of those (censored) pseudoprogressors also received the benefits of DCVax-L treatments.