Total confusion in the post. PFS is of zero interest. Best OS results of all GBM trials in history. Need to understand the JAMA article to get rid of the fog in the post.
There were no post hoc changes. Look at the SAP date. Or, are we back to the crazy theory of Linda Powers channeling her inner Jason Bourne and going rogue by breaking into the shipping facility to find out this info?!
False. The endpoints were changed due to the discovery of pseudoprogression and the fact that the FDA mandated a crossover arm which resulted in essentially no placebo group. The fact that you can’t comprehend these basic concepts is interesting.
So last decade protests!; ). PFS failure due to treatment response is not true PFS so the measures or endpoints had to be changed because no measure for PFS has proven to be sufficient to accurately measure it and the regular rules and especially exceptions to adequate and well controlled trials allowed for this. OS was confounded by treatment effect in crossover patients who were obviously living longer than expected AND confirmed earlier research that suggested DC treatment enhances other salvage therapy attempts. I have been pointing to this earlier research since beginning to post on ihub. I think FDA is very well aware of this and perhaps even anticipated this. That might be another unspoken reason why the crossover was required by them. Go figure!; ).