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Friday, February 14, 2014 3:20:07 PM
The trial design in this case will not randomize pseudo progression patients into the main body of the trial until they can determine for certain that the patient is not suffering from true progression.
The early subacute true progression patients typically do not suffer from inflammation due to chemoradiation therapy, and they will typically end up being pro neural and possibly neural.
The pro neural patients with true progression will not be randomized into the main body of the trial.
Classic subtypes will not typically show pseudo progression nor early subacute true progression yet they also respond quite well to chemoradiation (at least initially) and DCVAX-L.
In other words, this trial is likely to weed out pro neural and perhaps neural subtypes to a greater extent. Because neither chemoradiation nor DCVAX-L can help these groups much at all, and because pro neural does relatively well by itself, the opportunity to show a better comparison between the S.O.C. v. DCVAX-L in the remaining (mostly) 2 to three subtypes is enhanced. Thus the ability to focus on the statistical significance in the patients actually enrolled in the trial is enhanced and will, imo, most likely come down to the two subtypes.
Note: Bearing in mind, of course, the patients are not being selected based upon their subtypes, this simply happens because their exclusion and inclusion process happens to draw in more of some subtypes than others.
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