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flipper44

01/29/15 1:50 PM

#28782 RE: austinmediainc #28778

He was talking about just ePD being placed in that group at that point forward! My point in the thread is that they have been placing potential ePD and ePD in the 55 arm all along, and they place the ones that were able to be determined as psPD, in 8-10 weeks past the initial radiotherapy, into the phase III trial. There has never been any published exclusion of psPD in the phase III trial at clinical trials.gov.. Potential ePD may ultimately be proven psPD or ePD, but they were/are not willing to take the chance with the phase III trial -- only with the info arm. psPD determination at 8-10 weeks, on the other hand, because the inflammation might recede, demonstrates more conclusively it was not ePD. If you want to get deeper into this, the reason a small amount of potential ePD likely turned out to be psPD in the group of 55 is because some of the "progression" was actually tumor infiltration by t-cells as opposed to just inflammation, which also resembles progression. The key is they wanted/want to error on the side of caution on the phase III trial side when introducing a pure sample of pseudos -- people they know had a very high chance of receiving benefit in the trial, thus the 8-10 week enrollment observation waiting period beyond "normal" tumor response to chemoradiation.