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Sunday, April 12, 2020 8:59:42 AM
All of these reports refer to 23 patients.
One of which was Brad, no doubt.
Yes there was an earlier Prins paper in 2006, I think, that researched just one of the two adjuvants that they later investigated, so that is not part of my confusion.
But these 23 patients were studied as a P1, then as a P2, it would appear.
The question for me is whether the research into the use of either adjuvant, (and all the subsequent abstracts right up until this new one), is based on the same 23 patients, as was the research finding about extended survival of mesenchymal patients.
I've posed this question before to myself (and the Board), but without any conclusive answer.
That research conclusion is in this report:-
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3071163/
It includes the oft-quoted Table 1, which includes the case by case breakdown, including which gene expression, which adjuvant if any, ndGBM or rGBM, and OS of each of the 23 patients.
The abstracts referring to survival extension by use of adjuvants never give the dates when patients were recruited, which is the main reason I think all the reports are about the same 23 patients.
You might remember Pyrr flagging up that they didn't use either adjuvant in the P3, and asserting that results would suffer as a result...
The debate was had on the Board about 4 or 5 years ago as to why they didn't use an adjuvant in the P3 and how that might affect trial outcome. Though obviously no board consensus was reached.
I guess (with hindsight) that if they had included use of an adjuvant in the P3, then they would actually have been de facto trialling a combo, so any resulting approval would have had to be for the same combo...
And you really have to go monotherapy first.
One could argue that there are still grounds to suggest that L could possibly be further potentiated by use of an adjuvant based on those preliminary findings, but that hypothesis can only be addressed after the P3.
And 23 patients is a very small sample from which to try and draw multiple conclusions.
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