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koman

03/13/15 12:42 PM

#30683 RE: Pyrrhonian #30677

Thanks for the reply, Do you know at what point a co can apply for AA? is it after the primary end point is reached? I have read papers concerning the association of medPFS as a predictor of med OS numbers but unfortunately I'm not sure if the FDA is on board with that concept and that may only be academic for now (though I do recall some disease that progress so rapidly that PFS is acceptable, but I see no precedence in first line GBM, maybe in rGBM. Also, there are papers that show no PFS advantage but a large OS advantage in GBM (thanks to posters here for that paper- forgot who it was maybe it was Obutz?) but it was a small pI trial like most other papers I have read- just too small to make a clear conclusion. And that is the other thing I don't like about PFS which depends on the reader of those scans. What happens if it was a pseudoprogressor that this board talked about. There is judgment to be made to say when a tumor has progressed, but OS is clear cut (usually).