Clark, I do not think the CVA's seen has anything to do with brain met's...in my 10 yrs in oncology, I have only seen 1 pt that had a true parenchymal brain met in a met prostate Ca setting...I have seen a few with leptomeningeal dz and obviously alot with cranial bony dz...so its extremely rare to have a brain met from prostate cancer..getting back to CVA risk, could it relate to the Provenge.. maybe???...but not likely imo...the CVA p value came in at 0.8 if I recall...thats not to say this wouldnt turn into 0.05 if there were a 1000 pts on 9901/2a but given the small number of pts in 9901/2a, I wouldnt put too much weight on this although the FDA will given their current paranoia on all drugs with potential CVA risk...funny thing is this, if Scher/Hussain/Fleming are not willing to accept the p=0.01 OS data because the primary TTP barely missed at 0.052, then where do they get the nerve to bring up potential CVA risk coming in at 0.8?. If I recall, Taxotere leads to a 2% death risk from the taxotere itself..how come nobody talks about this risk??? And when you ask MO's about it, they says its ok because the small OS benefit outweighs to death risk from Tax itself in a end stage setting...a double standard here????
I know that all trials using Avastin will exclude pts with brain mets due to CVA risk...the lung Avastin trials also exclude SCCA's due to fatal pulmonary hemoptysis risk...its ironic cause pathologically, Avastin seems to completely obliterate the tumor and the blood vessels in some responding pts...some think the response is too good.
AI
