% 3-year survival breakout by Gleason Score: 9901
GS<=6 Provenge arm: 41% or 9/22
GS<=6 placebo arm: 28.6% or 2/7
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GS = 7 Provenge arm: 32.1% or 9/28
GS = 7 placebo arm: 11.1% or 2/18
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GS = 8 Provenge arm: 40% or 4/10
GS = 8 placebo arm: 12.5% or 1/8
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GS>=9 Provenge arm: 27.3% or 6/22
GS>=9 placebo arm: 0% or 0/12
<<Note: Could someone find the original source of these data? Not the original IV post. That's where I got it.
These data suggest that the treatment advantage increases with GS.
For GS<=7 18/50 alive with Provenge and 4/25 for control.
For GS>=8 10/32 alive with Provenge and 1/20 for control.>>
Wolfeman, the original source for this data was a slide at the Feb 2005 ASCO Prostate Cancer Symposium. I don't know where it would still be online. Perhaps there is another table in the FDA briefing docs for the March 2007 meeting.
Additionally,
PC specific survival analysis was strongly in favor of the treament.
Sensitivity analyses checking for trial arm imbalances based on prognostic factors confirmed that the results were stat sig.
<<F_cking 9902A. What is the explanation for the poor stat results and lower survival times for 9902A? Without a reasonable explanation the 9901 results are unverified leading to much uncertainty. That's why the FDA didn't approve. Not some conspiracy theory. With 500 patients the 9902B trial should be well balanced.>>
The patients in 9902A were sicker as a whole than the patients in 9901, especially concerning the # of brain metastases. The 9902A trial was not the main factor considered by the FDA in not approving Provenge. There was comparatively little mention of it in the FDA briefing docs, and CBER went along with DNDN's contention that 9902A, being unfinished in both # of patients and # of Provenge infusions per patient, should be seen merely as a supportive proof-of-concept trial. The June issue of BSR closely examined what I believe was the likeliest explanation for the CBER decision (I'm giving it about a 75% chance), with the Form 483 issue the other possibility.
