RK, first of all I enjoy your really long posts full of quotes and other stuff. I do wish you would put more analysis of those quotes though and just provide links.
Concerning your quote, I knew it was from the pIII leaked protocol, but it is not kosher to change a quote to suit your needs. It no longer becomes a quote but your personal view which you should make clear. To be clear, this current p3 trial is using Day zero as the time of randomization or 1st injection instead of the time of initial diagnosis/surgery. Why is this okay to do? Because the variability of time difference should be negligible. All patients should be randomized about 3mths after surgery.
To also be clear, the earlier pI trial data uses the day zero as being the time of initial diagnosis/surgery AND time of surgery for 1st recurrence. I really hope you are not trying to state that their PFS data is based on a different day zero than their OS data. But let's forget about PFS because it would only add to your confusion.
The authors CORRECTLY used the day zero to be time of surgery for first recurrence. The 7-30wk range was for initiation of the vaccine DC therapy which HAS NOTHING TO DO WITH the time day zero for their trial. The authors decided IMO CORRECTLY NOT TO USE the time of DC therapy initiation as day zero.
So in summary, there were actually three cohorts of rGBM data to look at and compare using the COMMON denominator of day zero being from time of initial diagnosis/surgery:
Cohort 1 (n=6): medOS for the first pI using acid eluted peptides = 16.6mths
Cohort 2 (n=8): medOS for the 2nd pI using whole tumor lysates = 17.8mths
Cohort 3 (n=19) from their info arm presentation labeled rapid progressor grp: medOS = 15.1mth
Compare ALL the medOS numbers for the various cohorts of rGBM patients from three separate trials: 16.6 mth, 17.8mth, and now 15.1mth all from INITIAL diagnosis of GBM. What was STUPP trial anticipation for the medOS of nGBM patients- around 14.6mths. Gee if this doesn't give a BIG clue that there won't be much of a cross-over effect, I'm not sure what other or more evidence you want.
The abstract decided to use the day zero as being from the time of surgery for first recurrence. Assuming that those eight rGBM patients are from the cohort 2 above, the medOS should have been around 11.3mths and NOT 14.7mths which AVII noted was the MEAN of those eight data points. Gee that should change their conclusion of the number of months of potential survival advantage of using their DC therapy.
