Friday, January 13, 2023 11:19:07 PM
HyGro, despite the fact that the maximal tumor resection and the exclusion of many rapid progressors from the DCVax-L trial was most likely more extensive than was the case in the ECA trials, the mOS of the 131 unmethylated GBM treatment patients in the DCVax-L trial was almost equivalent to the mOS of the unmethylated GBM patients in the ECAs. In fact, since DCVax-L was responsible for a 5(+) year survival of 8 of the 131 unmethylated GBM treatment patients, it probably carried also a benefit for some of the shorter living unmethylated treatment patients and without the DCVax-L treatment, the mOS of the unmethylated GBM treatment patients could have even been somewhat shorter than the mOS of the ECAs. This strongly suggests that the comparison between the DCVax-L and ECAs is valid.
Thus, the equivalence of the mOS values of the treatment patients and the ECAs is most likely due to the orthodox exclusion of the potentially long living pseudo-progressors from the DCVax-L trial and that balanced the effect of the less extensive tumor resection and less orthodox exclusion of rapid progressors in the ECA trials.
The maximal resection of the DCVax-L patients was necessary because it was essential to provide enough tumor material for vaccine production and the exclusion of rapid progressors was necessary because the positive effects of the vaccine are delayed but are then expressed over a long period of time. However, the similar mOS of the unmethylated GBM patients in the DCVAX-L and ECA trials, demonstrates that the different exclusion/inclusion criteria of the trials affirmed the validity of the OS comparison of the DCVax-L trial to the ECA trials.
As to your second point, the partial hold was not equivalent to terminating and invalidating the trial. No presentation or publication of the trial's results have to include an explanation for this partial hold.
Thus, the equivalence of the mOS values of the treatment patients and the ECAs is most likely due to the orthodox exclusion of the potentially long living pseudo-progressors from the DCVax-L trial and that balanced the effect of the less extensive tumor resection and less orthodox exclusion of rapid progressors in the ECA trials.
The maximal resection of the DCVax-L patients was necessary because it was essential to provide enough tumor material for vaccine production and the exclusion of rapid progressors was necessary because the positive effects of the vaccine are delayed but are then expressed over a long period of time. However, the similar mOS of the unmethylated GBM patients in the DCVAX-L and ECA trials, demonstrates that the different exclusion/inclusion criteria of the trials affirmed the validity of the OS comparison of the DCVax-L trial to the ECA trials.
As to your second point, the partial hold was not equivalent to terminating and invalidating the trial. No presentation or publication of the trial's results have to include an explanation for this partial hold.
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