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AVII77

01/24/20 4:13 PM

#261296 RE: Doc logic #261277

Since we want apples to apples as best we can, what is the comparison of the L Phase 3 second surgery % to the trials you are comparing it to?



Liau's JTM paper reports (emphasis mine):

Since other treatments were allowed following disease progression, we assessed their usage in this trial. While on study, three patients (1%) had another resection, 103 patients (31%) received bevacizumab, 53 patients (16%) received CCNU and 6 patients (1.8%) were treated with tumor treating fields. In multiple reported studies, neither bevacizumab nor CCNU have been shown to extend survival [9, 25].


This has been widely interpreted to mean only 3 of the 331 patients had a repeat resection upon progression.

I do not believe that is a correct interpretation of the text.

"While on study" means still taking DCVax in the x-over setting.

Stupp 2005 reports:

At the time of progression, 23 percent of patients in both treatment groups underwent a second surgery, and 72 percent of patients in the radiotherapy group and 58 percent in the radiotherapy-plus-temozolomide group received chemotherapy.


So Stupp 2005 was 23% and DCVax-l was 1%?

No. That 1% was "While on study" (still receiving DCVax in the x-over setting).

At the time of the Liau paper ~230 of the patients had died. You can't honestly believe that for only 3 of them the doctor tried a repeat resection.

You would then have to ask: what is it about DCVax that made it impossible for more than 3 of those 230 dyeing patients to have a crack at a repeat surgery?

So, the answer to your question:" what is the comparison of the L Phase 3 second surgery % to the trials you are comparing it to?" is: we don't know. The DCVax trial has not reported the second surgery rate. They only reported the rate for those still "on-study".