Adjuvant cycles means after radiation in TMZ's case. It doesn't necessarily mean before progression or follow-up. I don't think patient accounts are "proof". Those accounts raise "doubt" over whether doctor are interpreted in or out of protocol. We have no idea what is contained in the investigator brochure. They could be following a clause on what is allowed to be modified from STUPP protocol. Again the statistical analysis covers looking at TMZ usage as a covariate at both progression and overall survival. If Doctors do prescribe more than 6 cycles it doesn't have to mean "censored". TMZ does not fall into the category of "not permitted". It is allowed both before and after progression. It is probably one of the only drugs that can be reviewed retrospectively, as they can always review scans to determine if it was necessary to ward off progression and then mark an event. No we do not agree that patients get more than 6 cycles before follow-up or progression. What we do agree on is that "maybe" UCLA (designed the protocol) figured out a way to make doctors use judgment calls on TMZ and that's why "or more" is there in the event there remains evidence of disease on a scan. But "or more" isn't definitive on meaning and patients accounts do not constitute proof as how to interpret protocol. I do not think that it will be standard practice that all sites go to 12 cycles. And 6 cycles continues to be STUPP protocol. I truly believe we will learn that they allow 6 cycles. Again, since it's following STUPP protocol, and that hasn't changed, I honestly think that progression events may end up being need to be revisited in the cases you mentioned. Time will tell.
The UCLA abstract makes it quite clear that early on in a trial that two consecutive scans are needed before patients can be removed to confirm whether it is Psuedoprogression or Rapidprogression. Not one Indeterminate that has not progressed grew after DCVax-L on their second scan or later that remains alive.
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