Monday, September 01, 2014 6:12:13 PM
1) vaccines patients need to have > or = 1000 so those with < 500 who then become 200 (49 % loss) after 6 weeks radiation and chemo would have been denied entry into the study
1a) those denied, either fall in the 99 category (additional open study) or the 55 compassionate use arm
1b) but because the research was of mostly biopsy patients, the 40 percent is also a blown figure, as most of these 96 research paper patients would have also been excluded from the dc vax trial, either due to improper tumor resection, use of steroids, and ...
1c) these depressed 200 level die due to disease progression, essentially before poor immune system kills them
1d) these overall numbers seen in this research paper were on steroids so their CD4 level likely isn't indicative of DCVax screening group .
2) of those screened with > 1000 who do make it into the DC Vax trial, on average their CD4 drops around 500 points after radiation/chemo, and some as much as 79 percent (generally the higher the CD4 the greater the hit), which brings our group will clearly be above the 200 depleted state.
2a) if they make it in, they need to be off steroids for at least 10 days before beginning the vaccine and have up to 14 days after SOC radiation ends to begin trial vaccine, which means some patients will only have a 4 day window if they don't taper off the steroids sooner, and could have ended up post screened in the 99 denied portion of the study.
2b) very small percentage of severely depressed state would have made it into our study
My own thoughts and assumptions:
1) If DC Vax trial screening is removing the low CD4 candidates, then our placebo group will likely also fair better.
2) this cd4 depressed state shouldn't reduce our PFS numbers. At most, it could potentially affect OS years down the road, as a depressed state below 400 still resulted in hospitalization from varying systems.
Did I understand and read it properly?
Typing on my iPad so I hope my shorthand babble is clear ;)
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