AI
Tuesday, January 31, 2017 1:55:25 PM
Did you notice that he has been using the first Phase I trial as his example of what he calls poor survival? We are talking pre-STUPP protocol. -RKMatters
That is a gross mischaracterization.
Here, let me help you.
For this subgroup of patients, the median overall survival was 11.7 months, which is not significantly different from those of historical and concurrent glioblastoma multiforme patients treated at our institution. - Dr. Liau's 2005 pre-Stupp paper
You are taking Dr. Liau's words and twisting them to suit your incorrect view.
But I am glad you brought up her first Phase 1 paper. It gave me the opportunity to see how they handled "time zero" for their measurement of OS in rGBM.
Did they do it the way you repeatedly assert (from injection)?
Let's see......
No, it's not as you assert. They did it the same exact way as I said, from the surgery.
By the way, do you see Patient 5 above? In the meta-analysis paper they report 1 patient with an "objective response" to DCVax.
She's still alive today.
But there are two things to note about this patient.
1. She would not have made it to randomization in the Phase 3 trial.
2. Her "objective Response" was very likely pseudoprogression. Or, as Dr. Liau said in her paper:
One patient (patient 5) had near complete regression of residual tumor, which was seen on MRI 2 months after completion of peptide-pulsed dendritic cell vaccination and before any additional adjuvant treatment. Both the size of the areas of T2W hyperintensity and the contrast-enhancing tumor decreased in this patient (Fig. 2). Although this radiographic change is more likely related to a delayed response to radiation therapy, it is interesting to speculate that dendritic cell–based immunotherapy might have contributed to this clinical response,
Earlier I challenged MD1225 to figure out what all 4 still-living patients from the two earlier DCVax trials had in common. This is one of those 4 patients (the other 3 are from the second Phase I/II trial). For all 4 of these patients, their MRI got "worse" before it got "better". Think back to the Hoos videos recently discussed. What does that suggest for PFS?
