UCLA used McDonald criteria for measuring response. Response Assessment in Neuro-Oncology (RANO) is the imaging criteria that they are using now, and it is essentially modified McDonald as it takes into account assessments on non-enhanced lesion.
He is making serious allegations that they, UCLA, did not follow McDonald criteria to the letter T. He is suggesting they ignore progression to push through a failing science. Mind you, the patients that UCLA did not give a progression event ended up being patients who went on to become long-tail survivors. They never progressed and yet he finds fault with their subjective "no progression" event. His allegations are absurd.
He is completely misunderstanding and misinterpreting how psuedos are assessed in any trial. Instead he adds his own meaning to words that scientists have said. He completely takes things out of context.
He is also looking at non-enhanced lesions on T2/Flair imaging of old slides and measuring them with his eyes for size. But non-enhanced lesions are not measured for size! They are monitored for changes and patients are only removed if disease is "unequivocal". Psuedo by definition is "equivocal".
"4.2. Non-enhancing Lesions
In addition to enhancing lesions, non-enhancing lesions on T2/FLAIR images are reviewed when evaluating GBM response. Non-enhancing lesions are not measured but instead are monitored for changes in size. It is important to note that the extent of the non-enhancing component of the tumor can be difficult to determine since localized swelling and damage caused by radiation have a similar radiographic appearance. Changes in T2/FLAIR signal that suggest presence of an infiltrating tumor include mass effect, infiltration of the cortical ribbon, and location outside of the radiation field. " -- RANO
"Patients with nonmeasurable enhancing disease whose lesions have significantly increased in size and become measurable (minimal bidirectional diameter of ≥ 10 mm and visible on at least two axial slices that are preferably, at most, 5 mm apart with 0-mm skip) will also be considered to have experienced progression. The transition from a nonmeasurable lesion to a measurable lesion resulting in progression can theoretically occur with relatively small increases in tumor size (eg, a 9 × 9 mm lesion [nonmeasurable] increasing to a 10 × 11 mm lesion [measurable]). Ideally, the change should be significant (> 5 mm increase in maximal diameter or ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions). In general, if there is doubt about whether the lesion has progressed, continued treatment and close follow-up evaluation will help clarify whether there is true progression." RANO criteria
"Non-enhancing (T2/FLAIR) These are assessed subjectively I Some rules are recommended for objective assessment of progression I e.g. if a non-measurable enhancing lesion becomes measurable, AND either has absolute increase of >5mm OR >25% in SPD I However, ultimately the decision of when progression is evident is a judgment call by an expert reader." -- ICON the imaging specialist on RANO criteria of non-enhanced lesions.
What do ICON state about RANO criteria as it relates to Psuedoprogression:
"Pseudoprogression I Enhancement that simulates tumor growth, most often caused by radiation (whole brain or focal).?I Growth of existing lesions or appearance of new lesions within 12 weeks of completion of radiation therapy may be the result of treatment effects rather than growth of tumor.?I Continued follow-up imaging can determine whether initial lesion growth was true progression or pseudoprogression.?I If lesion continues to enlarge, the initial growth is called true progression I If lesion stabilizes or shrinks, the initial growth is confirmed as pseudoprogression -In such cases, the baseline SPD is no longer included when choosing the nadir value for the purposes of determining when progression occurs?I Diffusion weighted imaging can help distinguish pseudoprogression from true tumor growth, but its use is still experimental. The use of MR perfusion and spectroscopy is also being explored. " - ICON
FYI, ICON is the imaging specialist for this trial. Not AVII.
"First Progression:
Progressive disease < 12 weeks after completion of chemoradiotherapy Progression can only be defined using diagnostic imaging if there is new enhancement outside of the radiation field (beyond the high-dose region or 80% isodose line) or if there is unequivocal evidence of viable tumor on histopathologic sampling (eg, solid tumor areas [ie, > 70% tumor cell nuclei in areas], high or progressive increase in MIB-1 proliferation index compared with prior biopsy, or evidence for histologic progression or increased anaplasia in tumor). Note: Given the difficulty of differentiating true progression from pseudoprogression, clinical decline alone, in the absence of radiographic or histologic confirmation of progression, will not be sufficient for definition of progressive disease in the first 12 weeks after completion of concurrent chemoradiotherapy." -- RANO criteria
AVII claims that this trial dismisses this aspect of RANO. His view is that the trial design to remove patients prior to baseline indicates that they disregard that point. He is wrong. They merely remove all equivocal and unequivocal progression prior to baseline in an effort to follow FDA suggestion to have a clear basis to start on analysis.
AVII claims that once a non-enhancing (T2/FLAIR) image shows up it is regarded as Progression. There is no "monitoring" of the suspected psuedo. This is just not true. Psuedo is not a progression event. If it was the trial would have reached 248-Patients events a long time ago!!
Progression for patients in this trial are being measure according to RANO.
“Updated Response Assessment Criteria for High-Grade Gliomas: Response Assessment in Neuro-Oncology Working Group.” Journal of Clinical Oncology. 2010 Apr 10; 28(11):1963-72.
He is also claiming that Immune Response will automatically be confused as Progression. He is so wrong so often. Neuro-oncology imaging is beyond his scope of expertise, and thus his comprehension skills falls significantly short.
They will be looking at scans for response to therapy. I just shake my head at how ridiculous his assertions are.
AVII is then charging that the scientist are not being truthful. And then he is taking data and creating new interpretations of the data in a post hoc fashion. He complete misses the boat on what recurrent is.
He has said and done so many backward things that the list continues to grow.
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