NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

RANO extends the period to let enhancement that qualify as possible psedoprogression to a 12 weeks period after chemoradiation. They give time for pseudoprogression to get better if they got progressively worse first. That aspect of RANO doesn't change the needing of a confirmation scan for "worsening" early on, according to MacDonald. A enhanced lesion that doesn't get worse after showing up on Post RT MR is not considered progression. It is considered pseudoprogression under MacDonald. Brad's confirmation scan did not get > 25% worse and so he fits the definition of pseudoprogression. He did not need that 12 week aspect of RANO. Plain old MacDonald worked out fine for him. His first scan was treated the same way as AVAglio treated suspected pseudoprogression, which is plain old MacDonald. He didn't get worse, that's fact. :)

Assessment of Pseudoprogression in AVAglio

The AVAglio protocol also standardizes the assessment of possible pseudoprogression. The potential occurrence of pseudoprogression is evaluated at the first disease assessment after radiotherapy (ie, 4 weeks after radiotherapy; see Table 2). If the investigator observes a =25% increase in index lesions and/or unequivocal progression of existing nonindex lesions relative to the baseline disease assessment, then the recommended assessment is pseudoprogression, and treatment is continued under the provision that a confirmatory scan be performed 2 months later (ie, 12 weeks after radiotherapy) (Fig. 3). If the confirmatory scan shows further tumor progression as compared to the previous MRI, the assessment is PD, and the patient is discontinued from further treatment. In such cases, the date of the first disease assessment after radiotherapy is considered to be the date of PD. Conversely, if the confirmatory scan shows SD or PR as compared to the previous MRI, the initial assessment is confirmed to be pseudoprogression, and the patient is continued on treatment. In cases of confirmed pseudoprogression, the measurements of first MRI after radiotherapy are used as the new baseline (Fig. 4) but as a consequence, patients with confirmed pseudoprogression are excluded from the response analysis population." -- off the AVAglio paper

Figure 3: link below:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3631110/figure/Fig3/