Replies to post #59900 on NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

there is no change in imaging standards. that is you either misunderstanding what is going on or you spinning it. -- Reefrad

The Journal of Neuro-Oncology, July 2015 addition, included an article written in Feb 2015, "RE-DEFINING RESPONSE AND TREATMENT EFFECTS FOR NEURO-ONCOLOGY IMMUNOTHERAPY TRIALS". Their paper specifically addresses the pseudo-progression issue you and AVII debated: "the complexity of radiographic worsening following immunotherapy". One passage below supports iRANO may be adopting a "serial imaging approach":

Immunotherapy responses assessment in neuro-oncology (iRANO) criteria

Although the principals underlying the irRC provide important response assessment guidance for ongoing immunotherapy efforts in general medical oncology, modifications of these criteria appear warranted in order to optimally and safely apply such guidance for neuro-oncology patients. Similarly, although the RANO criteria were drafted to provide more effective assessment of response for euro-oncology patients undergoing therapy in the modern era, RANO alone may not fully address relevant considerations for neuro-oncology patients undergoing immunotherapy treatments. Thus, a multidisciplinary and multi-national group of neuro-oncology experts is currently drafting guidance for response assessments of neuro-oncology patients undergoing immune-based therapies. The immunotherapy response assessment in neuro-oncology (iRANO) criteria will integrate key components of both irRC and RANO in order to take into account important nuances with neuro-oncology patients. A comparison of RANO, irRC and iRANO is summarized in Fig 2. Like irRC, iRANO criteria will also advocate for confirmation of radiographic progression among medical stable patients. However, careful consideration is being included to specify temporal parameters and degree of allowed changes in order to ensure patients safety given potential risk associated with robust immunotherapy changes within the confines of the intracranial space. In addition, iRANO will include guidance for response assessment among patients with either enhancing or non-enhancing tumors. Furthermore, and again in the context of preserving overall patient safety, iRANO will provide guidance on when to consider interrupting administration of an immunotherapy for patients with early radiographic progressive changes. Additional important considerations regarding corticosteroid dosing, the role of advanced MR and PET imaging techniques, the inclusion of metric of neurologic function and overall quality of life, as well as guidance on immunocorrelative parameters to be prioritized in clinical research, will be addressed in the iRANO manuscript. MRI imaging following immunotherapy for neuro-oncolgoy patients, as well as PET imagingapproaches suggest that theses modalities may be of benefit in distinguishing tumor recurrence from pseduoprogression. Growing literature also supports the role of MR spectroscopy to predict inflammatory changes from true tumor progression. Monitoring serial assessment over time using advanced imaging techniques may also prove to be particularly helpful rather than single time point assessments.