"The fact that tumor growth resumed is a clear sign that response at these levels is extremely dubious at best." Incorrect. Tumor reduction necessitating restaging confirmed in 6 drug resistant patients, multiple solid tumor types using recist 1.1 revised criteria is a clear,positive response. Disease progression following stabilization could be related to different factors which your post ignores, though blatantly obvious reason is most likely the tiny dose. We know these patients weren't near expected efficacious dose. Solid tumor reduction at known suboptimal dose is far from meaningless. It is, in fact, remarkably hopeful and unexpected. The continued progression of treatment resistant cancers, on the other hand, is to be expected at subtherapeutic dose. You do remember that they were all end stage with drug resistant tumors, right? And yet you find the fact drug resistant/treatment resistant tumors in 6 patients did respond to markedly suboptimal dose of this novel drug to mean little...
And 'tumors can appear to stabilize on their own'??? Again - end stage, multidrug and drug resistant solid tumors here. Can you tell me what the incidence of 'tumors appearing to stabilize on their own' could be in this end stage population? What is likelihood that 6 dying people had solid tumors that 'appeared to stabilize on their own'? You state that " errors can be significant due to technological imaging limitations". Are you aware of the machine used for this trial? It is the Aquilion One. If you are at all familiar with recent tomography technology then you know this machine and therefore know how off base your 'significant error' theory is. This is world leading research team. If you don't think they calculate in an overly generous standard margin of error %age in every restaging then...once again...you show your lack of familiarity with this whole process. Best team, scanner with sci-fi imaging function, actual mathematical formula for calculating restaging which includes standard of error...
And of course they need to continue affirming p21 activation. They gained a slight effect at these low doses. The company has written "p21 biomarker expression in patients:
Kevetrin activated p21 in 4 out of 5 patients treated with 20 or 30 mg/m2". That is very significant. That is an increase. It is reportedly slight and it exists - or else it simply would not have shown. The procedure used at this early stage is relative quantification. They simply compared gene expression in untreated sample with expression in treated sample of same patient. Purely mathematical and quantification completely automated - though checked by the lab team. Expression increased or it didn't - it's pretty black and white, even if increase is only slight. It suggests that since slight increase seen with 'slight' dose, sizable increase may be seen with sizable dose. We will have to wait for that supposition to prove out, but the fact that we have to wait doesn't make the small measured expression in 4 out of 5 patients at still scant dose an insignificant event. We have learned that there is evidence of p21 activation. Very important news.
AI
