Ann: PanCO Clinical Study on OncoSil Published in ESMO Open, page-10

Actually... it's worse, because its not a comparison of 20% to 23.8%.


Tablet 3 Efficacy analysis adapted from Ross P.J, Wasan H.S, Croagh D et. al. Results of a single-arm pilot study of 32P microparticles in unresectable locally advanced pancreatic adenocarcinoma with gemcitabine/nab-paclitaxel or FOLFIRINOX chemotherapy, ESMO Open, 2021, 7(1) https://doi.org/10.1016/j.esmoop.2021.100356.

The PP sample was 42. The patients that did not undergo implantation and just underwent Chemotherapy were 8. So the chances of a "surgical resection", compared to the PP population, occurring in the ITT population were 16% (because there are less patients).

But... to make matters worse, exactly 8 of the 50 were withdrawn, therefore, we need to compare a 23.8% to standard chemotherapy. We cannot compare the 23.8% to the 20% like the Table 3 wants to suggest (comparing Column A to Column B), because there was a problem with "column A", that problem being here:


Adapted with red circle highlighting the withdrawals in Figure 1. Participant flow in the PanCO study adapted from -Ross P.J, Wasan H.S, Croagh D et. al. Results of a single-arm pilot study of 32P microparticles in unresectable locally advanced pancreatic adenocarcinoma with gemcitabine/nab-paclitaxel or FOLFIRINOX chemotherapy, ESMO Open, 2021, 7(1) https://doi.org/10.1016/j.esmoop.2021.100356

Therefore.... One cannot even argue that the implantation caused 2.3% more surgical resections because 1) the sample size is not strong enough and 2) compared to what? If they are comparing the PP to ITT populations, that is a very poor comparison, because the only comparison is the "withdrawals" which are problematic patients, the 8people in the ITT were "withdrawn" due to adverse health conditions, anatomical conditions, or metastatic disease (so they most likely couldn't have had surgical resection even if they wanted to).

I am not saying this is a poor study, I am not saying they made any errors, all I am saying is, I don't believe there is enough evidence to claim P microparticle implantation is any better than control at this stage.