waiting, waiting, , page-2

I do cancer research myself, so here's my input:

We have no reason to doubt the efficacy of HA-irinotecan against CRC. What we lack at this point is sufficient evidence of reduction of side effects in patients given HA-irinotecan in comparison to irinotecan itself.

From the phase II results (
paper here)

I'll do some simple science cliff's notes as to why I believe this, but bear in mind when you consider the following that this study was performed on patients who have presented with late stage cancer:


"HA-Irinotecan patients had a significantly longer median progression-free survival of 5.2 versus 2.4 months (P = 0.017)."

- 5.2 versus 2.4 months progression-free survival at a p value of 0.017 in so few patients (41 vs 35) is pretty good evidence that HA-irinotecan works better than irinotecan at prolonging progression free survival.
- Overall survival doesn't look as pretty with a statistically insignificant increase of 10 months compared to 8 months (p=0.196 is well within the "could be bullshit" region) but again this is in late stage patients and there weren't many of them, but..
- PFS in late stage patients is very important even without statistically significant changes to OS.

To get a crude idea of how p values work in this context, p values are a way of judging the likelihood, out of 1, that a result has occurred just by chance. You can think of it as "chance that this is just a fluke". So, read "p=0.017" as "There is a 98.3% chance that HA-irinotcan is better at prolonging how long patients survive without any further disease progression than irinotecan by itself".

My concern is the increase in reported diarrhoea in the HA-irinotecan arm in the study. Remember the aim of the study was to confirm that "the formulation of irinotecan with the drug carrier, hyaluronan (HA) reduced toxicity of the drug." - this was not demonstrated in the phase II trial, and is our primary potential stumbling block.

Disclosure/Liability: Regarding the possibilities of HA-irinotecan (not to mention the numerous other drugs that could be treated with HA in a similar manner) my recommendation is to buy - but remember this is just my opinion, I'm not a financial advisor, and you should do your own research.