A few weeks back we were looking at the 5,000 cycles data and...

A few weeks back we were looking at the 5,000 cycles data and trying to work out its significance

I've been reading a bit about the phase 2 trial. In that trial the cycles were given every 3 weeks (as opposed to every 2 for the phase 3).

Median number of cycles for the control was 2 (with a median time to PFS of 2.4 months).
Median number of cycles for the HA arm was 6 (with a median time to PFS of 5.2 months).

One of the things that surprised me was how low the number of cycles are.

If one was to crudely take the this info and alter it to two weekly cycles, our control would hit a median of 7 cycles. The HA arm would be a massive 16+.

16+ cycles would actually mean that almost every HA subject has hit the maximum, but we have since learnt that despite treatment being advertised as for only 8 months it has gone on much longer for some people. 30 cycles for one person has been quoted.

If some subjects are up to 30 cycles then it becomes impossible for me to use mathematics to calculate a result, as I have now lost a definite.

But having said that, after weeks of investigating the 5,000 cycles information, I can conclude that this information indicates more strongly that the phase 3 trial is a success.

However the strongest indication of trial success is still the length of time that the trial has taken.

HA is just the delivery system and it is the cancer agent alone (probably) that does the work. Hence a better cancer agent (as Folfiri is compare to Irinotecan alone) the better the result. This is an exponential improvement in my opinion, as HyACT is known to deliver between 40 and 1,000 multiples of the chemo agent.

Cheers