Differences between Phase II and Phase III Reo H&N studies. Significant?
Some minor differences between the two studies exist, but will they change the results? Two things that I've noted:
1) A more detailed definition of the the cancers included in the study for phase III.
2) Patients must be taxane naive for phase III..
The second change could affect the response in both arms of the study, I suppose, but it's hard to say in what ways. Perhaps less variation among the responses? Maybe the potentiation of the effects of Reo only occurs the first time taxanes are used?
Have I missed anything more significant than that?
1) The patients will continue on Reo treatment if they haven't progressed after the 8 cycles of CPR.
2) The patients will mainly be second line. The PII European trial had 38% patients that were 3rd-5th. The average patient will be healthier than the populations they have treated in the past.
I am going to venture a guess that the for the Mets group, the control OS will be 4 months and the the Reo arm will be 9.5 months.
OK, those are details that I missed by relying so much on clinicaltrials.gov. Hmmmm.
I'm having a hard time coming up with OS numbers, but I expect stat sig OS difference easily for mets group, and less difference in the locoregional group, but still eventually stat sig because of a long tail. Your numbers are possible.