PDA

View Full Version : SABCS Her2 Vaccine May Be Effective


Christine MH-UK
12-18-2006, 09:30 AM
Although the vaccine seemed to halve the rate of recurrence, it was not a truly randomised trial. Approval for a phase III properly randomised trial is being sought.


http://www.medpagetoday.com/MeetingCoverage/SABCSMeeting/tb/4694

Becky
12-18-2006, 09:49 AM
This is a true statement because one had to be HLA - 2A positive to get the vaccine and this is a poorer prognositic indicator with the HLA-2A negative women standing as controls. So... it does reduce likelihood of recurrence against a better prognositic group (but how much so is this difference). They need to randomize differently including both groups. Secondly, the group was so small, when one additional recurrence occured prior to this meeting, the results became statistically irrevelant.


Dr. Winer commented later on the study saying it was interesting but the math was all wrong and how many boosters should be given after the intial set in order to maintain immunity?

More work needs to be done here for sure. Let's see if they have enough relevent data to get FDA approval for another clinical trial (or not)