Herceptin NSABBP trial - LVEF a cancer outcome probability factor?
I admit to being totally out of my depth, and realise that this suggestion could be very contentious, but here it is.
In the NSABBP trial dated october 20 2005 of 1833 randomly assigned women (p.7) 1159 appear to have completed the therapy (p.8). The reasons for exclusion were primarily decline in LVEF.
My question is has it ever been clinically determined if there is a link between cardiac health and cancer - not in the sense of a direct link but an underlying communality of cause - for example diet and an indicator of general health - e.g. omega three six balance in tissue.
Higher levels of omega three are known to be benificial to cardiac health, AND trials show that high levels of omega three correlate to very significantly lower cancer risks 70%, and impact on cell death both in vitro and in vivo.
SK-Br3 featured both in the fish oil trial referred to in the previous post and above.
THE QUESTION
Could exclusion of low LVEF patients in the treatment arm, but not in the control arm result in skewing of results data in favour of Herceptin consequent on low LVEF patients having a higher inherent predisposition to early recourence or spread - say due to lower omega three or wider general health factors that impact both on LVEF and onward cancer developement.
Food for thought,
RB
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