Debbie,
Here is the response I just received from the PI, COL George Peoples, MD:
Valid questions….here’s the scoop…
HER2/neu negative as used in clinical practice today does not mean that HER2/neu isn’t expressed, just not over expressed. The actual distribution of HER2 expression by IHC staining is as follows: 25% - IHC 3+ or over-expressed (the vast majority of these are also FISH >2), 50% - IHC 1-2+ (called negative but actually low-expressors), and approx 25% - IHC 0 (true negatives).
The E75 vaccine trial presented at AACR worked in all patients but best in the low expressors (LE).
The actual rates as reported for the OE (over-expressors – 25% of all breast cancer patients) and LE (low –expressors – 50% of all breast cancer patients):
Recurrence rate OE-controls = 18% at 3 years vs 14% in the OE-vaccinated
<DIR><DIR>LE-controls = 18% at 3 years vs 11% in the LE-vaccinated
</DIR></DIR>Mortality rate OE-controls = 9% at 3 yrs vs 3% in the OE-vaccinated
LE-controls = 7% at 3 yrs vs 0% in the LE-vaccinated
Mortality among patients that recurred
OE-controls = 50% vs 25% in the OE-vaccinated
LE-controls = 38% vs 0% in the LE-vaccinated
<DIR><DIR>
</DIR></DIR>
__________________
Cynthia
Diagnosed 9/03 @ 43 years (pre-menopausal)
Her2+++
4 nodes +; High Grade
ER+/PR+
Bilateral Mastectomy; Reconstruction
CAF x 6; Radiation; One Year Late Herceptin
Oophorectomy; Arimidex
Completed E75 Vaccine Trial; Completed E75 Vaccine Booster Series
|