We’ve
been involved in some randomized studies. The anastrozole study
is anastrozole versus tamoxifen versus the two together. So it’s
the same format as the ATAC study. So patients were treated with
neoadjuvant anastrozole alone or tamoxifen alone or the two together.
And what’s actually very useful about these neoadjuvant studies
is that you can look at biological markers as well. That’s
been done in the U.K. It was originally started by the Royal Marsden
Group.
The
idea originally is only to study about 300 patients. But what’s
clear is – working the meeting here on Faslodex and on other
drugs – is that you can get a very good idea of what’s
happening in tumors by looking at biological markers rather than
clinical endpoints. So, in these studies, and in these studies that
we’ve been doing, we’ve been taking biopsies at 10 to14
days and looking at what effect drugs have on proliferation, cell
death and a variety of genetic markers to see if we can start to
predict very early on whether the patient is going to get a benefit
from a drug. And that is potentially a very useful tool, because
a lot of patients wait 10 to 14 days (at least in the U.K.) from
the time of diagnosis to the time of surgery. If you got a core
biopsy at the time of diagnosis and you put a patient on a drug
and then you operate on them and you see that that drug’s done
something to the tumor and you know that that change is associated
with long-term benefit for that patient, then you have a potential
method to individualize treatment. So at least you know whether
if you don’t get a change, the change that you want and it’s
associated with benefit, then you can think about putting the patient
on a different neoadjuvant agent. So I think it’s a potentially
an interesting way to go, so that in the neoadjuvant ATAC we will
look at response rates, and we think 300 is enough to detect the
percentage difference in response.
Relevant
Articles:
ARIMIDEX'
as Neoadjuvant Therapy Causes Large Reductions in Tumour Volume
in Postmenopausal Women with Large Operable Breast Cancers. (Meeting
abstract). Dixon Michael. Renshaw L. Bellamy C. Cameron DA. Miller WR.
Proc Annu Meet Am Soc Clin Oncol. 18:A345, 1999.
Neoadjuvant
Treatment with Anastrozole ('ARIMIDEX') Causes Profound Suppression
of Intra-Tumor Estrogen Levels (Meeting abstract). Geisler Jurge. Bernsten H. Ottestad L. Lindtjorn B. Dowsett
M. Lonning PE. Proc Annu Meet Am Soc Clin Oncol 18:A311,
1999.
