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You are here: Home: BCU 6|2002: Supplement: Joyce O'Shaughnessy,
MD
DR LOVE: We had a 78-year-old woman who was ER-negative,
HER2-negative, with bone mets, who’s asymptomatic.
DR O’SHAUGHNESSY:
Mm-hmm.
DR LOVE: Okay. 78-year-old woman, asymptomatic,
ER-negative, HER2-negative, with bone mets with no prior adjuvant
therapy chemotherapy. What we saw there was 20 percent vinorelbine,
30 percent Taxotere, and 15 percent capecitabine, and the rest sort
of a smattering of others. What would you do with a patient like
that?
DR O’SHAUGHNESSY:
I will often pick either Navelbine or a low dose of Xeloda in those
patients. There, you’ve got a wide variety of single agents
to choose from, clearly single agents. Effectiveness is probably
pretty close with the agents. And so you’re looking for effectiveness
and quality of life and if you can avoid hair loss, why not? So,
I would either go with Navelbine or Xeloda. Because the only single
agent that has a survival advantage as a single agent is Taxotere
in the anthracycline pre-treated, and she’s not anthracycline
pre-treated. So, we really don’t have those data pushing us
there.
DR LOVE: We presented that same woman with ER-negative,
HER2-positive. What do you generally do with that woman?
DR O’SHAUGHNESSY:
I would give her Herceptin alone if she was totally asymptomatic.
DR LOVE: That was a common choice.
DR O’SHAUGHNESSY:
Good. Yeah. That’s neat.
DR LOVE: One more I want to throw out at you,
which was – and we did this in the end of December, and what
we did was, we also sent the physicians the summary slides from
the ATAC trial, in case they hadn’t seen it. We said, “What
adjuvant endocrine therapy would you recommend for the following
patients with ER-positive, HER2-negative breast cancer?” We
started out with a 65-year-old woman with a 2.2-centimeter tumor
and ten positive nodes. What endocrine therapy would you use for
a woman like that now?
DR O’SHAUGHNESSY:
I have been choosing Arimidex in the very high-risk woman, where
her risk of death from breast cancer far outweighs any concerns
about long-term effects. I want short-term benefit, and you want
the best you can get. So, the data from the ATAC trial would certainly
suggest that short-term, at least, Arimidex is better.
DR LOVE: It’s interesting when you look
at the numbers. I would have thought that people would have leaned
earlier towards node-positive, very high risk, also. We didn’t
actually see that. It looks like about a third of physician who
have just basically switched over in postmenopausal woman at this
point, based on what they’ve seen, to Arimidex. And it doesn’t
seem to change that much. I mean, we presented the same woman with
a 0.8 centimeter, node-negative tumor, and the percent saying Arimidex
is basically the same.
DR O’SHAUGHNESSY:
We’ve had to address this issue because of the adjuvant trial
I was talking to you about. We had to really come to grips with
this on the Breast Committee. And we’re finding the same thing,
about a third of physicians have gone over to Arimidex at this time.
The others are either in the tamoxifen camp or wanting docs to have
a choice. What we decided to do in this adjuvant chemotherapy trial
I was talking about, is that we are going to allow the doctors the
choice, but stratify up front, for whether the patients are going
to get tamoxifen or Arimidex. So, the docs are going to have to
put their nickel down, if they have a postmenopausal woman that
they’re going to be randomizing on AC followed by Taxotere
versus AC followed by Taxotere-Xeloda. They’re going to have
to decide up front if the patient’s going to get tamoxifen
or Arimidex.
DR LOVE: That’s very interesting. I’ve
heard that people are really struggling with that.
DR O’SHAUGHNESSY:
Oh, we’ve been struggling. I wrote to the cooperative group
chairs to get some input. It’s a tough one, Neil, because
if you are going to get just two or three more absolute percentage
points out of your XT, compared to your T, which is all we usually
ever get with an effective regimen. If it turns out, we’ve
got an absolutely difference in the ATAC now of 2 percentage points,
that, in my opinion, could easily be five points in five to eight
years of follow-up. It could easily get better.
DR LOVE: Hmm. Interesting.
DR O’SHAUGHNESSY:
So I’ve been very concerned that if we didn’t stratify
for tamoxifen versus Arimidex up front, that we were going to have
uninterpretable data.
DR LOVE: Well, either that, or just focus on ER-negatives.
DR O’SHAUGHNESSY:
Right. But, you’re going to leave out 60 percent of your patients
there. And we want to beat the NSABP in accrual.
DR LOVE: That’s fascinating.
DR O’SHAUGHNESSY:
We want to be first. We will be first. (Laughter)
DR LOVE: Well, that’s really going to be
a dilemma, because usually it’s sort of a given that, in these
chemotherapy randomizations, the people are going to give tamoxifen.
And, as you mentioned the doc’s got to give what they feel
comfortable with.
DR O’SHAUGHNESSY:
Absolutely, and one-third has gone over to Arimidex.
DR LOVE: Now, you talked about Arimidex. What
about the issue of the adjuvant use of either letrozole or exemestane
in a non-protocol setting. How do you feel about that?
DR O’SHAUGHNESSY:
I am not using those out of the non-protocol setting. I’m
using Arimidex in the adjuvant setting, because I try to stay as
data-driven as I can.
DR LOVE: Yeah. One of the things that’s
relevant to the last question, we asked these docs in terms of which
AI they would use, just what you addressed in terms of the fact
that you’re using Arimidex right now. And most of them pretty
much said the same thing you did.
DR O’SHAUGHNESSY:
At the end of the day, Neil, I think from an effectiveness standpoint,
from an anti-breast cancer standpoint, my guess is that they will
be very similar in effectiveness. At the end of the day it’s
going to be a balance of anti-breast cancer effects and other important
effects for our breast cancer survivors, who, as you know, we cure
most of them. They live a long time. It’s going to be a balance
of side effects, in terms of how they feel, bones, lipids, and,
of course, anti-tumor activity, which we’d never sacrifice.
But it may well be that they have very similar anti-tumor effectiveness.
There may be an irony here – it may not be, at the end of
the day, that you want the strongest aromatase inhibitor. It may
be that you want a good strong one, but maybe not completely sucking
the body dry of every estrogen molecule at the microenvironment
level. It may be that that gives you a balance there of maintaining
some bone density and some lipids, cardiovascular. What about the
brain, etcetera? But I think the bone story is going to be very
important.
DR LOVE: Do you have the sense that we’re
going to be able to follow bone density and just react to that without
the patients getting in much trouble in terms of a non-protocol
setting?
DR O’SHAUGHNESSY:
I do, Neil. I think that what’s going to probably happen –
and I know I’ve been doing this myself ever since hearing
the ATAC data – I’ve been thinking of bisphosphonates
hand-in-hand with Arimidex in the adjuvant setting. If somebody
is already known to have a little osteopenia – a lot of women
will come in and they will have had a bone density and they’ll
know where they’re at. If they’ve already got a little
osteopenia, if I start them on Arimidex, I’m going to start
them on weekly Fosamax or Actonel at the same time. I don’t
think that’s a big deal.
DR LOVE: Well, plus, there’s also the hint,
although it was with clodronate, that maybe it’s going to
have an effect on the tumor.
DR O’SHAUGHNESSY:
Correct. Correct. That’s right. That would be interesting.
I wouldn’t be surprised at that. So, I think that’s
going to be an interesting story, as well. So, that doesn’t
really bother me, particularly the weekly bisphosphonates are quite
well tolerated.
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