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Julie R. Gralow, MD: The Atlas Trial. Tamoxifen For Five Years or Ten Years?

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Dr. Julie Gralow sits down with Selma Schimmel and The Group Room at the 35th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) for a four-part interview. This is the second in the four-part interview where she discusses the Atlas Trial and the new data concerning Tamoxifen.

This is selma chimel for the group room at the annual san antonio breast cancer symposium joined now by dr. julie gray lo the joe bennett professor and director of breast medical oncology at the university of washington and the seattle cancer alliance also a member of the fred hutchinson cancer research center hello dr. gray though hi summa now on behalf of the

Adjuvant therapy there’s a lot of buzz going on at this meeting involving tamoxifen let’s talk a bit about tamoxifen and early stage breast cancer should you be on it for your whole life this is the question so the atlas trial was presented and that was a trial that compared five years of tamoxifen which has been the standard for decades with ten years of tamoxifen

Now we had a small study that was done previously that we thought had settled this a study of five versus ten years of tamoxifen done by the nsa bp that it showed that five years seemed optimal ten years was no better and gave you more side effects when was that study that was a long time ago now i actually don’t recall the year that that was released but that was

A long time ago we’ve been giving five years of tamoxifen for a long time but that study was actually a low-risk group of women no negative women so not a lot of recurrence has happened in the study so you don’t have a lot of room to show a difference if the recurrence rate is low so a couple of trials the atlas trial which has been presented here at this meeting

And the atom trial which will see the results of in the near future where trials of longer versus shorter tamoxifen they didn’t believe that they had answered the questions and and i heard that even the nsa bp statisticians who had released that trial i told you about that kind of settled the five years they said they didn’t have real statistical certainty that this

Was the right answer for all women either they encouraged trials of longer tamoxifen amido when did this the atlas trial begin a long time ago we have more than well from the time that women first started their tamoxifen we have a good 15 years of follow-up so i think the atlas trial has been ongoing for you know more than a decade for sure ticks you know the good

News is that the event rates are low and you need to do your analysis after you have enough events to show a difference so that’s the good news is that women are surviving breast cancer and they’re not having recurrences and they’re not having deaths so that means that it takes longer to get answers that’s also the frustrating news because we don’t get the answers

Fast enough so the results of the atlas trial showed ten years was better overall in absolute terms that reduced recurrences and deaths by twenty to thirty percent reduced deaths by about the same magnitude so that’s absolute terms that sounds high but if you take it in and sorry that was relative terms if you take it in absolute terms it’s about a three percent

Difference for the group as a whole three percent reduction in recurrences or deaths so for some women who have very high recurrence risk that will be a lot more than three percent and those women undoubtedly do benefit from longer endocrine therapy but for women with negative lymph nodes or lower risk they have much less than a three percent benefit and the side

Effects of an extra five years of tamoxifen likely outweigh the risks we definitely saw that there was a 1% absolute increase in uterine cancer you gotta weigh that against the reduction in breast cancer you i know have been following the advocates and what they’re blogging about and tweeting about tell us what you’ve been observing in regards to their reaction

To this news well it’s been very interesting to see the advocates presence at this meeting which is even it’s stronger than ever you know i’ve been doing the hot topics mentor session of the oh breast cancer foundation for years and it just was huge last night when i did that session and we talked a lot about the atlas trial so i i’m on twitter and i do follow

Several breast cancer advocates on twitter and i’ve been following the hashtag s abc s for the san antonio breast cancer symposium and this came out and all the scientists were saying statistically sound evidence to support longer tamoxifen and the advocates were saying oh my gosh five more years of hot flashes the night sweats do i really need to take this what

Does this really mean a 3% absolute difference is that what it’s going to be for me do i really need to keep taking it so there’s been a lot of discussion about this and it is true that it is statistically sound that there is a benefit but if there’s a 3% absolute difference in recurrences that means you give the drug an extra five years for a hundred patients to

Benefit three women so you we need to sort out who are those three women or who are the highest risk patients that still have a risk of relapse after five years of tamoxifen and do prolonged endocrine approaches in them if they’re pre menopausal we i would recommend five more years of tamoxifen if they become postmenopausal i’d give an aromatase inhibitor based on

An older nci canada ma 17 trial of five years of amarra after five years of tamoxifen do you think there’s going to be resistance because of the physical difficulty that patients have on tamoxifen i’ll tell you a lot of my patients it’s hard for me to even get them to five years and i definitely have some who after a couple of years say i just do not feel like myself

I i need to go off and they try very hard to be on it so i think it depends on how you feel some women have a marked deterioration in their quality of life on the drug and they are unlikely to be excited about continuing it longer but if we put we if they’re a high-risk group then they might be willing to do it looking at the data but if you have a good quality of

Life on tamoxifen and don’t a lot of side effects then you know there might be some benefits so why wouldn’t you stay on it it’s all about how you feel and what kind of side effects you’re getting from this drug and that varies widely this needs to be a real discussion between the patient understanding how she feels on the drug and what the drug is doing to her and

The physician and really trying to look at the data and what is the residual risk of relapse in a given patient after five years of tamoxifen we need to to try to individualize the recommendation well i just have a visual in my head right now of a doctor sitting with a patient saying well we’re gonna go for another five years i just i feel for the patient in that

Moment who wants to run out the door is say i’m done absolutely and that’s absolutely going to happen and the advocates are asking last night at the alamo hot topics mentor session you know they saw the press which all said favorable favorable statistically significant they said who’s going to do the articles and the papers that actually put in perspective all

The risks and all the benefits and put the quality of life into it so let me ask you since we have an opportunity in this interview to be able to help women think this through what would be two key questions when a woman now is going to go meet with her doctor to be addressing to help assess whether or not they should consider another five years well i think a key

Question to ask is what do you think now that i’m finishing my five years of tamoxifen my residual risk of recurrence is over the next five to ten years and actually the adjuvant online program that peter avidin developed you’ve interviewed him many times has a little risk calculator for the question about should you take tamarah after five years of tamoxifen if

You’re postmenopausal and we can use a calculator like that where you plug in what was the tumor size what was the lymph node status you know some information about what’s the patient’s age and all of those kinds of things to help calculate what the residual risk of recurrence how much of my recurring is now gone since i’ve survived five years and i’ve taken five

Years tamoxifen and how much remains that’s the first question the second question is saying here’s the side-effects i think tamoxifen is causing do you think that all of these side effects are really dude in tamoxifen or some of them due to the chemo i had or other things going on and and frankly i will frequently recommend a couple months trial off tamoxifen

To sort out what side effects the tamoxifen itself is causing versus all the residual from all the other cancer treatment plus aging you know just causing side effect and you can see how you feel off the tamoxifen and if some of the side effects you were blaming on tamoxifen actually don’t get any better or go away after a little bit a couple of month break from

It then you can’t really blame the tamoxifen for it you know so you might consider going back on tamoxifen if you thought some of your side effects were related to it but they don’t go away when you go off of it if you would have a significant benefit in recurrence reduction thank you dr. gray though i love our overviews with you you touched on so many important

Things and your research awfully important thanks for having me summit and thanks for everything that you do for all of your viewers dr. julie gray low the jill bennet professor and director of breast medical oncology at the university of washington and the seattle cancer care alliance also a member of the fred hutchinson cancer research center thanks again dr. agrella thanks so much

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Julie R. Gralow, MD: The Atlas Trial. Tamoxifen For Five Years or Ten Years? By Vital Options International