Tamoxifen for 10 years cuts breast cancer relapses...
Comments
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It seems so strange that new studies come out with totally contradictory results. I thought I had been reading all along that more than five years made no difference. But I will gladly stick with the drug for an extra five years for the additional 4% chance of non recurrence.
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Another article on this:
Adjuvant tamoxifen (TAM) for 5 years in hormone receptor–positive (HR+) early-stage breast cancer is the worldwide standard of care, leading to an improvement in both recurrence-free and overall survival. The effects of 5 years of TAM last beyond the treatment phase, with additional benefit conferred during years 5 through 9, then plateau. The ATLAS trial examined the effects of an additional 5 years of tamoxifen compared with placebo. ATLAS demonstrated a further improvement in both recurrence rate by 25% proportionally and 3.7% absolute reduction and an improvement in breast cancer mortality by 29% proportionally and 2.8% absolute reduction through year 15 after diagnosis by continuing TAM for an additional 5 years. This is a practice-changing result: given a favorable risk/benefit ratio for TAM, 10 years of therapy should now be considered for HR+ patients.
It is interesting that the residual risk for breast cancer relapse appears to persist for many years after diagnosis, demanding long-term strategies in this population. Many questions are raised by ATLAS; for instance, in postmenopausal women, would 10 years of an aromatase inhibitor yield similar results? Should women who completed TAM more than 1 year ago be considered for an additional 5 years of treatment now? How long should women with HR+ breast cancer be followed for recurrence? Perhaps, most importantly, the ATLAS results, extrapolated to an alternative of no adjuvant endocrine therapy demonstrate an overall 50% reduction in death from HR+ breast cancer, confirming once again that TAM is still the most important drug yet developed for this disease.
Abstract
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We're discussing this topic on the San Antonio Breast Cancer Symposium 2012 thread.
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See what Breastcancer.org has to say about this news:
Ten Years of Tamoxifen Better Than Five for Early-Stage, Estrogen-Receptor-Positive Disease
December 7, 2012
For women diagnosed with early-stage, estrogen-receptor-positive breast cancer, 10 years of tamoxifen offers more benefits than 5 years. Read more... -
Apparently only if you are not lobular cancer, according to another post here.
Stupid cancer; stupid medicine.
grrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
I am just so sad i wasted all those years and money on a useless treatment.
*SoB*
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Wallycat,
Why do you think these results don't apply to lobular? Can't find the post you're referring to...
Is it because there's no data on lobular or is there a proven reason it doesn't work?
Wondering and want to know about your info.
Amanda -
ML - I just found this link of older posts regarding Tamox vs ILC.
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I was so glad to see this news. No basis, but just from my own personal experience, the hormone positive ladies I've met who tell me they've been NED for 20-25+ years inevitably also tell me that they are still taking Tamoxifen. Apparently, at some point when Tamoxifen was introduced, the standard was for patients to take it for the rest of their lives. I'm sure there are exceptions to this but, almost everyone I've met in that situation, when I ask how long they took Tamox, they almost always say "oh I'm still taking it".
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lanagraves - may I ask if these long term Tamox users are Pre or Post-menopause as you mention 20-25+ years (which is WONDERFUL!!!)? Do you know if any had hysterectomy to continue long term use of this medication?
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The two ladies I am specifically thinking of (the ones I know enough about the situation to say for sure) - one was 41 when she was diagnosed, pre-menopausal, Stage III (she thinks, based on the size of the tumor and number of nodes). She is now 69 and still takes Tamoxifen - no recurrences or further issues. Not sure about a hysterectomy. The other was in her early fifties when she was diagnosed and is now pushing 80. She did have a hysterectomy and is still taking the Tamoxifen.
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lanagraves - Your post is so interesting; about the two women you know that have continued on tamoxifen. I am post menopausal and was looking forward to being off of tamoxifen in the two years that I have left, should I not follow the latest guidelines. Now your post has made me rethink going off when my two years are up. I will at least seriously consider taking it for a total of 10 years. Thanks for the information. Sending you good thoughts.
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My oncologist just told me about this study. I am 6 months into my Tamoxifen journey. At first, I was irritated that I would have to endure this drug in my body for 9 1/2 more years instead of 4 1/2. But then I thought, "Heck, you took birth control pills for 10 years, what's the big deal about this?" So, I guess I'll see this through to the end.
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Let's see if I understand this correctly. The reason that initially researchers thought that 5 years of Tamox was better than 10 years of Tamox was because over years 6 - 10 there was no difference in recurrence rate among those who stopped Tamoxifen after 5 years vs. those who continued to take it for the second 5 years. However, those who continued to take Tamoxifen also continued to experience side effects, at increasing rates. With those results, the logical conclusion was that there was no benefit to taking Tamoxifen for more than 5 years.
But the new study looked beyond 10 years. And not surprisingly, they found that the residual effects of 5 years of Tamoxifen starts to fade once you hit year 11 and beyond. But if you took Tamoxifen for the full 10 years, then in years 11- 15 you are still getting that residual benefit. So the real value of the extra 5 years of Tamoxifen doesn't happen during those extra 5 years when you are taking it, but it happens in the following years, when you get the residual benefit from having taken those extra 5 years of Tamoxifen.
If I've got that right, then wouldn't it make sense to take Tamoxifen for 5 years, then go off it for 5 years (years 6 - 10, during which time you are still protected because of the residual benefit) and then start up again for another 5 years (years 11 - 15)? Or maybe move to an AI instead at that point if you've become post-menopausal? Why take any drug during years 6 - 10 if you are protected by the residual benefit of the first 5 years? Wouldn't it be good to give your body a break from the side effects? Wouldn't a break possibly reduce the risk of the serious side effects? Once the residual benefit of 5 years of Tamoxifen wears off, around year 11, you start to take Tamoxifen (or an AI) again. And if you do this, if you take Tamoxifen (or an AI) during years 11 - 15, wouldn't that mean that you'd get the residual benefit over years 16 - 20? So isn't that a way to spread the benefit of 10 years of taking Tamoxifen (or Tamox and an AI) over 20 years?
I know.... it hasn't been tested and it would take more than 20 years to get the result if a test were to be initiated today. But doesn't that approach seem reasonable? Or have I missed something?
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Until they know what exactly drives cancer recurrence, hard to know the answer to your question, Beesie.
This link was posted by pip47: http://www.thestar.com/news/gta/article/1301826--cancer-cells-hide-by-going-dormant-princess-margaret-study-finds
If the women lanagraves (thanks for sharing!) mentioned have dormant cancer cells, maybe it is Tamoxifen that is keeping them dormant and therefore unable to increase gamma estrogen-related receptors (as per cp418's link on Tamoxifen resistance above). How long Tamoxifen can keep cells dormant after its withdrawal is another question.
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wallycat, the results in that study were relative. Tamoxifen still could have some benefit for ILC, but possibly with relatively high diminishing returns.
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Bessie -- what you described is EXACTLY what I've been wondering about to get LONGER benefit and protection from these medications. Yes, I've also thought that short vacations off medication might benefit to help get some of the side effects under control - - especially regarding osteopenia and bone issues. We need more / better LONG term protection from these medications considering the side effects we have to endure. Too many of us here are dx in our 40's - 50's and certainly need extended protection.
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For reasons that are unknown to science, sometimes when you stop taking a medication, then resume taking it after a break, the therapeutic effect can change. For better or worse. So can the side effect profile. Additionally, the risk associated with Tamoxifen in some cases is absolute (like the risk, say, of health problems and smoking cessation). Some SEs for some people are irreversible - and this is true for other drugs too. Again, the reason for this is not understood, but it is a problem many people with chronic conditions face.
This answer truly lies in getting to understand why and how Tamoxifen may work, or not work. We don't even know if it harms us from the purely bc perspective. That is, we assume that if we don't recur, the TAM must have helped, and that if we do recur, then the TAM was ineffective. Whet if, in some people, the TAM hastened crecurrence? That is known to happen with chemotherapy. We would need to find out if that happens - it may provide a clue as to the biological underpi9nnings of good and bad environments for such therapies.
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I like your train of thought Beesie. I'm going to ask my M.O. about that.
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Hi everyone... hi bessie, i am liking the way u think.. just wanna share
When I brought up this report on tamoxifen for ten years rather than five to my mo, she said that she would not keep me on tamoxifen for only five years. She stated that study was likely funded by AstraZeneca, the makers of tamoxifen and also after five years would increase risk of uterine cancer. She was adamant, however, on keeping me on hormonal therapy for up to 15 years. I am 31 and she mentioned pushing me into menopause after the five year tamoxifen period ( and hopefully after kids, at least two years on tamoxifen,kids, then another 3 years).. Then chenically induced or surgery induced menopause, so I can take the ai's. they say the post menopausal ai's are great. I am not keen about going into menopause at 36 or 37, but I am keen on not letting this bc come back, so I am ok with hormonal therapy for 20 years haha. Thanks for listening.. Would love some feedback...
Hey who knows what other studies will come up in the next few years... I didn't even finish chemo yetDx 10/8/2012, IDC, 2cm, Stage IIb, Grade 3, ER+/PR+, HER2- -
So...after not realizing that there was an ongoing discussion about this..I posted a link elsewhere earlier today about this...- and reading, now, the thread responses that say that ILC doesn't respond very well to tamoxifen -and I have or had ILC...why am I on tamoxifen at all? My MO was adamant that I take it. No problems so far-and she was quite excited About the ten year findings, and then so was I. I trust my MO but reading about ILC (this is the first time I heard about this issue) I'm pretty disappointed. How does anyone recover from ILC if chemo doesn't work so well on it and now tamoxifen? Feel pretty down about all this right now.
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Okay. I finally got the study and have read it several times. From the Discussion section:
"Previous trials have shown that, for women with ER-Positive early breast cancer, 5 years of adjuvant tamoxifen substantially reduces recurrence rates throughout the first 10 years after diagnosis and substantially reduces breast cancer mortality throughout the first 15 years. Thus, the effects of 5 years of treatment with tamoxifen on annual rates of mortality persist for at least a decade after treatment ends. Because of this carryover benefit after only 5 years of tamoxifen, it was already recognized when ATLAS began that there could well be little additional benefit during the first few years of additional treatment, even if worthwhile benefit would emerge later. WITH AN AVERAGE OF 7.6 WOMAN-YEARS OF FURTHER FOLLOW-UP AFTER ENTRY AT 5 YEARS, THE FINDINGS THUS FAR AVAILABLE CONFORM WITH THESE EXPECTATIONS. ATLAS HAS NOW SHOWN THAT COMPARED WITH STOPPING AFTER ONLY 5 YEARS OF TAMOXIFEN, CONTINUING FOR ANOTHER 5 YEARS (TO 10 YEARS) PROVIDES FURTHER PROTECTION AGAINST RECURRENCE AND BREAST CANCER MORTALITY, PARTICULARLY AFTER REACHING 10 YEARS."
Figure 3 contains a graph showing treatment allocation. It shows that at the 7th year mark of taking Tamoxifen, the number of recurrences begins to rise for those NOT having taken tamoxifen for two years. That number continues to increase consistantly out to the 15 year mark. So while the difference was small at first, the population that continued on the Tamoxifen began reaping rewards at the 7th year that continued into the 15th year.
So, regarding Beesie's hypothesis that taking tamoxifen for 5 years, followed by a break and then another 5 years, pushing out the potential carryover effect, doesn't seem to appear to be a good idea, because the benefit gained continuing on the tamoxifen during the uninterrupted second five years begins at the 7th year and continues, until it becomes a "remarkable" difference after the 14th year. Earlier data suggested that between the 5th and 10th years, there was no difference. But Atlas proves that while small, the difference does in fact occur and continues without interruption. So, if one chose to not continue after 5 years, I THINK they can never recoup that difference.
One thing that disappointed me about the study was that the patients were referred to as "early stage" but they weren't broken down by the grade. The good news was that we know their ages, nodal status, tumor diameter, menopausal status, what kind of surgery they received and whether or not they had a hysterectomy. The majority of the women chosen for the trial were POSTmenopausal. I guess the reason for that is because tamoxifen was in use longer at the time.
So, what did I learn from reading the study? While the risk of recurrence was LOWER during the second 5 years (meaning...you got the most bang for the buck during the first five years when you were more likely to recur), the "main effects on recurrence and particularly, on breast cancer mortality became apparent only during the second decade after diagnosis." Meaning...whether due to the carryover of the first five years or continuation of the second uninterrupted 5 years of tamoxifen, you reduced your risk by taking the tamoxifen, even though through the 7th year of taking the tamoxifen, the relative risk of recurrence vs. the benefit of therapy was small. HOWEVER, as you moved away from the 7th year of uninterrupted use of Tamoxifen, the benefits begin to widen over those who declined taking it past 5 years. A 1% difference at 7 years becomes at 15 years, a absolute difference between the two groups at over 3%....
So, what do I think? I think if we had more information, such as grade or genomic information about these subjects tumors it would have helped clinicians more in guiding treatment. Unfortunately, back when this study started, there was no Mammaprint or Oncotype DX test. So, a patient must decide based on the aggressiveness of their tumor if the absolute risk reduction benefit of 3% is worth the risk. Keeping this study in mind, we don't know if switching to an AI after a few years on Tamoxifen or even just 5 years of an AI for those women who are POST menopausal would cancel out the benefit of 10 years of Tamoxifen....
I welcome the number of other endocrine studies that are currently being done to find the answers to those questions.
In the meantime, I'm glad patients now have more options.
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So what about five years of tamoxifen and then when menopausal do u switch to ai? Or stay on tamoxifen? I thought they said ai's are more effective then tamoxifen when post menopausal... I was going I do tamoxifen for five then make myself menopausal ( medically or surgically) to switch to ai. However, in five years I will be 36 and if I can continue in tam for 10 years I would do that.. Would rather not be menopausal before 40.. Especially since I haven't had kids yet
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http://www.cancer.gov/ncicancerbulletin/121112/page2
"Even for postmenopausal women who can tolerate aromatase inhibitors, the ATLAS findings raise other questions, observed Dr. Trevor Powles of the Cancer Center London in an accompanying editorial
in The Lancet."No data are available to suggest that [the aromatase inhibitor] letrozole for 5 years is better for long-term benefit than 10 years of tamoxifen, which has a proven effect in terms of long-term risk reduction of relapse and mortality," Dr. Powles wrote."
-----------------------------------------------------------------------------------------------------------No answer to your question can't be answered yet....Check out the NCCN 2012 breast cancer treatment guidelines...professional version pages 93-98....they discuss the various endocrine studies underway...
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VR and I have been exchanging PMs about this all day. I still think my theory holds.
I've put together this example using some of the data from the study that VR has shared with me:
. Scenario A Scenario B Scenario C
. 5 Yrs Tamox. 10 Yrs Tamox. 5 Yrs Tamox/off 4 Yrs/5 Yrs. Tamox.
Recurrence Rates:
Years 1 - 4 12% 12% 12%
Years 5 - 7 11% 11% 11%
Years 8 - 9 7% 6% 7%
Years 10 -14 7.1% 4.4% 4.4%
Subttl Yrs.5-14 25.1% 21.4% 22.4%
Years 14 - 19 2.0% 2.0% 1.2%
Total 39.1% 35.4% 35.6%
Risk of Side Effects: Lowest Highest Middle
The first two columns represent what we pretty much know from the studies. The third column is my theory.
I made up Yrs 1-4 in all cases. Since the patients are all taking Tamoxifen in each of the three scenarios, the recurrence rate, whatever it really is, would be the same. So it's a wash across all the scenarios.
Yrs.5 - 14 uses data from the study, along with a few assumptions.
- The study tells us that the 5 year group had a recurrence rate of 25.1% during years 5 - 14, whereas the 10 year group had a recurrence rate of 21.4% over these years.
- We know from the study that the two groups had little to no difference in recurrence rates for the first 7 years. So this means that that Yrs.5 - 7 should reflect the same recurrence rate for both groups.
- The study also indicated that most recurrences happen around year 5, so I estimated the recurrence rate for Yrs.5 - 7 to be fairly high (relative to the Yrs.5 - 14 totals).
- The study says that in Yr.8 we start to see a small benefit for those who have continued to take Tamox vs. the group that stopped Tamox after 5 years. I've tried to reflect a small benefit.
- And the study says that from Yr.10 onwards we see a 'remarkable' benefit for the 10 year Tamoxifen group, and I've tried to reflect that.
- The numbers are all guesses (except for the Yrs.5-14 totals) but they are consistent with everything the study says, to the best of my knowledge.
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As for the 3rd scenario, my theoretical one, the recurrence rates for Yrs.1-9 will be the same as the recurrence rates for the 5 years of Tamoxifen group since I'm suggesting that women take Tamox for 5 years and then go off it for 4 years. I'm suggesting taking a break from Tamox for 4 years rather than 5 based on what the study says about the "remarkable" benefit of 10 years of Tamox starting in year 10. I take that to mean that the carryover benefit of 5 years of Tamox has pretty much worn out by year 10, which is why you start to see a real difference in recurrence rates between the 5 year and 10 year groups. I figure it makes sense to get back onto Tamox. before you see this significant difference, hence Yr.9. (Or maybe it should be Yr.8 - it's the principal I'm after, not the specifics). For Yrs.10-14, I'm assuming that the benefit of restarting Tamoxifen is the same as the carryover benefit that the 10 yr. Tamox group get. I think that's reasonable - after all, one would expect that you'd get the greatest benefit from Tamox during the years when you are actually taking it. So the recurrence rate during these years should be at least as good as the recurrence rate of the 10 year group, who are already into their 'carryover benefit' years. The biggest difference in my scenario is in Yrs.14-19. By then, the carryover benefit for the 10 year group would be done, but in my scenario, these would be the years where there would be a carryover benefit for the women who went back to taking Tamox after a few year break. I guessed at the recurrence rates during these years - obviously this many years out, the recurrence rate will be very low. But I show the carryover benefit that only the 3rd group will get.
The other benefit of my scenerio is that women would be extending the period of time during which they get protection against a new primary. To me the issue is not just recurrence risk, but overall protection against BC. New primary risk increases as we age, so by extending the number of years in which you get benefit from Tamoxifen (or an AI, if you substitute an AI once you reach menopause), whether it's direct benefit (while you are taking it) or residual benefit, has to be a good thing. And that new primary risk reduction benefit isn't built in here.
Does that make sense? Obviously I'm just playing around here, and I am working somewhat at a disadvantage, since I don't have the full study and I'm relying on the bits of data that I have, plus my knowledge of previous studies. I realize that there are reasons why this might not work, but I think it also could work. It will be interesting to see if anyone in the medical community comes up with this idea and tries to find a way to verify it (other than another 15+ year clinical trial). Thoughts?
Edited to make a couple of points clearer and to correct typos.
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Beesie - I haven't told you this in a while but....you're pretty amazing....
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I guess I feel a little better because regardless of its tamoxifen or an AI, my oncologist plans on keeping me on meds for 15 years.. Hopefully the extended period of time will reap extended benefits. Thanks ladies for intelligent discussions.
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Ok, excuse my ignorance.
I am seriously contemplating Lupron or ooph. I am 45, will I change to Al's after artificial menopause and do the Al's have the same effect as 10 year Tamox or hasn't that been researched? Thanks x
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Having done some of the mental gymanstics, it seems that the most benefit is the 5years...and we can try to extrapolate what may or may not happen but because many women will never have a recurrence, even if they do nothing at all, the "benefit" cannot be calculated accurately. What if the 10 year gals would have had equal outcomes with 5 years or 2 years, which many women do because they quit part way from the side effects.
Now, can we calculate the side effects (biopsies, triple negative possibility, uterine cancer, clots, etc.)...if we add that in, do we gain anything? No way to know since some women will never have side effects that amount to much while others do.
I'm sticking to my story...crap shoot.
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kyliet....there hasn't been a study yet comparing 5 years of an AI vs. 10 years of Tamoxifen yet. However, to answer your question regarding how effective is an AI along with ovarian suppression for premenopausal women, you need to look at the TEXT trial:
It's in the third phase of trials and is closed to new patients....so the answer to that question should be forthcoming in the next few years..
And just to confuse you even more...there's the SOFT trial comparing Tamoxifen or an AI and ovarian suppression....
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