How Many are doing 10 years on Aromatase Inhibitors
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Lucky - did your MO cite any studies when he said there's evidence pointing to 10 years? As far as I know, the only 10 year studies that have been published are for Tamox. Ten year studies for AIs are being done, but there have been no interim results published, at least as of July when I saw my MO. I'm curious if something has been released since that time.
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My MO's NP has been hinting that the studies are pointing to 10 years. This time I said will discuss this when the I've reached the 5 year point. I have 1.5 years to go before I reach 5 years.
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This is from the breaking research section on the BCO homepage:
Genomic Test Helps Estimate Risk of Recurrence More Than 5 Years After Diagnosis for Some Breast Cancers
Published on October 29, 2014 at 8:46 AM
A genomic test (also called a genomic assay) analyzes the activity of a group of genes linked to the risk of a particular disease. The tests are done on blood or tissue samples. For example, a genomic test may help figure out if a woman diagnosed with early-stage, hormone-receptor-positive breast cancer has a high, medium, or low risk of recurrence (the cancer coming back), as well as if she’s likely to benefit from chemotherapy to reduce that risk.
A study has found that the Prosigna Breast Cancer Prognostic Gene Signature Assay (formerly called the PAM50 test) can help predict the risk of distant recurrence (the cancer coming back in a part of the body away from the breast) for early-stage, hormone-receptor-positive breast cancer after 5 years of hormonal therapy treatment in postmenopausal women.
The study was published online on Oct. 20, 2014 by the Journal of Clinical Oncology. Read the abstract of “Prediction of Late Distant Recurrence After 5 Years of Endocrine Treatment: A Combined Analysis of Patients From the Austrian Breast and Colorectal Cancer Study Group 8 and Arimidex, Tamoxifen Alone or in Combination Randomized Trials Using the PAM50 Risk of Recurrence Score.”
The Prosigna test was approved by the U.S. Food and Drug Administration in September 2013. The test received the CE mark, which is Europe’s approval, in 2012.
The test looks at the activity of 58 genes (called the PAM50 gene signature) in early-stage, hormone-receptor-positive breast cancer. Based on these activity levels, Prosigna test results are reported as a risk of recurrence (ROR) score in two ways:
- node-negative cancers are classified as low (0-40), intermediate (41-60), or high (61-100) risk
- node-positive cancers are classified as low (0-40) or high (41-100) risk
In this study, the researchers wanted to see if the Prosigna test could accurately estimate the risk of distant recurrence for postmenopausal women diagnosed with early-stage, hormone-receptor-positive disease after they’d received 5 years of hormonal therapy. Knowing this could help doctors decide which women should stay on hormonal therapy for 10 years rather than stopping after 5 years.
The women in this study were all part of two studies that had already been done, so the researchers knew how many women had had a distant recurrence -- the point of the study was to see how accurate the Prosigna test’s predictions were.
The researchers looked at the records of more than 2,100 women in two studies:
- Austrian Breast and Colorectal Cancer Study Group 8 (ABCSG 8)
- Arimidex, Tamoxifen Alone or in Combination translational research cohort (TransATAC)
None of the women had had a recurrence in the 5 years after diagnosis while they were being treated with hormonal therapy. Also, none of the women had been treated with chemotherapy. The women had been followed for about 10 years after being diagnosed.
The ABCSG 8 study compared 5 years of tamoxifen to 2 years of tamoxifen followed by 3 years of Arimidex (chemical name: anastrozole) to treat early-stage, hormone-receptor positive disease in postmenopausal women.
The ATAC study compared 5 years of tamoxifen to 5 years of Arimidex to treat early-stage, hormone-receptor-positive disease in postmenopausal women. The TransATAC cohort was a subset of women from the ATAC study from whom breast cancer tissue samples were collected and stored.
The researchers tested cancer tissue samples from the women with the Prosigna test and recorded the risk of recurrence score for each breast cancer. They also looked at the clinical treatment score for each cancer. The clinical treatment score is based on:
- cancer size
- cancer grade
- women’s age
- how many, if any, lymph nodes are involved
- cancer treatment
The researchers found that the clinical treatment score was the best predictor of distant recurrence up to 5 years after diagnosis. The Prosigna risk of recurrence score also helped estimate the risk of distance recurrence in the 5 years after diagnosis, but wasn’t as accurate as the clinical treatment score.
From 5 to 10 years after diagnosis:
- the clinical treatment score offered the most accurate estimate of distant recurrence overall and for women who had positive lymph nodes
- the Prosigna risk of recurrence score offered the most accurate estimate of distant recurrence for women with negative lymph nodes and women with negative lymph nodes and HER2-negative breast cancer
Knowing whether a woman has a high or low risk of breast cancer coming back in a part of the body away from the breast more than 5 years after diagnosis can help doctors decide how long hormonal therapy medicine should be taken. Research has shown that taking tamoxifen for 10 years instead of 5 years can better lower the risk of recurrence and improve overall survival for some women. If doctors knew that a woman had a low risk of distant recurrence, they could spare her the extra 5 years of hormonal therapy treatment. At the same time, women at high risk would benefit from the extra 5 years of treatment.
When making treatment decisions, you and your doctor will consider a number of factors, including:
- your age
- your menopausal status
- the size of the cancer
- hormone receptor status
- cancer grade
- the results of any genomic tests, if you’ve had them
Armed with the best information possible, you and your doctor can decide on a treatment plan that makes the most sense for your unique situation
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I love this discussion. I received a PM from another member who states that MD Anderson is now giving the 10 year option to those who are ER+. So that's Vanderbilt and MD Anderson. Last year this information was presented at the European Breast Cancer Symposium and I discussed it with my onc. So glad that we are sharing great info.
Good luck to all and keep sharing.
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GrammyR, thanks so much for the post. Much love to you.
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This is an excellent discussion. When I was going through the high risk screening the genetic counselor was pushing Tamoxifen, and basically said if you take it five years, you're good for 15 - 20 years. From reading here and elsewhere it appears that is not really accurate. Any thought about "how long" it is good for? Is the thought that once you're off, you're off and those little rascals can start doing their thing again, and dependent on the agressiveness you may or may not find out about it in your lifetime? I think there is a question in there somewhere.
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So I have been off femara since June-- when I emailed my onc at Dana Farber about the new research her response was that the studies have been about tamoxifen- and that she had not seen any research that was convincing her to keep me on femara for more than the 5 years. But she did say that if there was new research on the AI's that was convincing, we could talk about going back on…. although that is the absolutely last thing I want…. but I agreed. I have great faith in my onc, her research and her understanding of my situation--so I am ok with it--- and I really would have to be convinced to go back on the drugs….but would for sure follow her advice..
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I was glad to be on it for 5 years, but it would take some pretty strong evidence for me to go back on (as in, I don't think I would do it in my particular situation). I believe there is a protective effect that lingers (I think at least for several years) after you are done.
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farmerlucy,
Studies have shown that 10 years is better for women.
Here's a link to the ASCO website that explains it better than I can
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farmerlucy using Tamoxifen as a preventative (before any breast cancer diagnosis) is probably different than being prescribed the drug once you've been diagnosed. They may have given you the correct numbers back then.
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Ruth
I agree with you-- it would take some real convincing for me to go back on--- and all of the studies have been about tamoxifen, not the AI's..... I think after 5 years, everyone's body needs a break..... I am still feeling some of the effects even after being off it for several months---- I suspect it will take a while....
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All the studies, so far, are only for Tamoxifin. Maybe the reason 10 years is better for people taking it is that most of them are pre-menopausal; so if they go off after 5 years, they will start to have lots of estrogen coursing back through their system, which will, indeed, increase the chance of recurrence. We who are post-menopausal are already on the downhill estrogen slide when we start out......and at 5 years have even less estrogen being produced than when we started because we are 5 years older......just my (unscientific) thought.
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MD Anderson and Vanderbilt support giving women who might benefit the option of continuing the AIs.
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Absolutely, but right now it is a 'might'....so you really have to weigh your own personal situation to see if that 'might' outweighs the known possible SEs for extended use......in many cases that answer will be yes (if I were Stage III, had multiple nodes etc. I would definitely want to stay on), but for others the answer will still be no.
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The fact that I was 100% estrogen and 100% progesterone positive was the reason my onc suggested that I continue. I expect that your own percentage of hormone + receptors should be taken into consideration.
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pip57 my MO said it didn't matter. It doesn't work that way. You can't be a little bit pregnant. I was 30%ER and 5%PR.
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I think that all should be given the option of taking the AIs for 10 years.
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I had asked my MO if I needed to continue after 5 years but she said no, then again, I am quite sure if I asked to stay on for 10 years, she would give me the script. I remember asking at the start if I needed chemo, she said no but if I wanted it, she would give it......and then described the lovely side effects of chemo
I really can not think that anyone would be denied 10 years
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Proud, I think in the case of very early BC such as DCIS, going longer than 5 years, even if your Onc said yes, would be denied by your insurance company as far as paying for the AI. You would likely have to pay out of pocket if you wanted to continue after 5 years (standard of care) for an early BC, particularly with an AI which is still in clinical trials for DCIS and prescribed off-label for us DCIS ladies. Only tamoxifen is approved for DCIS at this time although trials for AI's are wrapping up and are looking effective so it is only a matter of time for this to be added to the tx options for us DCIS people. But, it is only for 5 years that it is being studied. Doubtful insurance would pay beyond this...just a hunch.
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april485 You never know. If the MO is willing to fight it it's possible. My insurance denied my Prolia because standard care is one of the pills (like Fosamax), then Reclast and if that doesn't work the Prolia. Fosamax gave me gerd (no surprise there but had to try) and I have LE in one arm, other at risk. I won't let them infuse Reclast in my arm and they won't do it in my foot. Prolia is a injection (got mine in the belly). My MD did have to have a phone conference with them though even after she sent a letter.
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I am doing 10 years on Femara, and I am being treated at Johns Hopkins. My oncologist did not recommend 10 years as he said the studies are still ongoing; however, he told me it is a likely assumption that 10 years is better than 5. Because I don't have any major side effects and seem to tolerate pretty well, he is letting me stay on for 10 years. I think I am his guinee pig. He also told me that he would definately not approve me to take longer than 10, and would not have allowed me to stay on past five years if I was node negative. I was diagnosed with stage II, 1 pos node, in 2005. My 10 years will be up in 2016. I have no heart issues, some joint pain (mostly my neck), and have kept my osteopenia in check with Fosamax plus D. Although my oncologist wants me to go off Fosamax because I have been on it 7 years. I have an appointment with a specialist to look at other options to keep me from moving into the osteoporosis range. I am glad that I am staying on and AI for 10 years. I would have been upset if I stayed on only 5 and then the study results showed 10 years was better than 5 for aromatase inhibitors.
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April, good point on 10 years not getting approved by insurance for us DCIS folks, never thought on that as MO really is not suggesting it for me. And dang if I want to take it more! and bones are good now so not looking to play with that either. I want to put thins behind me bit and move on with life
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lizM123, Welcome to BCO. Thanks for sharing your story. Please stay connected. This is a wonderful community of people with shared experiences with Breast Cancer. We look forward to seeing you around the boards. The Mods
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I have done 10 years on Letrozole and my Dr says I should stop now. But I don't think anyone really knows what is the right length of time to be on AIs. Side effects are there (Not too bad) but what if the alternative is a recurrence?
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lizM123 that's great. My MO has hinted at 10 years because of the size of my tumor (no nodes). She says I'm at high risk for recurrence. But now I do have osteoporosis in my spine, rest is osteopenic but has been stable since 5 months post chemo. I'm only 3.5 years on AI.
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When I was approaching 5 years on Letrozole, I asked my onc if I could continue for another 5 years. She refused, saying there was no evidence of any benefit beyond that time. Fast forward a few months and she agreed, saying that the evidence was now pointing to 10 years instead of 5.
I am in the UK, being treated at the Christie, which is one of the main Cancer Centres in the UK, and my onc (who is heavily involved in research) is absolutely wonderful.
So here I am just finishing 6 years, and will continue as long as my bone density holds up. OK I have a few side effects but they are manageable.
I suppose the problem is that we'll never know if we needed the extra years...........we could be fine without, but for me it's a security blanket. A friend of mine was dx a couple of years before me, had 5 years of Tamoxifen, has just been dx with bone mets & is now on Letrozole.......it's powerful stuff!
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Great discussion. Thanks for everyone sharing.
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Roshan - Letrozole is the generic form of Femara. Letrozole was not available until the patent on Femara ran out in June 2011. So letrozole has not been available for 10 years.
I was on Femara from Feb 2010 to Aug 2011 (I get 3 months at a time) as my Dr wanted me on it and was only available then and have been on generic letrozole since.I used the last of my Femara.
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Kicks I think Letrozole would be the generic, chemical or drug name for Femara. I was prescribed anastrozole in 2010 when Arimidex was still under patent in Canada and so got the brand name drug Arimidex for the first 2 1/2 years then was switched to Taro-anastrozole when Arimidex went off patent. I noticed no difference whatsoever between the two pills, only a difference in packaging.
(Arimidex put the days of the week on the silver foil on the back of the pill sheet which made it easy to check whether you missed a pill or not. I put a little red dot on the Taro pill sheet to represent Mon so was able to keep track that way.)
In keeping with the topic I stopped taking anastrozole this summer a little over 4 years out. I am 70 and I think that age makes a big difference in considering risk of cancer recurrence against living with the consequences of side effects. (Having to adjust to wearing contact lenses with dry eyes was just the last straw.)
Kathy
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Just fyi, I tried the generic Arimidex and did not do as well as the non-generic. if you doc writes the RX for the real Arimidex, insurance will pay but you have to be assertive.
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