How Many are doing 10 years on Aromatase Inhibitors
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jojo9999, I had not heard of this study. Thanks for sharing.
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At my last appointment with my MO even though my BCI results indicate low benefit he indicated he would like me to stay on Femara if I can handle the SE. I decided to take a break prior to surgery on 5/17, due to a new trigger with my left thumb. I am now ready to re-start, after 5 weeks off, but have switched manufacturers from Teva to Roxane. Switching makers and drug types has worked for me in the past, and allowed me to complete the five years with minimal breaks. I am fortunate that my local pharmacy will let me order whatever manufacturer I like as long as it is a brand that is carried by them, and they order it from their warehouse for me. I have taken a break of at least three weeks every time I have switched manufacturers, or switched from Femara to Arimidex and back again. This is the longest break I have taken and I am really surprised at how many of the SE have disappeared, and at how good I feel. I am reluctant to go back on, and have very mixed feelings about resuming Femara, but even if I receive minimal benefit I still want it - so I will try. Since I have completed five years, and have a BCI result indicating low benefit, if I can't handle the SE going forward I will probably stop.
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I found an interesting recap of the study -
What Will You Tell Breast Cancer Patients About MA-17R?
5 doctors respond. from a Columbia U doc:
"The bulk of the [disease-free survival] benefit in the study was from a reduction of in-breast recurrences.... For women with minimal side effects, prevention of an in-breast recurrence or new primary may be meaningful, as it results in decreased need for surgery or other adjuvant treatments.
"The reality is that the patients in MA.17R agreed to be on a study of taking the medication for an additional 5 years after being on it for 5. Presumably, if they had severe side effects, they may not have been willing to be randomized on this study. Therefore, these results may not be representative of the whole population of women on aromatase inhibitors."
full discussion is here
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I have a related question--anyone know what the protocol is for bone density tests for those of us on AIs? I don't have osteoporosis as far as I know, and my baseline test was done 1/13 and was excellent. Since I'm high risk (told over and over by my MO, like I don't know that already) and have been given the news that I will probably be on AIs longer than even 10 years, provided I make it that long, when should I get DEXA scans? Every three years, 5, or ???
Claire
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I get my DEXA scan every two years because I am on Femara. My insurance covers it; however, my DEXA results have shown osteopenia since 2007 so that may be why I am allowed to get the scan every two years.
Jojo - I read about the SOLE clinical trial and took it upon myself to take a 3 month break when I was in my 7th year. I took my AI faithfully for 5 years so I figured it wouldn't hurt to take break for 3 months after I read about the SOLE trial. At my next annual appointment I told my MO about my 3 month break and he was not happy. He told me there were no results from the trial and not to take anymore breaks until I complete my 10 years, which is next month.
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claireinaz - I get a DEXA every two years, and had them prior to diagnosis because I had a total hyst/ooph at 45, nine years prior to breast cancer. I had one done the same day as the mammo/Us that led to diagnosis, so I had a good baseline prior to chemo and starting Femara. Six months after starting the AI I had significant demonstrated loss after remaining osteopenic, but very stable, for the preceeding nine years. Prolia has reversed the loss back to normal measurements, not even osteopenic.
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LizM - Interesting...Did you enjoy the 3 month break
? Sorry your doc poo-hooed it..... I plan on asking my endocrinologist if he can try to get some inside scoop on the study. Given that the trial began in 2007, some preliminary results ought to be available soon?? What if intermittent dosing is better? I really want to know now.0 -
I would be interested in the UK study that is looking at intermittent AI treatment.
Also, in the journal study posted here, there was no mention of those who had had double mastectomies. What is the rate of benefit for those of us who no longer have a contralateral breast, or our cancer breast for that matter (understanding that recurrence can occur of course).
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claireinaz,
I've gotten a DEXA each two years since peri menopausal in2003. The women in my family are predisposed to osteoporosis. This has continued through BC treatment. I will probably have the next one after only one year. My last showed a decrease and my MO and I haveto decide whether or not to continue AIs beyond 5 years.
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Claire, I've had DEXAs every other year for 6 years - long preceding dx - due to fracture history and osteopenia. As in SK's case, my last one was the day of the mammogram that led to dx and I'm due for another this August. I'm interested to see how nearly 2 years of Femara will have affected the reading. I've had one recent infusion of Zometa but suspect it will be too early for results to show on the DEXA.
I think every 2 years is pretty standard but there are obviously situations in which more frequent monitoring is optimal. It sounds to me as though you're overdue, however.
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My oncologist has been ordering yearly a Dexa scan ever since I was dx with osteopenia. I've had a total of 8 Zometa infusions in the past and recently I switched to Prolia. I'm hoping to see better benefit from a different drug.
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Just wanted to point out that if at all possible it is important to have your DEXA scans done on the same machine each time Changes in the way machines are calibrated, or machines of differing types, can account for differences in readings.
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claireinaz my oncologist did a dexta test every year till I finally did get osteoporosis. I had osteopenia even before chemo/chemopause. Once she started to treat (with Prolia in my case) I was tested every other year.
10 Years on AIs. I was wondering too since I had the BMX I know my risk is much lower (but not).
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I am on the every two year plan for DEXA's also. I think that is my insurance (medicare) protocol and I am fine with that. Just have my fingers crossed that my next one in March continues to show improvement. If so, my MO says I can stop the Zometa. If not, perhaps I will talk to her about switching to Prolia. Mostly, I got started on Zometa with my MO back in IL who believed that Zometa could possibly have an extra benefit since it is also used to treat bone mets. And my MO here in AZ liked the idea as well.
I have had to take a couple little breaks from Letrozole, as well. Mostly, just to see what side effects it was causing. I am so amazed at how fast the stiffness, muscle pain and fatigue goes away when I stop it. Gosh, 24-48 hours and I am a completely different person with so much energy! Crazy!
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Joan Prolia has those same benefits as Zometa. So far Prolia hasn't been a miracle drug for me. Will be talking with rheumatologist on Thursday.
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JoJo, I used to be able to access Medscape but it appears to me that they've redone their web site and put up a paywall that blocks access to that article.
Would you be kind enough to briefly summarize the gist of their comments.
Thanks, Kathy
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What Will You Tell Breast Cancer Patients About MA-17R?
Nick MulcahyJune 06, 2016
CHICAGO — When breast cancer clinicians return to their jobs from this year's American Society of Clinical Oncology (ASCO) 2016 Annual Meeting, they will likely face inquiries from postmenopausal patients who are or have been receiving adjuvant antiestrogen therapy about the MA.17R study that was featured at the plenary session.
The trial results were published in the New England Journal of Medicine and have been widely covered in mainstream media, such as the New York Times and the BBC.
The 1918-patient trial demonstrated that extending treatment with an aromatase inhibitor (letrozole [Femara, Novartis Pharmaceuticals Company], 2.5 mg daily) to 10 years after an initial 5 years of therapy with an aromatase inhibitor/tamoxifen (multiple brands) improves disease-free survival (but not overall survival).
Specifically, the disease-free survival rate for the additional 5 years was 95% for patients treated with letrozole and 91% for patients receiving placebo — an absolute improvement of 4% for patients on treatment.
This translated into a 34% reduction in the relative risk for disease recurrence/occurrence of a contralateral breast cancer (hazard ratio, 66%; P = .01) for the treatment group.
However, the improvement with the extra 5 years of treatment came at a cost. Most notably, there were more bone fractures in the letrozole group than in the placebo group (14% vs 9%; P = .001) and more cases of new-onset osteoporosis (11% vs 6%; P < .001).
"Bone health remains important to risk/benefit consideration," said the study's lead author, Paul Goss, MD, PhD, of the Massachusetts General Hospital Cancer Center, in Boston, at a meeting press conference.
Median follow-up in the study was 6.3 years; the median age of the patients was 65 years.
At a postplenary discussion of the results, Dr Goss did not advocate for the use of letrozole for an additional 5 years in postmenopausal women with hormone-positive primary tumors, saying he wanted to leave that to guideline committees and others. Clinicians can do "what they want to" with the data, he said.
To get a sense of what clinicians will tell patients about the study ― and whether or not they will advocate for the extra 5 years of treatment ― Medscape Medical News interviewed a number of oncologists attending the meeting.
Here is what five clinicians will be telling their patients about MA.17R and about taking an aromatase inhibitor for potentially 10 years.
Patricia Ganz, MD, University of California, Los Angeles. "This is a question that comes up frequently in practice. There are many women who are doing well on their AI therapy and have anxiety about discontinuing their medication, and [they wonder] what is going to prevent them from having a recurrence.
This is a question that comes up frequently in practice. Dr Patricia Ganz
"I will pull up the New England Journal article and show them that roughly 1000 women received the drug vs 1000 who received placebo, and if we compare the outcomes, we see 31 fewer recurrences [of any type] in those who took the drug [67 vs 98]. The majority of the [recurrence] benefit was in contralateral breast cancers [13 vs 31]. In terms of distant recurrence, there was a difference of only 11 cases [42 vs 53].
"I will also talk about the increased risk of fractures that occurred [in the active-treatment group] and subtle differences in quality of life. If they discontinue their aromatase inhibitor, they might have a return of some of the benefits of having estrogen in their body — some may appreciate that, some may not.
"I use this high-level evidence [from the study] to have discussion about their values and preferences. They may decide to stick it out longer to see how they do. Two or three years later, they may also decide to quit. And I can support that decision, because the number of events prevented by taking the medication for another 5 years is rather modest. At the same time, everyone taking the drug has the potential to have fractures and other symptoms.
"In terms of additional insights, our hope for this study is [that further analysis may answer the question]: Is there a high-risk profile? The absolute benefit of treatment may be greater for women with large tumors or those with lots of positive nodes. If we had that information, we could tailor who we recommend to have the extra treatment."
Stephen Vogl, MD, private practice, New York City. "I am going to tell my patients: the extra years of treatment didn't do much. They had a 30% reduction in distant metastases, but it is not clear if they are prevented or just delayed; it is not clear how lethal they are. The virulence of breast cancer relates to the time to recurrence [with earlier being more virulent]. These are very late recurrences, and nine of the extra 11 distance metastases were in bone, which are really not virulent.
No, don't bother. Dr Stephen Vogl
"I have patients who have been waiting for [the results]. I have been telling them: 'I am going to come back and tell you whether you should take some more of it or not.' Some of them have been off for a few years. I'm going to tell them, 'No, don't bother.' "
Harold Burstein, MD, Dana-Farber Cancer Institute, Boston. We have known from other trials that pushing the treatment envelope out to 10 years is a good idea. Ten years of tamoxifen is a little better than 5 years of tamoxifen; 5 years of tamoxifen and then 5 years of an aromatase inhibitor is a little better than 5 years of tamoxifen alone [which was the earlier study, MA- 17].
"The topline result is, yes, longer durations do reduce the risk of recurrence and do help prevent second cancers.
"But I think, for the clinical discussion, it comes down to two things: The first is, what is the patient's risk of recurrence, based on what we already know about the stage of the cancer? And number two, how well has that patient tolerated treatment so far?
For the clinical discussion, it comes down to two things. Dr Harold Burstein
"For women who have had high-risk breast cancer ― typically, stage 2 or 3 cancers, node-positive breast cancers ― their risk moving on in years 5 to 10, 10 to 15 is still reasonably high. And for those women, there is going to be a larger benefit to continuing treatment and pushing the therapy out to a total of 10 years. But in contrast, for the women who had smaller, node-negative cancers, there is probably going to be a lot less in the way of benefit ― their residual risk is a lot smaller.
"The second thing to discuss is how the patient is doing. Women will tell us how they are feeling on these AIs. Some women have symptoms, but it does not get in the way of their lifestyle, or they have very few symptoms at all. Those women will be willing to take longer durations of treatment even for a small benefit.
"Other patients who have a lot of difficulty taking the medications...stopping probably makes sense for them.
"But what I have found is that patients are really good at telling their doctor what the appropriate length of treatment is, because they intuitively understand how risky their cancer is at this juncture, and they understand how they have felt taking the medication."
Barry Kaplan, MD, PhD, Queens Medical Associates, Fresh Meadows, New York. "The benefits are small. There are no data showing improved survival. There are real side effects. It is an expensive treatment. Even though Dr Goss said it was a relatively cheap drug, if you take it for 10 years, it becomes not so cheap. I don't see the point of recommending or using it [for the extra 5 years]. I think the benefits are not proven if you are not getting a survival benefit. These patients have already survived for some time, so these are good patients with hormone-responsive breast cancer. I would not use this treatment after the first 5 years unless the patients really demand it."
Dawn Hershman, MD, Herbert Irving Comprehensive Cancer Center, Columbia University, New York City. "At the end of the day, there needs to be a discussion with each patient about the potential risks and benefits.
"I am more likely to encourage continuing treatment after the first 5 years for patients with high risk of recurrence, patients who still have both breasts and are at risk, and patients who have had minimal or no side effects on AIs.
"Also, for some women, especially those with few side effects, the medication can feel like a 'security blanket.' And discontinuing can cause stress and anxiety.
Discontinuing can cause stress and anxiety. Dr Dawn Hershman
"The bulk of the [disease-free survival] benefit in the study was from a reduction of in-breast recurrences.... For women with minimal side effects, prevention of an in-breast recurrence or new primary may be meaningful, as it results in decreased need for surgery or other adjuvant treatments.
"The reality is that the patients in MA.17R agreed to be on a study of taking the medication for an additional 5 years after being on it for 5. Presumably, if they had severe side effects, they may not have been willing to be randomized on this study. Therefore, these results may not be representative of the whole population of women on aromatase inhibitors.
"The discussions with patients will be more difficult when someone has had severe side effects and makes it through the first 5 years."
The trial was sponsored by the Canadian Cancer Trials Group. The authors have disclosed no relevant financial relationships.
N Engl J Med. Published online June 5, 2016. Full tex
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Thank for the full article jojo! Very interesting to see what other docs are saying.
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Thanks all for the quick replies to my question; I am not (as far as I know) osteopenic, nor does it run in my family at all. My lifestyle doesn't seem to make me at higher risk other than taking aromasin. So it seems every two years would be too much? I am not crazy about scans and the risks (I know, slight, but still) those scans carry as well.
So still can't determine what I should expect for a woman like me.
I appreciate the info (SpecialK) about getting scanned on the same machine every time. I remember I did not like the tech who did the latest one in 2013, but he'll probably be gone anyway.
I have a check up scheduled for June 23 so I guess I'll just ask my MO when I should expect the next one. I just checked the internet for my personal risk taking exemestane, and since I get adequate calcium, my Vit D is always at about 67 (both from sun and Vit D drops) and levels checked once a year, doesn't run in my family, I'm not petite, have a small frame or small bones, I don't smoke, and I get plenty of weight-bearing exercise, I figure I'm low risk for osteoporosis. Still will ask my MO. I wish she would track these things for me instead of me having to remind her or ask her about them.
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I took oral Fosamax plus D from 2007 until 2014. I read that taking it too long could cause hip fractures and questioned my PCP who sent me to an osteoporosis specialist. In addition to my DEXA, the specialist did additional blood-work and determined that while I haven't progressed from osteopenia to osteoporosis while on Femara, my numbers showed bone loss in the last year. She recommended I take reclast to last me until I go off the Femara at my 10 year mark, and then re-evaluate. I was never offered Zometa. I thought Zometa was for bone mets. Anyway, she did not recommend Prolia, and if I recall correctly she did not think it would be good for me as a cancer survivor, something to do with increasing blood flow or something like that. I should have asked for more details about Prolia but I was fine with taking Reclast. Now that I hear many of you mention taking Prolia, have any of you heard anything about Prolia not being good for cancer survivors?
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Reclast is Zometa. Usually Prolia is the last course they offer. Insurance doesn't like to pay for it. It's the most costly and they usually recommend when you fail the pills or reclast.
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Here is more information for Prolia.
http://www.breastcancer.org/research-news/bone-hea...0 -
CP, thanks for posting the latest research on Prolia - I missed that one. I went back and looked at the summary of my visit to my osteoporosis doc and she indicated she did not recommend Prolia due to lower than normal white blood counts, which would be an individual thing. My new normal, after chemo over ten years ago, is below the normal range. I didn't realize that Reclast is Zometa but at a much less dose. It's been a year since my last reclast infusion but I have been putting off asking for another one because I felt pretty awful after the last one. It only lasted a day or so but had a bad headache and body aches like the flu. I'm not due for my next DEXA until the fall and I go off Femara next month so I may just wait until after the DEXA to consider another infusion.
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LizM - I had those body aches and joint pain symptoms with my Zometa infusions. Prolia is shot in the arm and I had no issues afterwards. I much prefer it as easier for me.
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Thanks for posting that JoJo. It seems the docs interviewed have a balanced view of the results (unlike the headlines). I'm pleased that isn't a blanket recommendation.
I'm almost finished my 5 years and it has been very difficult to see it through. I'm certainly hoping for more than "subtle differences" in my quality of life once I'm off it.
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Dear Ched, Yes, indeed I do have Lymphedema! Mild, but annoying!! I am sorry yours is challenging! Sure hope it stays manageable for you!! Yikes, 15 years, I see my onc again in October! I will talk to her about it! I am just starting to lose weight, after being on Aromasin for over 10 years
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http://www.forbes.com/sites/elaineschattner/2016/0...
Report Touts Benefits Of Prolonged Medication After Breast Cancer. Is It Persuasive?
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Thanks CP - the part about resistance was a little scary but I guess we have to go with the data in front of us now, which shows better results with 10 years of Letrozole, even if a small benefit.
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Thanks for posting that, Jojo. Kmpod, I think Medscape is free but you have to register to see the articles. Maybe you should try registering again.
I did not think I was at risk for osteopenia (big bones, heavy all my life except for past 5 years, lots of exercise) but my recent scan showed I am osteopenic in my femoral necks. My spine is super dense and my total hip is normal, but just those necks have lost bone. I get tons of weight-bearing exercise but for the past ten years I have avoided anything high-impact to protect my bad knee from further deterioration. I am going to incorporate jump-squats into my day to give that area some high impact as long as my knee tolerates it. I will see if this can make any difference in a year. My Vit D was 44.9 which I think is plenty high. I'm taking extra calcium and Vit K2 also.
I have only been on arimidex for 7 weeks and already developed deQuervain's tendonitis in my right wrist. But I'll be off the pills for 4 months as I go thru chemo, which started yesterday.
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I can confirm that MedScape registration is free. However, registration is not require to view an article. One can google the title and access the full text without registration. Many of us provide both a link for registered users and the title for accessing via google search for unregistered readers.
BarredOwl
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