Tamoxifen for Non Invasive LCIS

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OCJenny42
OCJenny42 Member Posts: 4

I was diagnosed with LCIS in September 2013, my doctor said she wanted to remove the LCIS, which both the MRI and US showed to be really tiny. She said i would have to follow up ever 6 months and she would only put me on tamoxifen if the results came back invasive and she only does BPM on women who have poor follow up. I had the excisional biopsy done  on 12/5 the results came back non invasive, but she ended up removing 2" which came back all LCIS so now she's wants me to take tamoxifen because she believes I have very active tissue. I've been flip flopping on whether or not to take it. The side effects scare me, but the side effects of chemo are even scarier. My mother had DCIS, i have very dense tissue and have never been pregnant. I'm wondering what other women's experience have been with tamoxifen both good and bad who have LCIS. My mom was on it and only had hot flashes.  I have thought about having a BPM done, but want to wait to see how many more biopsies I might have to have. She did say if the biopsies get to much she would do a BPM. 

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Comments

  • MelissaDallas
    MelissaDallas Member Posts: 7,268
    edited December 2013

    hi OCJenny,

    I have LCIS also. I want to clarify something first. LCIS is never invasive. It is more considered a high risk condition. The excisional biopsy was to make sure that there was nothing worse than LCIS in there with it, such as DCIS or invasive ductal or lobular carcinoma.

    My suggestion would be to request a referral to a genetics counselor. They are the best at looking at your whole health history and  your family history to determine your personal overall risk and that might help with your decisions. Did your mom have breast cancer?

  • georgie1112
    georgie1112 Member Posts: 282
    edited December 2013

    Jenny,

    I had ILC and LCIS. This is a very old study, but stays Tamoxifen reduces LCIS risk of developing invasive cancer by 56%:

    http://www.ncbi.nlm.nih.gov/pubmed/9747868?dopt=Ab...

    Georgie

  • MelissaDallas
    MelissaDallas Member Posts: 7,268
    edited December 2013

    Georgie, around 50% is what most studies show, but she needs to know 50% of what. For the benefits to outweigh the risks you have to know if it is 50% of 10% or 50% of 40%.

  • georgie1112
    georgie1112 Member Posts: 282
    edited December 2013

    Melissa,

    Yes, determining the possible benefit of any treatment will depend on each person's risk factor of developing breast cancer. The statistics can be a crap shoot. I was told my neutropenia from sulfa is only experienced by 1 in 10,000 and that LE only occurs in 1-3% of women with sentinel node biopsies. But I still have LE. I was also told it is rare for calcifications to be LCIS and for me they were. So I look at statistics but know they may not apply to me.

    Jenny,

    Went back to see how old you are in your post. My understanding is that LCIS will increase the risk of BC by about 1% each year added to your risk. Determining what your risk factor might be can be done with an oncologist or  since your mom had DCIS, a genetic counselor. According to my oncologist for someone age 50 who might expect to live 30 or more years, you would add 30% to the average risk of 10-12% and it would give someone a lifetime risk of developing breast cancer of about 40%. If your mom had DCIS, I'm not sure how that would change your risk.

    Anyhow, I have been able to tolerate Tamoxifen and I couldn't handle the side effects of Femara and Aromasin. For me, the main side effect I notice is that my skin is thin and it is easy for me to get cuts. Other than that, I am not aware of other side effects. I do get depressed at times and don't know if Tamoxifen affects this for me. I had a hysterectomy so that removes one possible risk factor of taking Tamoxifen, though the increased risk of stroke is a concern for me.

    The good news is that this is not an emergency and you have time to research and make a decision on what makes sense for you. I feel a huge sense of relief that after my mastectomy I do not need to worry about multiple mammograms, MRIs, BSGIs, ultrasounds and biopsies and the stress around them several times a year. 

    The idea of waiting to see how the monitoring of your breasts goes might make sense. Some women do well with monitoring. But if you decide you really want surgery and your doctor does not support your decision, find a surgeon who will.

  • Anonymous
    Anonymous Member Posts: 1,376
    edited December 2013

    Jenny------I was diagnosed with LCIS over 10 years ago and my risk is further elevated by family history of bc (mom had ILC). All my docs felt BPMs too drastic even for my situation (and frankly so did I), so I went with closer monitoring and preventative meds.  I took tamoxifen for 5 years and now I have been taking evista for over 4 years; I continue with alternating MRIs and mammos every 6 months with clinical breast on the opposite 6 months. Fortunately, I have not needed any further biopsies in all these years; I would like to credit the meds for doing their job preventing any invasive bc, but who knows? maybe I would've been doing this well anyway, but there's simply no way to know. I feel like I am being as proactive as I can be (without doing the PBMs) taking the meds. Everything I've read states that tamox can lower the risk up to 45-50%, but as someone else said, you have to find out what your specific individual risk is first. (in order to figure out the risk/benefit  ratio). Having said that, it's not an easy task. They don't really truly know with LCIS; it's kind of an estimated guess (a "guesstimate"); even from the oncologists and the genetic counselors. As far as the tamox, both my mom and I tolerated it very well, mainly just with hot flashes.  I would just recommend a yearly transvaginal US to monitor both the uterine lining and the ovaries.

    anne

  • georgie1112
    georgie1112 Member Posts: 282
    edited December 2013

    Anne,

    Curious about your switch from Tamoxifen to Evista. Is Evista supposed to help with recurrence? My MO said it has less side effects but looks like Evista still has a risk of increased stroke. My MO suggested I switch but he didn't submit it to insurance and they rejected it. Cost per month is nearly $200 vs $9 for Tamoxifen. I am wondering what I will do. It sounds like Tamoxifen is more effective.

  • Anonymous
    Anonymous Member Posts: 1,376
    edited December 2013

    georgie----no, Evista is not intended to prevent recurrence of invasive bc; it is only intended for prevention of invasive bc (since you have already had ILC, it would not be indicated for you; I take it to decrease my risk of developing an invasive bc since I am high risk due to LCIS and family history). Tamox can be used to prevent recurrence if you've already had an invasive bc; you could also use an AI since you've had your ovaries removed.  (both tamox and evista do carry the risk of blood clots, I take a daily baby aspirin (81 mg) to help prevent it; check with your doctor to see if you can take baby aspirin)

    anne

  • georgie1112
    georgie1112 Member Posts: 282
    edited December 2013

    Thanks, Anne! I will keep doing research, but sounds like if this is correct, I will stay with Tamoxifen.

  • Beesie
    Beesie Member Posts: 12,240
    edited December 2013

    One thing to keep in mind when you are calculating the amount of risk reduction that you will get from any of these drugs (Tamoxifen, Evista or the AIs) is that you can't just take your lifetime risk (say it's 40%) and reduce it by 50%, thereby assuming that you get a 20 point risk reduction.  If you are aged 50 now, that 40% risk is spread out over the rest of your life, but at this point in time none of these drugs are being prescribed beyond 10 years (and I'm not sure if any are being prescribed beyond 5 years for high risk situations).  So the 50% risk reduction benefit that you get only applies to the years when you are taking the drug and for a few years beyond that, when there will be some residual benefit. 

    Using the numbers presented earlier in this thread, if you are 50 today, your risk level over the next 10 years is 12.38%.  That's the 2.38% risk that an average 50 years faces over the next 10 years (see the link below), plus the 1% extra risk per year because you have LCIS (as per the earlier discussion).  Assuming a full 50% risk reduction benefit for 10 years if one were to take Tamoxifen for 5 years, this would bring your 10 year risk down to 6.2%, and reduce your lifetime risk from 40% to 33.8%.  That's probably generous, however; I believe that the research suggests that Tamoxifen will work an extra few years, but doesn't necessarily provide the full 50% risk reduction during this residual period.

    Of course if you take 5 years of Tamoxifen, you can move on to 5 years of an AI afterwards.  And in 10 years, who knows what might be available?  So none of this is suggest that it's not a good idea to take a risk reduction drug for 5 years if that's what you are inclined to do, but simply is to point out that 5 years (or even 10 years) of any of these drugs does not provide a full lifetime of benefit.

    What is the average American woman’s risk of being diagnosed with breast cancer at different ages?

  • georgie1112
    georgie1112 Member Posts: 282
    edited December 2013

    Hi Beesie,

    That is not how my oncologist explained it to me. My understanding is that tamocifen reduced the lifetime risk. And studies I read ranged from 1-2% added risk per year for LCIS added to a woman's risk. Anyhow, need to do more reading! One more thing to study:)

    For me it is balancing risk of stroke with the benefit of tamoxifen. And for me I think adding a blood thinner in the form of high dose fish oil is what I will do.

  • MsVeryDenseBreasts
    MsVeryDenseBreasts Member Posts: 100
    edited December 2013

    FYI, Beesie's explanation is consistent with how my medical team has explained it and appears to be consistent with the peer reviewed literature as well.  Also, from what I've read in the medpubs and per my BS….they don't exactly know, but supposition is that 5 years of Tamoxifen get's you 10 years of lowered risk, not lifetime.  There is a school of thought that now thinks that 10 years of Tamoxifen gets you 20 years of lowered risk (when prescribed for those who have been diagnosed with and treated for actual cancer, not LCIS),  but that's controversial too because there are some studies that would seem to indicate that being on Tamoxifen for that long can cause other problems that the patient did not have to begin with.  Lots of equivocation…...   

  • Beesie
    Beesie Member Posts: 12,240
    edited December 2013

    Georgie, the Atlas study on Tamoxifen that was released late last year was done on breast cancer patients and it looked at recurrence rates and mortality, so it's not the same as when someone takes Tamoxifen for a high risk situation.  Nevertheless, what the Atlas study clearly showed was that when recurrences and mortality were evaluated over a 15 year period, there was a significant benefit to taking Tamoxifen for 10 years vs. taking it for only 5 years. This was because for those who took Tamoxifen for only 5 years, while their recurrence rate was significantly reduced for 10 years, there was little residual benefit beyond 10 years.  Therefore by taking Tamoxifen for 10 years rather than 5 years, the residual benefit remained during years 11 - 15.  This study is ongoing so in another 5 years we will find out if taking Tamoxifen for 10 years had any benefit beyond 15 years. 

    By applying the Atlas results to previous trials, here is an estimate of the effectiveness of 10 years of Tamoxifen vs. 5 years of Tamoxifen vs. no treatment:

    Table 3

    What this chart is saying is that compared to those who didn't take Tamoxifen at all, the women who took Tamoxifen for 5 years had a 53% recurrence rate ratio (i.e. a 47% reduction in recurrence) over years 0 - 4, a 68% recurrence rate ratio (i.e. 32% reduction in recurrence) over years 5 - 9, and a 94% recurrence rate ratio (i.e. a 6% reduction in recurrence) from year 10 onwards.  For those who took Tamoxifen for an additional 5 years (for a total of 10 years), their recurrence rate ratio during years 5 - 9 was lowered to 61% (i.e. a 39% reduction in recurrence) and their recurrence ratio at 10 years and beyond (to 15 years since that's as far as the study has gone) was 70% (i.e. a 30% reduction in recurrence).

    From this data, it's clear that the benefit from 5 years of Tamoxifen continues for another 5 years after you stop taking it (although the benefit is not as great as it is during the years when you are taking it) but beyond that,  there is little benefit left.  While this study was looking specifically at breast cancer patients and recurrence rates, it's probably reasonable to assume similar patterns of effectiveness for high risk patients who take Tamoxifen.  So what it means is that if you are 50 and expect to have another 40 years of life ahead of you, and if your cumulative breast cancer risk over these 40 years is 40%, 5 years of Tamoxifen will reduce your risk for the next 10 years (to about age 60), but not the entire 40 years till you are 90.

    Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial

    .

    Edited to Add:  MsVeryDenseBreasts, I was writing up my post as you were posting yours.  Looks like we are saying the same thing!  .


  • georgie1112
    georgie1112 Member Posts: 282
    edited December 2013

    Thanks for posting more detail on the study.  This is what I briefly looked up, copied from the Lancet:

    Background

    "For
    women with oestrogen receptor (ER)-positive early breast cancer,
    treatment with tamoxifen for 5 years substantially reduces the breast
    cancer mortality rate throughout the first 15 years after diagnosis".

    Interpretation

    "For
    women with ER-positive disease, continuing tamoxifen to 10 years rather
    than stopping at 5 years produces a further reduction in recurrence and
    mortality, particularly after year 10. These results, taken together
    with results from previous trials of 5 years of tamoxifen treatment
    versus none, suggest that 10 years of tamoxifen treatment can
    approximately halve breast cancer mortality during the second decade
    after diagnosis.
    "

    This differs from what Beesie posted. The point for me is that I will get a benefit for many years beyond how long I take tamoxifen which was what my understanding was from my doctors.

  • DiveCat
    DiveCat Member Posts: 968
    edited December 2013

    it is important to note that, georgie, that deals with preventing recurrence in a woman already diagnosed with a known ER+ cancer. It is known their BC had estrogen positive receptors. Tamoxifen works by blocking uptake of estrogen in these receptors that could fuel recurrence. It is not addressing new primaries in those women or never-diagnosed women. 

    I am in a different position than as I do not have LCIS but I have had high risk counseling on chemoprevention from a medical breast oncologist who heads a high risk program, two breast surgeons, and two genetics counselors...all at different facilities. The way it has been explained to me by all of them is that in a group of never-diagnosed high risk women taking tamoxifen there is a risk reduction in that they are estimated to have half as many bc dx's as would a group of high risk never-diagnosed women not taking tamoxifen (not quite same as 50% reduction in the individual though which is how I often seen it stated!). However, while they did say tamoxifen gave some lasting protection once tamoxifen was discontinued, it was certainly not for a lifetime. Also, they were not sure if in these high risk women taking tamoxifen there is any reduction in mortality. How is this? Well, tamoxifen may only reduce risk of being dx'd with a primary cancer that would have had lower mortality risk in first place and not those that are more aggressive and/or may have higher mortality anyway. 

    Take four high risk never-diagnosed women for example. Two are taking tamoxifen, two are not. Of the women not taking tamoxifen, one develops ER- bc, one develops ER+ bc. Of the women taking tamoxifen, one develops ER- negative bc. One does not develop any cancer. How do we know the cancer free one would have developed cancer if she did not take tamoxifen? We don't. Similarly, we do not know if the ER- woman taking tamoxifen or the one not taking it were ever at risk of ER+ cancer. None of them had a risk of 100%. We know there was 50% less primary cancer in the tamoxifen group versus the non-tamoxifen group but this tells us little about the invidual woman who is cancer-free and whether she had a risk reduction. Maybe it did prevent an ER+ cancer, maybe not. But of course, comparing the groups there is a 50% reduction! Say both the ER- women die of their cancer in 3 years. The ER+ woman and the never diagnosed women die of old age at 102. So, mortality between the two groups from bc is the same. 

    This is not to say tamoxifen is not right for you, OP, but it is important to know its limitations as well. Now, ER- bc is less common than ER+ cancer, but in some groups this is the reverse (ie BRCA1+ women) so tamoxifen is not one size fits all and there are issues taking results from studies on recurrence reduction in ER+ diagnosed women and applying to never-diagnosed women. 

  • DiveCat
    DiveCat Member Posts: 968
    edited December 2013

    There is also a difference in reducing "lifetime risk"...and reducing risk "for a lifetime". Risk is a very nebulous thing, really, and it often is very simplified by the media and even doctors.

    Here is how I understand it all from my own medical providers which includes my medical breast oncologist who deals specifically with high risk patients including those who have not had a personal cancer dx.

    The average lifetime risk is about 12%, but that is not 12% every year of your life. It is broken down into decades of your life. From Beesie's link above, these are the "ten-year risks" at the respective age:

    • Age 30 . . . . . . 0.44 percent (or 1 in 227)
    • Age 40 . . . . . . 1.47 percent (or 1 in 68)
    • Age 50 . . . . . . 2.38 percent (or 1 in 42)
    • Age 60 . . . . . . 3.56 percent (or 1 in 28)
    • Age 70 . . . . . . 3.82 percent (or 1 in 26)

    Before 30 and after 80 your ten-year risk is very low.

    You do not add risk you have "passed" back in. At 30 your lifetime risk is about 12%, but at 60 it is about 7.38%. You do not at 60 add back in the risk from 30-59 to still be at 12%.

    Say you are at double lifetime risk at 30 at 24%. Your risk will still be broken out across your lifetime, say double the figures in the chart above just for ease. Say you take tamoxifen from 30 to 35 and the protective effects continue until you are 40. Your risk may be reduced to the average risk of a 30 year old from 30-40 if we accept a 50% risk reduction, so 0.44%. You even reduced "lifetime risk because at 30-40 you were back at average risk for those years so added altogether you are now a little less than 24%. Very little less since the effects are not for a lifetime, and your risk at 30 is quite low even at double risk. So you are not down to 12% lifetime risk. At 40, you may be back at or near double lifetime risk as most high risk women take it 5 years and we know residual protection only lasts a few years after. Your lifetime risk at 40 will be lower than it was at 30 as you are now past the 30-39 years, but that does not mean your remaining lifetime risk is reduced by 50% for the rest of your lifetime. 

    So, a woman taking tamoxifen from 30-35 as prevention of a primary (not recurrence which is a different matter!) may not have a significant benefit in reducing her own lifetime risk OR her risk for a lifetime if she is low to moderate risk.  Now some high risk women may have 4-5x the average risk and find it worth it or until they are ready for other measures like an oopherectomy or PBMX or to wait and see if the do get a dx, but it is important to note that the effects are not forever and may have little impact on her lifetime risk. If her risk at 30-39 is 2.5%, she has to decide if a 50% reduction to 1.25% risk through her 30s is worth the side effects, and so on for her, and recognize the risk reduction does not last her lifetime.

    My medical providers who have counseled me on chemo-prevention say there is a very low uptake in high risk women aged 30 to 40-something to take tamoxifen after they understand the figures a bit better. I do not think a lot of doctors explain this very well, never mind the media. 

  • Beesie
    Beesie Member Posts: 12,240
    edited December 2013

    DiveCat, my understanding of risk is exactly the same as yours.  And it was my oncologist who explained it all to me.  I was lucky because I think you are right that too many doctors don't take the time to explain this well. 

    Georgie, the information you and I provided is from the same study, and it's completely consistent.  I provided recurrence rate data; you provided mortality rate data and that's the only difference.

    A breast cancer mortality is the result of a breast cancer diagnosis or a breast cancer recurrence.  Therefore mortality always lags diagnosis or recurrence, usually by a few years. So it is completely logical therefore that the mortality benefit from Tamoxifen will extend for a longer period than the recurrence benefit.  In fact the study specifically notes this.  Here is the first line of the Introduction section of the full report:  

    "For women with oestrogen receptor (ER)-positive breast cancer, treatment
    for 5 years with adjuvant tamoxifen substantially reduces the rate of
    recurrence not only during the treatment period but throughout the first
    decade, and reduces breast cancer mortality by about a third throughout
    the first 15 years (including years 10—14)
    "  

    So there you have it.  5 years of Tamoxifen reduces recurrence risk for 10 years (the first decade) and reduces mortality over 15 years.  

    You can see this lag effect on mortality rates in the data chart that I presented in my previous post.  When I was writing, I detailed only the recurrence rate data, but the mortality data is right there below the recurrence rate data in the chart.  It shows that taking Tamoxifen for 5 years results in a mortality rate ratio of 71% over years 0 to 4 (i.e. a 29% reduction in mortality), a mortality rate ratio of 66% in years 5 to 9 (i.e. a 34% reduction in mortality) and a mortality rate ratio of 73% from 10 year onwards (to year 15; a 27% reduction in mortality). Those who added the extra 5 years of Tamoxifen lowered their mortality rate ratio to 64% (i.e. a 36% reduction in mortality) in years 5 to 9 and to 52% (i.e. a 48% reduction in mortality) in years 10 onward (to year 15, since that's as far as the study has gone so far).  

    A couple of significant points.  First is that the mortality reductions are not as great as the recurrence reductions.  This makes sense since many recurrences can be successfully treated.  Second is that you can clearly see that mortality benefit lags recurrence benefit.  For those who took Tamoxifen for 5 years, their largest mortality rate reductions were in years 5 to 9. This is because (as the data shows) Tamoxifen provides the largest recurrence rate reduction during the years that you take it, years 0 - 4.  The women who were able to avoid recurrences while taking Tamoxifen therefore benefited by having fewer breast cancer deaths over the next 5 years.

    The reason I focused my earlier post on the recurrence rate benefit is because I think that's more comparable to the situation of high risk women who are trying to avoid the development a new breast cancer.  Just as someone who's had breast cancer wants to avoid a recurrence, someone who is high risk wants to avoid an initial diagnosis.  By avoiding the development of breast cancer, you never have to worry about breast cancer mortality.  The mortality reduction from Tamoxifen is really an indirect benefit rather than direct benefit; the mortality reduction exists only because the recurrence or new primary diagnosis never happened. So the period during which Tamoxifen is providing the direct benefit is the first 10 years (for those who take Tamoxifen for 5 years) or the first 15 years (for those who take Tamoxifen for 10 years).  The mortality benefit over the next 5 years in each case is simply the fall-out from the lower recurrence and cancer rates. During those next 5 years, although the mortality rates are lower, the recurrence rates and new diagnosis rates are only minimally reduced because Tamoxifen is no longer providing the same level (or a significant level) of recurrence or new cancer reduction benefit.

  • MsVeryDenseBreasts
    MsVeryDenseBreasts Member Posts: 100
    edited December 2013

    Excellent posts Beesie and Divecat.  These are worth bookmarking and re-reading a few times by the LCIS folks.   The details of these stats are well worth understanding before one makes important choices.  You can't ask too many questions and as noted here, the media is fast and loose with interpretation of statistics. It worries me that too often women are not being given this level of thoughtful analysis as a reference to weigh against the decisions they have to make.  Each person has to go with what is best for their particular circumstance (and anxiety threshold). It's critical to understand as best we can how the benefits and risk reduction measure up against potential quality of life and/or more serious possible side effects.  We're fortunate to have this forum.  Thx!    

  • Beesie
    Beesie Member Posts: 12,240
    edited December 2013

    MsVeryDenseBreasts, thanks!

    I tend to get complicated in some of my posts and since I wrote my post this morning, I've thought of a very simple way to explain why the 15 year mortality benefit really isn't relevant for someone who is high risk.

    If you are high risk and you take Tamoxifen, you are taking it specifically in order to stop the development of breast cancer.  If you don't develop breast cancer, your breast cancer mortality rate is 0%. The only situation under which you have to worry about breast cancer mortality is if you do develop breast cancer.  And if you do, it means that the Tamoxifen didn't work.  

    That's why someone who is high risk should be looking at how long Tamoxifen is effective at reducing breast cancer occurrence, and not at the extended benefit on mortality rates.  

  • Anonymous
    Anonymous Member Posts: 1,376
    edited December 2013

    I've always been told (and read) that tamox keeps working 5-10 years after you finish taking it for 5 years (although I don't really know the exact mechanism by which it does that).  I take evista now for high risk prevention; probably overkill, but since it also helps my osteopenia, all my docs think its' a good idea to keep on it indefinitely.

    anne

  • Suzanne89
    Suzanne89 Member Posts: 6
    edited January 2014

    I have just had a lumpectomy and have LBIS. My appointment with my oncologist is next week.  I have no history of breast cancer in my family.  These drugs sound so horrible.  My Dr. told me to come back for a mamo in a year, and to go talk to the oncologist.  Is there anyone who hasn't taken these drugs, and hasn't gotten cancer?  I wonder if there is a more natural approach, like Gerson Therapy thru nutrition, that could help.  This is so frightening, and any advice is welcome.  Thank you all

  • Moderators
    Moderators Member Posts: 25,912
    edited January 2014

    Suzanne, welcome to Breastcancer.org. We're sorry that you've had to find this wonderful community, but glad that you're here for information and support. You can read what Breastcancer.org says about Gerson therapy at the main site's article What to Know About Diets That Claim to Cure Cancer

    When you've met with your oncologist, you'll have a better idea of exactly what treatments are being recommended for you, and can connect with other members who know first-hand about side effects and how to deal with them. Although there are long lists of possible side effects with every possible treatment, everyone doesn't experience them.

    Best wishes,

    • The Mods

  • MsVeryDenseBreasts
    MsVeryDenseBreasts Member Posts: 100
    edited January 2014

    Suzanne, I have LCIS (diagnosed 4/08).  I have opted not to take Tamoxifen.  I've chosen close monitoring instead.  I have no family history of breast cancer (and a long history of female longevity), and no lifestyle or genetic risk factors.  I do have extensive family history for some of the most serious possible side effects of Tamoxifen (i.e. stroke, eye problems etc.) and I am not interested in running the risk of inviting problems I do not already have.  I constantly re-examine my decision against any new data that comes out in case a change of mind is warranted by new health or study circumstances. My surgeon agreed that Tamoxifen would be overkill for me and frankly I am fairly skeptical of big pharma when it comes to this sort of thing.  Unfortunately, as with everything we are dealing with here, it comes down to evaluating the medical info in the context of your own circumstances and trusting your gut with the decisions you make.  Another reason I opted against Tamoxifen is because the situation that generates studies/biopsies in my case is the appearance of clustered calcifications.  As my surgeon acknowledged, Tamoxifen is not going to prevent my body from forming these calcs because the docs don't know what causes it….so, if the standard of care is always to biopsy clustered calcs, I thought, "why bother with the quality of life impacts (and other more serious side effects) Tamoxifen can have".  I'm not a terribly anxious type so for now I'm comfortable with this choice.  Best of luck to you. 

  • leaf
    leaf Member Posts: 8,188
    edited January 2014

    Tamoxifen is an individual choice.

    It may be helpful to look at numbers.  Some people use risk-vs-benefits evaluations.  If one choice may cause horrible adverse effects, it may be helpful to find out the incidence of those horrible adverse effects.  You may make a different choice if the incidence of a horrible outcome is low versus high.  Humans are notoriously bad at estimating risk.

    I haven't done an exhaustive study on the incidence of adverse effects of tamoxifen, but one of the most detailed information comes from the package insert.  The incidence of tamoxifen adverse effects differs in different populations:  since tamoxifen can be used in everything from breast cancer prevention to metastatic breast cancer, it is reasonable to assume that often the people with metastatic breast cancer have had other treatments.

    A copy of the package insert can be found here.  http://www.accessdata.fda.gov/drugsatfda_docs/lab...

    Probably the P-1 trial is the most relevant, which can be found in Table 3 on page 11.  They compared 5 years of placebo to 5 years of tamoxifen.  These women were at higher risk of breast cancer.  (The study included a few ~25 people with a history of LCIS.)

       In it, you can see statistics such as              Incidence per 1000 women-years

         Adverse effect                                          Tamoxifen                  Placebo

                 Number of people in each group        1596                         1782

          Stroke                                                        1.43                           1.00

          Myocardial infarction    

                  Fatal                                                   0.29                           0.33

                  Nonfatal                                              0.84                           0.79

          Angina                                                        0.5                             0.5

         Acute Ischemic Syndrome                          0.92                            0.84

         Transient Ischemic Attack                           0.75                            0.88

         Endometrial Adenocarcinoma                     2.20                           0.71

         Uterine Sarcoma                                         0.17                           0

         Pulmonary Emboli                                       0.75                           0.25

         Deep Vein Thrombosis                                1.26                           0.79

         Cataracts developed during study             25.41                         22.51

    If you multiply these number by 5 (since tamoxifen was given for 5 years), you would get the incidence of the adverse effect over a 5 year course.  I do not know if they included more long-term numbers (after the 5 year course was over.)

    So, for example, for pulmonary emboli, they had 18 out of 1596 women had a pulmonary emboli (3 of which were fatal) on tamoxifen, whereas 6 out of 1782 women had a pulmonary emboli on placebo. So that means that (1596-18) + (1782-6)=  3354 out of 3378 people did NOT get a pulmonary embolus.

  • Beesie
    Beesie Member Posts: 12,240
    edited January 2014

    leaf, the way I look at the example you provided is that for those who took Tamoxifen, the percent who developed pulmonary emboli was 1.13% (18 of 1596 patients).  Of those who took the placebo, the percent who developed pulmonary emboli was 0.34% (6 of 1782 patients).  So while there is a very significant increase in the risk to develop pulmonary emboli (more than a 3-fold increase in risk), the absolute risk remains very low.

    In addition, I believe that the Tamoxifen studies have shown that the women who tend to develop these very serious side effects often started off being higher risk for these conditions. So if you start off with no risk factors for pulmonary embolism, then your risk from Tamoxifen is probably lower than 1.13%.

  • Anonymous
    Anonymous Member Posts: 1,376
    edited January 2014

    Beesie---you are right.  The risk of blood clots (DVTs and PEs) while taking tamoxifen are significantly higher in people who smoke or are obese/sedentary (versus those who do not smoke and are active and not obese; the risk is <1%).  Smokers and people who are obese/sedentary are actually at higher risk of blood clots even without the addition of tamox; so it is prudent to stop smoking and try to lose weight/exercise more when taking tamox! I'm not sure of the increase in endometrial cancer, but I would venture a guess that it would also be increased (as smokers and obese people have higher rates of cancer overall). Ironically, my docs never recommended I take a daily baby aspirin while on tamox, but then did when I started on evista, which has a lower risk of blood clots than tamox; maybe it was because I had turned the magic age of 50!

    anne

  • leaf
    leaf Member Posts: 8,188
    edited January 2014

    Yes, I agree - my point being that if you are concerned about having a pulmonary emboli, the absolute incidence of having a pulmonary emboli, whether or not you take tamoxifen, is quite low.  The number (18) with tamoxifen is quite a bit higher than without tamoxifen (6).  You do have to compare the incidence in the placebo group and the treatment group.  I just wanted to point out that some people, in their understandable fear, may assume incorrectly that everyone, or a large percentage, of those who take tamoxifen will get a serious adverse effect.

  • glorianna
    glorianna Member Posts: 92
    edited January 2014

    Side effects of Tamoxifen?

    What were your personal sideffects of Tamoxifen? When you report side effects to a doctor, they often do not

    report this in. The lists given here are good, but I am interested in you own experiences, they speak more.

  • Anonymous
    Anonymous Member Posts: 1,376
    edited January 2014

    glorianna--I had a bad yeast infection very early on when I first started tamox, but cleared up with diflucan and never happened again. My main SE was hot flashes, but they were mild.  I did develop large ovarian cysts which ruptured (but that is a long story and it is a very rare SE); it is a good idea to have a yearly transvaginal US when on tamox to monitor both the uterine lining and the ovaries. The risk of any serious SEs is actually very low (<1%), tamox is generally pretty well tolerated by most.  I was willing to take the very low risk of serious SEs, in order to decrease my high risk of invasive bc from my LCIS and family history of bc. We each have to look at our own situation and decide what is right for us individually.

    anne

  • georgie1112
    georgie1112 Member Posts: 282
    edited January 2014

    I have one side effect, thin skin. My skin tears and bleeds easily. But not a bad trade off. 

     It is possible I might be a little more depressed. But I had depression before bc. And bc issues certainly can make us depressed... 

  • Beesie
    Beesie Member Posts: 12,240
    edited January 2014

    Personal anecdotes can be helpful but the problem when people talk about their personal experiences with a drug is that you have no idea if the drug actually caused those issues.  

    leaf, that's what's so great about the information you provided. As you said, "You do have to compare the incidence in the placebo group and the treatment group."  Looking at the list of side effects that you provided, it's easy to see that whether someone took Tamoxifen or whether someone took the placebo, they had the same list of "side effects", to a greater or less degree.

    Within a year or so of my diagnosis of breast cancer, I suffered hot flashes and particularly, really bad night sweats.  I also had vaginal bleeding and required a D&C.  Oh, and I didn't take Tamoxifen. I just was entering menopause.

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