Tamoxifen absolute vs relative benefit--is it worth it?
Comments
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My MO told me 70% of women do fine on Tamox. We can all throw out our Anecdotal evidence all day, but KSusan's doctor is just as clueless as mine is until there is a large comprehensive following study done. I will say that using the latest study out of Britain, around 38% stop before 5 years. That means the majority continue - so I stand by my statement that the majority (which is at least 51%) of us can tolerate it well. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3778308/
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My MO is at a large teaching hospital. She told me this % after returning from a conference. I've seen it in the lit but can't pull it up right now. The discussion is confounded by statements in the lit along the lines of Most women tolerate tamoxifen well, but there are multitudinous problematic SEs. Those SEs are why many people discontinue treatment, even if major adverse effects are rare.
From the same conference: Breast cancer oncologists know that tamoxifen can cause weight gain in many women, even though it's not a labeled SE. Some are pushing for this to be added to the labeling.
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After 2 1/2 years on Tamoxifen I'm about to go off the drug. My chances of recurrence are 12% without Tamoxifen and 8% if I take Tamoxifen for five years. The medical community considers that a 33% reduction in chances of recurrence, but the reality is that it is only a 4% reduction. The side-effects are horrific - I sweat all the time, I have joint pain so bad I can barely move, I have gained at least 15 lbs though I'm dieting like crazy, I have mental confusion, I haven't had a good night's sleep since I started the drug, and, did I mention I sweat all the time? My onco (whom I really can't stand) thinks these are normal menopausal symptoms (I was not in menopause when I was diagnosed), so I'm going to stop the drug to see if he's right or if I am. He does not care about my quality of life which has suffered tremendously from this drug. There are no treatments for the side-effects, no matter what anyone says. I've tried Effexor, Gabapentin, Yoga, psychotherapy, exercise, and everything else that was supposed to vanquish the side-effects. Nothing works. BTW, before all this started I was a marathon runner, a competitive skier and a swimmer. I had a BMI of about 19%. Now I'm at 28%. After 913 days on the drug I can barely walk up a flight of stairs. I think we're all being hoodwinked by the cancer community. Tamoxifen is minimally effective, if at all, and it has major side-effects which the cancer culture we are living in refuses to acknowledge.
I should add that I also have endometrial hyperplasia so I need to have uterine biopsies twice a year. Thankfully my oncologist says that uterine cancer is "no big deal." Good to know. It's not like anyone has ever died of uterine cancer or anything. Oh, except my aunt. But I guess she doesn't matter.
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Lisey....that study is about Tamoxifen only. I stand by my findings that 50 percent do not complete the 5 recommended years on anti hormone therapy. IMO that is just not good enough!
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dtad, everytime I post about tamoxifen (only) you respond that I'm wrong that the majority handle/finish tamoxifen treatment. Perhaps going forward you will modify your position on Tamoxifen after reading that study. My MO said 70% of women handle Tamoxifen fine - I've never said AI's or all hormonals - just Tamoxifen - because that is the focus of the OP's I jump on. You follow some of us around and say 'that's just not the case" when in fact it is.
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I really don't understand why some are determined to negate the benefits of tamoxifen. I am just fine with people not taking it, THEIR CHOICE, but why harp on and on about perceived negative effects. We all know there are SEs, but to me, the benefits outweigh the risks. We who choose to follow our doctors' recommendations, and take the drug, deserve as much respect as those who decline. Just saying.
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At the top of every page on this Hormonal Forum, rests the following:
Forum: Hormonal Therapy - Before, During and After —Risks and benefits, side effects, and costs of anti-estrogen medications. Note: Please remember that there are good experiences and bad with ALL treatments and this is a safe place to share YOUR experience, not to be influenced or influence others.
It was put up a few months ago, for a very good reason. We can now see how wise the webmaster was, who placed those words on every, single, thread in this forum. -
The following is in reply to the discussion above about statistics and introduces the concepts of "compliance" verus "persistence", which are two different aspects of "adherence."
I realize this does not speak the difficult situation of the individual experiencing severe side effects that impact her quality of life, who incorporates information about her actual adverse experiences in reviewing the personal risk/ benefit profile of continued treatment.
Hi Lisey:
Thank you for the McCowan (2013) link. I added it to my "Adherence, Shorter Durations, and Meta analyses" folder. Here's a direct link to the pdf version:
McCowan (2013): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3778308/pdf/bjc2013464a.pdf
Re the 38%, I would urge caution in relying on a single study in a dense field, as well as a closer look at what was being measured in various studies. As explained in the Introduction of McCowan:
"Studies have reported that one-third to a half of women do not complete the recommended 5-year tamoxifen treatment and that this is associated with an increased mortality risk (Barron et al, 2007; Ma et al, 2008; McCowan et al, 2008; Owusu et al, 2008; Yood et al, 2008; Narod, 2010; van Herk-Sukel et al, 2010; Hershman et al, 2011; Murphy et al, 2012; Hadji et al, 2013; Huiart et al, 2013; Makubate et al, 2013). Other work has shown that 19–28% of women prescribed adjuvant tamoxifen in the community miss at least one out of five daily doses putting adherence below 80%, a level also associated with increased risk of all-cause mortality (Patridge et al, 2003; McCowan et al, 2008; Dezentje et al, 2010; Hershman et al, 2010, 2011; Makubate et al, 2013)."
Note that the completion of a full five-year course of therapy ("persistence") may be a different question from "adherence" during treatment ("compliance"). Also, the definition of "Adherence" may differ from study to study.
In the case of McCowan (2013), they reported that "Four hundred and seventy-five (38%) patients had low adherence over the treatment period." In the results, they provide more detail about this finding:
"During the period from diagnosis to recurrence or death, 475 (38%) patients had low adherence to medication, missing at least one tablet of every five over the course of their therapy. The average monthly adherence index for our patients reduced over time from diagnosis from 85% (s.d. 1⁄4 0.44) at 12 months to 81% (s.d. 1⁄4 0.48) at 36 months and, finally, 75% (s.d. 1⁄4 0.43) at 60 months."
I could be wrong, but they seem to be reporting on the compliance aspect of "adherence" during therapy (i.e., taking the medication as prescribed, while on the medication) rather than the number of patients who discontinued outright before five years was up.
Whatever they measured, as an aside, this particular study is also a longitudinal community study in the "Tayside region of Scotland" in the United Kingdom, and included all stages of breast cancer:
"We conducted an economic evaluation using data for all women with incident breast cancer between 1993 and 2000 who were subsequently prescribed tamoxifen in the Tayside region of Scotland."
"Women resident in Tayside, UK, diagnosed and treated for breast cancer between January 1993 and December 2008 were identified using previously described methods (McCowan et al, 2008; Makubate et al, 2013). Only those women resident in Tayside for the entire period of the study, or until death, were included. Community dispensed prescribing, hospital discharge records, cancer registry, cancer audit and General Registrar's Office death certificates were extracted, record-linked and anonymised for each patient."
I do not know if these findings are directly generalizable to a purely early stage population or to a population that lives in a materially different health system, with more uneven access to medications.
Here is another interesting and slightly more recent publication based on BIG 1-98 (Tamoxifen (Tam) versus Letrozole (Let)). This trial included four arms (Let only; Tam only; Let-Tam switch; and Tam-Let switch). I cite it not for its particular findings, but for the background and discussion:
Chirgwin (2016): "Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence"
http://ascopubs.org/doi/full/10.1200/JCO.2015.63.8619
(Free pdf available under PDF tab)
They note: "In the study of treatment adherence, terminology definitions vary, and investigation is hampered by the accuracy of the methods used to assess adherence."
Chirgwin distinguished between "Persistence" and "Compliance" in their study:
"Adherence to Endocrine Therapy
Persistence is defined as the duration of protocol treatment on the basis of the dates that protocol treatment started and stopped. The prescribed treatment duration was 60 months; however, any patient who completed at least 54 months of therapy was classified as having completed treatment, which is the operational definition for this report.
Compliance is defined as the consistency of taking protocol treatment. Treatment drug packs were distributed every 6 months. A patient was compliant for a drug pack if she took at least 80% of the pills during each 6-month interval, with no breaks of 7 days or more for any reason.(7) Pill count data were recorded for each drug pack, although this information was collected retrospectively before early 2003, reducing the reliability of compliance data in early patients."
They also note material differences in persistence between patients in trials and those in the general breast cancer population.
"The frequency and reasons for discontinuation in the current analysis are consistent with those of other trials in similar settings. In the Arimidex, Tamoxifen, Alone or in Combination (ATAC) and Intergroup Exemestane Study (IES) studies, discontinuation ranged from 8% to 15%. [30,31] On the other hand, the rates of discontinuation reported in BIG 1-98 are generally less than those reported in studies of endocrine treatment discontinuation in the general breast cancer population. [29, 32-42] A recent systematic review identified 29 studies of adjuvant endocrine treatment adherence: compliance ranged from 41% to 72% and persistence [ranged] from 31% to 73%. [29] This disparity suggests that clinical trial participants differ from the general population and are perhaps influenced by factors such as higher motivation, better support, and reduced treatment costs. Several small studies have suggested that information and support interventions improve adherence, lending credence to this possibility. [43-45]
The current analysis demonstrates significant differences in early discontinuation according to treatment arm, with greatest persistence associated with the tamoxifen monotherapy arm (86.9%) and least with the tamoxifen followed by letrozole arm (79.8%). Discontinuation rates are comparable for all treatments until 24 months; thereafter, discontinuation was higher in the sequential arms after therapy changed. This observation is especially noteworthy because letrozole-containing treatments remained blinded throughout the trial.
Contrary to our results, some previous studies demonstrated equivalent adherence to AIs and tamoxifen,[17] and a recent review [28] noted better adherence with AIs in the large randomized adjuvant and prevention trials. But, as seen here, other studies have demonstrated reduced adherence to sequential treatments. More patients in the IES,[31] Arimidex-Nolvadex (ARNO) [95], and Austrian Breast Cancer Study Group (ABCSG) studies [46,47] were adherent to tamoxifen continuation than to a switch to an AI, and a similar pattern is seen in clinical practice. [15,39,48]"
It appears that rates of "persistence" (continuation of prescribed therapy) may differ widely in different studies and contexts and may differ by drug type or regimen (e.g., Tam alone v switch regimens).
If I understand the above correctly, the above-referenced systematic review which found "persistence" for "adjuvant endocrine treatment" ranging "from 31% to 73%", would suggest early discontinuation of adjuvant endocrine therapy may range from as high as 69% down to 27%.
BarredOwl
[Edit: e.g. to i.e and typo]
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These articles may be useful for this discussion (my bolding). The first is T and AIs; the second is T only.
:
Adherence to Long-term Adjuvant Hormonal Therapy for Breast Cancer
Carolyn Gotay; Julia Dunn
Expert Rev Pharmacoeconomics Outcomes Res. 2011;11(6):709-715We identified 14 studies, five of which have been published in 2011. This is clearly an area of considerable current interest. The studies vary considerably in their patient populations, the way that adherence is measured, the sources of data, the duration of adherence that is observed, as well as the findings. However, despite these differences, it is clear that nonadherence is a concern in all studies. Not surprisingly, adherence is better at 1 year, with rates of adherence in studies that reported 1 year adherence ranging from 77 to 88%,[20,23,25,26] whereas studies reporting 4–5-year prescription-based adherence found rates between 27 and 49%.[21,23] It should be noted that these figures are very similar to those reported previously for clinical practice settings,[14] in which 30–50% of patients were nonadherent by 4 years. Studies that used patient self-reports of adherence yielded higher rates;[17,27] Ziller et al. found that whereas all 100 women in their study said that they adhered to their tamoxifen or AI regimen, prescription database information showed that actual adherence was likely to be 20–30% less.[27]Correlates of adherence vary, in many cases determined by the variables available in the dataset used. Age is frequently found to correlate with adherence, with nonadherence found to be higher in older[17,19–21,23,24]and younger[18,20–22,26] cohorts; given that not all studies included the same age ranges, these data are inconclusive at present, although it appears that middle-aged women (e.g., aged 50–69 years) may be most adherent. Low social support was associated with lower adherence in several studies,[16,17] but being married was linked with both lower adherence[18] and higher adherence.[21]Side effects were cited in two studies,[16,17] as was greater comorbidity.[19,21,26]Studies that reported both tamoxifen and AI adherence consistently reported better adherence with AIs,[20,22,27] although the women who received these different treatments differed in other important ways, such as age.
Cancer Prev Res (Phila). 2011 Sep;4(9):1360-5. doi: 10.1158/1940-6207.CAPR-11-0380.
Predicting adherence to tamoxifen for breast cancer adjuvant therapy and prevention.
Abstract
Treatment with the selective estrogen receptor modulator (SERM) tamoxifen for 5 years has produced dramatic breast cancer-related benefits in (a) the adjuvant setting, with 30% to 50% reductions in recurrence, contralateral disease, and mortality and (b) the prevention setting of healthy high-risk women, where tamoxifen reduces the risk of invasive and noninvasive breast cancer by 50%. Despite these striking data, adherence to tamoxifen is low, and low adherence is associated with poor survival. Although toxicity is a major predictor of poor adherence after starting therapy, pretreatment (baseline) predictors of poor tamoxifen adherence have been minimally studied. The adherence-survival link underscores the critical need to identify early predictors of poor adherence, and recent work is beginning to address this need. A major baseline predictor of poor adherence to prevention is current smoking, which is interestingly absent from studies of adherence to adjuvant therapy. Other important prevention adherence factors include breast cancer risk, extremes of age, non-white ethnicity, low socioeconomic status, and alcohol use. The strongest adjuvant therapy predictors are age (especially very young), ethnicity, and socioeconomic status. Future studies involving prospective systematic evaluation of these and other potential predictors in endocrine chemoprevention (e.g., other SERMs and aromatase inhibitors) are critical, as is the development of effective/targeted interventions to improve adherence and thus treatment outcomes in at-risk women.
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The benefits are minimal, no matter what your doctors say. The side effects, for some of us, are quite severe and life-altering. If you're not having side effects, good. Great for you. But you should still understand that when your doctor says the benefits are great, what he/she means is it's the best they can do. Ask you doctor exactly how much you are decreasing your chances of recurrence. Exactly how much. Don't fall for that "cut it by 1/3" because that sounds much better than it is. For me, as I said, five years of the tamoxifen punishment reduces my chance of recurrence from 12% to 8%. Sure, that's 1/3, but really, it's only 4%. I will go on forever about the deception of the "cancer culture" when it comes to this punitive drug.
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Thanks for starting this thread Tamoxitoxic. I agree that 12% to 8% risk reduction seems ridiculously small compared to the potential serious side effects. I can hardly believe I stayed on Tamoxifen for two years, my side effects were so debilitating. I was so reluctant to stop it because I believed it would stop recurrence. When I told my doctor that I'd stopped after two years, she barely reacted at all. I was getting heart palpitations every day even for a while after stopping it. Very scary.
I wonder if the AIs also provide such small benefits. Trying to comprehend statistics and mathematical equations isn't easy for everyone (including me). When you've already been through the shock of diagnosis, surgery, the waiting for results, other tests, radiotherapy, maybe chemo, the assault to the emotions and body has been so great that to fully understand the risks/benefits of hormone therapy is a step too far for many. Some MOs are better at explaining these matters than others.
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Sorry, just noticed that 9lives70 started the thread, not Tamoxitoxic! You can blame my letrozole-addled brain for that!
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Funny- my numbers are somewhat similar and I thought the percent advantage was significant. It is a 50% overall reduction from taking 5 years of adjuvant endocrine therapy but a 4%-6% actual improvement. My 5 year recurrence moves from 8% to 4% and my 10 year moves from 12% to 6%. I was told that there was no benefit to survival only reduced recurrence.
Unfortunately the Tamoxifen is making me feel like crap so I will have to revisit my thinking. From reading here-some women push through the SE's and get to a more normal place while for others the side effects persist.
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It seems like the studies show a great deal of discrepancy in terms of what percentage of women actually finish taking their tamoxifen as prescribed. However, there is no doubt many, many women struggle with this drug. Even if only 5% of us struggle with it, given how many women take it, that is a huge number which makes understanding the real benefits and risks very important IMO.
When our OCs say the benefits outweigh the risks, they are basically saying the percentage in risk reduction for BC recurrence (5, or 10% or 15% or whatever, depending on your personal numbers) outweighs the acknowledged risks (increased risk of endometrial cancer and blood clots-both of which can be fatal) of taking this drug to your physical health, because these problems even with tamoxifen usage are very, very rare, experienced by less than 1%. of users. What they never seem to factor in are extended health risks, medical issues and QOL.
For example, tamoxifen can cause chronic constipation. For me, this caused a rectocel, I did PE to avoid surgery to repair this. PE costs time and money and if I do eventually have to have surgery, there are the risks inherent in any surgery, plus the risks of developing bladder or bowel incontinence. My oncologist never discussed stuff like this with me! And I don't think they generally do. If you develop a rectocel due to constipation from tamoxifen use, you see your gyno and he or she treats you and the oncologist chalks your problems up to constipation, not tamoxifen usage!
My gyno, who has been practicing for many years, has said her patients taking tamoxifen have a lot more gyno problems (not endometrial-cancer related stuff but fibroids, polyps, cysts) than those not taking this drug, some serious, some requiring surgery, some problems annoying and painful. Benign ovarian cysts are common among tamoxifen users. They aren't seen as a health risk when considering risk/benefit ratios (because they won't kill you or shorten your lifespan), but they can be very painful, cause missed work, extra doctor visits and sometimes surgery. And then there is sexual dysfunction, not seen by our doctors as a health risk, but certainly a side effect that can affect your quality of life and your relationship with your partner. And on and on and on.
From reading on here, I don't think many women actually decline to take tamoxifen due to fear of the drug or possible side effects, although lots of us have reported staring at that first bottle for a few days or weeks before taking the plunge! Most women for whom it is recommended do try it and lots of them do just fine on it.
What I have a real problem with, and why I keep writing this stuff, is that women who do experience very bad side effects while taking tamoxifen, are sometimes/often led to believe taking this drug is SO important, that it is the only thing standing between them and a stage IV diagnosis, leaving them terrified that if they quit taking it they will certainly have a recurrence (which is so not true). They are told to keep taking it no matter what, to try taking other drugs, have surgical procedures, live without sex, etc. just don't quit taking your Tamoxifen because it's so stinking important!
However, the actual numbers say something very, very different; that most of us with early stage BC would be fine w/o taking anything! Sure, it's worth a try to hedge your bets and cut your risk of a recurrence by a few percentage points, but I think it is just horrible the way some women are encouraged to, told they really must continue taking this drug even when they are suffering from some pretty extreme side effects. Worth trying? Yes. Worth continuing no matter what? NO WAY!
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Thank you so much labelle for your above post - especially your last paragraph:
"However, the actual numbers say something very, very different; that most of us with early stage BC would be fine w/o taking anything! Sure, it's worth a try to hedge your bets and cut your risk of a recurrence by a few percentage points, but I think it is just horrible the way some women are encouraged to, told they really must continue taking this drug even when they are suffering from some pretty extreme side effects. Worth trying? Yes. Worth continuing no matter what? NO WAY!"
I discontinued taking tamoxifen due to a number of serious problems - not just annoying side-effects. Arimidex produced a toxic reaction. My oncologist gave a very hard sell to go back to tamoxifen in spite of the problems I had with it and my pretty good cancer profile. He made it sound like I would be likely to get mets if I didn't. But when pressed, he couldn't say that taking tamoxifen would would give any sort of guarantee either. I think "standard of care" requires that some type of medicine be recommended no matter what.
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Lisey...I understand what you are saying. However you need to know that my sole purpose is to support the many women who suffer from moderate to severe SEs on both anti hormone therapies. IMO there should be more research on better treatment options. It seems only those who do suffer can relate. I happy for anyone who does well on these drugs but let's not forget those who don't. In the future I will try to make the distinction between Tamoxifen/Aromatase inhibitors more clear. Good luck to all navigating this complicated disease and making these tough decisions.
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Thank you dtad, I appreciate it. I likewise want newbies to know many many of us are doing great on Tamoxifen and to always at the very least try hormonals because odds are it's not as bad as they think. I thought it would be bad for me, given I'm an ultra rapid metabolizer.. however, nothing has come up so far 10 months in. Even if I get SE in year 2, this year has helped me fight cancer and I'm grateful for it.
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Hello all! I have just received my Tamox prescription and can't wait to start, lol. I am very opposed to radiation so this is my only option to cut the recurrence rate down.
I am thinking of starting a work out routine, actually just did for two weeks before I start. Any tips on how to ease into the pill? Anyone try alternative therapies? I.e. grape extract, etc?
Bebe
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Bebe, easing into tamoxifen is a good idea. I took 10mgs for two weeks, then increased it to 2 10mg pills pills per day. I also began walking a month before I was to take it, and now walk about 5 miles per day. I am doing fine on Tamoxifen.
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Hi Michelle_in_cornland and thank you for your post. I have started a work out routine this week and will stay committed. I will start Tamox in about 2-3 weeks. I also have some minor virus that makes me a bit nauseated so I want to feel 100% before I start so I don't layer SE on the top of something else. Happy to hear you are doing well
Bebe
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Michelle: So glad to see your post. I have had very troublesome emotional/psychological SEs with two aromatase inhibitors. Have appointment with onc tomorrow and want to ask her about Tamoxifen and see whether I can tolerate. I'd never thought to ask re: starting on half a dose, then increasing. Thanks a lot, and I'll report back.
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labelle: I LOVE your post. I agree with so much that you said. I am now contemplating switching from AIs to Tamoxifen, due to intolerable emotional/psychological side effects. But I would really rather be taking nothing! Unfortunately, I am one of those women who have been scared half to death of NOT taking the drug. My 'index' cancer has a very low recurrence rate....but what about having LCIS, which I do and which raises recurrence/new cancer risk on both sides? I also have extensive family history but am BRCA negative.
I am so torn, wanting that extra protection but NOT wanting to give up quality of life for what my onc said was a "small" benefit. I nearly went around the bend on Arimidex....terrible. Too scared to drive the car or walk the dog, and needed someone with me all the time. I am petrified of this happening again! I went from anastrozole to exemestane, and so far the emotional effects haven't been nearly as bad, but I am definitely depressed, listless, unmotivated, etc. Am seeing onc tomorrow and will discuss with her trying Tamoxifen. My mother was on it for five years, decades ago, and had no side effects from it.
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Just had another thought, as I am making dinner in such distress over this. Instead of "deciding forever" what I will do, why can't I tell onc tomorrow of severe emotional side effects with anastrozole, and these to some extent continuing on exemestane....and suggest that I work with psychiatrist (and with myself) to get as emotionally stable and physically healthy as I can...and then consider re-trying the exemestane or trying Tamoxifen then? (I know that early years after first dx are highest-recurrence risk times, but...) Can I go all out to get as healthy emotionally and physically as possible, and then maybe take another pass at this in 4 or 6 months? Am trying to think out of the box on this to get some mental relief from worrying, and get some time and space between me and the whole first part of this BC mess.
I am fortunate that my recurrence risk has been called low to very low. I know many of us here don't have this "luxury." Am just wondering if this might be a way to preserve my sanity while considering the drugs. What do you think? Has anyone done this?
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hello i took tamoxifen for 5 yrs my side effect was weight gain But as i finished i eventually lost the weight i was glad to be here heavy n All then to not Praise God i am a 23yr Survivor. msphil idc stage2 0\3nodes chemo before n after Lmast then 7wks radiation was diagnosed while making wedding plans weu did get married between chemo n rads.
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Michelle,
Easing into tamoxifen is a wonderful idea. Didn't know we could do that. I will be starting it after my DMX sometime the end of May. So you take 20mg per day
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msphil,
What an honor to know you're a 23 survivor! Lifts my spirits. I will be on tamoxifen after BMX in May
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girl - I had a terrible time emotionally after dx and after trying Tamoxifen for ten days I quit it for a year. After that year I tried again and mainly had garden variety issues initially. I continued on for the next four years between Tamoxifen, Femara, Arimidex, and back to Tamoxifen. I quit it all a week ago. Good enough will have to be good enough.
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Girl53,
You definitely need to be mentally stable. I think that both your oncologist and psychiatrist need to work as a team. I started Prozac but come to find out we have to switch since it interferes with tamaxofen. But we're going to do it after my BMX
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Bebe,
I'll be starting tamaxofen the end of May after my BMX. Let me know how it goes, since you'll be starting a little bit before me
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Lisey,
I'm glad to hear you're doing good in tamoxifen. I hear so much bad stuff, that it scares me. Are you taking 20mg
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