Tamoxifen absolute vs relative benefit--is it worth it?
Comments
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I took it for 4 years. Started out taking Arimidex. My ONC never said anything about that either. The only issues I had with it was joint pain and some trouble concentrating and minimal weight gain. Nothing major.
Diane
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I take 10 mgs of Tamoxifen twice per day. Easing into it was very doable. I push myself to walk 5 miles per day or I can feel stiff. I eat a very raw diet with fish, nuts, cashew products, 6 veggies per day, sometimes eggs, gluten free, lactose free, soy free. I take 50,000 of D per week via prescription. I ditched my ovaries and uterus in January because I would have had to get injections to shut my ovaries down. I feel better than I have in years. The more I move, the better I feel. How you start is up to you, how you finish is up to your doctor. The long term goal is to stay on the medication.
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LordHelme, Yes, I'm taking the normal full dose. Not one side effect. No weight gain, in fact I think I'm thinner than at diagnosis. It's a sugar pill to me, and I know 5 others locally taking it with no issues either - so at the very least give it a shot. : )
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Lisey-that is what i want-sugar pill side effects!!!
I know it is likely not that simple but what brand of Tamoxifen are you on? I am teeing up for another try soon... Teva gave me the opposite of sugar pill se's. -
I'm set to start Tamox in the next week or two. 2nd MO appt next week -- though I already have the bottle sitting here waiting on me! LOL
Why does it seem that some MOs suggested ovarian ablation and some do not? With similar diagnosis? I see why for those much younger (I'm 49) but for those of us in late 40s and Peri or pre-M still -- is Tamox alone enough? know prior to SOFT trial results, some were taking Zolodex (I think it's called) AND Tamox but seems not the norm now.
My oncotype was 14 -- so no chemo called for at MD Anderson (where I had surgery) and expect the MO next week to agree. This is 2nd opinion as I did not love my first MO. Though I am willing to discuss all options but getting so far away from surgery and diagnosis, I think my window closed in any case.
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The SOFT trials showed that Tamox was effective equal to an OS/AI for women in the low risk category. However in the High risk / chemo category, AI/OS was superior. I'm 41 and not menapausal, I was deemed low risk from the mammaprint, so Tamoxifen should be effective for me at least for a few years. The oncologist wants me to keep my ovaries / hormones as long as possible for the health benefits they bring. some women do become tolerant/resistant to Tamoxifen a few years in, so that's why they switch to an AI at that point.
As for me.. I'm getting my endoxifen levels tested every year to make sure I'm in the therapeutic range (it's a free lab test for members of Kaiser when their MO orders it). As long as I'm in range, and having no side effects, I'll stay on Tamoxifen as long as possible. My manufacturer is MAYNE.
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Farmer and Lord: Thanks so much for your replies. I took the pill last night and will see onc today, and I think my hubby is going to go with me. I'll tell her I plan to shore myself up, get to a better place, and then try again when the time is right....I guess including switching from certain SSRIs that interfere with Tamox.
I just don't feel emotionally stable enough to do this right now. I'd hoped that the anxiety and depression meds my psychiatrist has me on would do the trick, and I'd be fine. But I'm not. I had been diagnosed with complex PTSD due to childhood trauma about a year before BC dx. The whole thing is bringing back fear and grief from the death of my first hubby of a brain tumor (after a 14-year battle). My twin sister's husband is now about to join a clinical trial to try to treat stage IIIc melanoma, and my boss, who is also a friend, has just been dx'd with colon cancer and will be out for months.
I had "flipped out" last September with tremors and acute anxiety and was a total mess until late January/early Feb. Had started feeling better so psychiatrist and I decided it was time to re-try the AI, March 25. It's been almost a month, and can feel the symptoms starting to creep back with the exemestane. Part of me is so angry and scared to "have to" make a decision like this...like it isn't fair. But what IS fair for almost any human on the planet? I guess we just have to take it a day at a time, and do the "next right thing," as a loved one's 12-step program tells her.
FarmerLucy, it sounds like the stop/start approach worked pretty well for you. Am glad issues that arose when you re-started were garden variety and not severe. And congrats for finishing course of meds....a week ago? Yay you!
Lordhelp, I wish you good luck with your procedure and with the meds. Let's all not lose touch. Maybe I"ll post this afternoon after come back from doc. Thanks again to you both.
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Hi Lordhelpmetoo:
From your profile, it looks like you had TC chemotherapy for a hormone receptor-positive, HER2-negative, node-negative tumor smaller than 1 cm. Was this based on receipt of the OncotypeDX test and your Recurrence Score? If so, please be aware that recurrence risk information provided to you based on the OncotypeDX Recurrence Score "assumes" the receipt of 5-years of Tamoxifen.
In the node-negative (N0) Oncotype report, the first graph shows the relationship between 10-year distant (metastatic) recurrence risk after 5 years of Tamoxifen. This is based on the results of a clinical trial in which all patients were assigned to 5 years of Tamoxifen alone.
The information in the second graph is taken from a different clinical trial in which patients were assigned to receive (a) chemotherapy plus 5 years of Tamoxifen; or (b) 5 years of Tamoxifen alone.
As you can see, all of the patients in both studies were assigned to 5-years of Tamoxifen at least, and one group received 5-years of Tamoxifen plus chemotherapy. This is why we say the test "assumes" 5-years of endocrine therapy.
So, if your medical oncologist provided information to you about 10-year distant recurrence risk based on an Oncotype report, this is by definition the risk after 5-years of Tamoxifen. The distant recurrence rates shown in the node-negative (N0) report would be much higher than shown in the report if the patients had not received Tamoxifen.
I hope you find you are one of those who tolerates treatment well.
BarredOwl
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BarredOwl,
Thank you for this information. My onco DX was 20.
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Lisey,
Good to know about this test. I'm also a kaiser member. Will definitely ask about it
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I will keep you posted. I am trying to feel better as I am fighting some viral infection, before I start.
Big hug
Bebe
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Lordhelpme, my oncotype was a 20 as well. No chemo for me as a 20 oncotype has a chemo benefit of only 3-4%. And for me the risks of Chemo were higher than that. Plus the mammaprint second opinion put me in low risk/no chemo. But tamoxifen however made my recurrence rate go from 26% to 13%. As a 20, that's what yours is as well. Your sheet would look exact to mine.
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Hi Lisey and Lordhelpmetoo:
Lisey, your estimate of an approximately 26% risk of 10-year distant recurrence with no Tamoxifen is an extrapolation from the 13% risk shown with Tamoxifen Alone (10-year distant recurrence after 5-years tamoxifen) for a Recurrence Score of 20, per the first graph of your node-negative report. That type of extrapolation may apply to you as a person who is receiving Tam Alone. However, a person who received both chemotherapy and Tamoxifen may not be similarly situated.
This is because the potential benefit of endocrine therapy is proportional to residual risk:
EBCTCG (2011): http://thelancet.com/pdfs/journals/lancet/PIIS0140-6736(11)60993-8.pdf
"Hence, the absolute risk reductions produced by tamoxifen depend on the absolute breast cancer risks (after any chemotherapy) without tamoxifen."
Lordhelpmetoo is receiving chemotherapy plus tamoxifen. If she would like an estimate of the potential benefit of Tamoxifen in her case, she should seek expert professional medical advice from her medical oncologist regarding her residual distant recurrence risk after chemotherapy (perhaps with TC specifically), along with an estimate of the additional risk reduction benefit that could be achieved by 5-years of tamoxifen.
BarredOwl
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Linsey,
My onco explained that it was more for distant recurrence. I wasn't given a mammaprint screening
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Hi 9lives70:
To your original question regarding the Opposing Views piece (the "piece"), I cannot locate the name(s) of any author(s) or any credentials to indicate that any author(s) have relevant training or experience in medical oncology. You may wish to consult your medical oncologist about it and inquire whether the analysis is sound.
I may be missing something, but here are my layperson impressions. The underlying publication is the EBCTCG (2011) meta-analysis:
EBCTCG (2011): "Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials"
Main Page: http://thelancet.com/journals/lancet/article/PIIS0140-6736(11)60993-8/abstract
PDF version: http://thelancet.com/pdfs/journals/lancet/PIIS0140-6736(11)60993-8.pdf
Supplementary web appendix: http://thelancet.com/cms/attachment/2001012705/2003807448/mmc1.pdf
In discussing the data in Figure 5, the piece asserts: "Ultimately, those in the tamoxifen group took the drug for five years." However, those in the tamoxifen group did not all receive five years of treatment. The title of Figure 5 itself is: "Effects of about 5 years of tamoxifen on the 15-year probabilities of recurrence and of breast cancer mortality, for ER-positive disease." The first page of the EBCTCG publication recites the phrase "about 5 years" four times, and includes details regarding the durations of Tamoxifen used in the trials included in the meta-analysis:
"In this Article, we report the trials of longer tamoxifen durations (described as about 5 years of tamoxifen).[4–26] Most trials were of exactly 5 years of tamoxifen,[4–16] four were of only 3 years,[17–21] one re-randomised some participants at year 2 to stop or continue to year 5 (with all re-randomised patients remaining in the analyses),[22] and two re-randomised some at year 5 to stop or continue to year 10 [23–26] (webappendix pp 18–36)."
The piece includes recurrence and mortality analyses based on the numbers printed below the two graphs in Figure 5. Inspection of Figure 5 reveals these values are "Recurrence rates (% per year)" and "Death rates (% per year: total rate minus rate in women without recurrence)." In the first step of the analysis, the piece states: "For all ER+ women, there were in years 0-4, a rate of 3.74% who had recurrences among those who took tamoxifen. . ." The piece seems to be equating a rate of 3.74 % per year in years 0 to 4 with the total percent who had recurrences over four years. I question whether that is sound. Also, I do not understand the need to use the "% per year" data to calculate the probability of recurrence (Figure 5, left); the probability of breast cancer mortality (Figure 5, right); or the absolute benefit between treatment groups when these can be read off the graphs.
Looking at Figure 5 (left), the 15-year gain (or absolute difference in recurrence) is printed under the curves:
"15-year gain 13·2% (SE 1·1)" in Recurrence
Looking at Figure 5 (right), the 15-year gain (or absolute difference in mortality) is printed under the curves:
"15-year gain 9·2% (SE 1·0)" in Breast cancer mortality
The EBCTCG authors explain the "absolute mortality benefit" observed between two treatment groups (about 5-yrs of Tamoxifen versus control; Figure 5 (right)) in terms of reducing breast cancer mortality in the accompanying text. The percentages given are rounded up from the values printed next to the curves [per notes in square brackets]:
"The absolute mortality difference was only 3% (9% [rounded up from 8.6%] vs 12% [rounded up from 11.9%]) at year 5, by which time trial treatment had ended (in all except the few patients re-randomised to continue after year 5), but it was three times as great (24% [rounded up from 23.9%] vs 33% [rounded down from 33.1%]) by year 15."
[Note: ~12% minus ~9 % = ~3% mortality benefit at 5 years; ~33% minus ~24% = ~ 9 % mortality benefit at 15 years]
Based on a prior 2005 study, in another paper Dowsett notes:
http://ascopubs.org/doi/full/10.1200/JCO.2009.23.1274
"In the trials studying approximately 5 years of adjuvant tamoxifen versus no tamoxifen in ER-positive disease, the main effect of tamoxifen on breast cancer recurrence was seen in the first 5 years (absolute gain of 12.5% at 5 years and roughly constant thereafter), but the main effect on breast cancer mortality was seen later (absolute gain of 3.3% at 5 years and 9.1% at 15 years)."
Note that the "absolute benefit" observed in various clinical trials can differ according to the particular endpoint used (e.g., recurrence, mortality, etcetera); timepoint (e.g., at 5 years, 10 years, 15 years); patient population (e.g., ER+ versus ER-); and comparator (e.g., placebo, comparator drug). Secondly, individual benefit may materially differ from the absolute benefit observed between patient groups with relatively diverse risk profiles (see below).
In view of the above, I would recommend that patients refer to original EBCTCG (2011) research paper and the explanations therein, and that they discuss any questions about it with their medical oncologist.
One of the most important conclusions of the EBCTG meta-analysis is that the benefit of Tamoxifen was proportional to individual risk:
"Hence, the absolute risk reductions produced by tamoxifen depend on the absolute breast cancer risks (after any chemotherapy) without tamoxifen."
This means that those with greater residual risk after all other treatments potentially reap larger absolute benefits than those with lower residual risk, as explained above by others.
The "relative risk reduction benefit" (in reducing recurrence) of five years of initial monotherapy with Tamoxifen in early stage invasive breast cancer (versus no endocrine therapy) is often given as ~45%.
With an estimate of individual distant recurrence risk (after chemotherapy, if any) ("RISK"), one can calculate individual absolute benefit in reducing said risk:
(RISK (%)) x (relative risk reduction benefit; e.g., 0.45 if 45%) = (absolute risk reduction benefit of Tamoxifen (%))
(RISK (%)) - (absolute risk reduction benefit) = (residual recurrence risk with Tamoxifen (%))
Because potential benefit is proportional to individual risk, patients may wish to seek case-specific advice from their medical oncologist regarding their estimated recurrence risk after all other treatments, the potential relative risk reduction benefit and estimated absolute risk reduction benefit of any proposed endocrine therapy regimen in their case. This in turn is weighed against the risks of treatment in a personalized risk/benefit analysis.
In early stage invasive breast cancer, endocrine therapy can reduce the risk of mortality, the risk of distant (metastatic) recurrence, as well as the risks of loco-regional recurrence or new disease (e.g., contralateral breast cancer). So be sure to ask about the type of any risk estimate provided to you by your medical oncologist, write it down and have your MO check the accuracy. For example, what type of recurrence risk is being discussed? (5-year? 10-year? Mortality? Distant recurrence? Other?)
Please review any information or materials from outside sources (including this post) with your medical oncologist to confirm accurate understanding, as well as currency and applicability to your specific case.
BarredOwl
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Amapola, my oncoDx was 20. Which is low end of grey area. I had a hard time accepting chemo. But like you, anything to reduce recurrence. I will be having BMX in may
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To the poster regarding SSRI's, there has been new research and publications categorizing SSRI's even further than what we know. Boston Medical Journal from Sept. 2016 discusses SSRI's from most impactful used with Tamoxifen to least impactful used with Tamoxifen. You can private message me for further information. The hormonal threads are to be used to give insight into our personal experiences with anti hormonals. The only side effect from Tamoxifen that I have is hot flashes and an overall sense of feeling warm.
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Hi Michelle_in_cornland:
Please note the text at the top of the page that provides additional guidance:
"Risks and benefits, side effects, and costs of anti-estrogen medications."
Reliable and objective information from the scientific medical literature about "Risks and benefits" or "side effects" would not seem to be prohibited. Drug-drug interactions can reasonably be considered as a risk of treatment, or (in certain cases) as having a potentially adverse impact on the benefits of treatment. Please do not hesitate to share your article in a post.
In any case, such information is freely available. Googling "SSRI and Tamoxifen" yields as the first hit an editorial from by Juurlink from the BMJ (Sept., 2016) (British Medical Journal) that discusses and links to a BMJ (2016) research publication.
BarredOwl
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Ladies: A quick update on my onc visit Wednesday. She told my husband and me that my risk, with no adjuvant endocrine therapy, is under 5 percent, and that absolute benefit of any endocrine treatment would be very low. Going off these meds is not something I would usually do -- I tend to be risk averse in general. But with the truly awful psych/emotional symptoms I've had on two AIs, I am just afraid. So doc and I agreed that I would stop taking the Aromasin, take 6 months to shore myself up, and then maybe try the Tamoxifen, understanding that the benefit would be very low. I often feel nervous about stopping since I never got an Oncotype score....tissue sample too small. Onc says that the tiny size and grade, etc., of my tumor "trumps" any other factors when it comes to risk....risk is very low. Hope she's right. Want to live healthy and be alert for for signs without being paranoid LOL!
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yes, ssri do impact tamaxofen. I'm currently on Prozac and wil switching to Effexor soon
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Some SSRI's have minimum effect on Tamoxifen, and some have more effect. Just be sure to always check with your own doctors. There has been some new research published that I am sure they are aware of.
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Yes, there are some SSRIs that interfere with Tamox. Celexa, what I'm on, is fine but MO tells me to take it in the am and Tamox in the pm, not take it together just to be sure.
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Thank you everyone here, I'm learning so much from all of you. I'm hoping to be able to tolerate the Tamoxifen with very little SEs.
Artista, I'm on Celexa as well as Wellbutrin. I'll have to check into the adverse effects of the Wellbutrin and Tamoxifen. I'm praying I can continue using wellas it's been a real life saver. Literally a life saver.
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One thing that I haven't seen mentioned yet is that for some of us, Tamoxifen may serve a dual purpose - reducing the risk of recurrence from a cancer we've already had, but also, especially for people who chose a lumpectomy (so still have plenty of remaining breast tissue), preventing a new primary.
My oncologist went over the risks of each (recurrence and new primary) and honestly, the potential to reduce the chance of a new primary was my primary motivation for taking it. I figure the surgery and radiation probably took care of the existing cancer, but if my body can create cancerous cells by age 45, and since I'm not expecting to go through menopause until 55 (based on my mother's experience), that's plenty more estrogen-exposed years to grow a new one. Just throwing that out there as an additional reason that some of us may choose to take it. It's possible that neither risk reduction alone would have convinced me, but the combination did.
That said, I've been on it for 4 years now, and while I've had some side effects (mostly hot flashes, minor leg cramps and weight gain) I can't swear that much of that wouldn't be happening anyway being that I am perimenopausal and most of my same age friends are complaining about hot flashes and weight gain even though they've never been on it.
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Lori, Wellbutrin does interfere with Tamox. Celexa is mild so my onc told me to take hours apart from each other.
https://www.verywell.com/antidepressants-that-inte...
http://www.health.harvard.edu/newsletter_article/a...
One thing to note with Effexor as I was on it long term for depression/anxiety and not hot flash is even if you slowly wean off of it, it makes you (me) feel like I have a bad case of the flu for a long while. If I missed taking the pill by 3 pm, I started to feel a bit flu-ish. Was the worst SSRI for that reason alone, so anyone looking at this, proceed knowing this could very well happen to you.
Double check with your onc but I'm pretty sure my onc said Wellbutrin wasn't a good one with Tamox.
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Also, do NOT take Paxil or Prozac while on Tamox. They are the worst inhibitors. "They found that taking paroxetine (Paxil) while on tamoxifen was associated with an increased risk of death from breast cancer and death from any cause."
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Artista, thank you for all the info. I can't take any of the meds you mentioned as they all turned me into a raving lunatic especially Prozac!! This should be interesting to say the least and I'm not looking forward to any changes to my meds as I feel more normal now than I did before my BC diagnosis ?
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It is stressful changing meds. I've taken many of the SSRIs over the years since '95 for major depression and anxiety, usually because it eventually stopped working. Effexor was the worst slowly weaning off of it. Others I transitioned fine. Thankfully Celexa/Citalopram has since 08. You could always try. If nothing else works then you can always go back. Lexapro/Escitalopram is the same class as Celexa/Citalopram and I've heard some do better on one than the other. Perhaps it's the filler, like it can be with the AIs where one is more tolerable than the others. Right now it would be nice to be a pharmacist!
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Artista, I already take Celexa along with the Wellbutrin and there's another one I take to help me sleep but I can't think of it right now. Chemo brain I guess? Sheesh I'm sure my PCP will figure something out that will work for me. 🤞
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From the day they handed me the "So You've been Diagnosed with BC" handbook, I dreaded the idea of Tamoxifin. I drew all sorts of frowny faces in that chapter. The MO tried to console me, asking if I was concerned about the weight gain & hot flashes. I said "NO, its the bone pain, joint pain & stroke that are my concerns. Plus a 50% reduction in occurrence sounded good, but I read the fine print & said "Whoa! That's 20% down to 10%...so it's only a 10% improvement..Maybe." Because of the statistical deception, I became even more hesitant. The first day I took it, I threw up, because mentally I was so opposed to taking it.
Like Annette47, my age, being premenopausal, and because I had to have 2 lumpectomies, I feel like I must endure this drug. I've been on it for 3 months. So far, I've had minor bone pain, an over-all feeling of heat especially on the left side of my face, very red eyes especially in the left eye, & insomnia. My periods are now 3 weeks apart and I just got diagnosed with anemia. Up until the anemia, everything had been acceptable. As many SE as this drug has, I really wish there would be some kind of scan or blood test to see if the estrogen is being blocked properly in MY body.
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