Important for Her2+ on Tamoxifen
Time to repost this:
Many of you may have seen references indicating that women with Her2+ BC don't do as well on tamoxifen as women with Her2- BC. In fact, there have been studies that demonstrated that tamoxifen can actually fuel Her2+ cancer growth in cell cultures. I asked my Mayo onc, given this, why shouldn't I have ovarian suppression (Lupron or ooph) and take an AI instead of tamoxifen? He explained to me that tamoxifen is not the active form of the drug. Tamoxifen is what is known as a pro-drug, it must be metabolized by the body into its active form called endoxifen. Unmetabolized tamoxifen can indeed fuel breast cancer growth. However, the metabolized form of the drug (endoxifen) is an extremely potent blocker of the estrogen receptor (recent research from Mayo has shown that endoxifen actually degrades estrogen receptors in cancer cells, slowing their growth). My onc went on to say that endoxifen is so potent, it blocks any stimulating effect tamoxifen has on breast cancer.
The potential problem is when tamoxifen is not effectively metabolized to endoxifen. An enzyme in the liver called CYP2D6 is responsible for the metabolism of tamoxifen into endoxifen. About 7% of Caucasians and African Americans are "poor metabolizers". They inherited a genetic form of the CYP2D6 gene that does not allow tamoxifen to be converted into endoxifen. In hormone receptor positive BC (the population including both Her2- and Her2+) poor metabolizers have significantly higher rates of breast cancer recurrence than good or "extensive metabolizers". There have been a few studies published that demonstrated this effect.
He went on to tell me that Her2+ poor metabolizers do exceptionally poorly on tamoxifen, much worse than even Her2- poor metabolizers.
There is a simple blood test that will tell you your metabilizer status. It costs only a few hundred dollars and some insurance will pay for it. I think its a good idea for all patients that are considering taking tamoxifen to be tested. But in light of what my onc told me about Her2+ BC having a much poorer prognosis if you are a poor metabolizer on tamoxifen, I think it is critical for Her2+ women.
Why not just go on an AI? My onc was very much in favor of tamoxifen for EMs due to quality of life issues and he was confident that Her2+ EMs do very well on tamoxifen. With trepidation, I went along with it; I have been on tamoxifen for a little over a year. Later, I found evidence that Her2+ EMs do, in fact, do very well on tamoxifen. (I'll explain in a later post as this one is getting very long).
In addition to "extensive metabolizers" (EMs) and "poor metabolizers" (PMs), there is also a group of people that inherited one of each gene. These people are termed "intermediate metabolizers (IMs) and in the Mayo study including all hormone receptor positive BCs (Her2- and Her2+) IMs fared slightly less well than EMs, but significantly better than PMs. We did not discuss the impact of IM status on Her2+ women.
Bottom line: If taking tamoxifen, please consider getting tested for metabolizer status. Also, stay away from drugs that interfere with the metabolism of tamoxifen.
Comments
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Orange1,
I just wanted to let you know how important your posts are to me. They are always extremely informative and accurate, plus you have a knack for cutting through the medical jargon to make it easier to understand. Please never stop posting!
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Yes..orange is a sweatheart!!!
I have still not yet had the test. I don't have any money now. Im hoping maybe next year. 7% of the caucasian population NOT extensive metabolizer is very low....I hope right now Im on the other end.
My onc feels the same way about tamox too. Quality of life....I already have some aches and stiffness from the lack of estrogen (Lupron + Tamox) an AI would be worse...and he agreed. I am happy about being on the tamox.
Orange..thanks for always shinning the light on Her2 disease...its good to put it out there that it is NOT a doom and gloom prognosis...but actually being Her2+ today...gives a woman evry reason to be optimistic.
Thanks.
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Lexislove, you're another one whose posts have taught me a lot over the last eight months so thanks!
I believe you live in Canada and was wondering if your onc's response to this test was similar to mine. First of all I'm being seen at a teaching hospital here in Toronto and my onc is also teacher, scientist, director of the breast centre, etc., etc........very intelligent but unfortunately, no time for her patients. I rarely see her but instead I get her Fellow (who I have little confidence in). I brought up my concerns about Tamox and asked the Fellow about the CYP2D6 test to which he replied "we don't do that here in Canada and I don't believe it's done in the US yet". I told him that it is done at the Mayo Clinic for sure and suggested that he discuss this with my onc. He did and came into the treatment room to tell me that my onc confirmed that this test is being done at the Mayo Clinic as well as some other centres in the states, but it's not being done in Canada and if I want to pursue this, they don't know how to help me?? Thanks for nothing......
Just curious as to what you have been told from your onc. I don't know how to move forward on this as I can't get anyone to listen.
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The Globe & Mail recently did an article on this, here is an excerpt:Gold-standard drug does nothing for some breast-cancer patientsDianne Theoret-Major, 47, of Halton Hills, Ont., was diagnosed with breast cancer earlier this year and tested in June for the genetic variation that affects the activity of enzyme CYP2D6. J.P. Moczulski/The Globe and MailDoctors split over recommending expensive test to determine benefits of tamoxifenLISA PRIESTFrom Thursday's Globe and Mail Published on Thursday, Oct. 15, 2009 12:00AM EDT Last updated on Thursday, Oct. 15, 2009 3:28AM EDTThousands of Canadian breast cancer patients who take tamoxifen for years in the hope of fending off a recurrence may be doing it for naught: Because of their genetic makeup, the drug is doing little or nothing to help them.A test that could tell which patients are less likely to benefit from the drug is not widely available in Canada. The test is being done in the United States, but it is expensive, and requires women to send blood samples or cheek swabs to the U.S. labs that perform it.The test is looking for a variation in the gene that controls the activity of the CYP2D6 enzyme that might make the tamoxifen less effective in combatting cancer.Some women are balking at the $500 cost for the test, while others are forging ahead, even though medical oncologists disagree on whether to recommend it to patients.The Canadian Association of Provincial Cancer Agencies hasn't taken a position because it says the scientific evidence isn't reliable enough.However, its executive director, Heather Logan, said women have a right to information about the test, and patients should discuss it with their clinicians.Ellen Warner, director of Pynk, the breast cancer program for younger women at Toronto's Sunnybrook Health Sciences Centre, said her "gut feeling" is that all women on tamoxifen should be tested. So far, about a dozen women have sent their blood to the Mayo Clinic for testing.Some physicians are also using Toronto-based pharmacy.ca, which sends patients' cheek swabs to a U.S. teaching hospital, providing results in two weeks.
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Thanks so much Beach!
I asked my onc about the test...this is what he said, "save your money." He said the same thing orange said around 10% of caucasian woman DON"T metabolize tamox well. The chances I will. He also said that IF the test showed that I wasn't an immediate metabolizer, doesn't mean that I wouldn't benefit from it at all. He is not bought on the whole Her2 and tamox thing...yet. He said studies haven't proved much.
Also, with being very pre menopausal, he believes that taking an AI for ME would leave me with poor quality of life issues.
The test is not available in Canada yet. You have to have blood drawn and have them send it down south. I think I got a quote of around $600.00. Well....right now I don't have it to spend.
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The problem, as I understand it from Dr. Goetz, is that in the case of run-of-the-mill hormone receptor positive BC (Her2-), poor or intermediate metabolizers are not helped as much by tamox as extensive metabolizers are. End of story.
But, in the case of Her2+, unmetabolized tamox actually fuels breast cancer growth, so Her2+ patients who take tamox and don't metabolize it have truely dismal outcomes. I believe - and my understanding is limited here - this is thought to be because the ER receptors and Her2 receptors are very close to each other, so the tamoxifen, not having been metabolized to endoxifen, binds the the ER receptor and at the same time stimulates the Her2 receptor and causes dramatically increased tumor cell growth.
I'm going to have to read up on this so I can be sure I am explaining it correctly. But I do know the numbers Dr. Goetz gave me for prognosis for Her2+ poor metabolizers - they were dismal. The mechanism of why this happens may be unclear, even to scientists, but the outcome is not theoretical, its real.
Many doctors won't put any Her2+ women on tamoxifen. They have seen or read about tumor flares and quick deaths. That's why I had much trepidation about taking tamox before talking to Dr. Goetz. He based his recommendation on data from retrospective studies - not just theory (it would be unethical to conduct prospective studies). The studies I have read seem well conducted and not hyped - so I trust his research.
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This is from a prestigieus journal, JAMA and came out just last week. It confirms that extensive metabolizers do better on tamoxifen compared with intermediate and poor metabolizers.
Source: JAMA. 2009 Oct 7;302(13):1429-36
Schroth W, Goetz MP, Hamann U, Fasching PA, Schmidt M, Winter S, Fritz P, Simon W, Suman VJ, Ames MM, Safgren SL, Kuffel MJ, Ulmer HU, Boländer J, Strick R, Beckmann MW, Koelbl H, Weinshilboum RM, Ingle JN, Eichelbaum M, Schwab M, Brauch H.
Dr Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Auerbachstrasse 112, 70376 Stuttgart, Germany. hiltrud.brauch@ikp-stuttgart.de
CONTEXT: The growth inhibitory effect of tamoxifen, which is used for the treatment of hormone receptor-positive breast cancer, is mediated by its metabolites, 4-hydroxytamoxifen and endoxifen. The formation of active metabolites is catalyzed by the polymorphic cytochrome P450 2D6 (CYP2D6) enzyme. OBJECTIVE: To determine whether CYP2D6 variation is associated with clinical outcomes in women receiving adjuvant tamoxifen. DESIGN, SETTING, AND PATIENTS: Retrospective analysis of German and US cohorts of patients treated with adjuvant tamoxifen for early stage breast cancer. The 1325 patients had diagnoses between 1986 and 2005 of stage I through III breast cancer and were mainly postmenopausal (95.4%). Last follow-up was in December 2008; inclusion criteria were hormone receptor positivity, no metastatic disease at diagnosis, adjuvant tamoxifen therapy, and no chemotherapy. DNA from tumor tissue or blood was genotyped for CYP2D6 variants associated with reduced (*10, *41) or absent (*3, *4, *5) enzyme activity. Women were classified as having an extensive (n=609), heterozygous extensive/intermediate (n=637), or poor (n=79) CYP2D6 metabolism. MAIN OUTCOME MEASURES: Time to recurrence, event-free survival, disease-free survival, and overall survival. RESULTS: Median follow-up was 6.3 years. At 9 years of follow-up, the recurrence rates were 14.9% for extensive metabolizers, 20.9% for heterozygous extensive/intermediate metabolizers, and 29.0% for poor metabolizers, and all-cause mortality rates were 16.7%, 18.0%, and 22.8%, respectively. Compared with extensive metabolizers, there was a significantly increased risk of recurrence for heterozygous extensive/intermediate metabolizers (time to recurrence adjusted hazard ratio [HR], 1.40; 95% confidence interval [CI], 1.04-1.90) and for poor metabolizers (time to recurrence HR, 1.90; 95% CI, 1.10-3.28). Compared with extensive metabolizers, those with decreased CYP2D6 activity (heterozygous extensive/intermediate and poor metabolism) had worse event-free survival (HR, 1.33; 95% CI, 1.06-1.68) and disease-free survival (HR, 1.29; 95% CI, 1.03-1.61), but there was no significant difference in overall survival (HR, 1.15; 95% CI, 0.88-1.51). CONCLUSION: Among women with breast cancer treated with tamoxifen, there was an association between CYP2D6 variation and clinical outcomes, such that the presence of 2 functional CYP2D6 alleles was associated with better clinical outcomes and the presence of nonfunctional or reduced-function alleles with worse outcomes.
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orange,
Say a Her2+ woman on tamox is NOT a IM. What would be the approx time line for recurrence?
2-3 years...just wondering.
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It is a bit technical and of course it is a retrospective analysis (so that is not as strong evidence as a so-called prospective study). But in any case, at 9 years of follow-up, the recurrence rates were 14.9% for extensive metabolizers, 20.9% for heterozygous extensive/intermediate metabolizers, and 29.0% for poor metabolizers.
I only read the abstract - I have yet to read the article. So I don't know if they also researched HER2+. Probably not because then it would have been mentioned in the abstract.
But, it seems to me that there is more and more evidence that testing for metabolizer status when starting treatment with Tamoxifen is a wise thing to at least consider. Like Orange has been pointing out numerous times.
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Great, I just found this and I believe Tamox is one of the drugs they plan on using for me. Well guess I will be talking to my Onc and insisting on the test. The last thing I need is something to increase my chances of a recurrance. My insurance should cover it and if not well I will just have to find a way to pay for it. Lovely
Thank you for this information I can't believe the things I have learned and wished I had never found out about.
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Hello. I am a HER2+ patient. I have finished my chemo treatments, had a double mastectomy and continue to take Herceptin every 3 weeks. My oncologist is suggesting that I begin taking tamoxifen. I have read many stories online about horrible side effects and would like to hear from anyone taking it now or that has taken it in the past. How did it effect you?
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Lexislove - He told me 15% of Her2+ poor metabolizer of tamox are alive in 5 years - that is 85% are dead. We did not discuss what set of data he was referring to - for example the proportion from each stage in the group he was referring to. We did not discuss IMs - intermediate metabolizers.
Helena - thanks for posting the abstract. I read the article - and you are right - Her2+ is not specifically addressed. I'm guessing the reason is that there were not enough Her2+ women that recurred to provide statistically significant results - so it is possible that is the results for Her2 could have been due to chance. I base this guess on.....
1325 women in the study and approx 20% are Her2+. So there are approximately 265 Her2+ women in the study. Assuming 8% are poor metabolizers, there are only 21 Her2+ poor metabolizers in the study. Assuming 85% of them die, 18 die due to being Her2+ PMs. This is out of 1325 women in the study - so it would be very difficult to show statistical significance with this few deaths.
Cparandjuk. I went into memopause while on chemo, so I suspect that most of my side effects are due to menopause, not tamox I'll let one of the younger women come along and tell you their experiences. I think most tolerate it very well.
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Cparandjuk, I'm 45 and was pushed into menopause just after my 4th chemo tx.......shortly after that the hot flashes, night sweats and trouble sleeping began. Started Tamox approx 2 mths later and noticed that all of these se's intensified slightly. I've been on it now for almost 2 mths and in addition to the above se's, I have noticed changes in my memory and cognitive function, as well as increased stiffness in my body. None are too severe except the stiffness.......look and feel like I'm one hundred when getting up off a bed, couch or chair and try to walk. This is the most concerning se for me but I'm still not quite sure whether it has been brought on by Tamox or not. It's still being investigated but so far a rheumatoid specialist has ruled out arthritis. Sending warm wishes your way.
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Beach, thank you for your note. I am 44 and was also pushed into menopause during chemo...my onc now wants me to begin taking tamoxifen for 5 years and I just want to cover all my bases. After reading these posts I will discuss getting tested for my metabolism status before moving forward.
I am concerned about the stiffness as I have already expereinced that through chemo and I am a very active person...I guess we have to take a little good with the bad.
thank you again!
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I had the metabolizing test done and was a good metabolizer of Tamoxifen, problem was I was breaking out in hives every day that I was on it for 3 1/2 months. So when I spoke with the attending ONCO in my hospital he asked me this one question:
"Are you having your periods any more?" (I finished TCH April 2009)
When I told him "no" (haven't had a period in nearly a year now) and tested post-meopausal with blood work up, he said he didn't have any problem with me not taking it OR and AI OR having an Oopherectomy because of the ZEBRA study. Has anyone else heard this before? This study, which you can read by clicking the words in purple here, shows that chemo induced amenoria (CIA) is as effective in early stage bc as compared to hormonal therapy for showing disease free suvival. I went along with this because I hated being on the Tamoxifen anyways (between the icky sticky green vaginal discharge AND the hives), and had read the book What Your Doctor May Not Tell You About Breast cancer which debunks the whole estrogen as being the big bad boy, which they say it is most certainly NOT. They cite that it is un-opposed estrogen (too low progestrone in the body) that proliferates BC. Has anyone else studied this?
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Isn't femora another option?
Stage 1 Nottingham 8 ER+ PR+ HER2++ AC, then taxol/herceptin, then radiation, then femora
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Femara or other AI is an option for post-menopausal women. If premenopausal, ovarian suppression or removal would be required along with the Femara.
Older women seem to tolerate Femara and other AIs a little better than the younger women. This may be because they are already used to low estrogen levels caused by menopause. Since tamoxifen blocks estrogen selectively - mostly in breast tissue - the side effects may be less severe than AIs + ovarian suppression. However, everybody reacts differently, of course; some tolerate it very well.
Once you have your ovaries removed, you can't have them put back in if the side effects turn out to be intolerable. So I suggest I trial course of ovarian suppression (with leuprolide or similar drug) before having irreversible surgery.
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Hi Orange1, i am very interested in your posting. I am currently on Herceptin and tried Tamoxifen. I had no side effects at all on Tamoxifen and very high oestrogen levels in my blood. The onc then recommended i have Zoladex but i am still on Tamoxifen - doing both together. What's your thoughts on this? I've heard AI's can stimulate the ovaries in pre-menopausal women on Zoladex - have you read anything on this with your extensive knowledge? I'm looking into having the tamoxifen metaboliser test now after reading your posting, i live outside USA so am looking for someone to do this for me.
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Thank you for posting this information. I saw one of my oncs today and when I asked about the test, he said yes, they can do it and put an order in at the lab. I was shocked as I belong to Kaiser a large HMO known to be very conservative with expensive tests. He mentioned that he had only ordered the test once before and he has been with Kaiser since 2001. Humm.
Orange1 thank you for getting the word out so we can take good care of ourselves
Juli
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Orange 12-
High blood levels of estrogen are expected if you are still premenopausal - even on tamox - because tamox does not block the formation of estrogen; it blocks the action of estrogen on breast tissue. I think its common to give tamox together with ovarian suppression (like Zoladex), especially to younger women, and it seems more common outside of the U.S.
I'm sorry I don't know the answer your question about AIs and ovarian stimulation. I haven't heard about it, but then I haven't read that much on AIs.
Especially with your lack of side effects, it makes sense to get you metabolizer status checked. If you are in Canada, it may not be that hard to have done, if your doctor is willing. If you live elsewhere you could try contacting Genelex, the makers of tamoxitest, and asking them how to get it done. Good luck with it.
Juli - thanks for posting. I am so excited to hear the oncs are finally starting to come around. There was a big article on this a few weeks ago, so maybe some of the insurers are starting to come around too. Or maybe they have finally figured out that having us on the right drug is much cheaper than a recurrence.
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Orange12,
Not sure where you are located but I'm in Toronto, Canada, also trying to get the CYP2D6 test done. My current onc doesn't seem to care about this, nor does she want to help me; however, my GP is finally listening and has sent a referral to another onc who actually weighed in on this issue in a recent Globe & Mail article also posted earlier in this thread. Currently I'm still waiting for an appt date. Will update here as I find out more.
Sandy
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I had ovaries removed but have uterus. So does femara present the same type of metabolic issue that require testing? +++
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Hi legs,
Femara does not require activation by the liver to be active, so it does not require testing.
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Orange1, thank you for all your information! It is so helpful and I appreciate it!
I have been taking Tamox for 1 week and am still on Herceptin. I have one herceptin treatment remaining. I haven't experienced too many SEs yet -- headache, fatigue and a little nausea -- maybe I will get lucky!
Thanks again for all the info!
Be good to you!
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Hi All, Just an update - turns out i am an intermediate metaboliser. My onc has given me 2 choices, stay on Zoladex and increase the dosage from 20mg to 40mg per day for tamoxifen, or stay on zoladex for 5 years and have an AI. The Dr advised being on an AI can stimulate the ovaries to produce more oestrogen and so needs to be monitored from a blood oestrogen level. we also discussed removal of ovaries, and onc agreed this was safer than zoladex . So my plan is to stay on tamoxifen until my immunity recovers (still low after surgery radio and chemo) and then have oophrectomy and go on an AI.
Anyone else got similar experiences to share?
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Finally received the test results back and I am a good metabolizer. I'm glad not to worry about taking tamoxifen next year. Thank you to all of you, for the valuable information.
Juli
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I finished up a year of Herceptin in Nov09 and now take Lupron to suppress the estrogen production. I am not taking Tamoxifen. I worry myself crazy about these decisions. My Oncologist feels that I could either take Tamox or the Lupron. I am ER+, PR+ and HER2+. I had extensive DCIS and then a small tumor (.4cm) of IDC was found hence the chemo and herceptin after my bi-lateral mastectomy.
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Christl, We are both about the same age and have a similar diagnosis. My onc has also recommended the lupron over the tamox for me (part of the decision lies in the fact that my mother had uterine sarcoma--tamox is known to increase the risk of uterine cancers and problems.) But, my onc wants me to do the lupron AND an AI, not just the lupron by itself. Did your onc give you any reasons as to why the lupron would be enough without the AI?
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Hi Weety,
No but I will ask. I go in for my monthly Lupron shot tomorrow and can ask the nurse. I thought the AI was for post menopausal women??
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Yes, you are right--the AI is for postmenopausal women, but when they shut down the ovaries with lupron, it is my understanding that then you are considered "post-menopausal" as well because your ovaries are no longer producing estrogen. Thanks for asking tomorrow. I am curious about it.
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