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Fri, Sep 13 1:49pm · Aromatase Inhihibitors: Did you decide to go on them or not? in Breast Cancer

I thought this article might be interesting.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4464018/ is the location.

I tried to highlight key sentences within the article, but there is no formatting permitted here. So I'll just copy and paste those four key sentences at the top with ***, which are taken directly from the study, which is posted in its entirety below. I have added the CAPITAL LETTERS for emphasis.

I personally have tried several of the AIs and SERMs and am using one now to reduce my breast cancer risk, so I am not on a mission to advocate against using the drugs.

Breast Care (Basel). 2015 Apr; 10(2): 141–142.
Published online 2015 May 7. doi: 10.1159/000430877

Aromatase Inhibitors in the Prevention of Breast Cancer
Elmar Stickeler, Chair,a,*,* Tanja Fehm, Participants,b Florian Schütz,c and Marc Thilld
Author information Copyright and License information Disclaimer

***1st sentence of interest***:
After 20 years, tamoxifen led to a 29 % reduction in overall incidence of breast cancer compared with placebo. Of note is the fact that NO REDUCTION IN BREAST CANCER MORTALITY and even an increase in estrogen receptor (ER)-negative breast cancers was observed.

***2nd sentence of interest***:
The key messages of this trial are: 1. less breast cancer incidence WITHOUT ANY BENEFIT FOR OVERALL SURVIVAL. 3. We have seen higher incidence of some cancer disease and deaths in the tamoxifen treated group.

***3rd sentence of interest***
But again, both studies FAILED TO SHOW DIFFERENCES IN THE BREAST CANCER RELATED MORTALITY between the groups treated with AI and placebo.

***4th sentence of interest***
It seems that both tamoxifen as well as AI are able to prevent breast cancer WITHOUT A BENEFIT IN OVERALL SURVIVAL.

———–
Here is the entire article, copied and pasted:

Aromatase Inhibitors in the Prevention of Breast Cancer
Elmar Stickeler, Chair,a,*,* Tanja Fehm, Participants,b Florian Schütz,c and Marc Thilld
Author information Copyright and License information Disclaimer
This article has been cited by other articles in PMC.

Question 1: How Do You Value the Role of Medical Prevention for Breast Cancer with the Knowledge of the IBIS-I Trial Results Presented at the San Antonio Breast Cancer Symposium 2014?
Fehm: In the International Breast Cancer Intervention Study I (IBIS-I), women at high risk for breast cancer had a significant benefit in the prevention of breast cancer from tamoxifen: After 20 years, tamoxifen led to a 29 % reduction in overall incidence of breast cancer compared with placebo. Of note is the fact that no reduction in breast cancer mortality and even an increase in estrogen receptor (ER)-negative breast cancers was observed. Thus, tamoxifen might play a role in the prevention of breast cancer in a subgroup of high-risk patients that is not yet clearly described.
Schütz: The key messages of this trial are: 1. less breast cancer incidence without any benefit for overall survival. However, it was difficult to show a benefit in overall survival due to the very effective medical and surgical intervention in breast cancer patients. 2. Tamoxifen has some severe side effects that may influence patients’ compliance. 3. We have seen higher incidence of some cancer disease and deaths in the tamoxifen treated group.
Thill: Considering the results of the extended long-term follow up (20 years) of the IBIS-I breast cancer prevention trial, there is only a role for the preventive use of tamoxifen in women who have an increased risk of developing breast cancer based on a family history of breast cancer or abnormal benign disease. In the IBIS-I trial a significant risk reduction only for estrogen receptor-positive breast cancer was shown that was maintained in the subsequent years after a 10 year follow up; for ductal carcinoma in situ (DCIS) it was only recorded in the first 10 years of follow up. However, a significant reduction in mortality was not found. Therefore, I would talk with women at risk about a possible prevention by the use of tamoxifen to reduce the incidence but not the mortality of endocrine responsive breast cancer and let the patient decide. Anyway, with 29 for invasive breast cancer and with 22 for all breast cancers the number needed to treat is not very high.
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Question 2: What Is the Impact of Aromatase Inhibitors in Medical Prevention?
Fehm: Studies such as the IBIS-II trial and the MAP.3 trial could show the impact of aromatase inhibitors (AI) in medical prevention. In the IBIS-II trial, anastrozole significantly reduced the incidence of breast cancer after a median follow up of 5 years: 40 women in the anastrozole group (2 %) and 85 in the placebo group (4 %) developed breast cancer. In the MAP.3 trial, exemestane reduced the incidence of all breast cancers by 53 % after a median follow-up of 3 years. But again, both studies failed to show differences in the breast cancer related mortality between the groups treated with AI and placebo.
Schütz: Any endocrine treatment can reduce the incidence of hormone receptor-positive breast cancer. In IBIS-II the AI anastrozole has shown that it can reduce the incidence of breast cancer effectively in postmenopausal high-risk women. However, like tamoxifen it was not able to give a benefit in overall survival. Surprisingly, most of the side effects that are well known from adjuvant breast cancer trials had not been seen in the IBIS-II trial (e.g.musculo-sceletal events).
Thill: As shown in the IBIS-II trial with anastrozole or in the MAP.3 trial with exemestane, the risk of breast cancer in postmenopausal women with an increased risk of breast cancer was relatively decreased by 65% and 60%, respectively. There was no significant reduction in breast cancer mortality. In the IBIS-II trial the incidence was absolutely lowered by 2.3% for all and by 1.4% for invasive ER-positive breast cancer after a follow-up of 5 years, in the MAP.3 trial the incidence was reduced from 0.55% to 0.19% after 5 years. AI reduced high-grade tumors more effectively than low-grade tumors.
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Question3: Which Group of Patients Would You Think of, to Discuss AI Use for Prevention?
Fehm: AI use for prevention can be discussed in the group of postmenopausal patients included in the contemplated studies: women at increased risk for breast cancer in their family history or patients who had a lobular carcinoma in situ, an atypical hyperplasia, or an ER-positive DCIS treated with mastectomy.
Schütz: Postmenopausal high-risk patients like patients with B3 lesions detected by mammography screening are candidates for AI prevention.
Thill: Along the line with the current data I would consider a preventive treatment with AI only for postmenopausal women with a risk at least 2.0 times higher than in the general population without evidence of severe osteoporosis. Risk factors are family history, atypical breast lesions (lobular carcinoma in situ, atypical ductal hyperplasia) and high breast density. In case of osteoporosis concomitant intake of bisphosphonates would be necessary.
Question 4: In Your Opinion What Would Be the Strongest Objective to Recommend AI for Medical Prevention?
Fehm: The strongest objective to recommend AI for medical prevention is a significantly increased risk for breast cancer. Women have to be postmenopausal. Before starting the medical prevention, it is important to calculate the benefit and the risks.
Schütz: We have to keep in mind that those patients who escaped from breast cancer by using medical prevention may also be saved from breast surgery, chemotherapy, and radiotherapy and its toxicities. Therefore it seems more reasonable to prevent the disease in high-risk patients than detecting it early by intensified screening programs.
Thill: In my opinion, the strongest objective is the prevention of clinically evident invasive and not subclinical in situ breast cancer in a postmenopausal high-risk population. It makes no sense to treat subclinical breast cancers that would be diagnosed in the mammography anyway and call it prevention. The side effects of AI are too troublesome for healthy women.
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Question 5: What Is, in Your Opinion, the Objective to Prefer Aromatase Inhibiors over Tamoxifen?
Fehm: Tamoxifen has a different side-effect profile than AI. Patients treated with tamoxifen have a higher risk for adverse effects like endometrial cancer, stroke, thrombosis, and pulmonary embolism. Postmenopausal women with risk factors for those events should be treated with an AI.
Schütz: It seems that both tamoxifen as well as AI are able to prevent breast cancer without a benefit in overall survival. However, toxicities of tamoxifen seem to be more severe than those of AI, especially the incidence of other cancer and thrombo-/embolic events. AI toxicities are also well known but do not seem to affect patients as much as tamoxifen although a direct comparison has only been done in the adjuvant setting. Therefore AI should be preferred in postmenopausal patients. Tamoxifen can be used in the premenopausal setting.
Thill: Tamoxifen increases thromboembolic and gynecological adverse events. In the IBIS-I trial the side effects were mainly confined to the active treatment period. Nevertheless, the risk of endometrial cancer and thromboembolic events, although it is low, in my opinion would lead to a preference of an AI over tamoxifen if the woman or patient is postmenopausal. In addition, the reduction of invasive breast cancer is higher with an AI than with tamoxifen.

Tue, Aug 20 2:39pm · SERMs and AIs - Choosing not to take them in Breast Cancer

Because side effects differ so greatly for every person and for every drug, I hesitate to state my own particulars, which may not apply to others, and prefer to emphasize trying the different medications in hopes that one works for you.

Evista/Raloxifene, which is the least effective of the 5 ( the other 4 being Tamoxifen, Armidex/Anastrozole, Femara/Letrozole, Aromasin/Examestane) has been ok for me now that I have strategies in place to reduce the frequency and severity of leg cramps when I sleep. I stretch my calves and lower legs often during the day, before bed, and if I have been particularly active or doing new activities, I get up in the middle of the night to stretch. No other side effect for me that I am aware of besides leg cramps. And I was prone to leg cramps before taking the drug, and my mother gets leg cramps too, starting at about the age I am. The oncologist told me that my weight and blood pressure mean the risk of blood clots are not elevated for me by taking Evista/Raloxifene.

Best wishes to you all in your decisions. It would be great if a better alternative without frequent side effects were developed.

Mon, Aug 19 10:24am · SERMs and AIs - Choosing not to take them in Breast Cancer

Speaking from experience of 2 SERMS and 2 AIs, I would suggest you try what is recommended by your oncologist. See how you do. If one of the SERMs is unacceptable, try the other. If the first prescribed AI is unacceptable, try the other 2. Once you know how you on the drugs, then you can decide if it is worth taking them. If the side effects are intolerable, at least you'll know why you opted out and that you tried. The side effects go away when you stop the drug, especially if you halt it after a few months before permanent damage is done. All of my horrendous side effects disappeared within 30 days of halting the various drugs. After 3 failures that produced intolerable side effects or sent me to ER with what appeared to be a heart attack, one of the drugs has been fine and I've been on it a year.

A variety of studies show from 25% to 50% of women do not complete the duration of the prescription due to side effects.

Wed, Jul 31 12:27pm · Questions about Hormone Blockers: Side Effects? in Breast Cancer

Kathysway, sorry you find yourself in this situation. Having taken several of these drugs and having read extensively about the side effects and the experiences of others, it seems there is no rule of thumb regarding symptoms.. Every person reacts (or does not) differently and every drug can affect you in surprisingly different ways. My approach was to give one drug a try and see what happens. If it's no good, on to the next one. There are 5 that a post-menopausal woman may take, but do consult your doctor. If all are intolerable, then at least you know you gave the drugs a shot. One of them did prove to be acceptable to me after some miserable failures that produced no lasting effects. Good luck to you.

Sat, Jun 29 9:53pm · Letrozole in Breast Cancer

Yes, I did try Tamoxifen–the low dose of 5 mg per day. I was quite hopeful about this minimal dosage. I lasted just 10 days. Felt like a war going on in my body that was contained only by my skin. If it were a street drug, I would be on a very bad trip. Evista/Raloxifene has, for me, none of the unbearable side effects of the other endocrine drugs I have taken. But I must be awakened by my husband in the middle of the night to stretch or risk severe leg cramps that can leave me hobbled for days. He is up in the night a couple of times, serving as an alarm wakeup.

Despite the various side effects of the different drugs, I think it is worthwhile to try them. Some people do just fine.

Tue, Jun 25 9:50am · Letrozole in Breast Cancer

How enlightening to learn that others had the false heart attack symptoms too. I thought I was a real rarity. What is odd is that I take or have taken a variety of other meds over the course of my life with no side effects. But these endocrine drugs are really messing with me.

Mon, Jun 24 9:43pm · Letrozole in Breast Cancer

Letrozole mimicked a heart attack for me after 20 days. Zero heart problems before. Went to ER for EKG and followup stress test. No heart damage, just a rare side effect of Letrozole. Heart attack-like symptoms continued for a couple weeks after stopping Letrozole then ceased entirely. No problems since.

In response to joint and bone pain remedies–acupuncture has been shown to help. Unfortunately it is not usually covered by insurance.

Side effects are much more common and intense in reality in my opinion, based on my several years of experience with various drugs and interacting with women taking these drugs, than the "literature" suggests. "Well tolerated" my foot.

Sun, May 5 9:13pm · Concern over Gadiolinum dye in MRIs in Breast Cancer

Questions about the safety of gadolinium, the dye used in breast MRIs, have come up. The dye settles in the brain.
For those of us getting annual MRIs, have you changed your routine? Has your doctor suggested reducing the annual procedure? Are you concerned about the effects of the dye on your brain? Is there a substitute procedure that provides equal levels of screening as MRIs? If you have been relying on MRIs for early detection of breast cancer because you are at high risk, has this made you more likely to want a prophylactic bilateral mastectomy?

MODERATOR, does Mayo have an MRI gadolinium policy that can be shared?