Hi again,
The FDA is a regulatory/oversight agency, and does not actually perform studies of drugs. It reviews Clinical Trials reseach submitted to it, to decide whether to approve drugs for certain indications, and receives reports of adverse reactions, etc., which help it to decide if various drugs should be required to carry "black box warnings" (the most serious type of warning) or to be withdrawn from the market.
Another class of drugs that has been shown to have anti-cancer effects is the bisphosphonates. These drugs are primary prescribed to prevent osteoporosis, but are associated with lower risk for invasive breast cancer, and in some cases, lower risk for recurrence of BC, as well as being used to treat bone mets.
" December 11, 2009 (San Antonio, Texas) — Oral bisphosphonate drugs used for postmenopausal osteoporosis apparently offer protection against invasive breast cancer, according to 2 hypothesis-generating studies presented here at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS).
A huge analysis of data from several Women's Health Initiative (WHI) studies, which together involved more than 150,000 generally healthy postmenopausal women, showed that those who were taking bisphosphonates to protect their bones had a 32% reduction in invasive breast cancer.
A smaller study from Israel, which involved 4575 postmenopausal women, found a 34% reduction in the relative risk for breast cancer.
Previous data suggesting that bisphosphonates have antitumor properties have come from trials in women who already had breast cancer, which showed a reduction in breast cancer recurrence, as previously reported by Medscape Oncology."
Another recent study found that one of these drugs, zoldrenic acid, also has lasting anti-cancer effects in premenopausal women with hormone responsive early BC.
These drugs can be beneficial for women who want to protect their bones and possibly lower their risk for BC or for BC recurrence, and may be another way to go for those who cannot or will not take tamoxifen or the AIs. (They present their own set of possible side effects, of course.)
Regards,
bluebutterfly
Thank you for your excellent detailed answer. I really appreciate your taking the time to answer me.
I just do not understand why the FDA is not more aggressive in studying the use of alternatives to the class of antiestrogen drugs. Obviously estrogen is a necessary hormone in the female body and just stopping its production or the ability of the estrogen to be taken in by the receptors on a tumor, is traumatic to the female body.
It makes no sense to me to eliminate an essential female hormone from the body and/or not allow tumor cells to react to it. Is there any research going on that deals with destroying the ability of cancer cells to proliferate other than the antiestrogen drugs?
There really needs to be more research done into alternatives to antiestrogen drugs, and we women must be more vociferous and outspoken in this area!
Judy
I did use cream and had to fight for it. Given just how bad my side effects were my oncologist gave permission to my gynecologist who really put up a fuss about not wanting to write the prescription. It took me 3 months to get the cream. I was warned that even low doses applied vaginally can be an issue. I used it short term and not to the amount prescibed. I wanted some relief and less risk.
Best wishes
Hi,bb
That is excellent information,on both your comments.
My Surgeon also told me that testing for hormone (Estrogen) is not reliable,since the levels could vary from day to day.
Thank you so much!
p.s. In responnse to your original question, one reason oncologists don't periodically run hormone level tests on their patients is that, unlike insulin or thyroid hormone, female hormones cannot be titrated to customize a formula for an individual woman. Female hormone levels are very dynamic and no single measurement can capture what the hormone levels might be the next day or even later on the same day
I have asked my oncologist these questions and he just says that taking the AI's is the best proven way to try to stop the recurrence of breast cancer. What I am finding is that the "older" doctors have been doing it this way for 20+ years and are not willing to change. When I asked him to check my hormone levels - he said that was "garbage in garbage out" since hormone levels vary there is no reason to check them. (He is in his 60's, and interestingly I too am 67).
I am a retired science teacher and have done some research - and what bothers me is the fact that the female body does need estrogen to help with mood swings, osteoporosis, vaginal lubrication etc. and there is a very weak form of estrogen called estriol which can be given as patches or creams, and why can't we have a small amount of that present in our body and let the AI's get rid of the other 2 types of estrogen which aid the growth of breast cancer cells which are esradiol and estrone.
This concept borders on the fuzzy line between tried and true western medication and newer ideas from integrative/alternative medicine. Why can't we patients get the best of both worlds. I don't want to go the complete alternative route and I don't fully believe the old western method either. I can't seem to get any answers from either side. I have contacted an integrative MD who won't just do the hormone part for me - he said he treats the whole body and I must go through his entire workup before he will consent to see me - and it is extremely costly and not covered by insurance.
What I find unbelievable is the notion that women should just destroy all estrogen in the body! How would men react if they were told to destroy all their testerone in their body to help them fight their cancer!
I truly feel there is some middle ground here that is missing and we women are basically scared into believing that if we don't get rid of all our estrogen we will die of breast cancer, and so we feel we have no choice as we want to live! My next trip is to see a doctor that deals with bio identical hormone therapy to see if I can balance getting rid of the estradiol and estrone and have some estriol.
I am hoping one of the doctors on this site can give me some good medical reasons why we women cannot be on oral antiestrogen meds and still get estriol through vaginal creams or patches?????????????
The hormones you are speaking of are so significantly reduced by the medications that there is really no reason to check for them. My BC is ER/PR+, and I have done okay on Arimidex. I was post menopausal when diagnosed, and at that time they checked my estradiol levels to make sure I was through menopause. I know that having some estrogen in the body would make me feel better, but I am not going to play with cancer....to the point that I had a full hysterectomy to make sure my ovaries could not produce even a drop of estrogen....and I have my adrenal glands checked periodically, as this is the only gland left that can produce (through a chain of activity) some estrogen. The point of the Arimidex is to stop that chain of activity.Hopefully the day is not too far away that will allow docs to tailor doses specifically to each individual...we are almost there....but not yet. The Oncotype and Mammaprint tests are the closest we have to really seeing each person's BC individually, and helping in treatment decisions.
So, I guess it may seem like overkill....and for many it probably is. My Oncotype score ( a 1), showed that I would not benefit from chemo, but that I would benefit from hormone therapy. So, if it's overkill that is fine with me. I would rather deal with overkill than with BC any day. I have 2 years to go on it.....I deal with the side effects....and I hope that someday this will just be a memory of a tough time in my life. Thanks to modern medicine...I am a survivor....and plan to stay that way!
By the way, those questions would be good to ask your oncologist...I'm sure he/she can give you much more thorough answers.
Blessed Be......from one survivor to another...
I hear your misery!
The reason they give the drug in the first place is because your cancer was fed by your hormones. Even if you'd had your ovaries removed your body still produces estrogen from the adrenals and body fat.
I remember trying to get my oncologist to cut my prescription in half and she was adamant that it remained where it was. Common sense told me that with my cancer being 95% estrogen & progesterone positive she was right. But living without estrogen isn't easy.
Best wishes.
Along with other symptoms, women may experience vaginal thinning or vaginal atrophy associated with the reduction of estrogen that results from menopause or related to Tamoxifen and the AIs. This can cause irritation, pain, or even vulvar or vaginal tearing when attempting intercourse.
This is certainly an important issue, and one which severely impacts the quality of life of many women, including BC survivors!
Although we do not yet have data on the safety, for ER+ BC survivors, of the use of locally (vaginally) applied estrogen products, two, Vagifem and Estring, provide very low doses of estrogen. Estring, for example, releases over 90 days an amount equivalent to taking oral estrogen for just 2 days, and Vagifem, aready a very low dose estrogen product, is now available in a 10 mcg dose, as well as the original 20 mcg dose. (Both of these are reported to be preferrable to a similar third product, Estrace.) These products also appear to have a very, very low level of systemic absorption.
Due to these factors, many oncologists are becoming more comfortable having women who have had BC use these preparations.
A clinical trial using Vagifen 10 mcg in women with BC is currently under way, and use of Estring is also being researched.
For women not wanting to take the chance of using even this form of estrogen supplement, some women experience benefit regarding discomfort during sex from gel type lubricants. Also, Pjur Original Bodyglide is recommended by many GYNs. Although it works as both a moisturizer and a lubricant, it is oil-free, water-free, and fragrance-free, and not at all sticky or gooey. It contains Dimethicone, somewhat similar to the spray lubricant for treadmills :-) and is safe to use with latex condoms. Another product, which is very similar in consistency to natural vaginal secretions, is Miracle of Aloe's "Perfect Match."
I would NOT recommend going the route of "bioidentical" hormones, as these are not regulated and can actually be LESS safe than traditional, FDA approved HRT:
"There is no evidence that so-called bioidentical hormones compounded in a pharmacy are safer than other hormone products. In January of 2008 the FDA sent warnings to a number of large compounders of bioidentical hormone replacement therapy (BHRT) products, expressing concern about these manufacturers' claims about the safety, effectiveness, and superiority of their products. In that same memo, the US Food and Drug Administration (FDA) warned about the use of estriol, a weak estrogen that has not been approved by the FDA for use in any product. Nevertheless, countless Websites, celebrities, other individuals, and pharmacies continue to make claims about BHRT. The FDA considers the term BHRT a marketing term."
Best wishes...