Topic: For Arimidex (Anastrozole) users, new, past, and ongoing

Jul 23, 2012 08:40AM - edited Jul 23, 2012 09:44AM by LindaF

vacationbound,

Here is what my oncologist sent me to urge me to go and get the Zometa...sorry it is so long...

"I'm basing the benefit for zometa on:

Zoledronic acid inhibits adjuvant letrozole-induced bone loss in postmenopausal women with early breast cancer.AUBrufsky A, Harker WG, Beck JT, Carroll R, Tan-Chiu E, Seidler C, Hohneker J, Lacerna L, Petrone S, Perez EASOJ Clin Oncol. 2007;25(7):829. PURPOSE: Treatment with aromatase inhibitors decreases bone mineral density (BMD) and may increase the risk of fractures in postmenopausal women with early-stage breast cancer. The addition of zoledronic acid to adjuvant letrozole therapy may protect against bone loss.

PATIENTS AND METHODS: Patients receiving adjuvant letrozole were randomly assigned to receive either upfront or delayed-start zoledronic acid (4 mg intravenously every 6 months). The delayed group received zoledronic acid when lumbar spine (LS) or total hip (TH) T score decreased to less than -2.0 or when a nontraumatic fracture occurred. The primary end point of this study was to compare the change in LS BMD at month 12 between the groups. Secondary end points included change in TH BMD and changes in serum bone turnover markers at month 12.

RESULTS: The upfront and delayed groups each included 301 patients. At month 12, LS BMD was 4.4% higher in the upfront group than in the delayed group (95% CI, 3.7% to 5.0%; P<.0001), and TH BMD was 3.3% higher (95% CI, 2.8% to 3.8%; P<.0001). In the upfront group, mean serum N-telopeptide and bone-specific alkaline phosphatase concentrations decreased by 15.1% (P<.0001) and 8.8% (P = .0006), respectively, at month 12, whereas concentrations increased significantly in the delayed group by 19.9% (P = .013) and 24.3% (P<.0001), respectively.

CONCLUSION: With 1 year of follow-up, results of the primary end point of the Zometa-Femara Adjuvant Synergy Trial (Z-FAST) indicate that upfront zoledronic acid therapy prevents bone loss in the LS in postmenopausal women receiving adjuvant letrozole for early-stage breast cancer.

************************
Magee-Womens Hospital, University of Pittsburgh Cancer Institute, Pittsburgh, PA 15123, USA. brufskyam@upmc.eduPMID17159193 51 TIEffective inhibition of aromatase inhibitor-associated bone loss by zoledronic acid in postmenopausal women with early breast cancer receiving adjuvant letrozole: ZO-FAST Study results.AUBundred NJ, Campbell ID, Davidson N, DeBoer RH, Eidtmann H, Monnier A, Neven P, von Minckwitz G, Miller JC, Schenk NL, Coleman RESOCancer. 2008;112(5):1001. BACKGROUND: Letrozole is safe and effective in postmenopausal women with estrogen receptor-positive early breast cancer, but long-term aromatase inhibitor use may cause bone loss and increase fracture risk. This study evaluated an immediate or delayed strategy of bone protection therapy with zoledronic acid.

METHODS: A total of 1065 patients who were receiving adjuvant letrozole were randomized to immediate-start or delayed-start zoledronic acid (4 mg intravenously biannually for 5 years). The delayed group received zoledronic acid if lumbar spine or total hip T-score decreased below -2.0 or when a nontraumatic fracture occurred. The primary endpoint was change in lumbar spine bone mineral density (BMD) at Month 12. Secondary endpoints included changes in total hip BMD, serum bone turnover markers, and safety at Month 12.
RESULTS: Lumbar spine BMD increased from baseline in the immediate arm, while it decreased from baseline indelayed-arm patients. At Month 12, the differences between the groups in lumbar spine and total hip BMD were 5.7% (P<.0001; 95% confidence intervals [CI], 5.2% to 6.1%), and 3.6% (P<.0001; 95% CI, 3.3 to 4.0%), respectively. Both regimens were well tolerated with few serious adverse events. Bone pain was higher in the immediate group, as expected, because some patients experienced acute-phase reactions after zoledronic acid infusion.

CONCLUSIONS: At 12 months, immediate zoledronic acid therapy prevented bone loss in postmenopausal women who were receiving adjuvant letrozole."

So that was what he was looking at, I guess.   Hope this helps.  But on second look, I don't see anything here about cancer-protective, so I guess I don't know what studies he was basing that on.   Sorry!

Linda

Jul 24, 2012 08:04AM vacationbound wrote:

Hi JO-my cholesteral also shot up! Never EVER had a problem-this happened only after 6 weeks, not 6 months like you.

Linda-I have to go to work but I'm going to get back with you on the Zometa-want to share something with you-their are no current studies to show how long one should use it, the initial effiacy is tested but long term use is the question....They are currently studying this 

Jul 24, 2012 08:49AM - edited Jul 24, 2012 08:52AM by nancyjac

I discussed bisphosphonates with my MO and she is a bit leary of prescibing them.  Her concerns is that there is not yet enough data on their long term use and effects and since I may be on anastrozole or another AI indefinitely, she doesn't want to use them as a first line treatment for bone density loss.  She feels that weight bearing exercise is just or more beneficial without the side effects and unknown long term effects of bisphosphonates.  She is also going to measure my vit D uptake as part of my next lab work (in about 3 weeks).  

Jul 24, 2012 07:22PM - edited Jul 25, 2012 06:19PM by vacationbound

I bought an Elipitical machine from Academy-very cheap, $119.00, easy to assemble and my goal is to lose 40lbs! This will not only help the estrogen levels in my body decrease but the exercise is the key to losing the weight! I think the reason why we do not lose weight after treatment is because our metabolisms have changed so we do not burn as many calories as before. I can eat like a bird and not lose one pound. I'm taking Lecithin and Omega 3 to get the cholesteral down. I also take an aspirin everyday. 

Linda-here is an interesting article posted by BCO on the ongoing Zometa/Bisphosphonates studies

www.breastcancer.org/treatment... 

Here is the article from the NEJM about Bisphosphonates and long term use

www.nejm.org/doi/full/10.1056/... 

also NEJM article  http://www.nejm.org/doi/full/10.1056/NEJMp1202623

 If you read the New England Journals, it states that not all the bisphosphonates have the same biologic functions; the Zometa website states: ZOMETA (zoledronic acid) 4 mg/5 mL Injection is a treatment for hypercalcemia of malignancy (HCM; a condition resulting in high calcium blood levels due to cancer). ZOMETA is also used to reduce and delay bone complications due to multiple myeloma and bone metastases from solid tumors; used with anti-cancer medicines. ZOMETA is not an anti-cancer therapy. http://www.us.zometa.com/index.jsp

I know they are still trying to prove this statement but the manufacturer Novartis clearly does not state any such claims that Zometa is an anti-cancer therapy. (see above reference)
I myself have been told that I will need to start Zometa shortly and I am on the fence as well as I do not know if it is right for me, that is why I will do the research for myself and make my own best judgement relative to the scientifically proven evidence.
-I have seen many claims that it has anti-angiogenesis effects but these clinical trials are what I want to get my hands on. The Strontium I choose to take instead makes no claims about preventing angiogenesis either and in essence, does just the same thing as the drug but without the side effects. If you look at the Europe report, they really only study Zometa for it's efficacy regarding Osteoporosis-look under post-marking report section for reference to Oncology indications relative to cancer therapy-not much there; they also refer to the Flex, Horizon and FIT trials but also state that this study has a number of limitations including the relatively short length of bisphosphonate treatment in the majority of patients in the FIT and HORIZON trials

www.ema.europa.eu/docs/en_GB/d... 

www.ema.europa.eu/docs/en_GB/d... 

here is other half since link is being censored: docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000336/WC500115455.pdf

So take out of it what you will, discuss it with your Oncologist but just remember that these drugs are under review. My point by posting this info is not to scare you but to help you be aware of the pros and cons relative to your treatment needs and for me, this knowledge will help me make the right informed decision regarding my treatment. Given the links I have provided, it would seem that these bisphosphonates are being looked at in regards to pharmacodynamics (i.e., response in the dose-response curve), pharmacokinetics (i.e., dose in the dose-response curve), and biological variance (i.e., shift in the dose-response curve). Pharmacodynamics deals with drug potency at one or more sites of action. Pharmacokinetics deals with the qualities of the drug that determine what the drug concentration is at its site of action. Biological variance deals with patient-specific factors that individualize expression of the dose-response relationship.

Just wanted to give you some more clarity on the subject of Bisphosphanates, and in particular, the claim that Internet media hype make stating that these/this drug has anti-angiogenesis effects: as I stated that Zometa/Novartis makes no such claim and if you look at the product sheetwww.pharma.us.novartis.com/product/pi/pdf/zometa.pdf it states down in 12.2 Pharmacodynamics that ZA does not inhibit P450 enzymes. If it does not open, try this link-http://www.us.zometa.com/patient/zometa-prescribing-information.jsp
click on the highlighted "see full prescribing information" link, the other pdf file I copied will not open for me but this will take you to it. Also read 12.3 Metabolism section

Here is a website describing the genomes
http://www.acnp.org/g4/gn401000086/ch085.html
and also
http://en.wikipedia.org/wiki/Cytochrome_P450

which means to me that if ZA does not inhibit any P450 enzyme then it does not interfere with blocking any gene disruptive behavior which means it has no type of anti-cancer mechanism. EX: Aromatase is an enzyme, we take Arimidex to block this enzyme as it is a member of the P450 superfamily, if Zometa were an enzyme inhibitor, don't you think they would label it that?

Jul 25, 2012 06:44PM kjiberty wrote:

HI Ladies.  I am new to this thread.  I have my rx for arimidex filled and am hestitating on using it.  I have decided I wil start on 8/1.  Started rads today 4 weeks PFC.  I really appreciate all this info posted on this thread.

Jul 26, 2012 06:05AM Allagashmaggie wrote:

I had my 6-month followup mammo this past Monday, the 23rd and all was clear though I had a few tense hours.  I get scheduled for the mammo then with my breast surgeon each time to go over the results.  The radiologist wanted my right breast (the good one) to have an ultrasound as I have such dense tissue they wanted to be sure nothing was lurking in the shadows.  So there was two hours between appointments that I had this on my mind.  The ultrasound was fine and I am good to go for another 6 months unless I notice something before that time.  It is amazing that I am living in 6-month intervals now.  But.....I was much relieved.  I did ask my breast surgeon if the arimidex could be causing the breast pain in my right breast that I have been experiencing and she said yes it was possible.  Any time you mess with the hormones she said, it is a possibility but she thought my pain might be coming from the fibromyalgia in my right shoulder that I have suffered from since my 20's.  I am now in my late 50's.  Whenever I get anxious, it goes to my right shoulder.  She sounded that area very thoroughly and all was fine.   I did not ask her if arimidex can exaserbate fibromyalgia pain.  Any thoughts on that from any of you?

 Overall, I am handling the arimidex fine but have only been on it 3 months.  Jo-5 you are quite an inspiration and I have to agree with you.  The SE of arimidex are much easier to treat than breast cancer.  I feel fortunate so far that I am handling it.  Being on the move does indeed help.

 Some of you really have your information together on this subject so if I start having questions, I feel this site is a good source of information.  Thank you one and all.

Jul 26, 2012 08:00AM JO-5 wrote:

I did have breast pain in the other breast while I was on the Arimidex. That is much better now.

 I also have fibromylagia and it's hard to say if the Arimidex made it worse. I thought at times that it did, but now being off Armidex I still have bad bouts with the fibromylagia. Fibromylagia is a difficult thing to deal with also. I have found that the Lebed exercises help with that as well as the lymphedema in my right arm.

Ladies, I see that most of you are not far into your journey and I sure do understand the frequent appointments. At first I was seeing 4 different drs. .... and am now still seeing 3 but I only see each one once a year and get a yearly mammogram.... unless a problem pops up.

It gets better..... hang in there!

JO-5

Jul 26, 2012 08:11AM JO-5 wrote:

edwards750,

Good idea about the calcium and D3.... If I would have had that going on during my 5 yrs with Arimidex I don't think I would have hurt as much....... (it's a long story why I didn't have it)

 so.... If you gals have not had your D level checked do everything you can to find out. I really think it will help you with the se's.....

I don't know if this will help you but I started taking Claritin (allergy meds) with a Pepcid AC. It seemed to help with the stomach issues as well as the headaches.

I ate a lot of Brussels sprouts and cooked cabbage with white potatoes. That is thought to help the stomach and it really did the job for me. I still eat that a lot!

JO-5

Jul 26, 2012 10:11AM Mini1 wrote:

I've been hearing a lot about Strontium for osteoporosis and AI bone loss. I can't take any osteo meds and probably wouldn't anyway after doing the research. Anyone out there using Strontium with their cacium and D?

Jul 26, 2012 01:20PM Msbelle wrote:

How often is everyone getting bone density scan?

Jul 26, 2012 01:42PM Mini1 wrote:

Vacation - Thanks. I wonder why people are having trouble posting links. I've seen others complain of the same thing on other threads. I forgot you were the one with the fab 4. :-) I'm going to give Strontium a try. It can't be worse than the side effects of the biophosphates that they have approved for use. What kind do you use if you don't mind my asking? I see several on the market. I don't want any manufactured in some unregulated pill mill.

Msbelle - I've started having bone density tests once a year and will for at least the next five years of the AI.

Jul 26, 2012 07:04PM Lee7 wrote:

Once a year for the dexa scan for me too.

vacationbound- I'm making sure I get those 4 (cal, mag, pot, D3), and I don't seem to have much bone pain, thankfully.  I think my worst SE from Arimidex is insomnia.   What's the strontium do?

ruthbru, I've started with the prunes!  I found I like them a lot better than I remembered.

Jul 27, 2012 06:53AM Mini1 wrote:

If gluten-free helps with AI, than YAHOO. I am already gluten-free and though I'm stiff in the morning (probably from osteoporosis) I don't have a lot of discomfort form my AI. Anastrazole was another story. Hurt everywhere, all the time, bones and muscles. My change to Aromasin was a big help; maybe the GF diet has something to do with it, who knows? I'm learning more and more how diet can effect our bodies. I have a friend that has MS and is a vegetarian. Someone asked her why she was a vegetarian; was if because of allergies, PETA, etc. She said that she just feels better when she doesn't eat meat, so she doesn't.

I think like Blessings mentions above, we have to get in tune with our bodies. I know last year after having to go on a strict liquid diet and re-introduce foods back into it, I found I didn't even like some of the foods I had been eating anymore, and when I did eat something that I shouldn't, the physical repurcussions were a quick reminder of why I can't eat it. Now food taste better (salt and sugar dull the taste buds) and I eat better because I want to not because I was told I need to, and consequently I feel better. My hair is not falling out, my nails are growing again, my skin is better, and I generally just feel better physically and mentally. 

Jul 27, 2012 03:06PM JO-5 wrote:

I had a dexa scan when I started the Arimidex, then another after being on Arimidex a year. That scan was good so it went two years before I got another one.

If they are good, and mine were ok so I got them every 2  years. After getting my D level back up my bone density this year was - quote "Better than most 30 yrs olds" so I won't be getting another scan for 3 years.

That's what the insurance will pay for unless the Dr. thinks there is a problem.

JO-5

Jul 28, 2012 05:34AM kjiberty wrote:

Well, I made the decision to start today. I am going to take it in the am and see how I do. Wish me good luck!