Here is What I was told about Zometa and News from conference

Pure

So bottom line Zometa is for post menopausal women according to the most recent study ( study done on women 5 years after last period)

Yes there is the AZURE trial and Australian study that show otherwise so there is still hope but for the most part what is now being reported is the above.

BUT zometa is still essential for women who are in menopause no matter what your age. The reason being we will have tremendous bone loss due to chemo and menopause at an early age and it's critical we keep our bones strong. There could be a correlation between our bones breaking done and cancer cells escaping and causing a reoccurence so I will be staying on Zometa.

She also said that exercise daily and keeping BMI at atleast 29 but 25 ideally is as important if not more helpful at preventing a reoccurence as chemo.

She said a lot of posters was on excercise and low bmi.  She also said that women who had menopause at a young age are like 17 times more likly to develop heart disease and that keeping out body weight low is CRITICAL to living a long life not only to prevent reoccurence but b-c of heart disease. She went to a whole session on this as well.

weety

Thanks Pure, I'm not stage III, but I've been trying to gather as much new info about zometa as I can since I just got my wisdom teeth out in preparation to start zometa next week.  I hope my onc is still willing to give it to me off-label.  I'm a little worried all this negative hype might have changed her mind.  (I'm post-menopausal due to hyster/ooph I had back in April) 

everyminute

Again - the question remains....

Is someone who had a hysterectomy and thrown into instant menopause the equivilant of someone who is 5 years since their last period?

KerryMac

Well, my BS said at my last check-up the three most important things I could do for myself were exercise, keeping my weight normal and Vit D. So, that is all good.

I am very interested if the 5 years post-menopause correlates with surgical menopause too. I am imagining it has something to do with lack of estrogen in the bones. Something I read was that estrogen stops the bones from absorbing Zometa, and zometa stops the cancer cells from getting in the bone marrow....?

You know, I am amazed at how random these studies seem to be - how could they not gather data on that population? Surely it is common?? 

I have decided that if my Onc is OK with me staying on it, I will (much as I hate the needles) The other problem I might have is with the infusion - Norvatis does it for free, and this new data may change their policy.

Anyhow, I am not going to worry about it until March, when I see my Onc and am due Zometa #4. I am also getting a bone density then, so after Mary's experience, I may need to be getting it anyhow.

Medigal

Thanks for latest info on Zometa however, I cannot and willnot take that drug again!  I took it one time through an IV and it tortured my body!  I now just take Citracal once daily and extra Vit D3 for bones and do a bone density test annually.  I cannot exercise in any way due to other medical problems so I just have to trust I will end up ok.  Research doesn't have ALL the answers.  We are all individuals and what works for one may not be the answer for another, IMO.

Mamita49

Hmmm, I dont know. When i asked my BS last year about the Zometa, he said I need to be way post-menopausal. Even switching from tamox to Arimidex, I would need to wait a couple of months, since my status of post or pre- meno has to be sure. 

I still want the Zometa, hey.......dont we wanna take everything that is possible to take to survive this ordeal.

But my doc said to me, even if I would have my ovaries out, I still would need to wait for the Zometa. He said, be patient, you must be post meno, and than its not too late to get the Zometa.

I dont know anymore........ Its so confusing, and sometimes, I get paranoid, thinking the doc is not giving the drug to me, cause he want to keep it for later, when my bones really need it.

Husband11

Here's what I'm thinking, if there was a significant residual effect of estrogen that for years after cessation inhibits the benefit of zometa, then why would the pre-menopausal women in the Austrian study get so much (immediate) benefit.  There was no 5 year wait after getting chemical suppression of their ovaries with goserilin.  They did it all simultaneously.  Why should removal of the ovaries be any different or less effective?

Pure

I don't no but she said everyone was pretty dissappointed about the outcome of the study.

Mary-no taking out your ovarys is NOT equal to being 5 years post menopausal according to what I was told today. With that said our bones being strong is very important and in the future they may find a correlation to our bones breaking down and reoccurence ( as I was explained it) so I should still receive it for the 3 years.

But yes she did agree there are studies proving otherwise.

So for right now exercise-bmi under 25-eating healthy- all critical to our success in beating the disease. She talked about fat cells and how they contain estrogen and something else ( I am forgetting) but she talked about the importance of building muscle mass as well.

voraciousreader

ABCSG-12 Shows Benefit for Zoledronic Acid in Early Breast Cancer

By: KERRI WACHTER, Internal Medicine News Digital Network

12/17/10
 | 

SAN ANTONIO - Despite the negative results overall of the AZURE trial, it may not be time to put the final nail in coffin of adjuvant zoledronic acid for the treatment of hormone-positive breast cancer.

[Zoledronic Acid Sinks as Breast Cancer Therapy in AZURE Trial]

Updated results for the ABCSG (Austrian Breast and Colorectal Cancer Study Group) Trial 12 continue to show disease-free and overall survival benefits 2 years after stopping adjuvant endocrine treatment with zoledronic acid (Zometa), according to an update presented at the annual San Antonio Breast Cancer Symposium.

The positive Austrian trial randomized 899 premenopausal women on goserelin (Zoladex) to 3 years of zoledronic acid with either tamoxifen or anastrozole (Arimidex) and 904 comparators to endocrine therapy alone (N. Engl. J. Med. 2009;360:679-91).

At a median follow-up of 62 months (2 years after treatment completion), zoledronic acid reduced the risk of disease-free survival events by 32%, compared with endocrine therapy alone (hazard ratio, 0.68; P = .008). Better disease-free survival was seen whether the women were on tamoxifen (HR, 0.67) or anastrozole (HR, 0.68). A trend toward reduced risk of death with zoledronic acid also endured (HR, 0.67; P = .09).

"We observed persistence of benefit with adjuvant zoledronic acid in the ABCSG-12 trial," said Dr. Michael Gnant, president of the ABCSG, at the press briefing where Dr. Robert Coleman reported no disease-free survival benefit overall (adjusted HR, 0.98; P = .79) from adjuvant zoledronic acid in the AZURE (Adjuvant Treatment With Zoledronic Acid in Stage II/III Breast Cancer) trial.

"Why are the ABCSG-12 results so different from the premenopausal [women] in AZURE?" asked Dr. Gnant, professor of surgery at the Medical University of Vienna. "I believe that when you look closely, there is minimal overlap in patient selection and treatment," he said.

"All of them [in the ABCSG-12 trial] were put into artificial menopause for 3 years with the use of goserelin. None of these patients had adjuvant chemotherapy. I think that's an important difference from the AZURE trial," said Dr. Gnant.

In the AZURE trial, 96% of patients had adjuvant chemotherapy, and none got ovarian function-suppression treatment. Also, in the ABCSG-12 trial, about 70% of patients had low-risk, stage I breast cancer. Patients in the AZURE trial had stage II or III breast cancer.

Patients in the ABCSG-12 trial were randomized to one of four treatment groups: 20 mg/day tamoxifen; 20 mg/day tamoxifen plus 4 mg zoledronic acid every 6 months; 1 mg/day anastrozole; or 1 mg/day anastrozole plus 4 mg zoledronic acid every 6 months. Treatment lasted for 3 years. All patients received 3.6-mg subcutaneous goserelin every 28 days.

In all, 1,803 patients were enrolled between 1999 and 2006. As of May 18, 2010, 186 disease-free survival events and 73 deaths were recorded: 45 locoregional relapse events, 100 distant relapse events (including 53 bone metastasis events), and 14 contralateral breast cancer events. Adding zoledronic acid to endocrine therapy was associated with a continued reduction in recurrences inside and outside bone.

[FDA: Bevacizumab Should No Longer Be Indicated for Breast Cancer]

Adverse events associated with zoledronic acid treatment (arthralgia, bone pain, and pyrexia) were generally mild and consistent with the established safety profile. Zoledronic acid did not increase the occurrence of serious adverse events, compared with endocrine therapy alone. Importantly, there was no significant renal toxicity and no confirmed cases of osteonecrosis of the jaw.

"I find it quite intriguing and actually reassuring that with this therapeutic intervention that lasted 3 years - just an infusion every 6 months - you can change something in the long-term outcome of these patients," said Dr. Gnant. "When we break it down according to additional preplanned subgroups, actually we see that ... adjuvant bisphosphonate treatment works in every subgroup, at least if you look at the tumor-derived parameters."

The addition of adjuvant zoledronic acid may not make much difference in patients younger than 40 years, he suggested: "It's exactly that group of patients where we cannot assume that the goserelin treatment will lead to full suppression of ovarian function and to very low estrogen levels," he said.

Among patients aged 40 years or older in ABCSG-12, however, there was a roughly 40% difference in disease-free survival, which translated into a 40% reduction in the risk of dying from breast cancer, although this did not reach statistical significance.

[Dual Anti-HER2 Blockade Called the Future of Breast Cancer Therapy]

The AZURE researchers also did extensive planned subgroup analyses. "One clearly stands out from all the others. That is the treatment effect on disease-free survival according to menopausal status," observed Dr. Coleman, a professor of medical oncology at the University of Sheffield (England). There was a clear overall survival benefit for women at least 5 years out from menopause on zoledronic acid. These women had a 29% reduction in the risk of death (P = .017).

"While obviously it's fair to say that the overall result of AZURE is a little bit disappointing, scientifically it makes perfect sense," said Dr. Gnant. "Perfect suppression - or a natural lack of estrogen - in combination with adjuvant zoledronic acid leads to significant disease-free and overall survival benefit."

To put the results in practical terms, Dr. Gnant noted that for the past 2 years, he would have put his 42-year-old wife on zoledronic acid if she developed ER-positive breast cancer, but not his 83-year-old mother. "This has changed this afternoon. Now, my 83-year-old mother would also receive zoledronic acid," he said.

The ABCSG-12 trial was sponsored by Austrian Breast & Colorectal Cancer Study Group, with support from AstraZenaca (which makes Arimedex) and Novartis Pharmaceutical (which makes Zometa). Dr. Gnant disclosed that he has significant financial relationships with several pharmaceutical companies, including Novartis.

[Women's Health Initiative: New Findings on Big-Three Cancer Rates]

The AZURE trial was sponsored by the University of Sheffield. Dr. Coleman disclosed that he receives grant support from Novartis and is a speaker for Novartis and Amgen.

AgentMo

I was told not to interpet the current study as Zometa not having an effect. The most likely reason for the outcome is that it is a question of dosage. The plentiful positive results for Zometa exist and are not wrong simply because this study does not show them. The important thing to find out now is why is sometimes works and sometimes not.

As several uses have been pointing out: one important difference was the use of zoladex in the Austrian study that showed effects. Another difference indeed was chemo. The dosage of zometa has also been different. 

I hope I will get Zometa despite this study in the future. It usually does not have serious side effects, so I would like to gamble on my chances.