Zometa twice a year to prevent bone mets?

OneBadBoob · August 2008

Not sure where to post this, so I put it here.

Has anyone heard of this?

My rheumatologist recommended I start once a week actinol for bone strength, but the onc would rather I had twice yearly shots of Zometa because the research is coming in that this reduces the risk by up to 35% that cancer in ER+ women will go to bone mets.

Any thoughts, opinions, information?

So many decisions!

mjanewc · August 2008

Hi Jane

I have also had my onc recommend the zometa infusions(although she said mine would be one infusion (IV) every 3 months. I will discontinue Boniva and have the first zometa infusion in September.

I will go with the zometa and hope for no bad side effects!

Good luck to you

Jane (good name we have,huh?)

TenderIsOurMight · August 2008

I bookmarked this a bit ago to review with my oncologist. This would suggest that twice yearly Zometa (4 mg IV q 6mo), not once yearly Reclast (5 mg IV annually) is appropriate for aromatase inhibitor induced bone lost. This is an individual question for discussion with our personal oncologist. The abstract does question, could this reduce bone mets too? No proof as yet though.

Here you go:

Integrated Analysis of Zoledronic Acid for Prevention of Aromatase Inhibitor–Associated Bone Loss in Postmenopausal Women with Early Breast Cancer Receiving Adjuvant Letrozole

Adam Brufskya, Nigel Bundredb, Robert Colemanc, Rosemary Lambert-Fallsd, Raul Menae, Peyman Hadjif, Lixian Jing, Nora Schenkg, Solveig Ericsong, Edith A. Perez Z-FAST and ZO-FAST Study Groups

"Background. The interim (12-month) results of two similarly designed, ongoing studies (the Zometa®-Femara® Adjuvant Synergy Trials [Z-FAST and ZO-FAST]) suggest that zoledronic acid (4 mg intravenously every 6 months) when initiated with adjuvant letrozole increases bone mineral density (BMD) of the lumbar spine (LS) in postmenopausal women with early-stage breast cancer compared with patients who receive zoledronic acid only when bone loss became clinically significant or a fragility fracture occurred.

Methods. An integrated analysis was performed to maximize the value of the large pool of data from the two studies in answering clinically relevant questions. The primary objective was to compare the change in LS BMD at month 12. Secondary objectives included comparing (a) the change in total hip (TH) BMD, (b) changes in bone turnover marker concentrations, (c) time to disease recurrence, and (d) safety at month 12.

Findings. The integrated analysis included 1,667 patients. At month 12, LS BMD was 5.2% higher in the upfront group than in the delayed group; TH BMD was 3.5% higher. N-telopeptide and bone-specific alkaline phosphatase concentrations decreased by 21.3% and 12.8% in the upfront group and increased by 21.7% and 24.9% in the delayed group, respectively (p < .0001 for intergroup comparisons). Fewer patients receiving upfront zoledronic acid experienced disease recurrence than patients in the delayed group—seven patients (0.84%) versus 17 patients (1.9%) (p = .0401). Fracture rates were similar. No confirmed osteonecrosis of the jaw was reported.

Conclusions. The results of this analysis strengthen the statistical validity of the preliminary results of the Z-FAST and ZO-FAST studies, showing that upfront zoledronic acid prevents aromatase inhibitor–associated bone loss more effectively than delayed-start zoledronic acid in postmenopausal women with early-stage breast cancer receiving letrozole. Additionally, disease recurrence appears to be lower with upfront zoledronic acid, but further follow-up is needed to confirm these interim results. "

The Oncologist, Vol. 13, No. 5, 503-514, May 2008; doi:10.1634/theoncologist.2007-0206

Link to Article: http://theoncologist.alphamedpress.org/cgi/content/abstract/13/5/503

Hope this helps,

Tender

saluki · August 2008

My Oncologist was also impressed with the preliminary findings so he has started giving me the twice a year Zometa infusions. Since I am stage II and not in the Zometa study- the only way he could get insurance to pay is as an infusion with the diagnosis of Osteopenia.

Frankly, I wanted to be back on something because RSD which I have can cause osteoporosis. I had stopped my oral Bisphosphonates when I had a complicated tooth extraction.

Very funny or at least something I wasn't expecting. I've been on both Fosamax and later Boniva----Very queer that within 24 hours of taking either of them I'd be suddenly doubled over in excruciating stomach pain--so bad I was thinking that I may be having a heart attack and should get to the emergency room. It would leave within a half hour just as mysteriously.

I had the same thing happen after my first infusion---very queer and down right scary----

Other than that nothing else except incredibly dry, irritated eyes, lids stuck to them....vision is a little blurry and eyes burn on awakening.

FloridaLady · August 2008

My onc. does not like any of the studies. He is a ex-NCI doctor. He said way to early to show proof? He also the risk of toxic kidneys for someone in treatment is too high, and the risk of jaw bone breakdown is still too high. My Mom has been on Fosamax for years and now has jaw bone loss.... Family history even a bigger NO NO. Well... I asked the qestion... My doctor is usually up for these things. I was surprise his stance on this. I am using Avastin and he said that was the big concern for my kidney's. Just to much toxic stuff.

Flalady

BethNY · August 2008

send a PM to nosurrender. Her onc recommended zometa for prevention and she started it last week.

gsg · August 2008

I took the press release regarding the new research findings with me to my appointment with my onc last month. He isn't recommending it yet either. His words to me were: "The jury is still out on those studies." He sits on the Breast Cancer Board for the State of Maryland and teaches at Hopkins, so I'm pretty sure he stays up-to-date on the new stuff. I'm going to have to trust him at this point. But I'm going to be doing a lot of my own reading on it, too. If it seems like more and more doctors are recommending it, I'm going to ask him about it again when I see him in January.

saluki · August 2008

My Onc tests kidney function a few days before treatment. If I were on any medications that affected the kidneys I would not have elected to try a twice a year infusion. By the way, kidney damage with this is usually reversible. But I guess that would be assuming they were not compromised by other factors.

I was very worried about possible kidney damage. I kept myself well hydrated and took some comfort in the fact that the infusion was over a twenty minute period. It is a consideration especially if you are taking other meds that can compromise the kidneys. The ones I was taking can affect the liver.

OneBadBoob · August 2008

Thanks everyone for the information. And thanks Saluki for the info on kidney damage, I had not heard of that.

One of my biggest concerns is the onj--I have been googling and found this dated July 08:

Decreased occurrence of osteonecrosis of the jaw after implementation of dental preventive measures in solid tumour patients with bone metastases treated with bisphosphonates. The experience of the National Cancer Institute of Milan

http://annonc.oxfordjournals.org/cgi/content/abstract/mdn526v1

Background: Screening of the oral cavity and dental care wassuggested as mandatory preventive measures of osteonecrosisof the jaw (ONJ) in patients receiving bisphosphonates (BPs).We investigated the occurrence of ONJ before and after implementationof dental preventive measures when starting BP therapy.

Patients and methods: Since April 2005, 154 consecutive patientstreated with BPs (POST-Group) have undergone a baseline mouthassessment (dental visit ± orthopantomography of thejaws) to detect potential dental conditions and dental careif required. A retrospective review was also conducted of allconsecutive cancer patients with bone metastases (PRE-Group)and treated for the first time with BPs from January 1999 toApril 2005 in our clinic without receiving any preventive measure.Incidence proportion and incidence rate (IR) were used to estimatethe incidence of ONJ.

Results: Among the study population (966 patients; male/female= 179/787), 73% had breast cancer. 25% of patients were givenzoledronic acid (ZOL), 62% pamidronate (PAM), 8% PAM followedby ZOL and 5% clodronate. ONJ was observed in 28 patients (2.9%);we observed a reduction in the incidence of ONJ from 3.2% to1.3%, when comparing-pre and post-implementation of preventivemeasures programme. Considering the patients exposed to ZOL,the performance of a dental examination and the applicationof preventive measures led to a sustained reduction in ONJ IR(7.8% in the PRE-Group versus 1.7% in the POST-Group; P = 0.016),with an IR ratio of 0.30 (95% confidence interval 0.03-1.26).

Conclusions: ONJ is a manageable and preventable condition.Our data confirm that the application of preventive measurescan significantly reduce the incidence of ONJ in cancer patientsreceiving BPs therapy. Dental exams combined to the identificationof patients at risk in cooperation with the Dental Team canimprove outcomes and increase the number of ONJ-free patients.

So, I guess those of us who are going to do the Zometa should be super careful of our oral care and see our dentists often.

Oddly enough, it is my dentist who is jumping up and down that I not do this.

alittlebird · August 2008

I'm new to the group and the topic caught my eye because I'm about to take my first infusion of Zometa for adjuvant purposes. My oncologist says the research is very encouraging though not definitive. He approved the treatment for me as I could certainly benefit from the osteoporosis side (on Arimidex) and may as well from the met side.

Has anyone had experience with Zometa? I've heard s/e are minimal.

Age 60, Dx 10/07 IDC, stage 1, grade 2, 1.2cm tumor, 0/2 nodes ER+/PR-/Her2-.
My oncotypeDx score was 27 so I've completed CT x 4 mid March.

TenderIsOurMight · August 2008

Welcome, alittlebird, though sorry for the circumstances of your finding this forum.

Yes, the suggestion of Zometa used adjuvaantly as well as in recurrence/mets for prevention/limitation of bone disease is exciting.

As with any drug, all react differently. A common SE of Zometa is a flu-like feeling post infusion for a variable amount of time. Some here suggest this may be limited by asking for a 30 minute infusion instead of the minimum (i.e., not to go under) 15 minute infusion.

There is a search feature to the top right of the page. If you type in Zometa, you will get many responses. For specific numbers on side effects, you can always turn to the package insert posted on the pharmaceutical manufacturers website.

It sounds like you have a very pro-active oncologist, which with breast cancer many like to have. Of course with every drug there is risk, and with Zometa ONJ (osteonecrosis of the jaw) is a known and debilitating risk. There is a small risk of kidney damage also to keep in mind, so best to know where you start with your own kidney function prior to your first infusion.

Hope this helps,

Tender

alittlebird · August 2008

Thanks, Tender for your information. I called my dentist to discuss ONJ. He feels my dental health and hygiene is very good (my dad was a dentist so I learned early!) and only suggests more frequent cleaning and exams, 3-4 per year instead of the usual 2. My oncologist said the infusion would take around 30 minutes and will check my kidney function before each infusion. Staying well hydrated is also encouraged so I'll have my water bottle with me. I think after getting a high score from the OncotypeDx I became even more worried about mets. I lost my mother from breast cancer which still looms large in my mind. It sounds like you and many others here are past some of the early anxiety after diagnosis and are getting on with life, putting cancer in the background. I hope to join those ranks soon. Thanks again!

kerry_lamb · August 2008

I have been talking to my onc here in Australia, and he has been talking to our most prominent international cancer-chemicals specialist ( who we know socially), and they are both saying, "If it was my wife, I'd give it to her." They both talk about getting the dental hygiene thing sorted before starting..more along the extraction front, should that be necessary, and fully healed. Bit hard if you are on the chemo-carousel.

It's not on the PBS here and costs $400 a go. In the big scheme of things it doesn't seem a lot..should be free. We are always a few years out from the US.

alittlebird · August 2008

Hi Kerry,

Interesting comment from your oncologist,"if it was my wife..." I asked my onc the same thing! Zometa at $400 is a bargain! It's not covered by my insurance and I'll be paying $1150 per treatment.I'm grateful my oncologist is on board with the treatment and hope it will be worth the cost/risk in preventing mets. I'm on Arimidex which will thin my bones so Z will help that too. And I can say I tried A to Z!

First infusion is tomorrow ...

kerry_lamb · September 2008

Hey little!

Well..that IS cheap. You can get it free here once your osteop causes you to break a bone Frown .

Can you believe that? Anyway, my (German) onco is so keen on my keeness to be his own mini-trial girl that he seems to have some 'way' with the hospital pharmacy and I may get it even cheaper. That's one good thing about being behind, I guess. It's all very personal here in the bush!

You go girl! A TO Z has this bastard of a thing covered for sure.

otter · September 2008

I just had my twice-a-year routine dental exam and cleaning, so I asked my dentist what he thought about risk and management of ONJ due to bisphosphonates.

He told me there is less concern about ONJ than there had been originally, because the incidence has turned out to be very low. Even my hygienist knew about it--she said the problem occurred most often with dental extractions. (It can occur with other procedures too, though, and even without anything being done.)

Anyway, my dentist said he had just returned from a C.E. program where ONJ and bisphosphonates had been discussed. He said dentists (dental surgeons?) are even doing dental implants now, on patients taking bisphosphonates. I suppose there is a lot of monitoring and preventive care going on, as described in the article Jane mentioned in her post.

My dentist's attitude seemed to be, "Do whatever you have to do, and we'll deal with it!" He was very upbeat and optimistic, but that's how he always is.

I am not currently on a bisphosphonate. Prior to my initiation to chemo, my med onco mentioned the clinical trial that's underway to test 3 bisphosphonates, including Zometa, for reducing the risk of mets. I declined to enroll then because I didn't want the additional SE's.

Now, I'm on Arimidex, and my baseline DEXA scan in July showed very early osteopenia. My med onco doesn't want to put me on a bisphosphonate yet, but she will if I lose much more bone.

We just never know where we'll come out of this maze, do we?

otter

onwardandforward · September 2008

I just finished 4 AC and 4 Taxol and plan to start the study (my doctor is participating). It's Zometa (IV once a month for 2.5 years) versus Boniva/ibandronate (oral daily for 3 years) versus Clodronate (oral daily for 3 years) and you need to enroll within 8 weeks of your last chemo. If you don't go on the study, you can get the clodronate through Canadian pharmacies if your insurance won't cover the Boniva (I'm premenopausal and had a bone density two years ago which was great so I doubt anyone will cover anything). My doc said it can reduce the risk of recurrence by a third (for me that's 9% down to 6%). You just need a dental exam first and then regular blood tests (including kidney function).

I figure, little risk but reasonable potential gain....and you can always stop it if you have side effects....

Good luck!

DATO · September 2008

I'm in that clinical trial that is looking at Zometa and two oral forms of biphosphonates to help prevent bone mets. I'm in the Zometa arm of the trial and I'm about half way through. I now get the Zometa once every 3 months. I have had absolutely no side effects from the Zometa. I get blood work done before every infusion and I've had no abnormal results. I'm also on Arimidex and I've had a bone density scan and my bones are in good shape.

Darlene

Zometa twice a year to prevent bone mets?

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