Topic: Zometa anyone?

Hi Sherri,

I had my first infusion last month. I believe the first one was about 30 minutes, the ones after that should take about 15 minutes. I felt nothing that day and thought I was home free. The next day in the afternoon I had some flu-like symptoms and felt achy and feverish, but Ibuprofen helped a lot. Next day I felt fine -- fine enough to go running! So, all in all, I would say very doable! I'd say it's worth it!

Good luck with your onc!

Jackie

I brought it up to my oncologist and though she didnt give me her opinion either way, she did get it for me.  I originally was trying to get in a trial but it isnt offered at my oncs practice .  She said plan A was to get me zometa to prevent "osteoporosis" since I had hyst. and if the insurance wouldnt approve it that she would call onc for me at practice that was offering the trial and see if he would work with her and I so I wouldnt have to travel.  my ins did approve it so that is the route we went. 

First infusion was flu like for me - about 24 hours.  I was pretty sick and ibuprophen and tylenol didnt touch it actually!! But in a day or two I was fine - hopefully it will be better next time. 

I guess if she were against it she wouldnt have gone to such trouble

Sherri,

My onc is not on board yet.  We just had this conversation a week ago and his view is that the data is not conclusive and he does not want to risk the side effects.  Now, I am on Tamox and I know you are on an AI...and he did admit that if I was on an AI he would not be as against it.  He said Tamox helps protect the bones against osteoporosis.  I'm torn...but choose to go with his view right now.

The nice thing about that conversation is that he said "you have a long life ahead of you..I don't want to risk your kidney function until we have better data". 

Hugs,

Bugs

I plan to ask my onc next month, too, when I see him.

In the States, I know it isn't covered yet by insurance unles you have been diagnosed with osteopenia (or bone mets), so I plan to have a bone density scan done. I've been on Arimidex for about six months now, and haven't had a bone density scan in about two-three years. The last one did see some loss from the previous scan done a few years before that (in all, about seven years before bc), so I have some baseline scans to compare to the post-Arimidex scan.

If I get a report of any further loss, I hope my onc will be able to get my insurance to cover it. 

Hey Sherri, I have been on since beuing back home(2006) I get my infusions every 6 mos and I pushed for it.

I feel certain it will be rec/FDA approved( sometime!) as the studies have shown not only does it help prophylactively with Bone Mets, but it also has an overall Cancer inhibitory factor.( Which surprised the researchers)

Docs are very cautious esp. in the US ( including for  litiginous reasons) with prescribing a Rx that is" NOT FDA approved For that particular indication".

 Also there is concern re. a nasty side effect possibility of jaw necrosis. ( rare but a possiblity)

Presently it IS FDA approved for Osteopenia which is the precurser DX to osteporosis.

For me personally, I am very grateful I am on it. I have absolutely no problems.

Any other questions , let me know!!

Kerrymac, regarding the oophorectomy, you would be a good candidate for arguing your status is like the women in the Austrian study who received benefit.  All of those premenopausal women were receiving a drug goserilin, which chemically suppresses the ovaries.  Its a chemical alternative to oophorectomy.

We are going to fight for getting it for my wife.  The way I see it, if you compare the probability of harm 1) Zometa group: approx 1800 women received zometa in the study and had no serious side effects.  Compare to 2) Women who didn't receive zometa, 36% more almost certainly incurable recurrances.  How can they say the risk even comes close to overshadowing the harm?  It all depends on your risk of recurrance.  The higher your risk of recurrance, the greater the ratio of benefit to risk.  That's my argument.  There are two studies that show benefit, the Austrian work public in the New England Journal of Medicine and the Z-Fast / Zofast studies that combined it with adjuvent therapy with  femera.  I think those with the greatest risk of recurrance, have the most to lose by not gaining any possible risk reduction, and should be pressing for more aggressive adoption of the treatment.

i tried to copy and paste but it said the website has expired. I have the abstracts that were presented at the St.Gallens Cancer Conference this March 2009. I will type out one of the abstracts that might be beneficial to some woman. BRB...

 11th International Conference March 11-14 2009 , St. Gallen Switzerland. Sponsored by GSK Oncology

Abstract 0132: The effect of Zoledronic Acid (Zometa) in postmenopausal woman (PMW) with early breast cancer (EBC) receiving adjuvant letrozole: 24 months integrated followup of the ZFAST/ZOFAST trials

GOALS: Ai's administered alone or sequentially are the preferred treatments for Er+ EBC in PMW. Z-FAST and ZO-FAST are 2 multi-center open labelled randomized studies wich evaluated therapy with zoledronic acid (ZOL) in PMW with EBC receiving adjuvant letrozole. This 24 month integrated analyisis reviews two predefined secondary endpoints: fractures and disease.

METHODS: the intent-to-treat population is 1,667 PMW patients, with Stage l-lllA  Er+ EBC treated with Let (2.5mg every day x 5 years). Patients with a bone mineral density (BMD) T-score > 2, were randomized to upfront ZOL (N=833) vs delayed ZOL (N=834). Patients in the delayed arm receive ZOL if their post baseline T-score reaches <-2.0 or if a non-traumatic fracture occured. the primary endpoint was percent change of BMDin the lumbar spine at month 12,which has been reprted previously.

RESULTS: Upfront ZOL had 26(3.1%) pts who developed clinical features while the delayed arm had 28(3.4%) pts. 1664 pts were evaluable for disease recurrence; 30 (3.6%) pts in the upfront arm had disease recurrence VS 46(5.5%) pts in the delayed arm. The estimated hazard ratio for disease free survival (DFS) for upfront VS delayed was 0.573 (95% CI:0.358,0916.log rank p=0.0183). Bone metastasis were identified in 9 (1.1%) patients in the upfront arm VS 14 (1.7%) in the delayed arm; 9 (1.1%) deaths were recorded with upfront ZOL VS 16 (1.9%) with delayed ZOL.

CONCLUSION: at 24 months, the number and percentage of patients with fractures in the upfront arm apperas to be slightly lower than in the delayed arm. Disease free survival was improved in breast cancer patients receiving upfront ZOL VS delayed, illustrating the benefits of ZOL beyond bone health.

This was small...but I think they are on to something.

Sherri, I had my first infusion in January and will continue every 6 months.  I have also read that, in addition to preventing bone mets, that it has anti-tumor properties. My Onc gives it to me but since it is not approved, I have to pay for it myself.  $1,128.00 per infusion. Money well spent from everythig I read. I had no side effects at all.  Carol

Hello DATO.  I too am in the SWOG study.  I just finished my first consecutive months of zometa and now I go to the every three month schedule for 2/1/2 years.  Initially I did have a slight bit of achiness (flu like) but it now seems to be disapating.  Biggest thing for me is I wish I had my energy back.  I'm improving, but don't think I'm quite there yet.  I finished radiaton in January.

Hi SherriG,

I just had this discussion with my onc as have been reading about the studies. he is impressed by the study and the results. My recent BMD tst showed Osteoporosis so am on a bisphosphonate already. I live in canada...so when things are not yet standard of care a case has  to be made for coverage. it is something I will pay for myself.

 I hate to miss the boat on this and unlike the ER positive ladies have no treatment at the moment. It will feel good to do something to keep things away. So he is checking it out, and I am quite sure I will be starting in the near future.

My wife's onc has warmed up to the idea and is going to go to bat for us in trying to get it prescribed.  He may face some obstacles owing to the restrictions, but I'm really relieved that he's willing to let my wife try it, if he can get approval.

We just settled on my treatment path today, and my oncologist did recommend that I go on Zometa based on this new data coming out and my "setting."  I'm 42, premenopausal, and at an oncotype of 17 have decided not to do chemo (in part because of the Zometa option).  Two oncologists in the last week have said that in their opinion, Zometa looks to give me the same (albeit small...3%) reduction in recurrence risk as doing chemo. 

So I'll do that later in the summer, after radiation and as I go on tamoxifen.  We're hoping by then that the FDA will give approval for Zometa's use in BC therapy (not just for osteoporosis) and it will therefore be covered by insurance, though I'll also get a bone density scan in case.

Both oncologists acknowledged that Zometa in a situation like mine is not yet the standard of care, but they're convinced by these recent studies that it's worth considering taking, esp. if you're not doing chemo.

I confess to some worry about some of the side effects talked about, esp. the horrible-sounding jaw problems and joint pain, but am willing to risk it.  So interesting to see where I'm comfortable with risk and where I'm not...I've never been more aware of it!  

I will be starting Zometa in a couple of weeks.  I didn't realize that the side effects mentioned here were possible.  I will definitely be doing some research.