Zometa

Kim, that's great to hear.  We had to convince Bev's oncologist.  At first he said it couldn't be obtained and he didn't think the treatment had value.  I called a drug store and found out that wasn't an issue.  As well, I learned from talkingn to the chemo nurses that Zometa is being used there for men with prostate cancer spread to the bone.  We brought him articles, in particular the NEJM journal, told him that it was an issue of informed consent and that Bev was aware of the risk of complications (low) vs the risk of recurrance (taking the onc's worst stat's and using that in our favor).  He eventually said he'd go to bat for us and got approval.  But then a small miracle, Bev got drawn for the Zometa arm of the clinical trial and suddenly it became easy and "above the board" so to speak.  Good for you for persisting.

CP418 - I'm not at least offended by your response - actually I think I may call my onc tomorrow and see if we can get it sooner!  Thanks!

Great news!

I just had my second Zometa infusion 2 days ago -- definitely fewer achy, flu-like symptoms! Just took a couple of Ibuprofen yesterday and today and I was good to go!

so worth it!

Jackie

Still waiting to hear on the CT.   I'm going to ask when I call my onc about the Zometa.

I hope she lets you do it, the more I read about Zometa, the happier I am that i am getting it.

Oh, thanks! Persistance pays off. Well, actually she went off to the San Antonio conference and saw the light!  There was also an issue with prescribing off-label, but luckily Norvatis stepped in there to help (guess they wanted me to buy their drug!) Our private insurance covered 90% of it (not OHIP)

Springtime,  I don't know how many of the women in these two studies, if any, had pCRs to chemo, but it might be something to look into.  I think all the ZO-FAST trialists would be ER+ if they were being treated with Femara.  Data from the AZURE trial which involved chemotherapy is preliminary but promising.

http://cme.medscape.com/viewarticle/588198

More Results Suggesting Benefit for Zoledronic Acid  Released: 02/12/2009

One set of results come from the AZURE (Neo-Adjuvant Zoledronic Acid to Reduce Recurrence) trial, conducted in 3360 patients with stage II or III breast cancer, both premenopausal and postmenopausal. Preliminary data from a subgroup of 205 women for whom a retrospective pathology analysis had been performed suggest that, when given before surgery, neoadjuvant zoledronic acid worked synergistically with chemotherapy and resulted in a greater shrinkage of the tumor, leading to fewer mastectomies.

The other set of results come from ZO-FAST (Zometa-Femara Adjuvant Synergy Trial), which showed that zoledronic acid can prevent bone loss associated with the aromatase inhibitor letrozole (Femara; Novartis) in postmenopausal women with early breast cancer. However, they also show that women who took zoledronic acid throughout the 3-year study had significantly lower breast cancer recurrence.

From Medscape Medical News

SABCS 2008: Zoledronic Acid Has Direct Effect on Breast Cancer

Zosia Chustecka

December 12, 2008 ( San Antonio , Texas ) - New data suggest that zoledronic acid (Zometa, Novartis) has a direct effect on breast cancer. The bisphosphonate is currently marketed for osteoporosis and bone metastasis, but there is growing evidence to suggest that it might also have a role to play in breast cancer.

Preliminary results from a clinical-trial subset presented here at the 31st Annual San Antonio Breast Cancer Symposium show that when zoledronic acid was used with chemotherapy in the neoadjuvant setting, the combination led to a significantly greater shrinkage of the primary tumor than was seen with chemotherapy alone.

Together with chemotherapy, you get this exquisite synergy.

Also, data from molecular studies presented here show that the combination produces a change in the expression of a number of genes and proteins associated with cell-cycle regulation and apoptosis, but neither produced these changes when used alone. "Zoledronic acid on its own had no appreciable effect, but together with chemotherapy, you get this exquisite synergy," commented coauthor Robert Coleman, MD, FRCP, professor of medical oncology at the University of Sheffield, United Kingdom.

These new results are the second time this year that zoledronic acid has shown an effect on breast cancer. When added to adjuvant chemotherapy, it significantly reduced the relapse rate in early breast cancer in the Austrian Breast and Colorectal Cancer Study Group trial 12. These results were presented at this year's American Society of Clinical Oncology meeting, and reported by Medscape Oncology at that time.

Neoadjuvant Use Increased Tumor Shrinkage

The latest data come from the AZURE (Neo-Adjuvant Zoledronic Acid to Reduce Recurrence) trial, conducted in 3360 patients with stage 2 or 3 breast cancer. Patients received standard neoadjuvant chemotherapy with or without the addition of zoledronic acid before surgery, and then standard adjuvant chemotherapy with or without zoledronic acid after surgery. The study was funded by the manufacturer.

The overall results of this trial are still being evaluated, but at the San Antonio meeting, Dr. Coleman presented preliminary results for a subgroup of 205 patients for whom a retrospective pathology analysis had been performed.

The results from this subgroup suggest that the addition of zoledronic acid leads to a greater shrinkage of the primary tumor. After surgery, the median residual tumor size was significantly smaller in women receiving both chemotherapy and zoledronic acid (20.5 mm vs 30.0 mm) than in those receiving chemotherapy alone (P = .002). In addition, a complete pathologic response was seen in 10.8% of women in the combination group vs 5.8% of those in the chemotherapy-alone group (P = .02).

Fewer Women Had a Mastectomy

In this neoadjuvant setting, the goal is to reduce the size of the tumor, and in doing so to potentially improve breast conservation rates and longer-term outcomes, explained coauthor Matthew Winter, MBChB, MSc, clinical research fellow at the University of Sheffield . In this analysis, fewer women in the combination group required a mastectomy (65.3% compared with 77.9% in the chemotherapy-alone group).

"The results support a potential antitumor benefit of combining zoledronic acid with chemotherapy in the neoadjuvant treatment of breast cancer," Dr. Winter commented in a statement.

Dr. Coleman emphasized that these results come from a retrospective and exploratory analysis and, hence, they should be regarded as hypothesis generating. But if the results from the overall AZURE trial confirm these findings, they could be practice changing, he suggested.

The final results from AZURE are expected in the next 2 or 3years, according to a Novartis spokesperson, who said Novartis is "committed to further exploring zoledronic acid as an anticancer treatment."

Less Bone Loss

Another presentation at the meeting reported an effect of zoledronic acid on breast cancer in yet another setting. ZO-FAST (Zometa-Femara Adjuvant Synergy Trial) assessed the effect of zoledronic acid on bone loss associated with the aromatase inhibitor letrozole in postmenopausal women with early breast cancer. The interim results at 36 months, assessed by bone-mineral-density measurements, show that the bisphosphonate is effective in preventing this bone loss, reported lead researcher Holger Eidtmann, MD, from University Frauenklinik, in Kiel, Germany.

However, the results also show an effect on breast cancer, he noted. In this study, one group of patients took zoledronic acid throughout the study (the immediate-zoledronic-acid group), and the other group took the drug only if bone-mineral density fell or they had a fracture (the delayed-zoledronic-acid group). The immediate group had a significantly lower disease recurrence than the delayed group (22 events vs 37 events; P = .0423), he reported.

When asked whether he would recommend zoledronic acid for breast cancer patients who are at increased risk for relapse, Dr. Eidtmann said: "No, I think it is too early for that; these results are only 3-year follow-up [data]. But I do believe that there is antitumor activity of zoledronic acid in breast cancer."

AZURE and ZO-FAST were funded by Novartis. Dr. Coleman reported serving on the speakers' bureau for Novartis. Dr. Eidtmann has disclosed no relevant financial relationships

sure...There is a conference this week in San Francisco-its a mini version of the San Antonio Conference in December. I hope to have more info at the end of the week and will send it along.

Once every 6 months is standard. I am pregnant so I can't have it but I am trying to get it in January when I start the 2nd half of chemo. I know this study is early but it can't hurt to have it at the same time of chemo and these prelimary studies are pretty promising about having it done at the time of chemo. I am working with a lady who is an expert in breast cancer. She sits down with all the major researchers and funds a lot of studies. She is going to get more info to me after this weeks conference. If i get any more studies I will post them here.

Tomorrow I start my first Zometa infusion. One of the Onc that I was seeing before we moved to another state said she did not see any need for it. When I mentioned it to my new Onc she said that i was a good candiatate for it and was ready to set me up for it.  Interesting that you hear different opinions from one Onc to another.  I am so thankful for the ladies on here, I get a wealth of information each time I get on this site. God Bless.

I will have my first Zometa infusion next week.  I had to find another onc to prescribe it.  I went to a research onc who said no problem.  I do not have a dramatic decrease in my Dexascan and do not have osteopenia.  The first onc just said no with such a lack of caring and no discussion.  The research onc was pretty amazed when I could quote the studies already published on Zometa.  Unbelievable that an onc would say no to Zometa when in reality there were no SEs of necrosis of the jaw in the studies.  It took me over a year to get the Zometa infusion.  Be persistent.  It is your life not the onc or the insurance company's.

it seems that necrosis is a 'side effect' of many of the post treatment drugs.

I never had any side effects from it Aug. Good luck. Report back!

I just had my first Zometa infusion and was reading the information on Zometa infustion.  My onc gave me 2 MG.  Is everyone else taking 4 MG Zometa?  I am a small woman about 113 lbs.  Could that be the reason that the dose was decreased?