Zometa - Latest News out of San Antonio Meeting
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Shanagirl -Thanks for the update from your oncologist. I've spoken with my physician assistant and my niece who is an oncologist. Still waiting for the oncologist to digest all the data. He was in San Antonio last week. My niece, bless her, read all the data and has been speaking with her colleagues. I'll report back to everyone when I hear what they advise me to do. Meanwhile, the PA informed me that if I still am a candidate for the Zometa infusion, they will schedule it right away if that's what we decide to do.
I don't think the decision is so black and white. I'm glad everyone is taking their time and thinking it through. I'm inclinded to go forward with the infusion since I'm in the former group. We'll see.
Shanagirl, hope you're feeling well afterwards.
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Would love to know what the signifigance of the hysterectomy is on the the "instant menopause". Is having a hyst equivilant to 5 years past menopause?
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I am meeting with someone today about this so I will share what I learn!
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Good question Everyminute. Assuming the Austrian study is valid and repeatable (and I see no reason to question that), women who were put into menopause by way of zolodex / goserilin received as much benefit from zometa as has ever been seen. No time delay of 5 years. So what could be the difference between an oophorectomy and chemically induced ovarian suppression? It should result in instance cessation of hormones of ovarian origin. Another study, zofast, repeated positive results for menopausal women who were on an aromatase inhibitor and zometa. That seems to validate the view that zometa plus a lack of estrogen reduces recurrance. Shows the Austrian work wasn't a one off.
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everyminute,
I was wondering the exact same thing. I'm supposing that with regular menopause, it takes that long for your body to slowly lose its estrogen and that's why they say 5 yrs out. But with hyster/ooph, it is immediate, so I'm thinking we are in the same boat estrogen-wise as a 5yr. out post-menopausal woman.
I guess that would also explain why it didn't seem to help estrogen negative gals--they wouldn't have been on an estrogen depriver.
Please, anyone, let us know what you find out!
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I want to add,
I hope all this hype about it not working doesn't scare oncs (and insurance) into not giving it to their patients! I was supposed to start it the week before Christmas (yikes--that's next week) and I'm very curious to what will happen now.
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Since estrogen levels can be tested, I'd like to know what level of estrogen would put a women into the same level as a woman 5 years into menopause. My wife is currently in chemopause, and wondering if it is permanent, and whether it is sufficient to get benefit from bisphosphonates in terms of cancer recurrance prevention. I've read that 10-20 pg/ml is a typical menopausal level of estradiol. Also that less than 25 is typical of a woman 5 years into menopause. So if a woman tests in that range, is she as likely to get benefit from zometa as the women who did in AZURE?
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Finally heard back from my physician and niece. Bottom line, for me, is to continue with the Zometa. The doctor said there is one more study that should be coming out in the next six months that should shed additional light on the data. Until then, since I haven't had any side effects and since I was thrown into menopause because I'm doing ovarian suppression, at the very least I will get the bone benefit from the Zometa.
I agree with what other posters have said about perhaps the women who are 5 years past menopause probably have the circulating estrogen of the women who were abruptly put into menopause. Let's hope that future studies will confirm that.My best wishes and prayers are with everyone on this board.
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Here is evidence support zometa for early-stage breast cancer in the Nov. 2010 issue of Annals of Oncology:
Efficacy of Zoledronic Acid in Postmenopausal Women With Early Breast Cancer Receiving Adjuvant Letrozole: 36-Month Results of the ZO-FAST Study
Ann Oncol. 2010 Nov 1;21(11):2188-2194, H Eidtmann, R de Boer, N Bundred, A Llombart-Cussac, N Davidson, P Neven, G von Minckwitz, J Miller, N Schenk, R Coleman
After a 36-month follow-up period, early initiation of ZOL provided significant benefits in bone health and improved DFS in postmenopausal women receiving adjuvant AI therapy for early hormone-receptor...TAKE-HOME MESSAGE
After a 36-month follow-up period, early initiation of ZOL provided significant benefits in bone health and improved DFS in postmenopausal women receiving adjuvant AI therapy for early hormone-receptor positive breast cancer.Abstract
SUMMARY
OncologySTAT Editorial Team
Aromatase inhibitors (AIs) have greater efficacy than tamoxifen as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive early breast cancer. Bisphosphonates such as zoledronic acid (ZOL) have been demonstrated to prevent bone loss and reduce the risk of fracture associated with AIs, and have also been demonstrated to improve cancer outcomes. Eidtmann et al reported the results of a 36-month follow-up of the Zometa-Femara Adjuvant Synergy Trial (ZO-Fast). Patients for whom ZOL treatment was initiated immediately after randomization (immediate ZOL group) experienced improved bone health and disease-free survival (DFS) compared with those for whom ZOL treatment was delayed (delayed ZOL group).In this open-label multicenter randomized trial, patients were postmenopausal women or women who were recently menopausal because of chemotherapy or ovarian suppression for hormone-receptor positive early breast cancer. Baseline lumbar spine (LS) and total hip bone mineral density (BMD) T-scores were required to be > -2.0. Patients were randomly assigned to receive immediate or delayed ZOL treatment. All patients received oral daily letrozole for 5 years and daily calcium and vitamin D supplements. In the immediate ZOL group, ZOL was provided beginning immediately after randomization. In the delayed ZOL group, ZOL was provided if the patient's T-score became < -2.0 after a nontraumatic bone fracture or if an asymptomatic fracture was detected by spinal x-ray.
A total of 1065 patients were randomly assigned in the original ZO-Fast trial. Baseline and 36-month BMD data were available for 314 patients in the immediate ZOL group and 319 in the delayed ZOL group. From baseline to 36 months, LS BMD increased by 4.39% (95% confidence interval [CI], 3.69%-5.11%) in the immediate ZOL group, and decreased by 4.9% (95% CI, -5.54% to -4.25%) in the delayed ZOL group (least squares mean difference between groups, 92.9%; 95% CI, 8.37%-10.20%; P < .0001). Slightly smaller but still significant changes were observed for total hip BMD (P < .0001). More patients in the immediate ZOL group than in the delayed ZOL group with baseline lumbar T-scores between -2.0 and -1.0 transitioned to normal BMD (P < .001), and more patients in the delayed ZOL group than in the immediate ZOL group developed severe osteopenia/osteoporosis (P < .001). However, similar proportions of patients in the immediate and delayed ZOL groups experienced fractures (5.0% vs 6.0%; P = .502).
A total of 506 of 532 immediate ZOL patients and 489 of532 delayed ZOL patients were disease free and alive, corresponding to an absolute difference of 3.2% between the two groups and a relative reduction of 41% in the risk of having a DFS event (hazard ratio [HR] = 0.588; 95% CI, 0.361-0.959; P = .0314). Compared with the delayed ZOL group, the immediate ZOL group had fewer local (0.4% vs 1.9%) and distant (3.8% vs 5.6%) recurrences, and fewer immediate than delayed ZOL patients developed bone metastases (1.7% vs 3.2%). Adverse events were similar between groups. Influenza-like symptoms were more common in the immediate than in the delayed ZOL group. Renal failure or impairment was less common in the immediate than in the delayed ZOL group (0.2% vs 0.6%). Osteonecrosis of the jaw occurred in 2 patients in the immediate ZOL group.
The results of this analysis showed that early initiation of ZOL provided significant benefits in bone health and improved DFS in postmenopausal women receiving adjuvant AI therapy for early hormone-receptor positive breast cancer.
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My onc addressed this today at my 3 month appt. I've in a study and get 50 mg of Boniva daily. She basically said that it was up to me if I wanted to continue and felt confident with the recent results shared in San Antonio. I've decided to stop as it was her opinion "it is of no benefit" and I'm concerned about other side effects of bisphosphanates (potential for osteonecrosis etc...) - I should add my onc was Dr Winers fellow at Dana Farber (he's one of the experts on the board)
Just my thoughts
Karyn
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Kward but didn't your doctor atleast feel it was benificial for bone loss?
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I had my estrogen level checked right after my hyster/ooph (before starting the AI) and it came back as <12. I think there is a test that is even more specific than that, but it wasn't offered to me.
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My second Zometa is supposed to be next Monday in conjunction with my onc visit. I'm also curious about his take on this. He's a colleague of Dr. Gralow who's been involved in the SWOG study and they are still aways out from publishing results. So I'm curious what he'll say.
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ABCSG-12 Shows Benefit for Zoledronic Acid in Early Breast Cancer
By: KERRI WACHTER, Internal Medicine News Digital Network
12/17/10
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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.
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I saw my oncologist today for a 3-month follow-up. I was scheduled to have my 4th Zometa treatment in March 2011. He said he was stopping it for me. We discussed it and I'm comfortable with the decision. I was 38 and pre-menopausal at the time of my diagnosis. It doesn't seem, even with being on Tamoxifen, that my "flavor" of menopause (whether it's still chemo-pause, or my body slowly getting itself into a true menopause), that I would fall into any of the groups that show clear benefit from the Zometa. He said that some of his patients he currently has on Zometa, he will keep on it; mainly older women who are truly post-menopausal (not borderline like me), and who are on AI's, so at a minimum they will benefit from the bone strengthening that Zometa gives you. I currently get that benefit from Tamoxifen.
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Hmmm...am really off label..I am 49..ER/PR neg..., still menstruating but osteoporotic prior to Zometa.
I am now osteopenic..:)))...my subgroup is small and not well studied...I am hoping, my onc will continue it.
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O.k., here is what I was told: it is very curious that Zometa did not show any effect in this study, but this surely is not representing Zometa not having an effect. Rather, it seems to be a question of dosage. The positive results for Zometa exist and that plentiful. They should not be discarded simply on this one study.
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PURE - My original done density was the high end of normal and the option to stay on was totally mine. I'm concerned about the possibility of osteonecrosis of the jaw (I'm a dentist) and will have another bone density this summer. If there is any change I will consider resuming treatment. I did complete 18 months of Boniva on the study (higher dose than Sally Feild takes) so I've got a bit in my body already. They do think there is no additional benefit after 2-3 years for osteoporosis for the IV form or higher dose oral. Time will tell, certainly interesting.
Karyn
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I know these types of study results can cause a lot of questions, second quessing and anxiety regarding the most effective treatment plan for each of us. I too am very interested in hearing about any additional studies or research data that can better clarify the role Zometa may play in reducing the chance of metastatic spread. I have learned some time ago however, not to believe that any study can be completely accurate or even applicable under all the varied circumstances cancer can present.
I have a heavy investment both emotionally and physically in Zometa since I have been receiving IV infusions for almost 5 years now. Obviously, there is no way I can know beyond certainty why I still remain NED 5 years after having 23 positive nodes but my gut tells me the Zometa has had a role to play in that. I will be seeing my onc in mid January and will discuss the topic with her but I am more than willing to continue to get what will be my last Zometa dose in July of 2011.
Based on the Azure results it appears I may meet the criteria for the subgroup of women who did show benefit from Zometa. I went into chemo induced menopause in 2000 after my first BC dx at the age of 47 so was definitely post-menopausal in 2005 when I had my second primary BC dx at the age of 52. My estrogen levels a few years ago were at a low of 8 plus I have been on Aromasin for 4.5 years. I started on Zometa infusions in 2006 immediately following chemo and radiation txs and have now had a total of 10 infusions with my 11th and final dose scheduled for July.
I know that my oncologist will have an opinion on the recent study data and I will be very interested to hear her perspective as it relates to me and my cancer presentation specifically. Obviously, each of us has to be treated uniquely and with therapy that is designed to target our BC pathology and presentation. I still hold out strong hope that Zometa will be found to be a powerful cancer treatment weapon for many of us. I am not inclined to disregard its usefulness based solely on the Azure trial but hope to see a trend revealed by future studies that can refine under what circumstances Zometa is best used.
Its not time to give up on Zometa yet. I believe the jury is still out and there is just too much positive data to disregard at this point. I do believe, however that it is wise to have ongoing discussions with your oncologists to help understand why it may be more appropriate for some and not others.
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Had my onc visit last week and was supposed to be scheduled for Zometa. I asked about the Azure study and his response was that there were 3 studies out there showing positive effects from Zometa. The one he found the most convincing is where they have seen reduction in tumors from neoadjuvant Zometa. But he didn't mention the study names and I forgot to ask. He wants to keep throwing everything we can at this.
So we go back to the infusion room to wait and that's when we find out that starting Dec 1 Regence requires pre-authorization. No coincidence that this change was made and the Azure study results are released. I'm still waiting to here back from the cancer center if they were able to get the pre-authorization. I suspect the initial response was no so it's moved up to the onc writing a letter to justify.
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Here is some positive data just released
2010: ABSTRACT #P5-11-02: The Carry-Over Effect of Adjuvant Zoledronic Acid: Comparison of 48- and 62-Month Analyses of ABCSG-12 Suggests That the Benefits of Combining Zoledronic Acid with Adjuvant Endocrine Therapy Persist Long after Completion of Therapy[San Antonio Breast Cancer Symposium]
Background: ABCSG-12 examined the efficacy of ovarian suppression using goserelin combined with tamoxifen (TAM) or anastrozole (ANA) ± zoledronic acid (ZOL) in premenopausal patients with endocrine-responsive early breast cancer. Results: at 48 months and at 62 months show that adding ZOL significantly improved disease-free survival (DFS) and reduced disease recurrence.
Methods: Premenopausal patients with endocrine-responsive early breast cancer (N = 1,803) were randomized to goserelin (3.6 mg q28d) and TAM (20 mg/d) or ANA (1 mg/d) ± ZOL (4 mg q6mo) for 3 years. Endpoints included DFS and overall survival, both analyzed using log-rank test and Cox models.
Results: At 48 months' median follow-up, ZOL significantly reduced the risk of DFS events by 36% versus no-ZOL (hazard ratio [HR] = 0.64; P = .01); this was maintained at 62 months' follow-up (HR = 0.68; P = .009). In addition, the trend toward reduced risk of death with ZOL was maintained at both 48 months (HR = 0.60; P = .11) and 62 months (HR = 0.66; P = .10) compared with no-ZOL. Patients receiving ZOL also had fewer distant recurrences compared with no-ZOL: 29 versus 41 events at 48 months, and 44 versus 56 events at 62 months. No significant renal adverse events or confirmed cases of osteonecrosis of the jaw (ONJ) have been reported.
Conclusions: Comparisons of 48- and 62-month data suggest a possible carry-over of the ZOL anticancer benefit 2 years after treatment completion. Additional analyses will be presented, including disease outcomes during therapy and after treatment, as well as overall survival -
I was supposed to be starting Zometa any time now- my insurance won't cover it, so the plan was to put me on a once a year plan, I would pay once, maybe twice (the most I could really afford)(it's expensive!!), and by then it would have been standardized as a tx and I could get it covered. And then the San Antonio results came out and the makers puled the application for coverage and I'm totally screwed. I'll never get it covered now, and although my onc will give it to me for cost, that's $1600 a dose and I just don't have it. We haven't gotten to having a sit down yet but I don't know now. I feel so upset that this tx that could make a really big difference for me (being in the group that showed benefit even in the new study) is maybe just inaccessible to me. Is it worth just getting it once or twice if I can't do more? I guess probably but the whole thing is just so upsetting.
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I'm still wondering if I'll be able to get the zometa, too. Not because of the cost--my onc was going to prescribe it and she said if she prescribes it, it will be covered, but now. . . who knows if she will even still prescribe it. I got my dental clearance last week and emailed to let her know I was finally ready to start. I still haven't heard back from her--I'm assuming it's because of the new controversy (but I could just be being a big pessimist and it might actually be because of the holidays.) I'm going to give her tomorrow, but I think on Tuesday, I'll either email her again or even call her office. I hate being a pest, but I really want that zometa!
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Well, against my oncologist's preference, I got my second dose of Zometa today. I'm pre-menopausal, but I've been on ovarian suppression since completing radiation. So unless I missed something (which is possible as I don't have much time tonight so I've done a little scanning here...) I don't fit perfectly into any group, but it seems there may still be some benefit. My onc said they'll sort it out over the next year, but for right now nobody really knows for sure if it will help someone like me. He didn't want me to get it today, and didn't think my insurance would cover it anyway. My response was that I'd rather get it and not need it rather than wait and find out I did need it and didn't get it. So finally I asked him if he would let me get it if the insurance company pre-authorized it, so at least I'd feel covered while it was all sorted out. He agreed, the insurance company gave us a green light, and I'm good to go for another 6 months.
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Peace of mind is priceless, and that's what second opinions give us, right?
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I am totally confused. Do I or don't I? I was 40 at the time of d/x and I received Zoladex injections every 3 months for ovary suppression and also take Femara. Do I fall into the "to receive" Zometa or "not to receive"? I'm scheduled for my third dosage the first week of January and don't see my onc until the later in the month. I guess I'm just looking for reassurance that I'm doing the right thing.
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The ABCSG study looked at women who were pre-menopausal, never had chemo, but on ovarian suppression (zolodex / goserilin), and they benefitted from zometa and continue to benefit after continued follow up. This is not contradicted by the other study in which premenopausal women were not on ovarian suppression (and did not receive benefit from zometa).
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Thanks for the clarification Timothy. That's how I thought I fit in there. Though I did have lots of chemo, the pre-menopausal and ovarian suppression from the earlier study fit my case, and I couldn't see how the other study contradicted that.
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Why would the chemo vs. no chemo affect much? Does anyone know? I understand why the ovarian suppression would because of the estrogen involvement, but why the chemo? Would it be because chemo pushes many premenoupausal women into chemo-pause?
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OK girls, what do I do? My 3d infusion on zometa is coming up in two weeks. MY onc told me to think about it since the new study cane out. I started zomenta 2 yr after DX. I was premetpausal before Dx just barly. Also I am ER+PR-. My onc said it was up to me and I feel, I should go for it, I feel it can't hurt. What so you think? Thanks
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