Zometa - Latest News out of San Antonio Meeting
WebMD Health News Reviewed by Laura J. Martin, MD
Dec. 9, 2010 (San Antonio) -- The bone-building drug Zometa does not appear to prevent breast cancer from coming back in most women, researchers report.
Adding Zometa to standard therapy, usually chemotherapy, also did not extend lives, according to results of the study of more than 3,000 women.
In women who were at least five years past menopause, however, the addition of Zometa improved overall survival rates by 29%, compared with standard treatment alone.
"This wasn't a small subgroup; 1,101 women fell into the category," says Robert Coleman, MD, professor of medical oncology at the University of Sheffield in England.
"The benefit was so great we don't think it's a chance finding," he tells WebMD.
Still, the results of a subgroup analysis cannot be considered conclusive, Coleman says.
Based on the findings, Novartis Pharmaceuticals, which makes the drug and funded the study, will withdraw U.S. and European applications for approval of Zometa to prevent breast cancer recurrences.
Coleman presented findings of the study, dubbed AZURE, at the San Antonio Breast Cancer Symposium.
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Earlier Studies Raise Hopes
Zometa, given as an infusion, is a member of a class of drugs called bisphosphonates that help maintain bone strength.
Animal and lab research suggests that bisphosphonates may fight breast cancer in a number of ways -- by directly killing tumor cells, by cutting off their blood supply, or by stimulating the immune system to mount an attack against the tumor, says Rowan Chlebowski, MD, PhD, a medical oncologist at Harbor-University of California, Los Angeles Medical Center.
The new research builds on a study presented at the 2008 breast cancer meeting showing that Zometa appears to prevent breast cancer from coming back.
Then, last year, Chlebowski presented an analysis of data on more than 150,000 women that showed that there were 31% fewer cases of breast cancer among women who took bisphosphonate pills than among women who didn't.
Zometa Does Not Appear to Prevent Breast Cancer Relapses
The new five-year study involved 3,360 patients with breast cancer that had spread to the lymph nodes.
A total of 404 women given Zometa plus standard therapy and 403 of those given standard treatment alone had a recurrence, developed a new cancer, or died before they had a recurrence.
Altogether, 243 women on Zometa and 276 on standard treatment alone died, a difference so small it could be due to chance.
Twenty-six women on Zometa had confirmed or suspected cases of osteonecrosis of the jaw, a side effect of bisphosphonates that causes the jawbone to decay.
Routine Use of Zometa for Breast Cancer Treatment Not Warranted
Since only women who were well into menopause appeared to benefit from the drug, Coleman says he suspects it works best in an environment of little or no estrogen.
Commenting on the findings, Sharon Giordano, MD, MPH, of the University of Texas M.D. Anderson Cancer Center in Houston, says the scientific community has been waiting to hear these results.
The bottom line, she tells WebMD, is that the routine use of Zometa to prevent breast cancer recurrence is not warranted at this time.
As for its apparent benefit in postmenopausal women, Giordano says, "Those findings are very intriguing, but not definitive."
Four trials are under way that should better define bisphosphonates' role in breast cancer prevention, she says.
The results do not affect Zometa and other bisphosphonates' "important role in treating bone loss among women with breast cancer," Giordano says.
Zometa is approved for the reduction or delay of bone complications across a broad range of cancers that have spread to the bone and multiple myeloma. It costs about $1,000 an infusion.
This study was presented at a medical conference. The findings should be considered preliminary as they have not yet undergone the "peer review" process, in which outside experts scrutinize the data prior to publication in a medical journal.
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View Article Sources
SOURCES:
San Antonio Breast Cancer Symposium, San Antonio, Dec. 8-12, 2010.
Robert Coleman, MD, professor of medical oncology, University of Sheffield, England; consultant, Novartis Pharmaceuticals.
Rowan Chlebowski, MD, PhD, Harbor-University of California, Los Angeles Medical Center.
Sharon Giordano, MD, MPH, University of Texas M.D. Anderson Cancer Center, Houston.
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"In women who were at least five years past menopause, however, the addition of Zometa improved overall survival rates by 29%, compared with standard treatment alone.:
This bit pleased me as I am exactly that time out from menopause and have had 1 zometa infusion so far.
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Well, sh*t....not the news I was hoping for.
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KerryMac -- Me too! I'm supposed to have my latest 6 month infusion on Monday....
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Yes I read this. Now I'm wondering if my onc will put me on Zometa as planned when I go on Arimidex. I have osteopenia but now I wonder if Zometa is the right drug to combat that.
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This is very bad news. I am due for a 6-month infusion next Tuesday. Zometa was my one treatment, after I was forced to abandon hormone therapy.
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Lago - There are still some on going studies. I'd like to hear more about what Dr. Gnant has to say. I saw him quoted only briefly so far.
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Here is another link. Why did this study show no protective effect while the Austrian study did, for pre-menopausal women?
The speculation is that once deprived of estrogen, the benefits women derive from Zometa are more visible because the other protective effect -lack of estrogen- has been taken out of the equation. But if estrogen remains equal, Zometa by itself won't make much of a difference. Here is the link to a good article:
SAN ANTONIO (EGMN) - Sharp contrast with previous findings, zoledronic acid failed to improve disease-free survival when added to adjuvant chemotherapy for women with stage II/III breast cancer in a highly anticipated phase III trial.
"In terms of primary analysis and primary end point, this is a negative trial," Dr. Robert Coleman said during a press briefing on Dec. 8 at the annual San Antonio Breast Cancer Symposium. "It is highly unlikely that this conclusion will change with further follow-up."
The randomized, open-label AZURE (Adjuvant Treatment with Zoledronic Acid in Stage II/III Breast Cancer) trial involved 3,360 women with stage II/III breast cancer at 174 participating centers. Based on the results, Novartis, maker of zoledronic acid (Zometa), announced that it is withdrawing applications for the drug's approval as an adjuvant breast cancer treatment in the United States and Europe. The company said it will evaluate its plans based on the data, which did include one positive finding.
Older women who had undergone menopause at least 5 years earlier showed a significant 29% improvement in overall survival with the osteoporosis drug added to standard therapy. This was not true for premenopausal or perimenopausal women, however, and no benefit was seen in disease-free survival, the primary end point.
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I'm dead.
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1Athena! - I read that too, last night. But what was interesting was that it applied to women at least 5 YEARS post menapausal. I'd like to know if the other studies that are on going are looking at premenapausal women who are doing ovarian suppression. I didn't see anything mentioned about that with regard to the Zometa in this study. Did you see anything about this?
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Here's an article from the NY Times with the only comment that I've seen, so far, from Dr. Gnant.
Mixed Result for Bone Drug in Cancer Study
The results of a new study are tempering hopes that a drug used to treat bone loss might also help stave off relapses of breast cancer, especially for younger women, researchers said Thursday.
The clinical trial found that women with early breast cancer who were treated with the bone drug zoledronic acid did not have fewer recurrences of their cancer than women who did not receive the drug. The results surprised and disappointed some experts because they conflicted with the findings of a previous, widely publicized trial.
"Most people in the breast cancer community were very hopeful that this would be a positive study," Dr. Sharon Giordano of the M. D. Anderson Cancer Center in Houston said in an interview. She was not involved in the study but is to deliver a commentary about it on Friday at the San Antonio Breast Cancer Symposium, where the results will be presented.
Still, Dr. Giordano and others said the latest results would not be the final word because additional studies were under way. Moreover, the new study suggested that the bone drug could help stave off recurrences for women well past menopause.
Zoledronic acid, sold by Novartis under the name Zometa, is one of a class of bone drugs known as bisphosphonates. It is approved to prevent fractures and other skeletal problems that can occur when breast cancer or other tumors spread to the bone.
A study published in The New England Journal of Medicine in February 2009 suggested that zoledronic acid would be useful in treating the cancer itself. In that trial, the bone drug reduced the risk of breast cancer recurrence or spread by about a third.
A leading theory for that effect was that the breakdown of bone provided substances that stimulate tumor growth. Drugs that slow that breakdown deprive tumors of those substances.
But the new study contradicts those findings. This study involved 3,360 patients, mainly in Britain, who had their breast tumors removed by surgery and underwent whatever chemotherapy or other treatment their physicians chose to prevent recurrence. Half the patients also received intravenous infusions of zoledronic acid for five years.
After nearly five years, the number of women who had had a recurrence or had died without a recurrence was about the same - 403 in the control group and 404 in the group receiving zoledronic acid. Those receiving the bone drug had a somewhat lower risk of dying, but the difference was not statistically significant.
However, the bone drug did seem to help women in the study who were at least five years past menopause, who accounted for about 30 percent of the participants. Among these women, there were 116 recurrences for those who got zoledronic acid compared with 147 in the control group, a risk reduction of 27 percent. Their risk of death was reduced 29 percent, with 86 deaths among those who got the drug compared with 120 deaths in the control group.
Dr. Robert E. Coleman of the University of Sheffield in England, the lead investigator of the study, said this suggested that zoledronic acid could help prevent relapse or spread only in the absence of estrogen or some other substance no longer produced by postmenopausal women.
In the study from nearly two years ago, the 1,800 participants were all premenopausal but were given a drug that shut down their ovaries, preventing them from making estrogen.
Dr. Michael Gnant of the Medical University of Vienna, who was the lead investigator of the earlier study, said at a news conference at the San Antonio symposium that the new results strengthened his belief in zoledronic acid.
But Dr. Giordano said that conclusions based on a subset of patients must be regarded with caution and that they should not change medical practice. She and others said there were other differences between the trials that might explain the divergent outcomes.
One thing experts agreed on was that zoledronic acid should now not be given to younger women with functioning ovaries unless the cancer had spread to their bones. That is true not only because the new trial showed no cancer benefit for these women but also because the drug can destroy jawbones in some patients.
The new study was sponsored by the University of Sheffield. Dr. Coleman and Dr. Gnant are paid consultants for Novartis, which contributed some money.
Just last week, a study published in The Lancet showed that zoledronic acid reduced the risk of disease progression and improved survival in patients with multiple myeloma, a cancer of the bone marrow.
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Voraciousreader: No - and that's the confusing thing and where we all need clarification.
How many of you here are taking Zometa MORE than 1/six months? I take it according to the Austrian protocol: 1/6 months, 4mgs per infusion. I know that Stage IV people take it every few weeks and that is how women in the AZURE study take it.
Edited to delete part of post while I double-check some facts.
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1Athena1 -- This is what is confusing with emphasis on the words "or other treatment." This is why I love evidence based medicine. Can't they narrowly define their trial subjects??!
"But the new study contradicts those findings. This study involved 3,360 patients, mainly in Britain, who had their breast tumors removed by surgery and underwent whatever chemotherapy or other treatment their physicians chose to prevent recurrence. Half the patients also received intravenous infusions of zoledronic acid for five years."
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Voracious - I just found this blog entry which gives details of how the study was conducted and has tables of characteristicws of patients in the study and control groups. It seems to be authoritative, so I am believing it. :-) The tables are from the University of Sheffield, where the study was conducted. I cannot cut and paste any portion of it, unfortunately.
But you will see that it was a very diverse group of patients - with and without chemo, endocrine therapy, and some being er-negative. The Austrian study had women on ovarian ablation and Tamoxifen.
The two studies are hard to compare. Re. the AZURE study, in the chemo group, some had anthracyclines, some had the taxanes, some had neoadjuvant. some not, etc.... I haven't seen any information about whether there is a difference for those who did chemo versus those who didn't.
Very frustrating.
However, the fact that the study was partly financed by Novartis and that, following these findings, Novartis has withdrawn its application for approval of Zometa for the porevention of recurrence says a lot.
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Thanks for following up 1Athena!....
That was EXACTLY my thoughts when I read the study last night.
I also noticed someone started a thread on the AIs...that they're causing an increase in heart issues. Saw that one too, last night! Didn't sleep well. My game plan was to switch to an AI...but my father died young of a heart attack, so genetically speaking, if I survive BC, I hope a heart attack doesn't kill me.
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Oh, man! At this point, I'm ready to do a rain dance and sacrifice sheep!
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Hmmm...very interesting. I'll be meeting with my oncologist next week for a follow-up. I am pre-menopausal (I think, it's kind of an open question as my ovaries can't decide what they want to do), 40 years old, had Stage 3b IDC, and my doctor started me on Zometa every 6 months last Fall 2009. He said I would get it every 6 months for the rest of my life.
I'm now wondering if he will change his mind based on these results? He is at this conference, so we'll see what he says.
Alaina
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Sherri, I would definitely take this study to your onc. It's not definitive, but things look better for postmenpausal women here. I'm no expert, but IF the speculation is that in a landscape of little or no estrogen Zometa has a chance to show benefit, then it might be a good option.
You would also want to ask you onc about dosing, though. I'm not clear why, in the study, they gave Zometa so frequently....I get it once every six months.
More will be coming out soon, I'm sure....I don't know if the study had anything to say re: bone density.
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The following link says a bit more about the differences in the Austrian study and the AZURE study (the one now in question). In the Austrian study, which only tested stage I and II women, no mention is made of chemotherapy. I can't figure out if that is because the women studied in the Austrian group didn't do chemo or because it wasn't a variable examined.
(Note: DSF = Disease Free Survival - which is different from OS or Overall Survival):
Commenting on the results (OF THE AZURE STUDY), Sharon Giordano, MD, of the University of Texas MD Anderson Cancer Center in Houston, said the outcome difference by menopausal status is intriguing but not definitive.
"Routine adjuvant use of zoledronic acid to prevent recurrence is not indicated," said Giordano.
"Bisphosphonates continue to have an important role in treating bone loss among women with breast cancer," she added.
The results differed substantially from those of the Austrian Breast Cancer Study Group (ABCSG) XII trial, which showed a 36% improvement in the hazard for DFS after 48 months (N Engl J Med 2009; 360: 679-691). After an additional 14 months of follow-up, adjuvant endocrine therapy plus zoledronic acid maintained a significant advantage over endocrine therapy alone, Michael Gnant, MD, of Medical University of Vienna, reported at the news briefing.
That trial involved 1,808 premenopausal women with stage I/II breast cancer. Following surgery, the patients were randomized to adjuvant hormonal therapy alone or with zoledronic acid. The primary endpoint was DFS.
After a median follow-up of 62 months, 76 qualifying events had occurred in the zoledronic acid arm compared with 119 events in the patients randomized to endocrine therapy alone. The difference translated into a 32% reduction in the hazard in favor of zoledronic acid (HR 0.68, P=0.008).
Analysis of overall survival demonstrated a trend in favor of the zoledronic acid arm (HR 0.67, P=0.143).
"Adding zoledronic acid to endocrine therapy for three years produced durable disease-free survival benefits and a strong trend towards improved overall survival," said Gnant."
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Yes that was the paragraph I got hooked on plus the fact that the company is now pulling out of future testing. I went into chemo peri-menopausal but I have yet to have a period since I started. Doesn't sound like Zometa will do more than stop my bones from becoming full blow osteoporosis. I will be interested in what my onc decides now.
So when is the dance/sacrifice happening?
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Hi everyone!.. I just have some question..I just had my SNB and re-incission last Nov. 18th..Have a little sore still once in awhile..My oncologist requested me to see the radiation oncologist for the radiation which i have and she(radiation onc) requested for another mamogram..I am a little bit apprehensive about the mamo because it is only less than a month that i had my surgery..I am trying to contact my BS but i couldn't because he is doing some surgery at this moment..They already scheduled me for monday because they know that i will be have a CAT scans so they want me to do at the same time while i will be there..I don't know if it would be right to do it or i need to wait and give some time to heal..Does anyone have the same situation like mine i would appreciate any advice..Thanks!..
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((((Sherri)))) Wish you could join three of us for lunch in the DC area today to drown our sorrows in alcohol - that's what you get when you stay away from us East Coast liberals - you miss a good meal!
Good to know about "time of study" benchmarks. That was the one answer I couldn't give you.
Actually for the rest of us to clarify:
1) Novartis is withdrawing its request for approval of Zometa as a recurrence preventor in early stage women with breast cancer pending further analysis of the study data. So this does not mean it is gone for good.
2) Zometa is already approved and routinely used for metastatic bc and nothing in this study changes that.
3) This study does not necessarily negate the validity of the Austrian study - at least until further notice. It merely indicates that Zometa should not be routinely used for early stage bc treatment. What we have is a very perplexing situation. Both studies were well designed and they are not the same in their design.
I just have one request for any and all: If anyone on BCO says that cancer treatment is a "crap shoot" and that statistics are "meaningless" please don't dismiss what they are saying. They are not completely right, but they are 90 percent right, and damned closer to the truth than those who say "there is no crap shoot and statistics rule."
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Spoke to my oncologist's physician assistant at 9 AM. She looked over the info and called my onco at the conference. She called back at 10:30 and told me that the doctor said NOT to come in on Monday for the Zometa infusion. She said that there were going to be additional meetings and discussions this afternoon on the subject. She also said that once the oncologist returns and has a chance to look at the data further, she will contact me.
So, bottom line, holding pattern for now.
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Has anyone been told to stop the Zometa clinical trial?
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Experts disagree on why the new results differ from those of the 2009 study.
Some scientists suspect it's because the patient groups and treatments were slightly different. Women in the Austrian trial had an earlier-stage disease than those in the AZURE trial, and most did not undergo chemotherapy, unlike the patients in the AZURE study.
In addition, the women in the Austrian study received drugs to stop estrogen production and put them into menopause. The level of estrogen in bones could affect how well bisphosphonates work to prevent cancer recurrence, said the lead author of the AZURE study, Dr. Robert Coleman, professor of medical oncology at the University of Sheffield in England.
"We need to understand why" the two studies differed, Coleman said. "I don't believe one is right and one is wrong."
shari.roan@latimes.com Register with The Baltimore Sun and receive free newsletters and alerts >>Copyright © 2010, Los Angeles Times
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I'm posting a great link that appeared on the Stage III thread and that anyone interested in this should go to. It has an audio of the press conference discussing the results:
This recording is a discussion of the AZURE findings but also talks about differences and similarities with the Austrian study and hypotheses about why there were different findings.
--In the Austrian study, Gnant, the lead investigator there, said that NO women were given chemotherapy (I wasn't 100 percent sure of that before). In AZURE, most women got it and the study wasn't even controlling for that. Women could choose any of the usual treatments so long as they had no prior history of bisphosphonate use. I wonder if chemo is the elephant in the room. Could the chemo have interfered with the Zometa? That's an unanswered question.
--All women in the Austrian study were premenopausal but on Goserelin; the AZURE study, as we know, had a diversity.
--I thought the discussion at the press conference was interesting about what it means to be post menopausal. The reason why those with most benefit from Zometa in the AZURE trial were at least five years out from menopause is because estradiol levels take years to really dip, so the estrogen environment may be different five years out than at immediate menopause. That is the hypothesis discussed by Coleman, the lead researcher in AZURE, that to me is most significant. There was hypothesizing that true menopause may have to be redefined. This says to me that IF this hypothesis is correct, the goserelin-treated women of the Austrian study, with induced menopause and only a total of three years out, may have had a more pre-menopausal looking environment in their bodies.
--Most of the women in the Austrian study were stage I and the rest were stage II. In AZURE, the patients were stage II/III.
Note also that at the press conference it was revealed that the Austrian study continued to show a strong protective effect for Zometa for its patients, both in terms of disease free survival and overall survival, in 5 year follow-up findings.
As someone who did not do chemo, I am feeling a bit better about this today than I did yesterday.
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I'm really looking forward to hearing what my oncologist has to say this week...once he gets an opportunity to digest all of the information. My niece is also an oncologist and was very enthusiastic about me taking it.
I agree with you 1Athena! that there were so many more variables in the AZURE study that I can't see how they were able to compare it with the Gnant results. I fit the profile perfectly according to the Gnant trial. I took a course in statistics while in college. In retrospect, it probably was the most important class I ever took! I really want to go over the evidence carefully with my doctor.
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Same Here!
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One more thing, 1Athena1 -- When I spoke with the PA yesterday, the issue of who is menopausal was EXACTLY what I questioned her about. Both of us agreed there really has to be a better definition for clinical purposes and design study. Because I'm taking Lupron, I wanted to know if I was truly menopausal in the clinical definition. I'm glad it was discussed at the symposium because I told her that every time I read a study, it refers to pre or post menopausal as women being below 50 or after 50. Now that they are questioning 5 years "post" menopausal, we really have to be very concrete in the design of studies as well as extropolating from meta-analysis. Very confusing. But I'm glad it was addressed yesterday.
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Really confusing for someone like me who was perimenapausal but hasn't had a period since 2 week before chemo and turns 50 at the beginning of February.
Talk about being right in the middle!
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Voracious - at this point I, personally, am tipping towards staying on Zometa for now. The only issue may be the insurance.
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