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Bone Drug Zometa Flops Overall as Breast Cancer Treatment


5 Star


Bone Drug Zometa Flops Overall as Breast Cancer Treatment

Our Review Summary

This story offered a solid, informative overview of a randomized controlled trial called AZURE—which assessed the benefits and risks of zoledronic acid as a treatment for early stage breast cancer. Its clarity, and cautious interpretation of this clinical trial, make it stand out in comparison with the other story we reviewed on this topic. The story accurately described the main conclusions of the study and did not oversell the promise of a subgroup analysis showing that zoledronic acid might give post-menopausal women a survival advantage. The story pointed out specific adverse events, including bone disease in the jaws of some women in the trial.It pointed out financial support from the pharmaceutical company that sells the drug being studied. The article wasn’t perfect. It didn’t explain the regulatory status of zoledronic acid for women with early breast cancer.  It expressed the survival advantage of the subgroup of post-menopausal women in relative rather than absolute terms. But then so did the study summary provided by the drug company which sponsored the trial.


Journalists have limited access to study information at meeting presentations. And the author of the Healthday article was careful to point out that the results of AZURE should be regarded as preliminary.


Why This Matters

Zoledronic acid and other bone-density enhancing bisphosphonates have been employed as treatments for osteoporosis and to prevent skeletal complications among women with metastatic breast cancer. However, their role in the prevention of recurrence among women with early stage breast cancer isn’t clear.


Animal studies suggest that bisphosphonates may have direct anti-tumor effects in bone. Proponents of zoledronic acid believe it may provide a significant advantage for women with early stage breast cancer—in terms of recurrence and survival. But the results of studies in humans have been contradictory.


A large randomized controlled trial from Austria (the ABCSG-12 trial) published in 2009 suggested that the addition of three years of zoledronic acid to hormonal therapy following surgery for early stage breast cancer provided a 32% advantage in disease-free survival, compared to subjects who did not receive this drug. All the women in the ABCSG-12 trial had chemically induced menopause.


The AZURE trial attempted to confirm the benefits of zoledronic acid in a different study population, one that included both premenopausal and postmenopausal women with early stage breast cancer.


AZURE and other trials are important not only to assess any benefits of zoledronic acid but also to study its adverse effects—which include the potentially devastating side-effect of osteonecrosis of the jaw bone.


Does the story adequately discuss the costs of the intervention?


We won’t require a discussion of costs in this story because the use of zoledronic acid for early stage breast cancer is still up in the air. However, since the drug is already being sold for other indications, the story would have been better if it had told readers something about the costs of using the drug for approved indications.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?


The article accurately framed the only potential benefit documented by the AZURE study: that it might provide a recurrence and survival advantage among a subgroup of post-menopausal women… and that this results is something to be studied further.

Does the story adequately explain/quantify the harms of the intervention?


The article accurately reported on the incidence of a serious side effect among the women taking zoledronic acid.

Does the story seem to grasp the quality of the evidence?


The article accurately characterized the main conclusions of the study and the results of a secondary subgroup analysis. It also told readers that an earlier trial reached a different conclusion and that other studies are underway, thus helping make clear that these results are just part of a larger picture. The story emphasized—through the quote of an independent expert—that the subgroup analysis indicating older women with early stage breast cancer might get some benefit should lead to further research rather than changing standard practice now.

Does the story commit disease-mongering?


There was no hint of disease-mongering in this article.

Does the story use independent sources and identify conflicts of interest?


The article quoted an independent source. It also addressed conflicts-of-interest among the researchers.

Does the story compare the new approach with existing alternatives?


The story did point out that the women in this trial did receive standard therapy (and it did so more clearly than the other story we reviewed), though it did not specifically say what that treatment entails. We will give the story a satisfactory rating since it is not clear that there is a proven alternative that would provide the type of recurrence and survival benefits seen in a previous study of zoledronic acid for early stage breast cancer.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The article did not make it clear that the FDA has not yet approved zoledronic acid as adjunctive treatment for women with early breast cancer.


Does the story establish the true novelty of the approach?


The article made it clear that zoledronic acid is already in use for other applications.

Does the story appear to rely solely or largely on a news release?


The article did not appear to be overly reliant on a news release.

Total Score: 9 of 10 Satisfactory


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