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.
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.
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.
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.
The article accurately reported on the incidence of a serious side effect among the women taking zoledronic acid.
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.
There was no hint of disease-mongering in this article.
The article quoted an independent source. It also addressed conflicts-of-interest among the researchers.
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.
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.
The article made it clear that zoledronic acid is already in use for other applications.
The article did not appear to be overly reliant on a news release.
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like