Everolimus: The New Miracle Breast Cancer Drug?

by Gwen on February 10, 2012

© 2012 Carl H. Stritter All rights reserved.


Please see my original post on everolimus here

Today, the prestigous New England Journal of Medicine published results of the eagerly anticipated BOLERO 2 clinical trial[1]. It showed that adding everolimus (brand name Afinitor) to exemestane (brand name Aromasin, an aromatase inhibitor) greatly improved outcomes for women with metastatic and advanced hormone-positive (ER+ and/or PR+) breast cancer.

A couple of red flags immediately popped up for me though. First, there was a discrepancy between what the independent (“central”) radiologists reported and what the radiologists on the research team reported. There was a whopping increase of 7 months in the progression-free survival (PFS) period for those who added everolimus according to the independent radiologists. Contrast this with a much more modest increase of 4 months reported by the local researchers. Usually you see the opposite, with the researchers giving more glowing reports than independent reviewers. When this paper was presented at the San Antonio Breast Cancer Symposium in December 2011, I fully expected one of the esteemed professors in the audience to ask about this unusual disagreement but amazingly, no one did so.

That discrepancy and the fact that this research was funded by the company that manufactures everolimus (Novartis), make me a little leery of this report’s findings. It took me a while to chase down the authors’ conflicts of interest and, not surprisingly, there were lots.

Only 6 of the 21 authors did not have a financial relationship of some sort with Novartis. 5 of the authors are Novartis employees and own stock in the company. The other 10 were consultants, authored presentations, received travel and accommodations to medical conferences such as the SABCS and/or received grants from Novartis. Dr. Baselga, the lead author is a Novartis board member. Needless to say, I would love to see an independent research team corroborate this group’s findings.

The report also identified adverse effects of the everolimus/exemestane combination: mouth sores (stomatatis), rash, and diarrhea were the most common (less than 15% risk of each). Fortunately, life-threatening (grade 4) reactions were rare (~1%) .

Based on the symposium presentation, many hormone-positive metastatic breast cancer patients have been very interested in trying this combination. However, to date no oncologist has been comfortable doing so since there wasn’t even a report in a peer-reviewed journal to bolster their argument.

That changed with publication of this research paper. Right on cue, I recently found out that an oncologist (this one is at a highly respected academic breast oncology department) has prescribed everolimus. Of course, the insurance company denied coverage. Now I am helping the patient strategize an appeal for this very expensive drug (approximately $9,000/month!). If our strategy works, I will post it on this blog, so stay tuned…

Bottom line: the BOLERO 2 report, red flags not withstanding, suggests that adding everolimus to exemestane improves outcome for those with metastatic breast cancer. Of note, there is gathering clinical data that suggests everolimus is likely to similarly improve outcomes when combined with other anti-estrogen therapies. If I had advanced or metastatic ER+ or PR+ breast cancer, I would certainly discuss this report with my oncologist.

Please see references below.

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*Information on the Breast Equity blog is provided on an “as is” basis for general information only. It is not intended as medical advice and should not be relied upon as a substitute for consultation with a qualified health professional.*

© 2012 Gwendolyn M Stritter, MD. All rights reserved.



© 2012, Gwen. All rights reserved.

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