Drug OK’d to Fight Breast Cancer Relapse
Reviewed By
Rating
Drug OK’d to Fight Breast Cancer Relapse
Our Review Summary
This story summarized some of the findings from a recent New England Journal of Medicine article on the BIG I-98 Trial, which randomized approximately 8,000 women to either letrozole or tamoxifen for 5 years. The outcome of this study and similar large-scale, randomized double-blind trials have shown that aromatase inhibitors are effective in reducing rates of breast cancer recurrence in post-menopausal women with estrogen receptor positive tumors. However, there is not enough emphasis here that this is only for post menopausal women with invasive disease — e.g. last quote citing 800,000 women assumes all ER/PR positive women are eligible.The FDA has approved two aromatase inhibitors, Letrozole and Arimidex, for early-stage breast cancer. While this story provides a decent overview of how these medications work and the findings on which the new FDA approval is based, there is little information on some of the potentially serious side effects noted in the women who look letrozole. These side effects include an increase in cholesterol levels and cardiovascular disease, as well as a significant increase in the risk of bone fractures. There are no quantitative 5-year estimates of these side effects, nor is there a quantitative comparison with the Tamoxifen group, though the safety of each drug is briefly mentioned. Additionally, there is no mention of the cost of either drug. Since hormonal drug regimens (i.e. tamoxifen alone, aromatase inhibitors alone or aromatase inhibitors following a course of tamoxifen) might be prescribed for 5 years or more, a cost comparison would be important. It’s good that the story points out that the study is funded by pharmaceutical money and that some of the researchers own stock in Novartis. An independent source from the National Cancer Institute is quoted for balance, presumably with no ties to pharmaceutical funding.
Criteria
Not Satisfactory
Cost of treatment not mentioned.
Satisfactory
5-year estimated outcomes were given after only 2 years of data. No quantitative data on safety presented. Absolute numbers
provided. Limited long term data and small absolute benefit are key issues here.
Not Satisfactory
Does not mention the increase in
cholesterol and cardiovascular disease among the women in the aromatase inhibitor group. Tamoxifen may have a positive,
cholesterol-lowering effect, which is also not mentioned.
Not Satisfactory
Study design not adequately discussed. It didn’t really describe
that some of the data were likely gathered on women with more advanced disease where the benefits would be bigger.
Satisfactory
Gives estimates of women diagnosed with this type of breast cancer. Perhaps not enough
emphasis that this is only for post menopausal women with invasive disease — e.g. last line in story assumes all estrogen
receptor/progesterone receptor positive women are eligible.
Satisfactory
Journalist notes that the study was
funded by Novartis, maker of Femara, and that many of the researchers own stock in this company or in companies for rival
drugs.
Satisfactory
Mentions other
adjuvant drug treatment, tamoxifen, as well as some side effects of both of the aromatase inhibitor drugs (Femara and
Arimide) studied as well as Tamoxifen.
Satisfactory
Story about FDA approval for women with early-stage invasive disease.
Satisfactory
Discusses how drug is already
in use for women with advanced breast cancer.
Total Score: 7 of 10 Satisfactory
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