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Drug OK’d to Fight Breast Cancer Relapse


4 Star

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.


Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Cost of treatment not mentioned.

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


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.

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

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.

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

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.

Does the story commit disease-mongering?


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.

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


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


Does the story compare the new approach with existing alternatives?


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.

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


Story about FDA approval for women with early-stage invasive disease.

Does the story establish the true novelty of the approach?


Discusses how drug is already

in use for women with advanced breast cancer.

Total Score: 7 of 10 Satisfactory


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