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Read Original Story

Bone drug cuts risk of breast cancer

Rating

2 Star

Bone drug cuts risk of breast cancer

Our Review Summary

This article presents the preliminary results from STAR, a large clinical trial comparing tamoxifen and raloxifene in postmenopausal women at increased risk of breast cancer. The study found comparable reduction in breast cancer risk. While the article reported that for the women taking raloxifene, the incidence of uterine cancer, blood clots, and cataracts were less than the women taking tamoxifen, only the difference in cataract was statically significant. This oversight is major as the incidence of uterine cancer and blood clots may be among the factors a woman considers when deciding which, if either breast cancer risk treatment option, is right for her. The other big omission is that the comparability in breast cancer reduction is only for invasive breast cancer; tamoxifen reduced the risk of less aggressive breast cancer (i.e. ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS) while raloxifene did not. If the risks for all breast cancer events had been compared, the reported outcome of the study may have differed.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

No mention of the costs of either tamoxifen or raloxifene was made.

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

Not Satisfactory

Failure to mention the lack of statistical significance for the incidence of uterine cancers and blood clots for women at increased risk of breast cancer taking raloxifene as compared with those taking tamoxifen is an important lack of framework. The story didn’t describe how well either drug prevents breast cancer (i.e. how many would have developed it and how many were prevented from developing it because of treatment. In addition, the reported impact on the quality of life was the same for the two treatments.

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

Not Satisfactory

The increased incidence of other, less-invasive forms of breast cancer (ductal carcinoma in situ and lobular carcinoma in situ) was not mentioned. The absolute number of cases for the side effects was not presented.

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

Not Satisfactory

The article discussed some recently released data from a large clinical trial comparing tamoxifen and raloxifene in postmenopausal women considered to be at increased risk of breast cancer. Though the study found that the reduction in invasive breast cancer was the same for the two drugs, the article failed to distinguish between differences in side effects that were and were not statistically significant (i.e. that there were 36% fewer uterine cancers and 29% fewer blood clots among women who took raloxifene were not statistically significant while the 21% fewer cataracts were statistically significant). As the purported benefit of raloxifene over tamoxifen is about the prevalence of side effects, this distinction is important.

Does the story commit disease-mongering?

Not Satisfactory

While it was noted within the story that the average five-year breast cancer risk for the women in the study was 3.4%, the overall tone of the article was one of disease mongering. One quoted expert (chairman for one of the studies) is quoted as saying that as many as 10 million postmenopausal women are at increased risk for breast cancer. Failure to present the absolute number of breast cancer cases and side effect cases in each study group serves to amplify concern about cancer risk.

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

Satisfactory

The results of this study , its analysis, and interpretation have not yet been peer reviewed or published. Two quotes, one from the executive director of Breast Cancer Action and a spokesperson from the American Cancer Society, contribute valuable cautionary interpretation for the rest of the material presented in the article.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The article mentioned tamoxifen, the only medication to date that has been approved by the FDA for reducing breast cancer risk in healthy women. However the article failed to mention that not doing anything, increased screening (such as more frequent mammograms, screening with MRI, ductal lavage) and prophylactic mastectomy are also options to decrease breast cancer risk.

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

Satisfactory

Although the article mentions that doctors could prescribe raloxifene for the purpose of reducing breast cancer risk, it is not yet approved by the FDA for this purpose and would therefore represent an off-label use of this medication.

Does the story establish the true novelty of the approach?

Satisfactory

The use of raloxifene as a medication to reduce breast cancer risk is new.

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

Not Applicable

We can’t be sure if the story relied solely or largely on a news release, although the story does appear to rely on information in the STAR study press release.

Total Score: 3 of 9 Satisfactory

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