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Read Original Release

Modest improvement after major treatment touted as ‘reduced risk of dying’ in women with low-threat DCIS

Rating

3 Star

Association of radiation therapy plus lumpectomy in reduced risk of dying in women with DCIS

Our Review Summary

This news release summarizes an association study comparing 140,000 women with a diagnosis of ductal carcinoma in situ (DCIS) who received three different treatments. The study utilized the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program database to evaluate outcomes. DCIS is a noninvasive form of breast cancer, sometimes referred to as stage 0 breast cancer. There is debate as to whether it should be called cancer at all. The study reported outcomes in three groups of patients:  1) patients who underwent lumpectomy (surgery to remove the tumor) plus radiation versus lumpectomy alone; 2) patients who underwent lumpectomy without radiation versus mastectomy (surgery to remove the breast); and 3) patients who underwent lumpectomy plus radiation versus mastectomy.  Women who received radiation had a slightly lower (0.27% reduction) risk of death from breast cancer at 15 years compared to women with lumpectomy alone.

The release mentions some limitations of the research but missing is a broader discussion of the potential for over treatment of DCIS, whether DCIS needs to be treated at all, and whether women with low-risk forms of the disease can be safely monitored without treatment. We’ve written about this previously.

 

Why This Matters

Over treatment is a widely discussed issue in many areas of cancer, including DCIS, a noninvasive early form of breast cancer that some physicians believe should not be strictly labeled “cancer,” primarily when it’s low grade, or grade 1 DCIS. Exposing women to radiation in addition to lumpectomy has the potential for unnecessary harms. This brief release does not provide that context. The published study itself includes this comment: “It is doubtful whether a benefit of this size is large enough to warrant radiotherapy.”

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The release does not include any cost information.

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

Satisfactory

The summary gives an absolute risk reduction percentage of 0.27% for patients who received radiation compared to those who did not. It also includes the number needed to treat (370) to save one patient. This is good detail, but we would also have liked more context on the controversies of DCIS treatment. A HealthNewsReview.org podcast provides a deeper look here.

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

The release briefly discusses harms. The release says patients who received radiation and lumpectomy had more “local” recurrences of the cancer, but their overall survival was modestly better than patients who did not have radiation (a 0.27% reduction over 15 years).

The release should have given some mention to the harms of radiation treatment, particularly since the potential benefit of radiotherapy was very small.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

The release provides details on the association study, which reviewed records from thousands of patients. The release also includes limitations of the study.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering. The release provides context on the prevalence of DCIS in the U.S.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The style of this news release was to punt the question of funders and “conflicts” into a web link where the reader has to chase it down. It would better serve readers to have funders and any conflicts of interest spelled out in the release.

Here is what the release states:

Editor’s Note: The article contains conflict of interest disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

The study notes that researchers received funding from Canadian government agencies.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The release let readers down in providing the broader context about controversies over appropriate treatment — if any — for women diagnosed with DCIS.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Applicable

It’s common knowledge that radiation and surgery are widely available treatments.

Does the news release establish the true novelty of the approach?

Not Applicable

There was no claim of novelty. The release stated that results are based on an association study of a national database containing more than 140,000 patient records. It’s unclear if similar studies have been completed.

Total Score: 5 of 8 Satisfactory

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