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Moffitt goes out on a limb suggesting benefits of non-standard treatment for early stage breast cancer

Radiation prior to surgery reduces risk of secondary tumors in early-stage breast cancer

Our Review Summary

breast cancerThis news release from the Moffitt Cancer Center promotes pre-surgury radiation for early breast cancer patients — a non-standard approach to treating patients with this type of cancer. The study the release is based on drew data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program, a national registry that’s been collecting data on cancer cases nationwide since the 1970s.

We like how the release clearly summarized the source of the data — a very large database of cancer cases spanning several decades.

But it’s important to keep in mind that the evidence supporting the treatment approach comes from a retrospective study, not randomized controlled clinical trials, and that point could have been made earlier. The SEER database didn’t capture why some early stage breast cancer patients were treated with pre-surgical — or neoadjuvant — radiation therapy but the release speculates that it was to reduce the size of the tumor before surgery. This treatment strategy also hasn’t been shown to improve survival as stated in the subhead; a randomized clinical trial that follows patients over a period of time is required to study survival outcomes.

 

Why This Matters

Breast cancer patients are hit with a barrage of decisions when the cancer is diagnosed. With radiotherapy, as with other therapies, quality evidence well-explained helps both doctor and patient make the best treatment plan possible.

Readers should keep in mind that while the release calls the study results “promising” it also states that randomized clinical trials are needed to confirm the benefit of pre-surgical radiation therapy for early-stage breast cancer.

Criteria

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

Not Satisfactory

The costs of neoadjuvant radiotherapy vs. postoperative-adjuvant radiotherapy were not discussed.

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

Not Satisfactory

The release doesn’t provide any numbers to support the benefit claims. It states, “Researchers discovered that among the breast cancer patients who tested positive for the estrogen receptor (ER) biomarker, patients who had neoadjuvant radiation therapy had a significantly lower risk of developing a second primary tumor than patients who had adjuvant radiation therapy.”

How much lower was the risk? Some absolute risk numbers should have been included here. They were available in the published study.

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

Not Satisfactory

There is no comment in the release about potential harms, although the study itself addressed the potential negative impact on healing.

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

Satisfactory

The release did a good job describing the database, some terminology, patient demographics, and some of the study limitations. It also includes some caution in the closing paragraph: “These data are promising, but randomized clinical trials are needed to confirm the benefit of neoadjuvant radiation therapy.”

However, while the news release is clear that the study was based on the SEER database, the opening sentence of the release notes that the Moffitt Cancer Center “launched a first of its kind study.” To a patient or lay person not familiar with the difference between a prospective randomized clinical trial and a retrospective database review (which this was), this could give the impression that the technique of utilizing radiation therapy prior to surgery was actually being performed and studied at Moffitt. Rather, what the researchers did was analyze a large database of patients who were diagnosed between 1973-2011 across the United States. That is explained in the third paragraph but it may not be enough to offset the false impression created earlier in the release that this was a contemporary study of patients recently treated at Moffitt.

Does the news release commit disease-mongering?

Satisfactory

There was no disease mongering noted.

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

Satisfactory

Funding sources were noted and do not appear to be a conflict of interest.

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

Not Satisfactory

The release briefly referenced chemotherapy and endocrine therapy as alternatives to pre- and post-surgical radiation but offered no comparison data.

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

Satisfactory

The evidence comes from the SEER database which has been collecting data on cancer incidence for several decades, indicating that the treatment has been performed. However, the authors clearly state a need for further clinical trials to validate their hypotheses that pre-surgical radiation is a good option.

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

Satisfactory

The release alludes to “a growing body of literature” that suggests radiotherapy may trigger an immune response that suppresses future tumor growth and that this study supports that view.

But when the release claims novelty in its description of “a first of its kind study” that’s misleading. It was not a controlled trial but a review of information captured in a database. This should have been spelled out clearly early on to avoid confusion.

Total Score: 6 of 10 Satisfactory

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